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ANI Pharmaceuticals (NASDAQ:ANIP) Stock, Chaîne d'Options

ANI Pharmaceuticals

ANI Pharmaceuticals Inc develops, manufactures, and markets generic prescription pharmaceuticals. It manufactures liquid, powder, and oral solid dose products. Its areas of product development include narcotics, oncolytic, hormones and steroids, and complex formulations involving extended release and combination products. Some of its generic products include Erythromycin ethyl succinate, Esterified Estrogen with Methyltestosterone (EEMT), Etodolac Fenofibrate, Fluvoxamine, Hydrocortisone Enema and Vancomycin. Its geographical segments are the United States and Canada, of which the majority of its revenue comes from the United States.

ANI Pharmaceuticals Inc

HC Wainwright &amp; Co. analyst Oren Livnat reiterates ANI Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ANIP#NASDAQ">ANIP</a>) with a Buy and maintains $94 price target.

News

Price Target

Reiteration

Analyst Ratings

ANIP

HC Wainwright & Co. Reiterates Buy on ANI Pharmaceuticals, Maintains $94 Price Target

Earnings

Guidance

Health Care

General

ANI Pharmaceuticals Expects 2024 Adjusted EPS Of $4.90-$5.05 Versus Prior Guidance Of $4.38-$4.82 Versus Consensus Of $4.72

Revised Full Year 2024 Guidance:
The Company is updating its full year 2024 guidance for the combined organization, which includes the anticipated results of Alimera from September 16, 2024.
<figure class="table"> 
<table>
<tbody>
<tr>
<td>Revised Full Year 2024 Guidance</td>
<td>Prior Full Year 2024 Guidance</td>
<td colspan="2">2023 Actual</td>
<td>Growth</td>
<td>&nbsp;</td>
</tr>
<tr>
<td>Net Revenue (Total Company)</td>
<td>$594 million - $602 million</td>
<td>$540 million - $560 million</td>
<td colspan="2">$486.8 million</td>
<td>22% - 24%</td>
</tr>
<tr>
<td>Cortrophin Gel Net Revenue</td>
<td>$196 million - $200 million</td>
<td>$185 million - $195 million</td>
<td colspan="2">$112.1 million</td>
<td>75% - 78%</td>
</tr>
<tr>
<td>ILUVIEN and YUTIQ Net Revenue</td>
<td>$30 million - $32 million</td>
<td>NA</td>
<td colspan="2">NA</td>
<td>NA</td>
</tr>
<tr>
<td>Adjusted Non-GAAP EBITDA</td>
<td>$149 million - $153 million</td>
<td>$140 million - $150 million</td>
<td colspan="2">$133.8 million</td>
<td>11% - 14%</td>
</tr>
<tr>
<td>Adjusted Non-GAAP Diluted EPS</td>
<td>$4.90 - $5.05</td>
<td>$4.38 - $4.82</td>
<td colspan="2">$4.71</td>
<td>4% - 7%</td>
</tr>
</tbody>
</table>
</figure>
ANI now expects total company adjusted non-GAAP gross margin to be at the high end of our previously communicated range of 61% to 62%. The Company will continue to tax effect non-GAAP adjustments for computation of adjusted non-GAAP diluted earnings per share at a tax rate of 26.0%, unless the item being adjusted is not tax deductible in whole or in part.
The Company now anticipates approximately 19.7 million and 19.9 million shares outstanding for the purpose of calculating adjusted non-GAAP diluted EPS for full year 2024 and fourth quarter 2024, respectively. The Company now expects its annual U.S. GAAP effective tax rate to be in the mid-single digits as compared to our previous expectation of between 22% and 25%, driven by the non-deductible nature of certain expenses incurred in conjunction with the acquisition of Alimera (against an annual forecasted GAAP pre-tax loss).

ANI Pharmaceuticals Expects 2024 Revenues Of $594M-$602M Versus Prior Guidance Of $540M-$560M Versus Consensus Of $590.315M

ANI Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ANIP#NASDAQ">ANIP</a>) reported quarterly earnings of $1.34 per share which beat the analyst consensus estimate of $1.09 by 22.94 percent. This is a 5.51 percent increase over earnings of $1.27 per share from the same period last year. The company reported quarterly sales of $148.33 million which beat the analyst consensus estimate of $144.35 million by 2.76 percent. This is a 12.52 percent increase over sales of $131.83 million the same period last year.

ANI Pharmaceuticals Q3 2024 Adj EPS $1.34 Beats $1.09 Estimate, Sales $148.33M Beat $144.35M Estimate

ANI Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ANIP#NASDAQ">ANIP</a>) is preparing to release its quarterly earnings on Friday, 2024-11-08. Here's a brief overview of what investors should keep in mind before the announcement.
Analysts expect ANI Pharmaceuticals to report an earnings per share (EPS) of $1.07.
Anticipation surrounds ANI Pharmaceuticals's announcement, with investors hoping to hear about both surpassing estimates and receiving positive guidance for the next quarter.
New investors should understand that while earnings performance is important, market reactions are often driven by guidance.
<h3>Earnings History Snapshot</h3>
Last quarter the company beat EPS by $0.08, which was followed by a 9.92% drop in the share price the next day.
Here's a look at ANI Pharmaceuticals's past performance and the resulting price change:

<table>
<thead>
<tr>
<th>Quarter</th>
<th>Q2 2024</th>
<th>Q1 2024</th>
<th>Q4 2023</th>
<th>Q3 2023</th>
</tr>
</thead>
<tbody>
<tr>
<td>EPS Estimate</td>
<td>0.94</td>
<td>0.99</td>
<td>0.85</td>
<td>0.84</td>
</tr>
<tr>
<td>EPS Actual</td>
<td>1.02</td>
<td>1.21</td>
<td>1</td>
<td>1.27</td>
</tr>
<tr>
<td>Price Change %</td>
<td>-10.0%</td>
<td>3.0%</td>
<td>-1.0%</td>
<td>-4.0%</td>
</tr>
</tbody>
</table>

<img src="https://www.benzinga.com/files/images/story/2024/1731006258_0.png" alt="eps graph" />
<h3>ANI Pharmaceuticals Share Price Analysis</h3>
Shares of ANI Pharmaceuticals were trading at $58.4 as of November 06. Over the last 52-week period, shares are up 12.64%. Given that these returns are generally positive, long-term shareholders are likely bullish going into this earnings release. 
<h3>Analyst Observations about ANI Pharmaceuticals</h3>
For investors, staying informed about market sentiments and expectations in the industry is paramount. This analysis provides an exploration of the latest insights on ANI Pharmaceuticals.
Analysts have given ANI Pharmaceuticals a total of 5 ratings, with the consensus rating being Neutral. The average one-year price target is $73.4, indicating a potential 25.68% upside.
<h3>Comparing Ratings Among Industry Peers</h3>
The following analysis focuses on the analyst ratings and average 1-year price targets of Tilray Brands, Collegium Pharmaceutical and Evolus, three prominent industry players, providing insights into their relative performance expectations and market positioning.
<ul>
<li>For Tilray Brands, analysts project an Neutral trajectory, with an average 1-year price target of $1.75, indicating a potential 97.0% downside.</li>
<li>The consensus outlook from analysts is an Buy trajectory for Collegium Pharmaceutical, with an average 1-year price target of $41.5, indicating a potential 28.94% downside.</li>
<li>The consensus outlook from analysts is an Buy trajectory for Evolus, with an average 1-year price target of $24.6, indicating a potential 57.88% downside.</li>
</ul>
<h3>Snapshot: Peer Analysis</h3>
Within the peer analysis summary, vital metrics for Tilray Brands, Collegium Pharmaceutical and Evolus are presented, shedding light on their respective standings within the industry and offering valuable insights into their market positions and comparative performance.

<table>
<thead>
<tr>
<th>Company</th>
<th>Consensus</th>
<th>Revenue Growth</th>
<th>Gross Profit</th>
<th>Return on Equity</th>
</tr>
</thead>
<tbody>
<tr>
<td>ANI Pharmaceuticals</td>
<td>Neutral</td>
<td>18.44%</td>
<td>$80.34M</td>
<td>-0.59%</td>
</tr>
<tr>
<td>Tilray Brands</td>
<td>Neutral</td>
<td>13.05%</td>
<td>$59.71M</td>
<td>-1.13%</td>
</tr>
<tr>
<td>Collegium Pharmaceutical</td>
<td>Buy</td>
<td>7.18%</td>
<td>$90.81M</td>
<td>8.94%</td>
</tr>
<tr>
<td>Evolus</td>
<td>Buy</td>
<td>35.59%</td>
<td>$47.83M</td>
<td>-60.12%</td>
</tr>
</tbody>
</table>

Key Takeaway:
ANI Pharmaceuticals ranks in the middle for consensus rating among its peers. It is at the bottom for revenue growth. In terms of gross profit, it is at the top among its peers. However, for return on equity, it is at the bottom compared to its peers.
<h3>Discovering ANI Pharmaceuticals: A Closer Look</h3>
ANI Pharmaceuticals Inc develops, manufactures, and markets generic prescription pharmaceuticals. It manufactures liquid, powder, and oral solid dose products. Its areas of product development include narcotics, oncolytic, hormones and steroids, and complex formulations involving extended release and combination products. Some of its generic products include Erythromycin ethyl succinate, Esterified Estrogen with Methyltestosterone (EEMT), Etodolac Fenofibrate, Fluvoxamine, Hydrocortisone Enema and Vancomycin. Its geographical segments are the United States and Canada, of which the majority of its revenue comes from the United States.
<h3>A Deep Dive into ANI Pharmaceuticals's Financials</h3>
Market Capitalization Analysis: The company's market capitalization is below the industry average, suggesting that it is relatively smaller compared to peers. This could be due to various factors, including perceived growth potential or operational scale.
Revenue Growth: ANI Pharmaceuticals's remarkable performance in 3 months is evident. As of 30 June, 2024, the company achieved an impressive revenue growth rate of 18.44%. This signifies a substantial increase in the company's top-line earnings. As compared to competitors, the company encountered difficulties, with a growth rate lower than the average among peers in the Health Care sector.
Net Margin: The company's net margin is a standout performer, exceeding industry averages. With an impressive net margin of -1.95%, the company showcases strong profitability and effective cost control.
Return on Equity (ROE): ANI Pharmaceuticals's financial strength is reflected in its exceptional ROE, which exceeds industry averages. With a remarkable ROE of -0.59%, the company showcases efficient use of equity capital and strong financial health.
Return on Assets (ROA): ANI Pharmaceuticals's ROA excels beyond industry benchmarks, reaching -0.29%. This signifies efficient management of assets and strong financial health.
Debt Management: The company maintains a balanced debt approach with a debt-to-equity ratio below industry norms, standing at 0.63.
<a href="https://www.benzinga.com/quote/ANIP/earnings">To track all earnings releases for ANI Pharmaceuticals visit their earnings calendar on our site.</a>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

A Peek at ANI Pharmaceuticals's Future Earnings

ANI Pharmaceuticals Says Following Final Approval From The U.S. FDA For Its Abbreviated New Drug Application, The Company Launched Estradiol Gel, 0.06%, Which Is The Generic Version Of Reference Listed Drug Estrogel Gel, 0.06%

Ratings for ANI Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ANIP#NASDAQ">ANIP</a>) were provided by 6 analysts in the past three months, showcasing a mix of bullish and bearish perspectives.
The table below summarizes their recent ratings, showcasing the evolving sentiments within the past 30 days and comparing them to the preceding months.
<table>
<thead>
<tr>
<th></th>
<th align="right">Bullish</th>
<th align="right">Somewhat Bullish</th>
<th align="right">Indifferent</th>
<th align="right">Somewhat Bearish</th>
<th align="right">Bearish</th>
</tr>
</thead>
<tbody>
<tr>
<td>Total Ratings</td>
<td align="right">2</td>
<td align="right">2</td>
<td align="right">2</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
<tr>
<td>Last 30D</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">1</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
<tr>
<td>1M Ago</td>
<td align="right">0</td>
<td align="right">1</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
<tr>
<td>2M Ago</td>
<td align="right">1</td>
<td align="right">1</td>
<td align="right">1</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
<tr>
<td>3M Ago</td>
<td align="right">1</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
</tbody>
</table>
In the assessment of 12-month price targets, analysts unveil insights for ANI Pharmaceuticals, presenting an average target of $76.83, a high estimate of $94.00, and a low estimate of $60.00. A 6.08% drop is evident in the current average compared to the previous average price target of $81.80. 
<img src="https://www.benzinga.com/files/images/story/2024/1729627223_0_0.png" alt="price target chart" />
<h2>Diving into Analyst Ratings: An In-Depth Exploration</h2>
The analysis of recent analyst actions sheds light on the perception of ANI Pharmaceuticals by financial experts. The following summary presents key analysts, their recent evaluations, and adjustments to ratings and price targets.
<table>
<thead>
<tr>
<th>Analyst</th>
<th>Analyst Firm</th>
<th>Action Taken</th>
<th>Rating</th>
<th>Current Price Target</th>
<th>Prior Price Target</th>
</tr>
</thead>
<tbody>
<tr>
<td>Gregory Fraser</td>
<td>Truist Securities</td>
<td>Raises</td>
<td>Hold</td>
<td>$62.00</td>
<td>$60.00</td>
</tr>
<tr>
<td>David Amsellem</td>
<td>Piper Sandler</td>
<td>Announces</td>
<td>Overweight</td>
<td>$68.00</td>
<td>-</td>
</tr>
<tr>
<td>Elliot Wilbur</td>
<td>Raymond James</td>
<td>Raises</td>
<td>Outperform</td>
<td>$83.00</td>
<td>$81.00</td>
</tr>
<tr>
<td>Oren Livnat</td>
<td>HC Wainwright &amp; Co.</td>
<td>Maintains</td>
<td>Buy</td>
<td>$94.00</td>
<td>$94.00</td>
</tr>
<tr>
<td>Gregory Fraser</td>
<td>Truist Securities</td>
<td>Lowers</td>
<td>Hold</td>
<td>$60.00</td>
<td>$80.00</td>
</tr>
<tr>
<td>Oren Livnat</td>
<td>HC Wainwright &amp; Co.</td>
<td>Maintains</td>
<td>Buy</td>
<td>$94.00</td>
<td>$94.00</td>
</tr>
</tbody>
</table>
<h3>Key Insights:</h3>
<ul>
<li>Action Taken: In response to dynamic market conditions and company performance, analysts update their recommendations. Whether they 'Maintain', 'Raise', or 'Lower' their stance, it signifies their reaction to recent developments related to ANI Pharmaceuticals. This insight gives a snapshot of analysts' perspectives on the current state of the company.</li>
<li>Rating: Analyzing trends, analysts offer qualitative evaluations, ranging from 'Outperform' to 'Underperform'. These ratings convey expectations for the relative performance of ANI Pharmaceuticals compared to the broader market.</li>
<li>Price Targets: Analysts predict movements in price targets, offering estimates for ANI Pharmaceuticals's future value. Examining the current and prior targets offers insights into analysts' evolving expectations.</li>
</ul>
To gain a panoramic view of ANI Pharmaceuticals's market performance, explore these analyst evaluations alongside essential financial indicators. Stay informed and make judicious decisions using our Ratings Table.
<a href="https://www.benzinga.com/quote/ANIP/analyst-ratings?utm_source=Benzinga Insights">Stay up to date on ANI Pharmaceuticals analyst ratings.</a>
If you are interested in following small-cap stock news and performance <a href="https://www.benzinga.com/news/small-cap">you can start by tracking it here</a>.
<h2>All You Need to Know About ANI Pharmaceuticals</h2>
ANI Pharmaceuticals Inc develops, manufactures, and markets generic prescription pharmaceuticals. It manufactures liquid, powder, and oral solid dose products. Its areas of product development include narcotics, oncolytic, hormones and steroids, and complex formulations involving extended release and combination products. Some of its generic products include Erythromycin ethyl succinate, Esterified Estrogen with Methyltestosterone (EEMT), Etodolac Fenofibrate, Fluvoxamine, Hydrocortisone Enema and Vancomycin. Its geographical segments are the United States and Canada, of which the majority of its revenue comes from the United States.
<h3>ANI Pharmaceuticals: Delving into Financials</h3>
Market Capitalization Analysis: Falling below industry benchmarks, the company's market capitalization reflects a reduced size compared to peers. This positioning may be influenced by factors such as growth expectations or operational capacity.
Positive Revenue Trend: Examining ANI Pharmaceuticals's financials over 3 months reveals a positive narrative. The company achieved a noteworthy revenue growth rate of 18.44% as of 30 June, 2024, showcasing a substantial increase in top-line earnings. As compared to its peers, the revenue growth lags behind its industry peers. The company achieved a growth rate lower than the average among peers in Health Care sector.
Net Margin: ANI Pharmaceuticals's net margin is impressive, surpassing industry averages. With a net margin of -1.95%, the company demonstrates strong profitability and effective cost management.
Return on Equity (ROE): The company's ROE is a standout performer, exceeding industry averages. With an impressive ROE of -0.59%, the company showcases effective utilization of equity capital.
Return on Assets (ROA): ANI Pharmaceuticals's ROA surpasses industry standards, highlighting the company's exceptional financial performance. With an impressive -0.29% ROA, the company effectively utilizes its assets for optimal returns.
Debt Management: The company maintains a balanced debt approach with a debt-to-equity ratio below industry norms, standing at 0.63.
<h2>How Are Analyst Ratings Determined?</h2>
Experts in banking and financial systems, analysts specialize in reporting for specific stocks or defined sectors. Their comprehensive research involves attending company conference calls and meetings, analyzing financial statements, and engaging with insiders to generate what are known as analyst ratings for stocks. Typically, analysts assess and rate each stock once per quarter.
Some analysts publish their predictions for metrics such as growth estimates, earnings, and revenue to provide additional guidance with their ratings. When using analyst ratings, it is important to keep in mind that stock and sector analysts are also human and are only offering their opinions to investors.
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Critical Insights From ANI Pharmaceuticals Analyst Ratings: What You Need To Know

Truist Securities analyst Gregory Fraser maintains ANI Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ANIP#NASDAQ">ANIP</a>) with a Hold and raises the price target from $60 to $62.

Truist Securities Maintains Hold on ANI Pharmaceuticals, Raises Price Target to $62

Avadel Pharmaceuticals plc (NASDAQ:AVDL) announced that the FDA has approved its supplemental new drug application (sNDA) seeking label expansion of Lumryz.
The drug is now approved in the United States for the treatment of cataplexy or excessive daytime sleepiness (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/eds#NASDAQ">EDS</a>) in patients aged seven years and older with narcolepsy.
The company&#39;s shares rose 5.1% on the news.&nbsp;
The stock fell 1.4% year to date compared with the <a href="https://www.zacks.com/stocks/industry-rank/industry/medical-biomedical-and-genetics-105">industry</a>&#39;s 0.7% decline.
<img alt="Zacks Investment Research" src="https://staticx-tuner.zacks.com/images/articles/charts/97/81744.jpg?v=1324361988" style="height:245px; width:624px" /> 
Image Source: Zacks Investment Research
<h3>Label Expansion Of AVDL&#39;s Lumryz</h3>
Lumryz is a once-at-bedtime formulation extended-release sodium oxybate. It was first approved by the FDA on May 1, 2023, for the treatment of cataplexy or EDS in adult patients with narcolepsy.
Along with the approval, the FDA also granted seven years of orphan drug exclusivity to Lumryz for the treatment of cataplexy or EDS in adults with narcolepsy due to a finding of clinical superiority of Lumryz relative to currently available oxybate treatments.
Narcolepsy is a chronic neurological condition, wherein the brain&#39;s ability to regulate the sleep-wake cycle is impaired.
The latest FDA approval expands the drug&#39;s indication for younger narcolepsy patients.&nbsp; The drug was also granted orphan drug exclusivity in pediatric narcolepsy patients aged seven years and older through Oct. 16, 2031.
Pediatric patients (seven years and older) living with narcolepsy will now have the same opportunity that adult patients with narcolepsy have &mdash; to choose a once-nightly treatment option that does not disrupt sleep for a middle-of-the-night dose.
<h3>Lumryz Uptake Boosts AVDL</h3>
Avadel generated $41.5 million of net product revenues from the sales of Lumryz in the second quarter of 2024.
As of June 30, there were more than 1,900 patients on Lumryz compared to more than 1,400 as of March 31.
Pediatric patients currently represent approximately 5% of all oxybate-treated narcolepsy patients. Hence, the label expansion of the drug for this population should boost sales.
In addition, a phase III double-blind, placebo-controlled, randomized withdrawal, multicenter study is evaluating the efficacy and safety of Lumryz in idiopathic hypersomnia (IH).&nbsp; Enrollment is open to patients who are currently being treated with a twice-nightly oxybate and those not taking oxybates. The study, which is expected to enroll approximately 150 adults diagnosed with IH, includes an open-label extension portion.
<h3>AVDL&#39;s Rank &amp; Other Stocks To Consider</h3>
Avadel carries a Zacks Rank #3 (Hold) at present.&nbsp; Some other top-ranked stocks in the drug/biotech sector are Catalyst Pharmaceuticals CPRX, ANI Pharmaceuticals ANIP and
<a href="https://www.zacks.com/stock/news/2353213/avadel-obtains-fda-nod-for-label-expansion-of-narcolepsy-drug-lumryz?cid=CS-BENZ-FT-analyst_blog|company_news_medical_sector-2353213">To read this article on Zacks.com click here.</a>

Biotech

Small Cap

Trading Ideas

ALNY

CPRX

Avadel Obtains FDA Nod for Label Expansion Of Narcolepsy Drug Lumryz

Alnylam Pharmaceuticals&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/alny#NASDAQ">ALNY</a>) announced that it has submitted a Type II Variation to the&nbsp;European Medicines Agency for vutrisiran, an investigational RNAi therapeutic being developed to treat ATTR amyloidosis with cardiomyopathy (ATTR-CM). Shares of the company gained 4.6% in response to the encouraging news.
Please note that Alnylam already markets vutrisiran in the EU under the brand name Amvuttra for treating hereditary transthyretin-mediated (hATTR) amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy.
The application seeking approval for vutrisiran to treat ATTR-CM is supported by positive&nbsp;results from ALNY&#39;s pivotal phase III HELIOS-B study, which met all primary and secondary endpoints across both the overall and monotherapy populations, each with statistical significance.
Year to date, shares of Alnylam have gained 57% against the industry&#39;s 1% decline.
<img alt="Zacks Investment Research" src="https://staticx-tuner.zacks.com/images/articles/charts/42/81532.jpg?v=982164009" style="height:310px; width:600px" />
Image Source: Zacks Investment Research
Per the data readout, vutrisiran reduced mortality and cardiovascular events while improving functional capacity (measured by the six-minute walk test), quality of life (using the Kansas City Cardiomyopathy Questionnaire), and heart failure symptoms and severity (via New York Heart Association class) in ATTR-CM patients.
Additionally, the safety profile of vutrisiran in the HELIOS-B study was consistent with its known profile for treating hATTR amyloidosis with polyneuropathy in adults. In the late-stage study, the rates of adverse events, including those leading to discontinuation, were similar between the vutrisiran and placebo groups.
<h2>Amvuttra &ndash; The Key Growth Driver for Alnylam</h2>
Please note that Alnylam also markets Amvuttra, the company&#39;s lead drug, in the United States for the treatment of adult patients with polyneuropathy of&nbsp;hATTR amyloidosis. The drug&#39;s sales contribute significantly to ALNY&#39;s top line. Amvuttra generated sales worth $425.4 million in the first half of 2024, up 82% year over year on a reported basis. The encouraging uptake of the drug is driven by new patients starting treatment as well as patients switching from Onpattro. Onpattro is approved in the United States and EU to treat hATTR amyloidosis in adults.
We remind the investors that a supplemental new drug application for vutrisiran, seeking its label expansion to treat ATTR-CM is also currently under review in the United States. If the regulatory applications in the EU and the United States are approved, Alnylam believes that vutrisiran has the potential to become the new standard of care for the treatment of ATTR-CM. This will expand the eligible patient population for the drug driving substantial growth for the company in the future.
Other marketed products include Givlaari for acute hepatic porphyria and Oxlumo injection for subcutaneous use for the treatment of primary hyperoxaluria type 1 to lower urinary and plasma oxalate levels in pediatric and adult patients.
Alnylam also markets a fifth drug, Leqvio (inclisiran), in collaboration with Novartis (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/nvs#NYSE">NVS</a>) to treat hypercholesterolemia in the EU. In the United States, it is approved to reduce low-density lipoprotein cholesterol (LDL-C) with two doses per year. Per the agreement, Alnylam has granted Novartis exclusive and worldwide rights to manufacture and commercialize RNAi therapeutics targeting PCSK9 for treating hypercholesterolemia and other human diseases, including Leqvio. Novartis has also received FDA approval to expand Leqvio&#39;s label to include earlier use in patients with elevated LDL-C who have an increased risk of heart disease, as an adjunct to diet and statin therapy.
<div class="chart_embed">
<h3>Alnylam Pharmaceuticals, Inc. Price and Consensus</h3>
<img alt="Alnylam Pharmaceuticals, Inc. Price and Consensus" src="https://staticx-tuner.zacks.com/images/charts/cd/1729169675.png" style="height:310px; width:600px" title="" />
Alnylam Pharmaceuticals, Inc. price-consensus-chart | Alnylam Pharmaceuticals, Inc. Quote
</div>
<h2>ALNY&#39;s Zacks Rank and Other Stocks to Consider</h2>
Alnylam currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the biotech sector are&nbsp;ANI Pharmaceuticals (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/anip#NASDAQ">ANIP</a>) and Amicus Therapeutics (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/fold#NASDAQ">FOLD</a>). While ANIP sports a Zacks Rank #1 (Strong Buy), FOLD carries a Zacks Rank #2 at present.
In the past 60 days, estimates for ANI Pharmaceuticals&#39; 2024 earnings per share have moved up from $4.69 to $4.81. EPS estimates for 2025 have improved from $5.37 to $5.86, during the same period. Year to date, shares of ANIP have gained 8.2%.
ANI Pharmaceuticals&#39; earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for Amicus&#39; 2024 EPS have remained constant at 20 cents. EPS estimates for 2025 have increased from 48 cents to 50 cents, during the same period. Year to date, shares of FOLD have lost 26%.
Amicus&#39; earnings beat estimates in three of the four trailing four quarters, missing the mark once, with the average surprise being 23.96%.
<a href="https://www.zacks.com/stock/news/2352442/alnylam-stock-up-on-cardiomyopathy-drug-regulatory-filing-in-the-eu?cid=CS-BENZ-FT-analyst_blog|company_news_medical_sector-2352442">To read this article on Zacks.com click here.</a>

Earnings Beats

Large Cap

Mid Cap

Markets

FOLD

Alnylam Stock Up on Cardiomyopathy Drug Regulatory Filing in the EU

MeiraGTx Holdings&#39; (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mgtx#NASDAQ">MGTX</a>) clinical bridging study of its gene therapy candidate, AAV-GAD, for treating Parkinson&#39;s disease (PD) met&nbsp;its primary study objective of safety&nbsp;and tolerability. The stock soared 14.9% in response to the news.
<h2>MGTX&#39;s PD Gene Therapy Candidate Betters Sham Treatment</h2>
The MGT-GAD-025 study of AAV-GAD for PD demonstrated significant and clinically meaningful improvements from baseline for key efficacy endpoints after 26 weeks of treatment.
Per the data readout, treatment with the candidate resulted in a statistically significant 18-point average improvement from baseline in the&nbsp;UPDRS Part 3 (motor examination) &quot;off&quot; medication score&nbsp;in the high-dose group at week 26. However, no significant change in the sham or low-dose groups was observed.
Additionally, MeiraGTx reported significant dose-dependent improvements from baseline in the disease-specific, patient-reported quality of life PDQ-39 score in both the high and low-dose groups with no significant change in the sham group at 26 weeks.
Year to date, shares of MeiraGTx have plunged 24.1% compared with the industry&#39;s 1.8% decline.
<img alt="Zacks Investment Research" src="https://staticx-tuner.zacks.com/images/articles/charts/4c/81354.jpg?v=599947683" style="height:310px; width:600px" />
Image Source: Zacks Investment Research
The investigational gene therapy was also found to be generally safe and overall well-tolerated. No serious, AAV-GAD treatment-related adverse events were&nbsp;observed.
Per MGTX, PD is the second most common neurodegenerative disorder after Alzheimer&#39;s, affecting nearly one million people in the United States, with around 90,000 new cases diagnosed annually. Globally, more than 10 million people are living with PD. Initially, most patients respond well to dopamine replacement therapy, but over time, its effectiveness often diminishes and adverse side effects may arise, significantly impacting quality of life and daily functioning. This represents a high unmet medical need.
While the cause of PD remains unknown for most, a small percentage have a genetic basis. In all cases, PD involves disruptions in movement control circuits.
AAV-GAD has a novel mechanism of action that aims to correct the aberrant circuitry that results from the depletion of dopamine in the brain of idiopathic PD patients as the disease progresses. Using the company&#39;s proprietary delivery instrument, AAV-GAD is administered as a one-time infusion into the subthalamic nucleus, a key regulator of the circuits responsible for normal movement.
<h2>MGTX&#39;s Path Forward for AAV-GAD Following Upbeat Results</h2>
Based on the encouraging data readout from the MGT-GAD-025 study, MeiraGTx is currently gearing up to discuss these results with regulatory bodies in the United States, EU and Japan to potentially initiate a phase III study that will support the approval of this disease-modifying treatment globally.
Apart from AAV-GAD, the company has multiple other programs in clinical development, including the phase III Lumeos study for X-linked retinitis pigmentosa, phase I/II programs in achromatopsia and RPE65-deficiency, phase II study for radiation-induced xerostomia and a different mid-stage study for Sjogren&#39;s syndrome.
<div class="chart_embed">
<h2>MeiraGTx Holdings PLC Price and Consensus</h2>
<img alt="MeiraGTx Holdings PLC Price and Consensus" src="https://staticx-tuner.zacks.com/images/charts/28/1729082088.png" style="height:310px; width:600px" title="" />
MeiraGTx Holdings PLC price-consensus-chart | MeiraGTx Holdings PLC Quote
</div>
<h2>MGTX&#39;s Zacks Rank &amp; Stocks to Consider</h2>
MeiraGTx currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are&nbsp;ANI Pharmaceuticals (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/anip#NASDAQ">ANIP</a>), Alnylam Pharmaceuticals (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/alny#NASDAQ">ALNY</a>) and Amicus Therapeutics (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/fold#NASDAQ">FOLD</a>), each sporting a Zacks Rank #1 (Strong Buy) at present.
In the past 60 days, estimates for ANI Pharmaceuticals&#39; 2024 earnings per share have moved up from $4.69 to $4.81. EPS estimates for 2025 have improved from $5.37 to $5.86, during the same period. Year to date, shares of ANIP have gained 6.3%.
ANI Pharmaceuticals&#39; earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for Alnylam&#39;s 2024 loss per share have narrowed from $1.20 to 63 cents. Loss per shares estimates for 2025 have narrowed from 34 cents to 26 cents, during the same period. Year to date, shares of ALNY have risen 50.1%.
Alnylam&#39;s earnings beat estimates in each of the trailing four quarters, with the average surprise being 108.53%.
In the past 60 days, estimates for Amicus&#39; 2024 EPS have remained constant at 20 cents. EPS estimates for 2025 have increased from 48 cents to 50 cents, during the same period. Year to date, shares of FOLD have lost 27.3%.
Amicus&#39; earnings beat estimates in three of the four trailing four quarters, missing the mark once, with the average surprise being 23.96%.
<a href="https://www.zacks.com/stock/news/2351620/mgtx-stock-up-on-upbeat-efficacy-data-from-parkinson-s-disease-study?cid=CS-BENZ-FT-analyst_blog|company_news_medical_sector-2351620">To read this article on Zacks.com click here.</a>

Regulations

MGTX

MGTX Stock Up on Upbeat Efficacy Data From Parkinson's Disease Study

Piper Sandler has initiated coverage on ANI Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ANIP#NASDAQ">ANIP</a>),&nbsp;an integrated specialty pharmaceutical firm that develops and markets <a target="_blank" href="https://www.benzinga.com/quote/ANIP" rel="noreferrer noopener">branded and generic medicines</a>.
The analyst notes that ANI&#8217;s business model has significantly transformed, shifting from a primary emphasis on generics to a new focus on integrating high-margin brand assets aimed at rare diseases. Cortrophin Gel (adrenocorticotropic hormone (ACTH)), the company&#8217;s lead asset, has been the centerpiece of that evolution.
Cortrophin gel sales more than doubled to $49.2 million in the second quarter of 2024, driven primarily by increased volume. The company raised the fiscal year 2024 Cortrophin gel outlook from $170 million-$180 million <a href="https://www.benzinga.com/pressreleases/24/08/g40182933/ani-pharmaceuticals-reports-second-quarter-2024-financial-results-and-raises-2024-guidance" target="_blank" rel="noreferrer noopener">to $185 million-$195 million</a>.
The FDA approved Cortrophin Gel in 2021, which covers several autoimmune diseases. At that time, there was only one other ACTH player, Mallinckrodt Plc&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/MNKTQ#OTC">MNKTQ</a>) Acthar Gel. The company and the drug have been associated with payer challenges, negative attention associated with the Medicaid rebate-related litigation and eventual settlement, and pandemic-associated disruption.
When ANI launched in the market, it identified significant promotion sensitivity linked to its relatively high-priced product, typically used after various more affordable immunomodulatory alternatives.
To address this, ANI developed a commercial framework concentrating on essential specialty areas, patient support systems, and market access.
Piper initiated with an Overweight rating and a <a target="_blank" href="https://www.benzinga.com/quote/ANIP/analyst-ratings" rel="noreferrer noopener">price target of $68</a>.
Earlier this year, ANI Pharmaceuticals acquired Alimera Sciences for $5.50 per share in cash and one non-tradable contingent value right (CVR) of up to $0.50 per share upon achieving certain net revenue targets <a href="https://www.benzinga.com/general/biotech/24/06/39460281/generics-player-ani-pharmaceuticals-strengthens-rare-disease-segment-with-380m-alimera-sciences-d" target="_blank" rel="noreferrer noopener">in 2026 and 2027</a>.
With the acquisition, ANI gained Iluvien and Yutiq, both intravitreal implantable forms of the corticosteroid fluocinolone for diabetic macular edema and <a target="_blank" href="https://www.benzinga.com/pressreleases/24/09/g40877461/ani-pharmaceuticals-inc-completes-acquisition-of-alimera-sciences" rel="noreferrer noopener">non-infectious uveitis</a>.
The transaction made sense, the analyst writes, especially since ANI had already established commercial infrastructure aimed at ophthalmologists to promote Cortrophin Gel, which is indicated for various ophthalmic conditions.
By incorporating Alimera&#8217;s current sales representatives, ANI can reach a broader pool of potential prescribers for Cortrophin Gel, thanks to the overlap with prescribers of Iluvien/Yutiq.
&#8220;ANI is well-positioned to de-lever considerably from the Alimera transaction in the next 12-18 months,&#8221; the analyst writes.
Price Action: ANIP stock is up 3.99% at $57.30 at last check Friday.
Photo: Illustration of Phrama lab worker created with MidJourney.
Read Next:
<ul>
<li><a href="https://www.benzinga.com/markets/equities/24/10/41295130/a-o-smith-slashes-fy24-guidance-as-china-woes-and-weak-water-heater-sales-drag-q3-performance" target="_blank" rel="noreferrer noopener">A.O. Smith Slashes FY24 Guidance As China Woes And Weak Water Heater Sales Drag Q3 Performance</a>.</li>
</ul>

Analyst Color

Equities

Initiation

Movers

MNKTQ

ANI Pharmaceuticals Shifts Focus From Generics To High-Margin Brand Assets, Analyst Sees Strong Potential

ANI Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ANIP#NASDAQ">ANIP</a>) has been analyzed by 5 analysts in the last three months, revealing a diverse range of perspectives from bullish to bearish.
Summarizing their recent assessments, the table below illustrates the evolving sentiments in the past 30 days and compares them to the preceding months.
<table>
<thead>
<tr>
<th></th>
<th style="text-align: right;">Bullish</th>
<th style="text-align: right;">Somewhat Bullish</th>
<th style="text-align: right;">Indifferent</th>
<th style="text-align: right;">Somewhat Bearish</th>
<th style="text-align: right;">Bearish</th>
</tr>
</thead>
<tbody>
<tr>
<td>Total Ratings</td>
<td style="text-align: right;">2</td>
<td style="text-align: right;">2</td>
<td style="text-align: right;">1</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
</tr>
<tr>
<td>Last 30D</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">1</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
</tr>
<tr>
<td>1M Ago</td>
<td style="text-align: right;">1</td>
<td style="text-align: right;">1</td>
<td style="text-align: right;">1</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
</tr>
<tr>
<td>2M Ago</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
</tr>
<tr>
<td>3M Ago</td>
<td style="text-align: right;">1</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
</tr>
</tbody>
</table>
Analysts have set 12-month price targets for ANI Pharmaceuticals, revealing an average target of $79.8, a high estimate of $94.00, and a low estimate of $60.00. Highlighting a 8.54% decrease, the current average has fallen from the previous average price target of $87.25. 
<img src="https://www.benzinga.com/files/images/story/2024/1728648105_0.png" alt="price target chart" />
<h2>Investigating Analyst Ratings: An Elaborate Study</h2>
A clear picture of ANI Pharmaceuticals's perception among financial experts is painted with a thorough analysis of recent analyst actions. The summary below outlines key analysts, their recent evaluations, and adjustments to ratings and price targets.
<table>
<thead>
<tr>
<th>Analyst</th>
<th>Analyst Firm</th>
<th>Action Taken</th>
<th>Rating</th>
<th>Current Price Target</th>
<th>Prior Price Target</th>
</tr>
</thead>
<tbody>
<tr>
<td>David Amsellem</td>
<td>Piper Sandler</td>
<td>Announces</td>
<td>Overweight</td>
<td>$68.00</td>
<td>-</td>
</tr>
<tr>
<td>Elliot Wilbur</td>
<td>Raymond James</td>
<td>Raises</td>
<td>Outperform</td>
<td>$83.00</td>
<td>$81.00</td>
</tr>
<tr>
<td>Oren Livnat</td>
<td>HC Wainwright &amp; Co.</td>
<td>Maintains</td>
<td>Buy</td>
<td>$94.00</td>
<td>$94.00</td>
</tr>
<tr>
<td>Gregory Fraser</td>
<td>Truist Securities</td>
<td>Lowers</td>
<td>Hold</td>
<td>$60.00</td>
<td>$80.00</td>
</tr>
<tr>
<td>Oren Livnat</td>
<td>HC Wainwright &amp; Co.</td>
<td>Maintains</td>
<td>Buy</td>
<td>$94.00</td>
<td>$94.00</td>
</tr>
</tbody>
</table>
<h3>Key Insights:</h3>
<ul>
<li>Action Taken: In response to dynamic market conditions and company performance, analysts update their recommendations. Whether they 'Maintain', 'Raise', or 'Lower' their stance, it signifies their reaction to recent developments related to ANI Pharmaceuticals. This insight gives a snapshot of analysts' perspectives on the current state of the company.</li>
<li>Rating: Analysts unravel qualitative evaluations for stocks, ranging from 'Outperform' to 'Underperform'. These ratings offer insights into expectations for the relative performance of ANI Pharmaceuticals compared to the broader market.</li>
<li>Price Targets: Analysts navigate through adjustments in price targets, providing estimates for ANI Pharmaceuticals's future value. Comparing current and prior targets offers insights into analysts' evolving expectations.</li>
</ul>
Understanding these analyst evaluations alongside key financial indicators can offer valuable insights into ANI Pharmaceuticals's market standing. Stay informed and make well-considered decisions with our Ratings Table.
<a href="https://www.benzinga.com/quote/ANIP/analyst-ratings?utm_source=Benzinga Insights">Stay up to date on ANI Pharmaceuticals analyst ratings.</a>
If you are interested in following small-cap stock news and performance <a href="https://www.benzinga.com/news/small-cap">you can start by tracking it here</a>.
<h2>Unveiling the Story Behind ANI Pharmaceuticals</h2>
ANI Pharmaceuticals Inc develops, manufactures, and markets generic prescription pharmaceuticals. It manufactures liquid, powder, and oral solid dose products. Its areas of product development include narcotics, oncolytic, hormones and steroids, and complex formulations involving extended release and combination products. Some of its generic products include Erythromycin ethyl succinate, Esterified Estrogen with Methyltestosterone (EEMT), Etodolac Fenofibrate, Fluvoxamine, Hydrocortisone Enema and Vancomycin. Its geographical segments are the United States and Canada, of which the majority of its revenue comes from the United States.
<h3>Key Indicators: ANI Pharmaceuticals's Financial Health</h3>
Market Capitalization Analysis: Reflecting a smaller scale, the company's market capitalization is positioned below industry averages. This could be attributed to factors such as growth expectations or operational capacity.
Positive Revenue Trend: Examining ANI Pharmaceuticals's financials over 3 months reveals a positive narrative. The company achieved a noteworthy revenue growth rate of 18.44% as of 30 June, 2024, showcasing a substantial increase in top-line earnings. As compared to its peers, the company achieved a growth rate higher than the average among peers in Health Care sector.
Net Margin: ANI Pharmaceuticals's net margin is impressive, surpassing industry averages. With a net margin of -1.95%, the company demonstrates strong profitability and effective cost management.
Return on Equity (ROE): ANI Pharmaceuticals's financial strength is reflected in its exceptional ROE, which exceeds industry averages. With a remarkable ROE of -0.59%, the company showcases efficient use of equity capital and strong financial health.
Return on Assets (ROA): ANI Pharmaceuticals's ROA stands out, surpassing industry averages. With an impressive ROA of -0.29%, the company demonstrates effective utilization of assets and strong financial performance.
Debt Management: ANI Pharmaceuticals's debt-to-equity ratio is below industry norms, indicating a sound financial structure with a ratio of 0.63.
<h2>The Core of Analyst Ratings: What Every Investor Should Know</h2>
Analysts work in banking and financial systems and typically specialize in reporting for stocks or defined sectors. Analysts may attend company conference calls and meetings, research company financial statements, and communicate with insiders to publish "analyst ratings" for stocks. Analysts typically rate each stock once per quarter.
Some analysts publish their predictions for metrics such as growth estimates, earnings, and revenue to provide additional guidance with their ratings. When using analyst ratings, it is important to keep in mind that stock and sector analysts are also human and are only offering their opinions to investors.
If you want to keep track of which analysts are outperforming others, you can view updated analyst ratings along withanalyst success scores in <a href="https://benzinga.grsm.io/register174">Benzinga Pro</a>.
Which Stocks Are Analysts Recommending Now?
Benzinga Edge gives you instant access to all major analyst upgrades, downgrades, and price targets. Sort by accuracy, upside potential, and more. <a href="https://www.benzinga.com/premium/ideas/benzinga-edge-checkout/?t=be8be9arja3be22bz21&amp;utm_source=benzinga-insights">Click here to stay ahead of the market</a>.
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Peeling Back The Layers: Exploring ANI Pharmaceuticals Through Analyst Insights

Piper Sandler analyst David Amsellem initiates coverage on ANI Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ANIP#NASDAQ">ANIP</a>) with a Overweight rating and announces Price Target of $68.

Piper Sandler Initiates Coverage On ANI Pharmaceuticals with Overweight Rating, Announces Price Target of $68

AstraZeneca (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/azn#NASDAQ">AZN</a>) announced that it has signed an exclusive license agreement with China-based CSPC Pharmaceutical Group Ltd for developing an early-stage, small molecule Lipoprotein (a) (Lp(a)) disruptor for helping patients with dyslipidaemia.
The latest agreement is likely to strengthen AstraZeneca&#39;s cardiovascular pipeline, which is being studied for treating various cardiovascular diseases.
Year to date, shares of AstraZeneca have rallied 14.1% compared with the industry&#39;s rise of 18.5%.
<img alt="Zacks Investment Research" src="https://staticx-tuner.zacks.com/images/articles/charts/fa/80674.jpg?v=23295027" />
Image Source: Zacks Investment Research
<h2>More on AZN&#39;s Latest Agreement</h2>
Per the deal, AZN will make an upfront payment of $100 million to CSPC. The company is also entitled to pay up to $1.92 billion for further development and commercialization milestones plus tiered royalties to CSPC.
Per the latest agreement with CSPC, AstraZeneca will gain access to the latter&#39;s pre-clinical candidate, YS2302018, an oral Lp(a) disruptor, and develop the same for various cardiovascular diseases. The company will develop YS2302018 alone or in combination studies, including with the oral small molecule PCSK9 inhibitor, AZD0780.
Discovered by CSPC, YS2302018 has been shown to effectively prevent the formation of Lp(a), a form of low-density lipoprotein&nbsp;that plays a key role in transporting cholesterol in the bloodstream.
Per the company, the addition of YS2302018 to AZN&#39;s cardiovascular pipeline might help patients to more effectively manage their dyslipidaemia and cardiometabolic diseases.
<h2>AZN&#39;s Airsupra Meet Goal in BATURA Study</h2>
In a separate press release, AstraZeneca announced positive data from the phase IIIb BATURA study, which evaluated its pressurized metered-dose inhaler (pMDI), Airsupra (albuterol/budesonide).
Data from the study showed that treatment with Airsupra led to a statistically significant and clinically meaningful reduction in the risk of a severe exacerbation when used as an as-needed rescue medication in response to symptoms versus as-needed albuterol in patients with intermittent or mild persistent asthma. This was the primary endpoint of the BATURA study.
Airsupra is approved for as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and above in the United States. It is the first and only anti-inflammatory rescue medication for the given condition.
<h2>AZN&#39;s Zacks Rank &amp; Other Stocks to Consider</h2>
AstraZeneca currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the biotech sector are ANI Pharmaceuticals, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/anip#NASDAQ">ANIP</a>), ADMA Biologics, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/adma#NASDAQ">ADMA</a>) and Alnylam Pharmaceuticals, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/alny#NASDAQ">ALNY</a>), each sporting a Zacks Rank #1 (Strong Buy) at present. In the past 60 days, estimates for ANI Pharmaceuticals&#39; 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.38 to $5.86. Year to date, shares of ANIP have increased 1.3%.
ANIP&#39;s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for ADMA Biologics&#39; 2024 earnings per share have increased from 35 cents to 49 cents. Earnings per share estimates for 2025 have improved from 53 cents to 64 cents. Year to date, shares of ADMA have surged 346.5%.
ADMA&#39;s earnings beat estimates in each of the trailing four quarters, with the average surprise being 105.63%.
In the past 60 days, estimates for Alnylam&#39;s 2024 loss per share have narrowed from $1.20 to 63 cents. Loss per share estimates for 2025 have narrowed from 34 cents to 27 cents. Year to date, shares of ALNY have rallied 39.4%.
ALNY&#39;s earnings beat estimates in each of the trailing four quarters, with the average surprise being 108.53%.
<a href="https://www.zacks.com/stock/news/2347767/astrazeneca-inks-agreement-to-boost-cardiovascular-pipeline?cid=CS-BENZ-FT-analyst_blog|company_news_medical_sector-2347767">To read this article on Zacks.com click here.</a>

Events

ADMA

AstraZeneca Inks Agreement to Boost Cardiovascular Pipeline

Ionis Pharmaceuticals, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ions#NASDAQ">IONS</a>) announced that the FDA has granted a Fast Track designation to its investigational RNA-targeted therapy zilganersen for treating Alexander disease (AxD), an ultra-rare neurological disorder.
The Fast Track designation from the FDA facilitates rapid development and expedites the review of drug candidates to treat serious conditions for which clinical data demonstrate the potential to address unmet medical needs. The goal is to make these treatments rapidly available to patients in need.
AxD is a rare neurological disease that affects a type of cell in the brain called astrocytes, which has multiple roles in the brain to support neurons and oligodendrocytes. People living with this condition experience cognitive dysfunction and progressive neurologic deterioration, including swallowing and the ability to control muscles for large movements. Per Ionis, zilganersen is the first investigational medicine in clinical development for treating AxD. There are currently no approved therapies for AxD patients.
The FDA had previously granted Orphan Drug designation and Rare Pediatric Disease designation to zilganersen for treating AxD.
Shares of Ionis have declined 22.8% so far this year compared with the industry&#39;s 1.3% fall.
<img alt="Zacks Investment Research" src="https://staticx-tuner.zacks.com/images/articles/charts/a1/79966.jpg?v=1130269560" />
Image Source: Zacks Investment Research
<h2>Recent Updates on IONS&#39; Zilganersen</h2>
Zilganersen is currently being evaluated in late-stage studies for treating adults and children living with AxD.
The company completed full patient enrollment in a pivotal phase III study on zilganersen for treating AxD in July. Top-line data from the same is expected in the second half of 2025.
The primary endpoint of the study is to check the percent change from baseline in gait speed as assessed by the 10-Meter Walk Test (10MWT) at the end of the 60-week treatment period.
Zilganersen is one of Ionis&#39; wholly-owned pipeline candidates. The company intends to launch it independently in the United States.
<h2>IONS&#39; Promising Wholly Owned Pipeline</h2>
Ionis has collaborations with leading drugmakers/biotech companies that provide it with funds in the form of license fees, upfront payments and milestone payments to invest in its internal pipeline development.
Besides zilganersen, some of its wholly-owned candidates include olezarsen for familial chylomicronemia syndrome&nbsp;and severe hypertriglyceridemia, donidalorsen for hereditary angioedema and ulefnersen for amyotrophic lateral sclerosis, which is in phase III study.
In April 2024, Ionis filed a new drug application (NDA) with the FDA seeking approval for olezarsen in the FCS indication. A decision from the regulatory body is due on Dec. 19, 2024.
If approved, olezarsen will be Ionis&#39; first medicine to be launched independently.
Also, Ionis is making preparations to file an NDA for donidalorsen with the FDA later in 2024. The company expects donidalorsen to be its second independent commercial launch upon potential approval.
<h2>IONS&#39; Zacks Rank &amp; Stocks to Consider</h2>
Ionis currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/anip#NASDAQ">ANIP</a>), Krystal Biotech, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/krys#NASDAQ">KRYS</a>) and Fulcrum Therapeutics, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/fulc#NASDAQ">FULC</a>), each sporting a Zacks Rank #1 (Strong Buy) at present.
In the past 60 days, estimates for ANI Pharmaceuticals&#39; 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.38 to $5.86. Year to date, shares of ANIP have increased 7.8%.
ANIP&#39;s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for Krystal Biotech&#39;s 2024 earnings per share have increased from $1.91 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 46.3%.
KRYS&#39; earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, with the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics&#39; 2024 loss per share have narrowed from 46 cents to 28 cents. Loss per share estimates for 2025 have narrowed from $1.67 to $1.14. Year to date, shares of FULC have plunged 46.7%.
FULC&#39;s earnings beat estimates in each of the trailing four quarters, with the average surprise being 393.18%.
<a href="https://www.zacks.com/stock/news/2344661/ions-rare-neurology-disorder-candidate-gets-fda-s-fast-track-tag?cid=CS-BENZ-FT-analyst_blog|company_news_medical_sector-2344661">To read this article on Zacks.com click here.</a>

Penny Stocks

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IONS

KRYS

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NI&#39;s Ketoconazole Shampoo,&nbsp;2%&nbsp;is the generic version of the reference listed drug (RLD) Nizoral.
U.S. annual sales for Ketoconazole Shampoo,&nbsp;2%&nbsp;total approximately&nbsp;$69.2 million, based on July 2024 moving annual total (MAT) IQVIA data. 
&nbsp;

ANI Pharmaceuticals Reports FDA Approval And Commercialization Of Ketoconazole Shampoo, 2%

Shares of Biohaven Ltd. (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/bhvn#NYSE">BHVN</a>) were up 13.7% on Sept. 23 after the company announced positive top-line data from the pivotal BHV4157-206-RWE study, which evaluated its pipeline candidate, troriluzole, for the treatment of spinocerebellar ataxia (SCA), a rare and debilitating neurodegenerative disease.
Currently, there are no FDA-approved therapy for the given indication.
The study showed the efficacy of troriluzole on the mean change from baseline in the modified functional Scale for the Assessment and Rating of Ataxia (f-SARA) following three years of treatment.
Year to date, shares of Biohaven have gained 7.4% with no change for the industry.
<img alt="Zacks Investment Research" src="https://staticx-tuner.zacks.com/images/articles/charts/ee/78970.jpg?v=729085404" />
Image Source: Zacks Investment Research
<h2>BHVN&#39;s Pivotal BHV4157-206-RWE Study Data</h2>
The study met the primary endpoint on the change from baseline in the f-SARA at three years in all study population genotypes following treatment with troriluzole (200 mg) in SCA patients.
Also, treatment with troriluzole led to statistically significant improvements in the f-SARA at years one and two. Data collected from multiple analyses showed a robust and clinically meaningful slowing of disease progression in SCA patients.
Importantly, treatment with troriluzole slowed disease progression by 50% to 70%, representing a 1.5-2.2 years delay in disease progression over three years compared to untreated patients.
Treatment with troriluzole demonstrated statistically significant superiority on nine consecutive, prespecified primary and secondary endpoints of the study.
Per management, troriluzole is the first treatment to show a delay in disease progression for SCA patients.
<h2>BHVN&#39;s Upcoming Plans for Troriluzole</h2>
Based on the positive data from the BHV4157-206-RWE study, along with previous safety and efficacy data, BHVN plans to submit a new drug application (NDA) for troriluzole in SCA with the FDA in the fourth quarter of 2024.
If approved, the company plans to launch troriluzole in the United States in 2025.
The FDA has granted Fast-Track and orphan drug designation to troriluzole for treating SCA. The European Medicines Agency has also granted orphan drug designation to troriluzole for treating SCA.
As a result of the orphan drug and fast-track designations granted by the FDA, the NDA for troriluzole is eligible for a priority review.
Troriluzole is also being evaluated in two late-stage studies for treating obsessive-compulsive disorder (OCD). Interim analysis of the second phase III OCD study is expected later in 2024, while top-line data from the first phase III OCD study is anticipated in the first half of 2025.
<h2>Zacks Rank &amp; Stocks to Consider</h2>
Biohaven currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/anip#NASDAQ">ANIP</a>), Krystal Biotech, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/krys#NASDAQ">KRYS</a>) and Fulcrum Therapeutics, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/fulc#NASDAQ">FULC</a>), each sporting a Zacks Rank #1 (Strong Buy) at present.
In the past 60 days, estimates for ANI Pharmaceuticals&#39; 2024 earnings per share have moved up from $4.49 to $4.82. Earnings per share estimates for 2025 have improved from $5.51 to $5.93. Year to date, shares of ANIP have gained 9%.
ANIP&#39;s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for Krystal Biotech&#39;s 2024 earnings per share have increased from $2.09 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 45.3%.
KRYS&#39; earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, with the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics&#39; 2024 loss per share have narrowed from $1.33 to 28 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.14. Year to date, shares of FULC have plunged 52.6%.
FULC&#39;s earnings beat estimates in each of the trailing four quarters, with the average surprise being 393.18%.
<a href="https://www.zacks.com/stock/news/2340700/bhvn-stock-up-as-rare-neurological-disease-study-meets-primary-goal?cid=CS-BENZ-FT-analyst_blog|company_news_medical_sector-2340700">To read this article on Zacks.com click here.</a>

BHVN

BHVN Stock Up as Rare Neurological Disease Study Meets Primary Goal

Raymond James analyst Elliot Wilbur maintains ANI Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ANIP#NASDAQ">ANIP</a>) with a Outperform and raises the price target from $81 to $83.

Raymond James Maintains Outperform on ANI Pharmaceuticals, Raises Price Target to $83

ANI Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ANIP#NASDAQ">ANIP</a>) has been analyzed by 4 analysts in the last three months, revealing a diverse range of perspectives from bullish to bearish.
The table below summarizes their recent ratings, showcasing the evolving sentiments within the past 30 days and comparing them to the preceding months.
<table>
<thead>
<tr>
<th></th>
<th style="text-align: right;">Bullish</th>
<th style="text-align: right;">Somewhat Bullish</th>
<th style="text-align: right;">Indifferent</th>
<th style="text-align: right;">Somewhat Bearish</th>
<th style="text-align: right;">Bearish</th>
</tr>
</thead>
<tbody>
<tr>
<td>Total Ratings</td>
<td style="text-align: right;">3</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">1</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
</tr>
<tr>
<td>Last 30D</td>
<td style="text-align: right;">1</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
</tr>
<tr>
<td>1M Ago</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">1</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
</tr>
<tr>
<td>2M Ago</td>
<td style="text-align: right;">1</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
</tr>
<tr>
<td>3M Ago</td>
<td style="text-align: right;">1</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
</tr>
</tbody>
</table>
The 12-month price targets assessed by analysts reveal further insights, featuring an average target of $85.5, a high estimate of $94.00, and a low estimate of $60.00. A negative shift in sentiment is evident as analysts have decreased the average price target by 3.66%. 
<img src="https://www.benzinga.com/files/images/story/2024/1726574513_0.png" alt="price target chart" />
<h2>Interpreting Analyst Ratings: A Closer Look</h2>
The perception of ANI Pharmaceuticals by financial experts is analyzed through recent analyst actions. The following summary presents key analysts, their recent evaluations, and adjustments to ratings and price targets.
<table>
<thead>
<tr>
<th>Analyst</th>
<th>Analyst Firm</th>
<th>Action Taken</th>
<th>Rating</th>
<th>Current Price Target</th>
<th>Prior Price Target</th>
</tr>
</thead>
<tbody>
<tr>
<td>Oren Livnat</td>
<td>HC Wainwright &amp; Co.</td>
<td>Maintains</td>
<td>Buy</td>
<td>$94.00</td>
<td>$94.00</td>
</tr>
<tr>
<td>Gregory Fraser</td>
<td>Truist Securities</td>
<td>Lowers</td>
<td>Hold</td>
<td>$60.00</td>
<td>$80.00</td>
</tr>
<tr>
<td>Oren Livnat</td>
<td>HC Wainwright &amp; Co.</td>
<td>Maintains</td>
<td>Buy</td>
<td>$94.00</td>
<td>$94.00</td>
</tr>
<tr>
<td>Oren Livnat</td>
<td>HC Wainwright &amp; Co.</td>
<td>Raises</td>
<td>Buy</td>
<td>$94.00</td>
<td>$87.00</td>
</tr>
</tbody>
</table>
<h3>Key Insights:</h3>
<ul>
<li>Action Taken: Analysts respond to changes in market conditions and company performance, frequently updating their recommendations. Whether they 'Maintain', 'Raise' or 'Lower' their stance, it reflects their reaction to recent developments related to ANI Pharmaceuticals. This information offers a snapshot of how analysts perceive the current state of the company.</li>
<li>Rating: Analyzing trends, analysts offer qualitative evaluations, ranging from 'Outperform' to 'Underperform'. These ratings convey expectations for the relative performance of ANI Pharmaceuticals compared to the broader market.</li>
<li>Price Targets: Analysts provide insights into price targets, offering estimates for the future value of ANI Pharmaceuticals's stock. This comparison reveals trends in analysts' expectations over time.</li>
</ul>
Analyzing these analyst evaluations alongside relevant financial metrics can provide a comprehensive view of ANI Pharmaceuticals's market position. Stay informed and make data-driven decisions with the assistance of our Ratings Table.
<a href="https://www.benzinga.com/quote/ANIP/analyst-ratings?utm_source=Benzinga Insights">Stay up to date on ANI Pharmaceuticals analyst ratings.</a>
If you are interested in following small-cap stock news and performance <a href="https://www.benzinga.com/news/small-cap">you can start by tracking it here</a>.
<h2>Delving into ANI Pharmaceuticals's Background</h2>
ANI Pharmaceuticals Inc develops, manufactures, and markets generic prescription pharmaceuticals. It manufactures liquid, powder, and oral solid dose products. Its areas of product development include narcotics, oncolytic, hormones and steroids, and complex formulations involving extended release and combination products. Some of its generic products include Erythromycin ethyl succinate, Esterified Estrogen with Methyltestosterone (EEMT), Etodolac Fenofibrate, Fluvoxamine, Hydrocortisone Enema and Vancomycin. Its geographical segments are the United States and Canada, of which the majority of its revenue comes from the United States.
<h3>ANI Pharmaceuticals: A Financial Overview</h3>
Market Capitalization Analysis: With an elevated market capitalization, the company stands out above industry averages, showcasing substantial size and market acknowledgment.
Revenue Growth: Over the 3 months period, ANI Pharmaceuticals showcased positive performance, achieving a revenue growth rate of 18.44% as of 30 June, 2024. This reflects a substantial increase in the company's top-line earnings. When compared to others in the Health Care sector, the company faces challenges, achieving a growth rate lower than the average among peers.
Net Margin: ANI Pharmaceuticals's financial strength is reflected in its exceptional net margin, which exceeds industry averages. With a remarkable net margin of -1.95%, the company showcases strong profitability and effective cost management.
Return on Equity (ROE): ANI Pharmaceuticals's ROE excels beyond industry benchmarks, reaching -0.59%. This signifies robust financial management and efficient use of shareholder equity capital.
Return on Assets (ROA): ANI Pharmaceuticals's ROA excels beyond industry benchmarks, reaching -0.29%. This signifies efficient management of assets and strong financial health.
Debt Management: ANI Pharmaceuticals's debt-to-equity ratio is below the industry average. With a ratio of 0.63, the company relies less on debt financing, maintaining a healthier balance between debt and equity, which can be viewed positively by investors.
<h2>Analyst Ratings: What Are They?</h2>
Ratings come from analysts, or specialists within banking and financial systems that report for specific stocks or defined sectors (typically once per quarter for each stock). Analysts usually derive their information from company conference calls and meetings, financial statements, and conversations with important insiders to reach their decisions.
Beyond their standard evaluations, some analysts contribute predictions for metrics like growth estimates, earnings, and revenue, furnishing investors with additional guidance. Users of analyst ratings should be mindful that this specialized advice is shaped by human perspectives and may be subject to variability.
This article was generated by Benzinga's automated content engine and reviewed by an editor.

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