Novavax

Many biotechs that rose during the pandemic have faced challenges as their COVID-19 candidates faltered. CureVac, after its mRNA vaccine's low efficacy, restructured and partnered with GSK. Novavax, despite FDA approval, struggled with uptake and faced a clinical hold on its flu/COVID shot. Inovio Pharmaceuticals, once a frontrunner with DNA-based tech, faced controversy and delayed its FDA application. Veru's antiviral sabizabulin was denied EUA and now focuses on GLP-1 related treatments.

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Novavax announced FDA removal of clinical hold on COVID-19-Influenza combination and influenza vaccine trials, allowing Phase 3 trials to start after addressing safety concerns.

Novavax received FDA clearance to proceed with phase 3 trials for its COVID-19-influenza combination and standalone influenza vaccines after addressing a clinical hold related to a reclassified adverse event.

Novavax received FDA approval to resume clinical trials for its Covid-19 and influenza combination vaccine (CIC) and standalone influenza vaccines after a month-long hold. The Phase III trial will evaluate the CIC vaccine's efficacy in adults aged 65 and older, comparing its immune response to standard flu and Covid-19 vaccines. Novavax aims to commence enrolment by the end of 2024 with preliminary results by mid-2025.

Novavax received FDA approval to resume clinical trials for its Covid-19 and influenza combination vaccine (CIC) and standalone influenza vaccines after a month-long hold. The Phase III trial will evaluate the CIC vaccine's efficacy in adults aged 65 and older, comparing its immune response to standard flu and Covid-19 vaccines. Novavax aims to commence enrolment by the end of 2024, with preliminary results expected by mid-2025.

Novavax's COVID-19-influenza combination vaccine and stand-alone influenza vaccine candidates have had their clinical hold removed by the FDA after addressing safety concerns. The serious adverse event initially reported was unrelated to the vaccine, allowing for plans to resume Phase 3 trials.

FDA lifts clinical hold on Novavax's COVID-19/influenza combo vaccine after addressing a serious adverse event initially reported as motor neuropathy, now identified as amyotrophic lateral sclerosis. Novavax plans to resume phase 3 trials with its Matrix-M adjuvant, enhancing immune response. The company recently secured FDA EUA for its JN.1-adapted COVID-19 vaccine and a $1.2bn licensing deal with Sanofi for co-commercialization.

Biopharma layoffs continue into 4Q 2024, affecting companies like Thermo Fisher, Charles River, Pfizer, Evonik, Johnson & Johnson, Bayer, Bristol Myers Squibb, AGC Biologics, and others. These layoffs are part of restructuring initiatives, site closures, and focus shifts in strategic core growth areas.

The FDA has lifted the clinical hold on Novavax's Phase III trials for a COVID-19-influenza Combination vaccine and standalone influenza vaccine, allowing recruitment to resume. The hold was due to a serious adverse event in a prior trial, which was later deemed unrelated to the vaccine. Novavax plans to start the Phase III trial as soon as possible, utilizing its Matrix-M adjuvant technology.