Novavax

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Novavax received FDA approval to continue testing its COVID-19-flu combination and standalone flu vaccines after a clinical hold was lifted due to a serious adverse event. The company's data indicated the vaccine did not cause the issue, and it plans to resume Phase 3 trials.

The FDA has lifted the clinical hold on Novavax's COVID-19 and influenza combination vaccine trials, allowing Phase 3 testing to resume after addressing concerns. The hold was due to a serious adverse event initially classified as motor neuropathy, later determined to be ALS, unrelated to the vaccine. Novavax aims to capitalize on a protein-based alternative to mRNA vaccines, despite market challenges.

The FDA has lifted the clinical hold on Novavax's COVID-19-Influenza Combination and stand-alone influenza vaccine candidates, allowing the initiation of a Phase 3 trial. The hold was due to a serious adverse event initially reported as motor neuropathy, later changed to amyotrophic lateral sclerosis, which was assessed as unrelated to the vaccine.

FDA considers removing oral phenylephrine from OTC guidelines due to lack of efficacy, not safety concerns. Public comments invited until May 7, 2025, before final decision. Phenylephrine is in many nasal decongestants like Sudafed and Mucinex. FDA's proposal does not affect nasal spray decongestants.

DelveInsight's 'Respiratory Syncytial Virus Pipeline Insight, 2024' report details 50+ companies developing 50+ therapies, including Nirsevimab, Sisunatovir, and RSVpreF, across various stages of clinical trials. Key companies include GSK, Pfizer, and Sanofi, with recent successes like GSK's Arexvy vaccine and MSD's clesrovimab. The report covers mechanism of action, route of administration, and market dynamics.

Sanofi reports 15.7% Q3 sales growth, driven by vaccine sales and strong business performance, raising 2024 EPS guidance. Dupixent sales up 23.8%, with full-year target confirmed at €13 billion. Pharma launches grew 67.1%, led by ALTUVIIIO, Nexviazyme, and Rezurock. Vaccines sales increased 25.5%, boosted by flu sales and Beyfortus. Opella sales rose 7.9%, supported by Qunol acquisition. R&D expenses grew 12.7%, while SG&A expenses grew 6.4%. Business EPS at €2.86, up 12.2% reported and 17.6% at CER. Four regulatory approvals and four positive phase 3 data readouts achieved. Negotiations underway to transfer a controlling stake of Opella to CD&R. 2024 business EPS guidance upgraded to low single-digit growth at CER.

Activist investors, like Starboard Value, are targeting pharma giants such as Pfizer and Novavax, pressuring them to improve performance post-pandemic. This trend reflects broader activism across industries, with investors seeking financial gains and operational changes. Successful activism can drive stock price increases, as seen with Carl Icahn's efforts at Apple and Illumina. For Pfizer, Starboard's involvement highlights dissatisfaction with pandemic-era acquisitions and stock performance, suggesting a need for strategic adjustments. The rise of activist investing underscores the importance of corporate governance and continuous shareholder engagement.