Recent Funding:
Mithradote Bio has secured $1 million in an oversubscribed seed round, co-led by Taho Pharma and Vickers Venture Partners. The funding will support the development of M-101, a sublingual antidote targeting a range of “date-rape” drugs. This innovative solution addresses the global issue of drug-facilitated sexual assault, providing a self-administered option for those who suspect they have ingested harmful substances.
Recent Layoffs:
Turnstone Biologics is restructuring, cutting its workforce by 60% and focusing on its Phase 1 TIDAL-01 program, a Selected Tumor-Infiltrating Lymphocyte (TIL) therapy for solid tumors. The restructuring aims to extend the company’s cash runway into Q2 2026. Leadership transitions include promotions and retirements as Turnstone pivots resources toward advancing TIDAL-01 in trials for colorectal cancer, head and neck cancer, and uveal melanoma.
M&A, Deals, Partnerships:
Lundbeck has announced plans to acquire Longboard Pharmaceuticals for $2.6 billion, gaining access to its lead asset, bexicaserin, a promising treatment for rare epilepsies such as Dravet and Lennox-Gastaut syndromes. The acquisition aligns with Lundbeck’s strategy to strengthen its neuro-rare disease portfolio, with bexicaserin entering a global Phase III trial. Expected to launch by 2028, bexicaserin holds blockbuster potential with estimated peak sales between $1.5 to $2 billion.
IPOs:
Upstream Bio raised $255 million through its IPO to advance its lead drug, verekitug, which targets TSLP, a protein driving inflammatory responses in respiratory diseases. The drug is in Phase 2 trials for chronic rhinosinusitis and asthma, and Upstream expects results by 2025. This IPO success reflects investor enthusiasm for immune drug research, with immunology-focused biotechs seeing the most IPOs outside oncology this year.
FDA Approvals:
Pfizer’s Hympavzi, a once-weekly injectable treatment for hemophilia A and B, has been approved by the FDA. Unlike traditional factor replacement therapies, Hympavzi reduces an anticoagulatory protein (TFPI), helping prevent bleeding. This expands Pfizer’s hemophilia portfolio, which now includes three treatment classes: anti-TFPI, gene therapy, and recombinant factor therapies. The approval offers new flexibility for patients and is expected to compete with existing treatments from Roche and Sanofi.
The FDA approved inavolisib, combined with palbociclib and fulvestrant, for treating endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer. In a trial, inavolisib significantly improved progression-free survival and objective response rates compared to placebo. This approval includes the FoundationOne Liquid CDx as a companion diagnostic test. The drug was reviewed under Project Orbis, a global oncology initiative.
Other Interesting News:
Gritstone bio has filed for Chapter 11 bankruptcy to restructure and seek strategic alternatives. The biotech, which develops next-generation vaccines and immunotherapies, aims to secure a stalking horse bidder and continue advancing key programs like its neoantigen immunotherapy GRANITE. The restructuring will allow Gritstone to maintain operations, minimize disruptions, and focus on its mission to deliver innovative treatments for oncology and infectious diseases.
Denali Therapeutics disclosed that Sanofi has discontinued the Phase 2 study of oditrasertib (SAR443820/DNL788) for multiple sclerosis. The decision came after the drug failed to meet its primary and key secondary endpoints. This update was shared under Regulation FD Disclosure and does not affect the company’s liabilities under the Securities Exchange Act. Forward-looking statements are subject to change based on future results, as outlined in Denali’s regulatory filings.
Gilead has terminated its collaboration with Yuhan for two metabolic dysfunction-associated steatohepatitis (MASH) therapies. Despite one candidate showing strong preclinical efficacy, Gilead decided to withdraw after reviewing the data. The termination means Gilead loses the $15M upfront payment but avoids $770M in potential milestone payouts. This marks another setback for Gilead in the MASH space, although the company remains involved in other liver disease therapies.
