Dernières nouvelles pour ANI Pharmaceuticals (NASDAQ:ANIP) Stock

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

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.
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<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>

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ANIP

FULC

IONS

KRYS

IONS' Rare Neurology Disorder Candidate Gets FDA's Fast Track Tag

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.
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<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.

Price Target

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.

In-Depth Examination Of 4 Analyst Recommendations For ANI Pharmaceuticals

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.

Reiteration

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

Ani Pharmaceuticals Launches Promethazine Hydrochloride And Dextromethorphan Hydrobromide Oral Solution

Top Wall Street analysts changed their outlook on these top names. For a complete view of all analyst rating changes, including upgrades and downgrades, please see our analyst ratings page.
<ul>
<li><a href="https://www.benzinga.com/analyst-stock-ratings/analyst/58a5e02a43eaaa00018d939e/edward-white">HC Wainwright &amp; Co. analyst Edward White</a> downgraded the rating for Adicet Bio, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ACET#NASDAQ">ACET</a>) from Buy to Neutral. Adicet Bio shares fell 3.4% to close at $1.43 on Tuesday. <a href="https://www.benzinga.com/quote/DACETPZ/analyst-ratings">See how other analysts </a><a href="https://www.benzinga.com/quote/ACET/analyst-ratings">view </a><a href="https://www.benzinga.com/quote/DACETPZ/analyst-ratings">this stock</a>.</li>
<li>B of A Securities analyst Graham Perry downgraded Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) from Buy to Neutral and lowered the price target from $135 to $130. Novartis shares fell 0.2% to close at $116.99 on Tuesday. <a href="https://www.benzinga.com/quote/NVS/analyst-ratings">See how other analysts view this stock</a>.</li>
<li><a href="https://www.benzinga.com/topic/david-amsellem">Piper Sandler analyst David Amsellem</a> downgraded the rating for Supernus Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SUPN#NASDAQ">SUPN</a>) from Overweight to Neutral and cut the price target from $41 to $36. Supernus Pharmaceuticals shares fell 1.2% to close at $33.49 on Tuesday. <a href="https://www.benzinga.com/quote/SUPN/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>Truist Securities analyst Gregory Fraser downgraded ANI Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ANIP#NASDAQ">ANIP</a>) from Buy to Hold and slashed the price target from $80 to $60. ANI Pharmaceuticals shares fell 5.1% to close at $55.48 on Tuesday. <a href="https://www.benzinga.com/quote/ANIP/analyst-ratings">See how other analysts view this stock.</a></li>
</ul>
Considering buying NVS stock? Here&#8217;s what analysts think: 
<figure class="wp-block-image size-large is-resized"><img loading="lazy" decoding="async" width="1024" height="537" src="https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/11091806/image-88-1024x537.png" alt="" class="wp-image-542353" style="width:625px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/11091806/image-88-1024x537.png 1024w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/11091806/image-88-300x157.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/11091806/image-88-768x402.png 768w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/11091806/image-88.png 1292w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure>
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<li><a href="https://www.benzinga.com/news/24/09/40792510/jim-cramer-says-aes-is-very-inexpensive-recommends-buying-this-industrial-stock">Jim Cramer Says AES Is &#8216;Very Inexpensive&#8217;, Recommends Buying This Industrial Stock</a></li>
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Downgrades

ACET

RLAY

SUPN

This Novartis Analyst Is No Longer Bullish; Here Are Top Downgrades For Wednesday

ALIM

ANI Pharmaceuticals And Alimera Sciences Announced That They Have Scheduled The Closing Of Their Transaction Pursuant To The Companies' Previously Announced Merger Agreement Before The Market Opens On Monday, September 16, 2024

Truist Securities analyst Gregory Fraser downgrades ANI Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ANIP#NASDAQ">ANIP</a>) from Buy to Hold and lowers the price target from $80 to $60.

Truist Securities Downgrades ANI Pharmaceuticals to Hold, Lowers Price Target to $60

ANI Pharmaceuticals Updates On Alimera Sciences Acquisition, States Discussions Regarding Closing Conditions Are Ongoing But Expected To Be Resolved Promptly

Alimera Has Filed Lawsuit in the Delaware Court of Chancery to Compel ANI to Close Merger Transaction and Honor its Contractual Obligations
Alimera Shareholders Approved Merger Agreement on September 4, Clearing Last Requirement for Closing

Legal

Alimera Sciences Takes Legal Action Against ANI Pharmaceuticals To Force It To Fulfill Its Contractual Obligation For Merger Agreement

WIIM

ANI Pharmaceuticals shares are trading lower after the company announced intent for a $250 million private offering of convertible senior notes.

Offerings

ANI Pharmaceuticals Announced Its Intention To Offer, Subject To Market And Other Conditions, $250,000,000 Aggregate Principal Amount Of Convertible Senior Notes Due 2029 In A Private Offering

ANI Pharmaceuticals shares are trading higher after the company reported better-than-expected Q2 financial results and raised its FY24 guidance.

Revised Full Year 2024 Guidance:
The following guidance for 2024 does not include contribution from the pending acquisition of Alimera.
<figure class="table"> 
<table>
<tbody>
<tr>
<td>&nbsp;</td>
<td>&nbsp;</td>
<td>Revised Full Year 2024 Guidance</td>
<td>&nbsp;</td>
<td>Prior Full Year 2024 Guidance</td>
<td>&nbsp;</td>
<td colspan="2">2023 Actual</td>
<td>&nbsp;</td>
<td>Growth</td>
</tr>
<tr>
<td>Net Revenue (Total Company)</td>
<td>&nbsp;</td>
<td>$540 million - $560 million</td>
<td>&nbsp;</td>
<td>$520 million - $542 million</td>
<td>&nbsp;</td>
<td colspan="2">$486.8 million</td>
<td>&nbsp;</td>
<td>11% - 15%</td>
</tr>
<tr>
<td>Cortrophin Gel Net Revenue</td>
<td>&nbsp;</td>
<td>$185 million - $195 million</td>
<td>&nbsp;</td>
<td>$170 million - $180 million</td>
<td>&nbsp;</td>
<td colspan="2">$112.1 million</td>
<td>&nbsp;</td>
<td>65% - 74%</td>
</tr>
<tr>
<td>Adjusted Non-GAAP EBITDA</td>
<td>&nbsp;</td>
<td>$140 million - $150 million</td>
<td>&nbsp;</td>
<td>$135 million - $145 million</td>
<td>&nbsp;</td>
<td colspan="2">$133.8 million</td>
<td>&nbsp;</td>
<td>5% - 12%</td>
</tr>
<tr>
<td>Adjusted Non-GAAP Diluted EPS</td>
<td>&nbsp;</td>
<td>$4.38 - $4.82</td>
<td>&nbsp;</td>
<td>$4.26 - $4.67</td>
<td>&nbsp;</td>
<td colspan="2">$4.71</td>
<td>&nbsp;</td>
<td>(7)% - 2%</td>
</tr>
</tbody>
</table>
</figure>
 &nbsp;

Guidance

Health Care

ANI Pharmaceuticals Forecasts 2024 Adjusted EPS Of $4.38-$4.82 Versus Prior Guidance Of $4.26-$4.67 And Consensus Of $4.49

ANI Pharmaceuticals Forecasts 2024 Net Revenue Of $540M-$560M Versus Prior Guidance Of $520M-$542M And Consensus Of $554.598M, With Cortrophin Gel Revenue Of $185M-$195M Compared To Prior Guidance Of $170M-$180M

ANI Pharmaceuticals Q2 2024 Adj. EPS $1.02 Beats $0.95 Estimate, Sales $138.040M Beat $129.054M Estimate

Lisata Therapeutics, Inc.&#39;s (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/lsta#NASDAQ">LSTA</a>) lead pipeline candidate is certepetide (formerly known as LSTA1), which is being developed for treating a range of solid tumors.
Earlier this month, the company announced upbeat data from a preclinical study evaluating certepetide for treating intrahepatic cholangiocarcinoma, an aggressive form of cancer, with a poor prognosis.
Data from the study showed that treatment with certepetide combined with standard-of-care (SoC) chemotherapy and immunotherapy improved survival in mice with intrahepatic cholangiocarcinoma.
Certepetide is an investigational drug candidate that allows co-administered or tethered anti-cancer drugs to better penetrate solid tumors by activating a novel uptake pathway. The candidate has exhibited the potential to improve the tumor environment, thereby making tumors more responsive to immunotherapy.
Notably, the phase IIa BOLSTER study is currently investigating certepetide in combination with standard-of-care chemotherapy as a first-line treatment for cholangiocarcinoma.
The positive preclinical data underlines the potential of certepetide in treating human patients with intrahepatic cholangiocarcinoma.
As a result, LSTA is now looking to add another arm to the BOLSTER study, which will evaluate certepetide in combination with SoC chemoimmunotherapy for treating intrahepatic cholangiocarcinoma.
Shares of LSTA have rallied 33.7% year to date (YTD) against the industry&#39;s decline of 2.7%.
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Certepetide is currently being evaluated as a combination therapy with various anti-cancer regimens in several early-to-mid-stage studies for treating multiple cancer indications, including metastatic pancreatic ductal adenocarcinoma.
The FDA granted an Orphan Drug designation to certepetide for treating osteosarcoma, a rare type of bone cancer, in April. The FDA also granted a Rare Pediatric Disease Designation to certepetide for treating osteosarcoma in March.
The FDA has previously granted Orphan Drug designation to certepetide for the treatment of pancreatic cancer and glioblastoma multiforme (GBM). The regulatory body has also granted a Fast Track designation to certepetide for pancreatic cancer.
Certepetide is also being studied for other forms of cancers, including pancreatic, esophageal, head and neck, appendiceal and colon cancers, as well as GBM.
Several clinical data readouts from various studies on certepetide are expected during the upcoming months, which, if successful, can significantly boost the company&#39;s growth prospect.
Progress with the ongoing studies and successful development of certepetide should continue the upward momentum for Lisata for the remainder of 2024.
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<h3>Lisata Therapeutics, Inc. Price</h3>
<img alt="Lisata Therapeutics, Inc. Price" src="https://staticx-tuner.zacks.com/images/charts/d2/1721136208.png" style="height:251px; width:531px" title="" />
Lisata Therapeutics, Inc. price | Lisata Therapeutics, Inc. Quote
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<h3>Zacks Rank &amp; Stocks to Consider</h3>
Lisata 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>), Adaptive Biotechnologies Corporation (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/adpt#NASDAQ">ADPT</a>) and RAPT Therapeutics, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/rapt#NASDAQ">RAPT</a>), each carrying a Zacks Rank #2 (Buy) at present.
In the past 60 days, estimates for ANI Pharmaceuticals 2024 earnings per share have improved from $4.41 to $4.44. Earnings per share estimates for 2025 have improved from $4.85 to $5.42. Shares of ANIP have jumped 14.7% YTD.
ANIP&#39;s earnings beat estimates in each of the trailing four quarters, the average surprise being 53.90%.
In the past 60 days, estimates for Adaptive Biotechnologies&#39; 2024 loss per share have narrowed from $1.30 to $1.29, while loss per share estimates for 2025 have narrowed from $1.08 to $1.02. Shares of ADPT have lost 17.7% YTD.
ADPT&#39;s earnings beat estimates in two of the trailing four quarters, meeting the same once and missing on the remaining occasion, the average surprise being 0.65%.
In the past 60 days, estimates for RAPT Therapeutics&#39; 2024 loss per share have narrowed from $2.94 to $2.93. Loss per share estimates for 2025 have narrowed from $2.06 to $2.05. Shares of RAPT have plunged 85.7% YTD.
RAPT&#39;s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 3.19%.
<a href="https://www.zacks.com/stock/news/2302707/lisata-lsta-stock-rallies-more-than-30-ytd-here-s-why?cid=CS-BENZ-FT-analyst_blog|price_surge_/_plunge-2302707">To read this article on Zacks.com click here.</a>

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Financing

Press Releases

ANI Pharmaceuticals, Inc. Closes $316.25 Million Convertible Senior Notes Offering Including Full Exercise of Initial Purchasers' Option to Purchase Additional Notes

ALIMERA SCIENCES INVESTOR ALERT by the Former Attorney General of Louisiana: Kahn Swick & Foti, LLC Investigates Adequacy of Price and Process in Proposed Sale of Alimera Sciences, Inc. - ALIM

Alimera Sciences Takes Legal Action Against ANI Pharmaceuticals to Enforce Merger Agreement

ANI Pharmaceuticals Provides Update on Closing of Acquisition of Alimera Sciences

ANI Pharmaceuticals and Alimera Sciences Announce Closing Date of Merger

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ANI Pharmaceuticals Initiates Closing of Acquisition of Alimera Sciences

ANI Pharmaceuticals, Inc. Completes Acquisition of Alimera Sciences

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