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.
Janssen Pharmaceutica NV and Exelixis Inc. are among the many companies releasing new data ahead of the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), which runs Feb. 11-13.
The week finished with flurry of biotech IPOs, seven of them, a record number in a single day, according to BioWorld stats. Last year was a record year for IPOs as 106 new offerings were completed and raised $22.5 billion, more than double the previous record of $10.7 billion set in 2018. The seven companies that priced Feb. 5 are anticipating total gross proceeds of about $1.06 billion.
Of the three companies launching IPOs Feb. 4, one struggled mightily, another posted double-digit gains while the third ended the day flat. Shares of Landos Biopharma Inc. (NASDAQ:LABP) dropped 25%, to $12 each, on their first day of trading. Sana Biotechnology Inc. (NASDAQ:SANA) had the strongest first day of trading as shares closed 40.4% higher at the close at $35.10. Sensei Biotherapeutics Inc. (NASDAQ:SNSE) saw its IPO launch roughly break even on its first day of trading, closing with only a half-point gain at $18.90.
Pfizer Inc. reported solid earnings for 2020 and said it expects even bigger things this year as the company projects approximately $15 billion in earnings from the COVID-19 vaccine it co-developed with Biontech SE.
Shanghai Junshi Biosciences Co. Ltd. could receive an aggregate $1.1 billion from Coherus Biosciences Inc. for the rights to develop and commercialize Junshi’s anti-PD-1 antibody toripalimab in the U.S. and Canada. The deal is powered by Coherus’ core biosimilar business and is designed to steer the company into the business of immuno-oncology.
