Sanofi

Vir Biotechnology's tobevibart and elebsiran granted Breakthrough Therapy and PRIME designations for chronic hepatitis delta treatment. Phase 2 SOLSTICE trial results show potential to suppress hepatitis delta virus. Company plans Phase 3 ECLIPSE program for 2025. Analysts revise earnings upwards despite stock decline.

ASH 2024 highlights include GSK's Blenrep Phase 3 data supporting re-market, J&J's Darzalex Faspro delaying progression in smoldering multiple myeloma, Arcellx's anito-cel showing comparable safety to Carvykti, and J&J/Legend's Carvykti improving survival outcomes. Kura Oncology's ziftomenib showed high response rates in leukemia, Eli Lilly's Jaypirca reduced disease progression risk, and Merck's zilovertamab vedotin achieved high complete response rates in lymphoma. Beam Therapeutics' BEAM-101 showed durable effects in sickle cell disease, Novo Nordisk's etavopivat reduced crises, and Bristol Myers Squibb's arlo-cel demonstrated durable responses in multiple myeloma. Galapagos' GLPG5101 showed encouraging cell therapy results, Orca Bio's Orca-T improved survival in blood cancers, and Sanofi's rilzabrutinib improved platelet response in thrombocytopenia. Regeneron's drug combo showed better disease control than Ultomiris in PNH.

Sanofi's two combination flu-Covid vaccines for people aged 50+ received FDA fast track status. Both candidates combine proven vaccines, showing favorable tolerability. One pairs Fluzone High-Dose with Novavax Covid-19, the other Flublok with Novavax. Sanofi aims for simpler scheduling and high efficacy, safety, and tolerability.

CD40/CD40L pathway is crucial for immune regulation and disease pathogenesis, with therapeutic potential in autoimmune diseases and cancer. CD40 targeting therapies aim to modulate immune response, with Frexalimab (SAR441344) showing promise in MS treatment. Despite no approved therapies as of December 2024, CD40 targeting therapies are expected to enter the market by 2029.

Hosts discuss PARASOL Initiative's efforts to establish surrogate endpoints for FSGS trials, focusing on proteinuria as a robust predictor of kidney failure, potentially enabling smaller, faster trials.

Sanofi's combination vaccine candidates for influenza and Covid-19 in people aged 50+ received FDA fast track designation. The candidates merge existing vaccines with demonstrated efficacy and tolerability. Two Phase I/II trials assess immune response and safety, aiming for simpler immunisation programmes.

Sanofi's COVID-19 and flu combination vaccines for individuals aged 50+ received FDA fast track designation. The vaccines combine Sanofi's Fluzone High-Dose or Flublok with Novavax's adjuvanted COVID-19 vaccine, aiming to simplify immunization and boost uptake. Clinical trials show efficacy and tolerability, with Sanofi initiating phase 1/2 studies. The partnership with Novavax includes a $1.2bn licensing agreement.

COVID-19 treatment companies focus on vaccines, antivirals, monoclonal antibodies, and supportive care. Vaccines like Pfizer-BioNTech and Moderna reduce severe cases, while antivirals like Remdesivir and Paxlovid limit viral replication. Monoclonal antibodies like Bamlanivimab offer early intervention. Supportive care remains crucial. Market growth is driven by COVID-19 spread, new variants, and increased demand for effective therapies. Government investments and rapid vaccine advancements accelerate treatment availability. The global pulmonary drug delivery systems market is projected to reach USD 97.8 billion by 2033.

The PARASOL Initiative aims to revolutionize FSGS drug development by validating proteinuria as a therapeutic endpoint. Experts discuss how proteinuria reduction can accelerate approvals, emphasizing the need for addressing podocyte dysfunction. The initiative also focuses on specimen banking for biomarker discovery and collaborative research models for rare kidney diseases.

Sanofi's combo vaccine candidates for flu and Covid-19 in people aged 50+ received FDA fast track designation, combining existing vaccines with demonstrated efficacy. Two Phase I/II trials assess immune response and safety, aiming for simpler scheduling and fewer injections.