Dernières nouvelles pour Novartis (NYSE:NVS) Stock

Novartis

Novartis develops and manufactures innovative drugs. The firm's key areas of drug development include oncology, rare diseases, neuroscience, immunology, respiratory, cardio-metabolic, and established medicines. The company sells its products globally, with the United States comprising close to one third of total revenue.

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Schrodinger, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SDGR#NASDAQ">SDGR</a>) shares are trading higher on Tuesday. The company disclosed a research collaboration and license agreement with Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) to <a target="_blank" href="https://www.benzinga.com/pressreleases/24/11/b41896013/schr-dinger-announces-multi-target-collaboration-and-expanded-software-licensing-agreement-with-no" rel="noreferrer noopener">advance multiple development candidates</a>.
The companies also announced an extended&nbsp;three-year agreement that grants Novartis broad access to Schrödinger&#8217;s predictive modeling and informatics platform, enabling large-scale integration across research sites.
Karen Akinsanya, president of R&amp;D, therapeutics at Schrödinger, said, &#8220;We are delighted to work with Novartis and leverage their strong expertise to jointly advance several of Schrödinger&#8217;s existing non-oncology discovery programs as well as collaborate on additional programs.&#8221;
Schrödinger will support full platform integration to enhance computational drug discovery for Novartis. As per the terms, Novartis will pay Schrödinger $150 million upfront, with potential for up to $892 million in research, development, and regulatory milestones, plus up to $1.38 billion in commercial milestones. Schrödinger will also earn tiered royalties.
Ramy Farid, chief executive officer of Schrödinger stated, &#8220;We are very pleased to enable the further integration of our platform across Novartis&#8217; research teams to realize our shared vision for modernizing drug discovery through a computational &#8220;predict first&#8221; approach.&#8221;
Additionally, in a separate release, the company reported third-quarter revenue of $35.3&nbsp;million, missing the <a target="_blank" href="https://www.benzinga.com/pressreleases/24/11/b41896184/schr-dinger-reports-third-quarter-2024-financial-results" rel="noreferrer noopener">consensus of $40.57 million</a>.
Software revenue rose 10% to $31.9 million, led by increased hosted license contributions. Adjusted loss per share of 87 cents missed <a href="https://www.benzinga.com/earnings" target="_blank" rel="noreferrer noopener">the street view for a loss of 60 cents.</a>
As of September 30, 2024, Schrödinger had cash, cash equivalents, restricted cash and marketable securities stood at $398.4 million.
Outlook: Schrödinger now anticipates 2024 software revenue growth of 8% &#8211; 13%, compared to its previous 6% &#8211; 13% range, while lowering its drug discovery revenue guidance to $20 million &#8211; $30 million from the prior <a target="_blank" href="https://www.benzinga.com/calendars/guidance" rel="noreferrer noopener">guidance of $30 million &#8211; $35 million</a>.
Geoff Porges, MBBS, chief financial officer of Schrödinger said, &#8220;This quarter we added $48 million to our cash balance as a result of Lilly&#8217;s acquisition of Morphic and expect to add even more capital from the payments associated with the collaboration announced today.&#8221;
Investors can gain exposure to the stock via&nbsp;ARK Genomic Revolution ETF (BATS:<a class="ticker" href="https://www.benzinga.com/stock/ARKG#BATS">ARKG</a>).
Price Action: SDGR shares are up 14.6% at $22.40 at the last check Tuesday.
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Schrödinger Scores Big Despite Q3 Miss As Novartis Collaboration Promises Billions In Milestones: Details

<ul>
<li>The companies also announced an expanded three-year software agreement that substantially increases Novartis's access to Schrödinger's computational predictive modeling technology and enterprise informatics platform.&nbsp;</li>
<li>s part of the multi-year, multi-target research collaboration and license agreement, Schrödinger and Novartis will combine their existing research efforts to identify and advance therapeutics for undisclosed targets in Novartis's core therapeutic areas. The agreement is intended to advance multiple development candidates for development and commercialization by Novartis. Schrödinger and Novartis will share responsibility for the discovery of development candidates under the collaboration. Novartis will be responsible for clinical development, manufacturing and global commercialization.</li>
<li>Under the terms of the agreement, Novartis will pay Schrödinger $150 million upfront, and Schrödinger will also be eligible to receive up to $892 million in research, development and regulatory milestone payments. Additionally, Schrödinger is eligible for up to $1.38 billion in commercial milestones and tiered mid single-digit to low double-digit royalties on net sales of each product commercialized by Novartis.</li>
</ul>

Biotech

Large Cap

Schrödinger Announced Research Collaboration And License Agreement With Novartis To Advance Multiple Development Candidates Into Novartis's Portfolio For Further Development, Schrödinger To Receive $150M Upfront And Eligible To Receive Up To Approximately $2.3B In Milestone Payments Plus Royalties

On Tuesday, Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) reported third-quarter sales of $12.823 billion, up 9% (+10% on constant currency), beating the <a target="_blank" href="https://www.benzinga.com/general/biotech/24/10/41598312/novartis-q3-earnings-beats-expectations-on-strong-sales-from-key-drugs-lifts-2024-outlook" rel="noreferrer noopener">consensus of $12.76 billion</a>.
Guidance: Novartis also raised its 2024 full-year guidance again this year.
In a statement, Novartis said it expects full-year core operating income to grow by a &#8220;high teens&#8221; percentage, compared with previous guidance of a &#8220;mid-to-high teens&#8221; percentage.
Novartis forecasts full-year sales growth in the low double digits, having previously guided for high-single to low-double-digit growth.
Pelabresib filing was further delayed, triggering a $800 million impairment charge related to the $2.9 billion <a target="_blank" href="https://www.benzinga.com/general/biotech/24/04/38497134/morphosys-says-novartis-deal-progressing-steadily-despite-safety-concerns-over-bone-marrow-cancer" rel="noreferrer noopener">acquisition of MorphoSys</a>.
Earlier this year, MorphoSys faced&nbsp;a burgeoning safety concern surrounding&nbsp;pelabresib.
Goldman Sachs notes that MorphoSys-related impairment charge is somewhat underwhelming, raising doubts about the company&#8217;s M&amp;A strategy.
Truist notes that Novartis is concentrating on preparing the market for the PSMAFore label, which is expected to triple its addressable market.
They also pointed out that growth opportunities in China and Japan, and metastatic hormone-sensitive prostate cancer (mHSPC) and oligometastatic disease, could push Pluvicto&#8217;s sales well above the projected $2 billion peak.
The company is committed to maximizing the potential of Pluvicto and its radioligand therapy (RLT) portfolio.
For other radiopharmaceutical companies targeting PSMA, entering this market may become more challenging.
A crucial question remains regarding the standards that must be met to compete with more effective radioligand products. This context relates to companies such as Eli Lilly And Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) and Bristol Myers Squibb &amp; Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>), which have RLT products in their pipelines, as well as smaller companies, including Y-mAbs Therapeutics Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/YMAB#NASDAQ">YMAB</a>) and Perspective Therapeutics Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CATX#NASDAQ">CATX</a>).
Novartis highlighted continued strong growth and momentum and sees room to grow the market size for B-cell inhibition in multiple sclerosis, relating Biogen Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>).
Truist highlights Novartis&#8217; strong balance sheet, which enables further bolt-on deals and share buybacks. Recent transactions primarily involve deals in the sub-$1 billion range, along with a few larger bolt-on acquisitions.
A Truist analyst indicated that they will be monitoring how the adoption of Leqvio may affect Amgen Inc&#8216;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>) Repatha and Regeneron Pharmaceuticals Inc&#8216;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) Praluent. Meanwhile, Novartis has reported that the launch is advancing smoothly, and Leqvio continues to grow, outpacing the overall market as per the management.
Novartis&#8217; Cosentyx witnessed strong uptake and continued brand growth driven by hidradenitis suppurativa expansion, and the market opportunity can accommodate several players, Abbvie Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NASDAQ">ABBV</a>), Incyte Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/INCY#NASDAQ">INCY</a>), and Kymera Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KYMR#NASDAQ">KYMR</a>).
Price Action: NVS stock is down 0.48% at $110.00 at last check Wednesday.
Photo by Taljat David via Shutterstock
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Positive Outlook For Novartis As Company Capitalizes On Growing Treatment Opportunities, Analyst Highlights

Last week, Lyell Immunopharma Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LYEL#NASDAQ">LYEL</a>) agreed to acquire ImmPACT Bio USA Inc., a privately owned clinical-<a target="_blank" href="https://www.benzinga.com/pressreleases/24/10/g41529414/lyell-immunopharma-to-acquire-immpact-bio-and-prioritizes-its-pipeline-to-focus-on-next-generation" rel="noreferrer noopener">stage biotechnology company</a>.
Lyell has prioritized its pipeline to focus resources on its most differentiated CAR T-cell clinical programs, including IMPT-314 following the close of the acquisition and LYL119.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/06/39510265/lyell-immunopharma-shares-plunge-on-one-patient-death-in-car-t-cell-therapy-cancer-trial" rel="noreferrer noopener">Lyell Immunopharma Shares Plunge On One Patient Death In CAR-T Cell Therapy Cancer Trial</a>
Lyell announced the discontinuation of the development of LYL797 to focus on the Phase 1 clinical trial of LYL119, which is expected to initiate enrollment of patients with platinum-resistant ovarian cancer or relapsed/refractory endometrial cancer this year or early next year.
The LYL845 tumor-infiltrating lymphocyte (TIL) program is also being discontinued, as the clinical data in patients with advanced melanoma did not meet pre-determined criteria for continued development.
Its next-generation TIL and rejuvenation programs that are in preclinical development will also be discontinued.
Lyell expects its cash balance to fund operations into 2027.
Deal terms include upfront consideration of $30 million in cash and 37.5 million Lyell shares.
ImmPACT shareholders will also be eligible for contingent consideration consisting of 12.5 million Lyell shares and a low single-digit royalty on future net sales.
BofA Securities has downgraded Lyell from Buy to Underperform, with a price target of $1, <a target="_blank" href="https://www.benzinga.com/quote/LYEL/analyst-ratings" rel="noreferrer noopener">down from $6</a>.
The analyst said, &#8220;While discontinuation of &#8216;797 isn&#8217;t a surprise, we think optimism is growing for next-gen &#8216;119&#8217;s improved therapeutic window.&#8221;
The acquisition of ImmPACT Bio for its IMPT-314 introduces complexities that could cloud the narrative. The analyst added that while the potential of &#8216;314 is visible, the program appears to lack clinical and commercial synergy, and with limited resources and rising competition, it risks becoming a distraction.
An analyst noted that with Lyell's focus on restarting its solid tumor program and expanding into hematology, it's challenging to maintain a positive outlook.
It remains uncertain if IMPT-314 can provide significant clinical improvements, and it will likely face tough competition from established players like Gilead Sciences Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>), Bristol Myers Squibb &amp; Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>), and Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>).
Price Action: LYEL stock is down 9.16% at $0.86 at last check Wednesday.
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NVAX

USDA Says H5N1 Bird Flu Detected In Swine For The First Time In U.S. In Oregon Backyard Farm; There Is No Concern About Safety Of The Nation's Pork Supply As A Result Of This Finding On HPAI Detections In Oregon Backyard Farm

USDA To Begin Bulk Milk Testing For Bird Flu Nationwide Following Pressure From Industry And Veterinary Groups; New Effort Aims To Curb Rapid Spread Among Dairy Herds

BMO Capital analyst Etzer Darout maintains Novartis (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) with a Market Perform and raises the price target from $118 to $120.

Price Target

BMO Capital Maintains Market Perform on Novartis, Raises Price Target to $120

<a href="https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-asciminib-philadelphia-chromosome-positive-chronic-myeloid-leukemia" title="https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-asciminib-philadelphia-chromosome-positive-chronic-myeloid-leukemia">https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-asciminib-philadelphia-chromosome-positive-chronic-myeloid-leukemia</a>

FDA Grants Accelerated Approval To Novartis's Asciminib For Philadelphia Chromosome-Positive Chronic Myeloid Leukemia; Clinical Trial Shows 25% Major Molecular Response Rate At 24 Weeks Compared To 13% For Bosutinib

<a href="https://www.cdc.gov/bird-flu/spotlights/bird-flu-response-10-29-24.html#:~:text=Since%20April%202024%2C%20CDC%2C%20working,infected%20dairy%20cows12" title="https://www.cdc.gov/bird-flu/spotlights/bird-flu-response-10-29-24.html#:~:text=Since%20April%202024%2C%20CDC%2C%20working,infected%20dairy%20cows12">https://www.cdc.gov/bird-flu/spotlights/bird-flu-response-10-29-24.html#:~:text=Since%20April%202024%2C%20CDC%2C%20working,infected%20dairy%20cows12</a>.

Macro Notification

US CDC Reports 36 H5 Bird Flu Cases In U.S. Since April; Six Cases In Washington Poultry Workers Confirmed Last Week; No Person-To-Person Spread Detected; Public Risk Remains Low But Higher For Those Exposed To Infected Animals; 15 Cases Linked To Infected Poultry And 20 To Sick Dairy Cows

On Tuesday, Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) reported third-quarter sales of $12.823 billion, up 9% (+10% on constant currency), beating the consensus of $12.76 billion. Volume contributed 12 percentage points to growth.
The Swiss pharma giant <a target="_blank" href="https://www.novartis.com/news/media-releases/novartis-continues-strong-momentum-q3-10-sales-growth-20-core-operating-income-growth-and-important-innovation-milestones-raises-fy-2024-guidance" rel="noreferrer noopener">reported</a> adjusted EPS of $2.06, up from $1.74 a year ago and beating the consensus of $1.96
Core operating profit for the third quarter grew to $5.15 billion from $4.41 billion the year prior.
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Novartis generated $6 billion in free cash flow for the third quarter, up 18% year-over-year.
&#8220;All key growth drivers contributed to the momentum. We achieved important indications expansions for&nbsp;Kisqali&nbsp;in early breast cancer and&nbsp;Fabhalta&nbsp;in IgA nephropathy, and we completed our PSMAfore filing for&nbsp;Pluvicto&nbsp;in the US. With the momentum in our business and pipeline, we were able to once again upgrade our full-year guidance and remain highly confident in our mid-term outlook,&#8221; said CEO Vas Narasimhan.
Quarterly Cosentyx sales gained 27% to $1.69 billion, driven by recent launches (including the HS indication and the IV formulation in the US) and volume growth in core indications.
Heart failure drug Entresto sales increased 26% to $1.87 billion, a demand-led growth. The drug has increased penetration in the U.S. and Europe following guideline-directed medical therapy for heart failure and in China with increased penetration in hypertension.
Multiple sclerosis drug Kesimpta sales reached $838 million, up +28%, reflecting increased demand for a high-efficacy product with convenient self-administered dosing.
Guidance: Novartis also raised its 2024 full-year guidance again this year.
In a statement, Novartis said it expects full-year core operating income to grow by a &#8220;high teens&#8221; percentage, compared with previous guidance of a &#8220;mid-to-high teens&#8221; percentage.
Novartis forecasts full-year sales growth in the low double digits, having previously guided for high-single to low-double-digit growth.
Price Action: NVS stock is down 3.29% at $111.82 during the premarket session at the last check on Tuesday.
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Novartis Q3 Earnings Beats Expectations On Strong Sales From Key Drugs, Lifts 2024 Outlook

WIIM

Novartis shares are trading lower. The company reported Q3 financial results

&bull; Full-year 2024 guidance raised
&nbsp;o Net sales expected to grow low double-digit (from high single to low double-digit)
o Core operating income expected to grow high teens (from mid to high teens)

Novartis 2024 Guidance Raised: Now Expects Net Sales To Grow Low Double-Digit (From High Single To Low Double-Digit) And Core Operating Income To Grow High Teens (From Mid To High Teens)

Novartis (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) reported quarterly earnings of $2.06 per share which beat the analyst consensus estimate of $1.96 by 5.1 percent. This is a 18.39 percent increase over earnings of $1.74 per share from the same period last year. The company reported quarterly sales of $12.823 billion which beat the analyst consensus estimate of $12.764 billion by 0.46 percent. This is a 8.85 percent increase over sales of $11.780 billion the same period last year.

Earnings Beats

Novartis Q3 2024 Adj. EPS $2.06 Beats $1.96 Estimate, Sales $12.823B Beat $12.764B Estimate

Monte Rosa Therapeutics Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GLUE#NASDAQ">GLUE</a>) stock is trading higher on Monday after the company announced a global exclusive development and commercialization license agreement with Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) to advance VAV1 MGDs, <a target="_blank" href="https://www.benzinga.com/pressreleases/24/10/g41569705/monte-rosa-therapeutics-announces-global-license-agreement-with-novartis-to-advance-t-and-b-cell-m" rel="noreferrer noopener">including MRT-6160</a>.
MRT-6160 is currently in an ongoing Phase 1, single ascending dose (SAD)/multiple ascending dose (MAD) healthy volunteer study for immune-mediated conditions.
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Under the terms of the agreement, Novartis will obtain exclusive worldwide rights to develop, manufacture, and commercialize MRT-6160 and other VAV1 MGDs and will be responsible for all clinical development and commercialization, starting with Phase 2 studies.
Novartis has agreed to pay Monte Rosa $150 million upfront. Monte Rosa is eligible to receive up to $2.1 billion in development, regulatory, and sales milestones, beginning upon initiation of Phase 2 studies, and tiered royalties on ex-U.S. net sales.
Monte Rosa will co-fund any Phase 3 clinical development and share any profits and losses associated with the manufacturing and commercialization of MRT-6160 in the U.S.
Monte Rosa remains responsible for completing the ongoing Phase 1 clinical study of MRT-6160.
In August, Monte Rosa Therapeutics dosed the first patient in the Phase 1 SAD/MAD study of MRT-6160. The company expects to obtain initial data from the Phase 1 study in the <a target="_blank" href="https://www.benzinga.com/pressreleases/24/08/g40436843/monte-rosa-therapeutics-announces-first-participants-dosed-in-mrt-6160-phase-1-study" rel="noreferrer noopener">first quarter of 2025</a>.
MRT-6160 is a potent, highly selective, and orally bioavailable investigational degrader of VAV1, a key signaling protein downstream of both the T- and B-cell receptors.
Preclinical studies have demonstrated deep degradation of VAV1, resulting in a significant decrease in cytokines linked to immune-mediated conditions, with no detectable effects on other proteins.
MRT-6160 has shown activity in preclinical models of multiple immune-mediated conditions.
Monte Rosa plans to provide further information regarding its updated cash position and runway in its third quarter <a target="_blank" href="https://www.benzinga.com/calendars/guidance" rel="noreferrer noopener">2024 earnings update.</a>
Price Action: GLUE stock is up 30.1% at $6.35 during the premarket session at last check Monday.
Photo via Shutterstock
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GLUE

Why Is Monte Rosa Therapeutics Stock Surging On Monday?

On Sunday, Novartis Presented 12-month Data From The Phase 3 APPEAR-C3G Study At American Society Of Nephrology Kidney Week 2024 Showing That C3 Glomerulopathy Patients Treated With Oral Fabhalta (Iptacopan) In Addition To Supportive Care Experienced Clinically Meaningful, Sustained Results At One Year

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CDC Issues Report On Missouri H5N1 Serology Testing; Confirms No Human-To-Human Transmission Of H5 Bird Flu Detected In US

A coalition of unions, consumer groups, and public interest organizations has written to Lina Khan, Chair of the Federal Trade Commission (FTC), voicing strong opposition to Novo Holdings&#8217; proposed <a target="_blank" href="https://www.benzinga.com/news/24/02/36986742/catalents-bloomington-plant-making-novo-nordisks-obesity-drug-faces-fda-scrutiny-regarding-drug-manu" rel="noreferrer noopener">$16.5 billion acquisition</a> of Catalent Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CTLT#NYSE">CTLT</a>).
The groups <a target="_blank" href="https://fingfx.thomsonreuters.com/gfx/legaldocs/byvrmlxkzpe/Consumer%20and%20Union%20Letter%20on%20Novo%20Catalent-10.17.24.pdf" rel="noreferrer noopener">argue</a> that the deal, which would unite the Danish pharmaceutical giant and dominant player in GLP-1 drug development, Novo Nordisk A/S (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>), with Catalent, a leading global contract development and manufacturing organization (CDMO), could harm competition in critical areas such as diabetes, obesity treatments, and gene therapies.
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The letter outlines concerns that the acquisition could lead to &#8220;vertical foreclosure,&#8221; limiting access for Novo&#8217;s current and future rivals in GLP-1 drugs and gene therapies.
Catalent, with its 50 global facilities, has been an industry leader in manufacturing GLP-1 drugs, including Novo&#8217;s own Ozempic and Wegovy.
Since 2017, Catalent has been one of the few CDMOs capable of providing the specialized fill-finish development and manufacturing services essential for GLP-1 therapies.
By acquiring Catalent, Novo would have the power and incentive to restrict other pharmaceutical companies from accessing these vital services, potentially diminishing competition in this critical drug category.
The letter also highlights Catalent&#8217;s significance in gene therapy manufacturing, particularly in producing treatments like Sarepta Therapeutics Inc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SRPT#NASDAQ">SRPT</a>) Elevidys and Novartis AG&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) Zolgensma.
Many of Catalent&#8217;s facilities focus on cell and gene therapies, and the coalition believes that Novo&#8217;s acquisition could disrupt the production and development of these treatments.
In summary, the coalition argues that keeping Catalent independent is vital for fostering innovation and maintaining competition in the pharmaceutical industry.
An independent Catalent would support future competitors to Novo in both GLP-1 drugs and gene therapies, ensuring that patients continue to have access to life-saving treatments without market limitations driven by consolidation.
Last week, United States Senator Elizabeth Warren wrote a letter to FTC&#8217;s Lina Khan, urging her to investigate the deal&nbsp;thoroughly, amid growing concerns about&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/10/41277809/ftc-faces-pressure-to-block-novo-nordisk-catalent-merger-over-antitrust-fears" rel="noreferrer noopener">potential antitrust violations</a>.
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After US Senator, Unions Urge Federal Trade Commission To Block Novo's $16.5B Acquisition Of Catalent

On Friday,&nbsp;Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) announced that the European Medicines Agency&#8217;s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion <a target="_blank" href="https://www.benzinga.com/general/biotech/22/12/29990021/novartis-kisqali-prolongs-progression-free-survival-benefit-in-metastatic-breast-cancer-versus-ch" rel="noreferrer noopener">for Kisqali (ribociclib)</a>.
The CHMP recommended approval granting marketing authorization for Kisqali (ribociclib) for the adjuvant treatment of adults with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC), at high risk of disease recurrence, <a target="_blank" href="https://www.benzinga.com//node/41399115" rel="noreferrer noopener">including those with node-negative disease.</a>
Also Read: <a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/24/09/40738489/goldman-sachs-shifts-stance-on-novartis-cites-lack-of-near-term-catalysts" rel="noreferrer noopener">Goldman Sachs Shifts Stance On Novartis, Cites Lack Of Near-Term Catalysts</a>.
The CHMP decision is based on data from the Phase 3 NATALEE trial.
In the trial, Kisqali plus endocrine therapy (ET), compared to ET alone, lowered the risk of cancer recurrence by 25.1% in patients with stage II and III HR+/HER2- EBC.
The data also demonstrated a consistent, clinically meaningful invasive disease-free survival (iDFS) benefit across key pre-specified subgroups.
Data from the pivotal trial also showed that the safety profile of Kisqali at the 400mg dose was well-tolerated, with generally low-grade symptomatic adverse events.
The European Commission (EC) will decide in approximately two months.
Last month, Novartis released new data from the ALITHIOS open-label extension study.
Data show first-line Kesimpta&nbsp;(ofatumumab) treatment for up to six years led to less disability and disease progression in recently diagnosed (≤3 years) and treatment-naïve (RDTN) people with relapsing multiple sclerosis (RMS), compared to those who switched from&nbsp;Sanofi SA&#8216;s <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40923550/novartis-multiple-sclerosis-drug-data-shows-most-patients-remain-with-no-disability-progression-f" rel="noreferrer noopener">Aubagio (teriflunomide)</a>.
Price Action: NVS stock is up 0.35% at $116.92 at last check Friday.
Photo via Shutterstock
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European Medicines Agency's Panel Supports Approval Of Novartis' Kisqali In Patients With Early-Breast Cancer

If approved, patients in Europe with stage II or III HR+/HER2- early breast cancer (EBC) at high risk of recurrence, including those with node-negative disease, will be eligible for adjuvant treatment with Kisqali (ribociclib) in combination with an aromatase inhibitor1
Recommendation is based on the Phase III NATALEE trial, where Kisqali added to endocrine therapy (ET) significantly reduced the risk of recurrence by 25% versus ET alone across a broad population of patients with HR+/HER2- early breast cancer 2
People with stage II or III HR+/HER2- EBC face significant risk of recurrence &ndash; often as incurable metastatic disease &ndash; despite adjuvant ET and regardless of nodal involvement3,4
In September, Kisqali was approved by the FDA in this setting5; at ESMO 2024, an updated analysis from NATALEE was presented, showing a deepening invasive disease-free survival benefit6

The Committee For Medicinal Products For Human Use Of The European Medicines Agency Has Adopted A Positive Opinion And Recommended Approval Of Novartis' Kisqali (Ribociclib) For Adjuvant Treatment Of Adults With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer, At High Risk Of Disease Recurrence

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>

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Alnylam Stock Up on Cardiomyopathy Drug Regulatory Filing in the EU

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Opinion

Press Releases

Cancer Research Sees Major Boost as New Breakthroughs Emerge from Key Oncology Players

How Critical Demand for Metastatic Breast Cancer Therapies is Producing a Multi-Billion Dollar Opportunity for Biotechs

Generate:Biomedicines Announces Multi-Target Collaboration with Novartis to Discover and Develop Protein Therapeutics with Generative AI

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Novartis receives positive CHMP opinion for Kisqali® to help reduce risk of recurrence in people with HR+/HER2- early breast cancer

OS Therapies Appoints Two Bio-Pharmaceutical Industry Veterans to the Board of Directors

Seaport Therapeutics Names Lauren White as Chief Financial Officer

PureTech Founded Entity Seaport Therapeutics Names Lauren White as Chief Financial Officer

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