Just as Wall Street had begun mulling the possible fallout of the regulatory vote against full U.S. FDA clearance for Amgen Inc.’s KRAS G12C therapy for non-small-cell lung cancer, a new – albeit not entirely unexpected – development cropped up in the space. Mirati Therapeutics Inc. disclosed Oct. 9 that Bristol Myers Squibb Co. (BMS) is offering to take over the firm in a deal that could be worth as much as $5.8 billion, historically one of the larger takeovers for 2023. Read More
Following an unexpected FDA complete response letter (CRL), Alnylam Pharmaceuticals Inc. said it will no longer pursue an expanded indication for Onpattro (patisiran) in the U.S. The RNAi therapeutic was approved in 2018 to treat polyneuropathy of hereditary transthyretin-mediated (ATTR) amyloidosis and seemed well on its way to snagging a second U.S. indication after the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-3 in September that the drug’s benefits outweighed its risks as a treatment for cardiomyopathy of ATTR amyloidosis. The FDA disagreed with the committee, saying in the CRL that patisiran’s clinical meaningfulness had not been established in the proposed indication. Read More
In what TD Cowen analyst Joseph Thome called an “upside surprise,” Anaptysbio Inc. reported positive top-line data from its phase III Gemini-1 study of imsidolimab, a monoclonal antibody designed to inhibit the interleukin-36 receptor, in patients with generalized pustular psoriasis (GPP), positioning the firm for a potentially productive out-licensing deal. Read More
The BioWorld Biopharmaceutical Index (BBI) has fallen from its highest point this year to close September up 5.91% since the start of the year. BBI was down 3.65% at the end of February, peaked at 7.87% at the end of August, then closed up 5.91% on Sept. 29, tracking higher than both the Nasdaq Biotechnology Index (NBI) and Dow Jones Industrial Average. Read More
For most psychiatric illnesses, the precipitating event is mysterious. Many conditions are thought to result from a mix of genetic risk and environmental factors, but the specific trigger remains unknown. In post-traumatic stress disorder (PTSD), the environmental trigger is usually clear. In many cases, it is all the affected individuals can think about. “Intrusive reliving” of the triggering situation is one of the core features of PTSD. Read More
There are several pan-PIM kinase inhibitors in development for cancer indications, but startup Mysthera Therapeutics AG hopes to become the first biotech company to develop them in the autoimmune diseases space, having secured $3.5 million in seed capital from founding investor Forty51 Ventures. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Gain, Mindbio, Moberg, Oncternal, Rivus. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Curasen, Ideaya, GSK, Mediwound, Protalix. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amylyx, Arcutis, ARS, GC, Janssen. Read More
