Novavax

INTREPID Alliance forms Scientific Advisory Board (SAB) to accelerate antiviral therapy development for future pandemics, with experts guiding research priorities and strategy.

Wave Life Sciences' RNA editing platform demonstrated successful editing of mutant Z-AAT mRNA in humans, leading to a 74% stock surge. Korro Bio and ProQR Therapeutics also saw significant stock gains due to their RNA editing therapies. Investors were impressed by the rapid and durable effects of Wave's WVE-006, with wild-type M-AAT protein reaching 6.9 micromolar at day 15. Analysts predict Wave's RNA editing platform will advance its pipeline and validate its technology.

Novavax's combined COVID-19 and flu vaccine program faces a clinical hold by the FDA due to a serious adverse event, causing a 20% share drop. The hold delays a potential major product for the biotech, adding uncertainty to its revenue prospects. Despite this, Novavax's latest COVID-19 vaccine is available in more locations, and the company plans to unveil an expanded clinical pipeline by year-end.

The FDA placed a clinical hold on Novavax’s COVID-19/influenza combination vaccine IND after a participant reported motor neuropathy. Novavax shares fell 16%, but their COVID-19 vaccine on the US market remains unaffected. The company is working with the FDA to resolve the issue and resume phase 3 trials, emphasizing safety as a priority.

FDA placed a clinical hold on Novavax's COVID-19-Influenza combination and standalone influenza vaccine candidates due to a reported serious adverse event of motor neuropathy in a phase 2 trial participant. Novavax is committed to working with the FDA to resolve the issue.

Sage Therapeutics cuts staff, Eisai/Biogen's Leqembi rejected in Australia, Sanofi invests in Orano Med, Novartis licenses Chinese cancer treatment, telehealth's GLP-1 boom driven by select doctor groups, former Trump official calls for IRA revisit, BMS CEO discusses company pivot, Lilly CSO warns against weakening patents, GLP-1s linked to lower opioid overdose risk, Novavax faces vaccine setback.

The FDA placed a hold on Novavax’s COVID-19 and influenza combination vaccine candidate due to a serious adverse event reported in a phase 2 trial participant. Novavax is working with the FDA to resolve the issue, emphasizing safety as a priority. The hold affects the combination vaccine and a standalone influenza vaccine, but not the standalone COVID-19 vaccine.

FDA places clinical hold on Novavax's COVID-19-Influenza Combination and stand-alone influenza vaccine candidates due to a serious adverse event reported in a Phase 2 trial participant. Novavax is working with the FDA to resolve the hold and prioritize safety.

Novavax shares dropped 20% after FDA halted clinical testing of its COVID-19/flu combo vaccine due to a serious adverse event. The hold could delay planned Phase 3 trials and impacts Novavax's future, which relies on combo vaccines and a recent $500 million deal with Sanofi.