Syros Pharmaceuticals Inc.’s phase III failure with oral retinoic acid receptor alpha agonist tamibarotene in myelodysplastic syndrome (MDS) meant not only severe stock damage but also defaulting on the loan facility with Oxford Finance LLC, which means an obligation may be accelerated for the company of about $43.6 million, including principal, interest, and other amounts, according to an SEC filing. Read More
Amgen Inc. has shrugged off a Cantor Fitzgerald analyst report that wiped about $12 billion from the company’s market cap. The Nov. 12 analyst report noted supplemental data from the company’s phase I study of obesity drug Maritide showing bone mineral density loss in patients. Read More
On the heels of U.S. FDA approval of its first T-cell therapy, Adaptimmune Therapeutics plc reported positive results from a pivotal study for its second candidate, letetresgene autoleucel, expected to support a rolling BLA submission in 2025 that could bolster the firm’s offerings as it narrows its focus on the rare sarcoma space. Read More
Daiichi Sankyo Co. Ltd. and Astrazeneca plc have submitted a new BLA to the U.S. FDA for accelerated approval for datopotamab deruxtecan for treating locally advanced or metastatic epidermal growth factor receptor-mutated non-small-cell lung cancer patients who have received prior systemic therapies. Read More
Apollo Therapeutics Group Ltd. and Sunshine Lake Pharma Co. Ltd. inked a potential $938 million licensing deal for APL-18881 (HEC-88473), Sunshine’s dual fibroblast growth factor 21 (FGF21)/glucagon-like peptide-1 (GLP-1) receptor agonist currently in a phase II study for type 2 diabetes. Read More
Six main cell types form glioblastomas, the most aggressive brain cancer due to its high rate of recurrence. Of these six, quiescent cancer stem cells are responsible for resistance to therapy and the reappearance of the tumor, according to a study that identified the six groups and highlighted the importance of these stem cells for the design of more effective therapies. Read More
For a small company, Modifi Biosciences has come a long way very quickly. Founder Ranjit Bindra talks about how his company went from tiny to nearly extinct at least twice until it was acquired by Merck for $30 million up front. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbisko, Astrazeneca, Code, Gilead, Gritstone, Hookipa, Insilico, Invivyd, Neurogene, Organogenesis, Quince, Spyre, Syndax, Viiv. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 23andme, Centessa, Egenesis, Enveric, Formation, Kancera, Medicinova, Mycomedica, Organox, Sanofi. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abeona, Actuate, Astrazeneca, Attralus, Intercept, J&J, Mirum, Vaxcyte. Read More