BAVARIAN NORDIC

Respiratory syncytial virus (RSV) market report by DelveInsight covers epidemiology, market forecast, and key companies like Bavarian Nordic, GlaxoSmithKline, Janssen, Sanofi, AstraZeneca, Moderna, ReViral, Pfizer, and others. Promising therapies include Nirsevimab, RSVpreF Vaccine, RSVpreF3 Vaccine, MVA-BN RSV Vaccine, Ad26.RSV.pre F Vaccine, mRNA-1345 Vaccine, NJ-53718678, Clesrovimab, EDP-938, MEDI8897, GS-5806, RV521, ALN-RSV01, and others.

ExpreS2ion Biotechnologies announces approval for Phase I trial of ES2B-C001, a novel HER2-expressing breast cancer vaccine, following successful preclinical studies. The trial aims to assess safety and efficacy, with potential to address multiple cancer types.

Novartis acquires Kate Therapeutics for $1.1B, Barclays predicts challenging 2025 for European pharma, Trump picks surgeon Martin Makary to lead FDA, Novartis partners with Ratio Therapeutics for up to $745M, Kyowa Kirin pays Kura Oncology $330M upfront for leukemia drug rights, global measles cases rise 20% to 10.3 million, Brookfield considers €7B bid for Grifols, Bavarian Nordic's 2025 order book reaches €320M, FDA supports REGENXBIO's Duchenne muscular dystrophy gene therapy, Merck's subcutaneous Keytruda matches infused version, Syndax Pharmaceuticals secures FDA approval for Revuforj, Aclaris Therapeutics licenses 2 antibodies from Biosion for over $40M upfront, Sandoz to cut 10% of workforce in France, Incyte halts testing and discontinues drugs, Sage Therapeutics discontinues dalzanemdor, Johnson & Johnson and Merck announce job cuts in China, Samsung Biologics signs $668M contracts, FDA grants accelerated approval to Jazz Pharmaceuticals' Ziihera, Lexicon Pharmaceuticals cuts 60% of workforce, Halozyme withdraws €2B bid for Evotec, mpox epidemic overwhelms hospitals in Kinshasa.

NanoViricides reported Q3 2024 financials with $3.87M cash and $7.36M net property assets. Lead drug NV-387, a broad-spectrum antiviral, is advancing to Phase II trials for MPOX, RSV, Influenza, and COVID. A Phase Ia/Ib trial was completed with no adverse events. The company raised $1.71M through an ATM offering and has a $3M credit line, but additional funding is needed for planned Phase II trials. NV-387 showed promising results in animal trials, potentially offering superior effectiveness over existing treatments.

110+ organizations urge Congress to reauthorize PAHPA by Dec 31, recognizing the opportunity to strengthen national health security during the 2025 leadership transition.

Bavarian Nordic plans to expand MVA-BN mpox/smallpox vaccine approval to children aged 2-11, initiating a Phase II trial. The study, partially funded by CEPI, aims to compare safety and immunogenicity between children and adults. MVA-BN is marketed as Jynneos in the US and Imvanex in Europe, with recent label expansions by EMA and GAVI agreements.

Bavarian Nordic initiates clinical study of MVA-BN mpox/smallpox vaccine in children 2-11 years in DRC and Uganda, aiming to extend vaccine approval to this age group. The study, partially funded by CEPI, follows recent EMA and WHO approvals for adolescents.