Bristol Myers Squibb Co. (BMS) is offering to take over Mirati Therapeutics Inc. in a deal worth as much as $5.8 billion. By way of a subsidiary it would acquire all of the outstanding shares of Mirati common stock at a price of $58 each in cash, a 52% premium to the 30-day volume-weighted average price as of the Oct. 4 market close. This means a total equity value of $4.8 billion, which corresponds to an enterprise value of about $3.7 billion, accounting for about $1.1 billion of Mirati’s cash. In addition, a contingent value right for each Mirati share held brings the total potential value up to $5.8 billion. The deal brings to BMS Krazati (adagrasib), the KRAS G12C inhibitor approved for non-small-cell lung cancer, and follows closely an FDA advisory committee’s negative vote for Amgen Inc.’s drug in the space, Lumakras (sotorasib). Unless another bidder intervenes, the merger is expected to close by the first half of next year. Shares of San Diego-based Mirati (NASAQ:MRTX) were trading midday at $57.38, down $2.82.

Alnylam: No new US indication for Onpattro following surprise CRL

Following an unexpected FDA complete response letter (CRL), Alnylam Pharmaceuticals Inc. said today 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 an FDA advisory committee voted 9-3 last month that the drug’s benefits outweighed its risks as a treatment for cardiomyopathy of ATTR amyloidosis. But the FDA disagreed, saying in the CRL that patisiran’s clinical meaningfulness had not been established in the proposed indication. The news shaved Alnylam (NASDAQ:ALNY) by as much as 9% this morning, with shares dropping from the Oct. 6 close of $176.92 to as low as $160.79.

Anaptysbio scores phase III win for imsidolimab in GPP

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), showing that 53.3% who received a single dose achieved a clear or almost clear score using the Generalized Pustular Psoriasis Physician Global Assessment vs. 13.3% of patients on placebo (p=0.0131). A BLA filing could follow by the third quarter of 2024, putting the drug up against Boehringer Ingelheim GmbH’s Spevigo (spesolimab), which gained U.S. FDA approval in 2022 as the first therapy for GPP, a rare, systemic autoinflammatory disease characterized by painful pustules erupting all over the body.

Biopharma stocks stay strong, end Q3 higher than NBI and Dow

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 and the Dow Jones Industrial Average. Among the industry’s biggest newsmakers are Amgen Inc. – which just completed its $27.8 billion acquisition of Horizon Therapeutics plc and received a negative vote by a U.S. FDA advisory committee for lung cancer drug Lumakras (sotorasib) – and Alnylam Pharmaceuticals Inc., which received an unexpected complete response letter for Onpattro (patisiran) to treat cardiomyopathy of transthyretin-mediated amyloidosis.

ECNP 2023: Boosting fear unlearning is one avenue toward treating PTSD

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. Ironically, the classic symptoms of PTSD such as hyperarousal, insomnia and hypervigilance start out as adaptive responses. This is true for combat veterans, but also for individuals with complex PTSD that can result from growing up in an abusive home.

Newco news: Mysthera launches with $3.5M in seed to advance first-in-class PIM kinase inhibitors

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. One of those diseases is myasthenia gravis, words of Greek and Latin heritage that describe the characteristic muscle weakness seen with the condition and which served as inspiration for the Basel, Switzerland-based firm’s name, while lupus nephritis is the firm’s focus indication. Both were hand-picked from the many autoimmune diseases on account of the PIM expression seen within inflammatory lesions in these diseases, and early preclinical evidence that supports a PIM inhibition approach.

Also in the news

Alvotech, Amylyx, Anebulo, Arcutis, ARS, Ashvattha, Astronautx, Curasen, Dyadic, Gain, GC, GSK, Ideaya, Imunon, Janssen, Leo, Lexicon, Limmatech, Lixte, Mediwound, Oncternal, Mindbio, Moberg, Protalix, Rivus