Asalyxa Bio Inc. has closed on an oversubscribed seed financing of more than $2 million designed to advance its lead candidate, ASX-100, into the clinic in acute respiratory distress syndrome.
Brainstorm Cell Therapeutics Inc. said FDA senior leadership told the company the level of clinical data in the Nurown (neurotrophic factor-producing mesenchymal stem cells) phase III trial in amyotrophic lateral sclerosis (ALS) does not provide the threshold of substantial evidence needed to support a BLA.
Pfizer Inc. and Biontech SE submitted new data to the FDA showing its COVID-19 vaccine’s stability can be maintained at temperatures often found in pharmaceutical freezers and refrigerators: -13°F to 5°F (-25°C to -15°C). That’s cold but not nearly as cold as the mRNA-based vaccine’s emergency use authorization label calls for, which is storage in an ultra-cold freezer at temps of between -112 to -76 degrees Fahrenheit (-80 and -60 degrees Celsius).
Rigel Pharmaceuticals Inc. cut the biggest deal of the company’s life with its new collaboration with Eli Lilly and Co. that could be worth $960 million. The two will co-develop and commercialize Rigel’s R-552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications including autoimmune and inflammatory diseases.
Excision Biotherapeutics Inc.’s CEO is specific when he talks about his company’s therapies and what they may achieve: a functional cure. “When you treat someone and they become cancer free, you can’t use the world ‘cured’ because the cancer may come back decades later,” Daniel Dornbusch told BioWorld. “But you can talk about a functional cure, meaning the cancer didn’t come back for a very long time. It’s functionally cured for maybe 10, 20 or 30 years."
Another monoclonal antibody therapy has entered the pandemic fray with the FDA granting emergency use authorization (EUA) for bamlanivimab (LY-CoV555) 700 mg and etesevimab (JS016 or LY-CoV016) 1,400 mg as a cocktail for treating mild to moderate COVID-19 in patients aged 12 and up at high risk for progressing to severe COVID-19 and/or hospitalization.
The FDA placed a partial clinical hold on atuzaginstat (COR-388) from Cortexyme Inc., of South San Francisco, stating that no new participants should be enrolled in the open-label extension portion of the phase II/III GAIN trial in mild to moderate Alzheimer’s disease.
Immunogen Inc. leads a busy earnings season with numbers that pushed the stock (NASDAQ:IMGN) 30.3% higher on Feb. 12. The antibody-drug conjugates developer posted revenues of $132.3 million for 2020 compared to its $82.3 million in revenues for 2019, a 62.2% increase.
Molecular Templates Inc., of Austin, Texas, has signed an R&D collaboration with Bristol Myers Squibb Co. (BMS) worth $70 million up front and potential development, regulatory and sales milestone payments of up to $1.3 billion. Molecular Templates will work on therapies designed for unnamed oncology targets to kill targeted cells by forcing receptor internalization, delivering payloads and enzymatically inactivating ribosomes.
Another monoclonal antibody therapy has entered the pandemic fray with the FDA granting emergency use authorization (EUA) for bamlanivimab (LY-CoV555) 700 mg and etesevimab (JS016 or LY-CoV016) 1,400 mg as a cocktail for treating mild to moderate COVID-19 in patients aged 12 and up at high risk for progressing to severe COVID-19 and/or hospitalization.
