This week, the FDA granted priority review status to J&J’s JNJ application seeking approval of key pipeline candidate nipocalimab for the treatment of generalized myasthenia gravis (gMG). The regulatory agency also asked Pfizer PFE and GSK GSK to include a new warning on the labels of their respective Respiratory Syncytial Virus (RSV) vaccines. Novo Nordisk NVO expanded its existing collaboration with artificial intelligence (AI)-driven drug development company Valo Health to develop novel treatments for obesity, type II diabetes and cardiovascular disease.

Here's a recap of the week’s most important stories.

FDA Grants Priority Tag to J&J's Nipocalimab BLA

The FDA granted priority review designation to J&J’s biologics license application (BLA) seeking approval of nipocalimab for antibody-positive patients with gMG, a rare, autoantibody-driven disease. The BLA was based on data from the phase III Vivacity-MG3 study. Nipocalimab is also under review in the EU for the gMG indication and is in mid and late-stage development for several rare autoantibody-driven rare diseases.

J&J’s MedTech unit is temporarily pausing sales of Varipulse, its pulsed field ablation therapy to treat atrial fibrillation in the United States, as it investigates four reported cases of neurovascular events. The pause on Varipulse procedures began on Jan. 5. The FDA approved the Varipulse platform in November last year.

The cases were related to an external rollout plan conducted by J&J. The pause does not impact the rollout in outside U.S. markets.

The FDA granted Fast Track designation to posdinemab, J&J’s phosphorylated tau-directed monoclonal antibody, for the treatment of early Alzheimer’s disease. The FDA had granted Fast Track status to J&J’s another candidate, JNJ-2056, anti-tau active immunotherapy for treating preclinical Alzheimer’s disease in July 2024. Both posdinemab and JNJ-2056 are being developed in phase IIb studies.

J&J’s phase III MARIPOSA study evaluating a combination of Rybrevant plus Lazcluze for the first-line treatment of certain patients with EGFR-mutated non-small cell lung cancer (NSCLC) met the final pre-specified secondary endpoint of overall survival. In the study, Rybrevant plus Lazcluze demonstrated clinically meaningful and statistically significant improvement in overall survival versus the current standard of care osimertinib. Rybrevant plus Lazcluze is already approved for the first-line treatment of patients with EGFR-mutated NSCLC in the United States and EU based on progression-free survival data from the MARIPOSA study.

NVO Signs Expanded Deal With Valo Health

Novo Nordisk announced that it is expanding its previous collaboration with Valo Health to discover and develop novel treatments for cardiometabolic diseases. The companies had originally signed the collaboration in 2023, under which the companies had agreed to the development of up to 11 drug programs, primarily focused on cardiovascular disease. Under the expanded deal, the companies will discover and develop up to 20 novel drug programs in obesity, type II diabetes as well as cardiovascular disease, leveraging Valo’s extensive human dataset and computation powered by AI.

Under the original deal, Valo was entitled to receive up to $2.7 billion in milestone payments plus R&D funding and potential royalty payments, which has now gone up to $4.6 billion, In addition, Valo will also receive NVO near-term payments totaling up to $190 million for the expanded deal.

FDA Requires New Warning on PFE & GSK’s RSV Vaccines’ Label

The FDA required Pfizer and GSK to update the safety information on the label of their RSV vaccines, Abrysvo and Arexvy, respectively. The FDA has asked Pfizer and GSK to include new warnings about the risk of Guillain-Barré syndrome (GBS), a rare neurological disorder following the administration of their RSV vaccines. The Prescribing Information section for both the vaccines has been updated to include the warning. Both Abrysvo and Arexvy were approved in May 2023.

The NYSE ARCA Pharmaceutical Index rose 0.8% in the past five trading sessions.

Large Cap Pharmaceuticals Industry 5YR % Return

Large Cap Pharmaceuticals Industry 5YR % Return

Here’s how the eight major stocks performed in the previous five trading sessions.

Image Source: Zacks Investment Research

In the last five trading sessions, Novartis rose the most (3.0%), while J&J declined the most (1.6%).

In the past six months, while AbbVie rose the most (5.0%), Novo Nordisk declined the most (38.8%).

(See the last pharma stock roundup here: Pharma Stock Roundup: PFE Ends Hemophilia Deal With SGMO & More)

What's Next in the Pharma World?

Watch this space for regular pipeline and regulatory updates next week.

J&J has a Zacks Rank #2 (Buy), while Pfizer has a Zacks Rank #3 (Hold). GSK and Novo Nordisk have a Zacks Rank #4 (Sell) each.

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here

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