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AbbVie enters pan-RAS with option to buy Kestrel for up to $1.45B
AbbVie agreed to a staged transaction that gives it an exclusive right to acquire Kestrel Therapeutics for up to $1.45 billion, contingent on milestones tied to Kestrel’s oral pan-RAS inhibitor,...
Eli Lilly expands genetic medicine with Profluent recombinase deal
Eli Lilly struck a deal with Profluent to develop new forms of gene editors that could, in principle, insert entire genes into patients, as reported by STAT+. The collaboration is described as...
Incyte’s povorcitinib scores twin Phase 3 vitiligo wins; plans to file
Incyte said its JAK1 inhibitor povorcitinib delivered success in two Phase 3 trials in nonsegmental vitiligo, and the company plans to file for approval. The readouts position the oral therapy as...
FDA action targeting Tavneos approval undermines Amgen’s rare disease drug
The FDA proposed withdrawing Amgen’s Tavneos (avacopan) approval after alleging untrue statements of material fact in the approval application. The agency’s Center for Drug Evaluation and Research...
Sun Pharma buys Organon for $11.75B to accelerate women’s health growth
Sun Pharmaceuticals agreed to acquire Merck spinoff Organon & Co for $11.75 billion in cash, a deal expected to close in early 2027. Sun said the acquisition expands its women’s health portfolio,...
Thermo Fisher sells microbiology business to Astorg for about $1.08B
Thermo Fisher Scientific agreed to sell its microbiology business to Astorg for about $1.075 billion, consisting of cash and a $50 million seller note. The unit provides antimicrobial...
Coultreon raises $125M to move SIK3 inhibition in autoimmune disease (oral pill vs injectables)
Coultreon Biopharma, a Galapagos-acquired spinout focused on immunology, raised $125 million in a Series A to advance a small-molecule SIK3 inhibitor program. The company plans Phase 2 studies in...
Coultreon identity update: rebranded Galapagos asset vehicle moves forward as a $125M Series A story
On the heels of its financing and clinical plans, the rebranded entity previously launched as Onco3R Therapeutics is now operating as Coultreon Biopharma, according to reporting on the $125...
Obesity drug development—dual-acting GLP-1/glucagon
Boehringer Ingelheim reported Phase 3 results for survodutide, a dual-acting obesity injection, showing substantially greater weight loss than placebo in its Synchronize-1 study. In participants...
Regulatory action—FDA alleges data manipulation and targets Tavneos
The FDA escalated its action against Amgen’s Tavneos (immunosuppressant for a rare disease), alleging that trial data supporting the drug’s approval were manipulated. The agency moved to withdraw...
CRISPR in vivo—Phase 3 win and FDA filing path
Intellia Therapeutics reported Phase 3 success for lonvo-z, an in vivo CRISPR-based therapy for hereditary angioedema, hitting the study’s primary endpoint and cutting attack rates by 87% versus...
Big pharma dealmaking—Lilly buys Ajax for next-gen JAK
Eli Lilly agreed to acquire Ajax Therapeutics for up to $2.3 billion, adding a next-generation JAK2 inhibitor program for myeloproliferative neoplasms to its hematology pipeline. The deal brings...
Dermatology pipeline—Oruka’s IL-23 leads to high PASI responses
Oruka Therapeutics reported strong Phase 2 psoriasis results for ORKA-001, including total skin clearance in 40 of 63 patients (63.5%) at 16 weeks. The company said 83% of patients achieved PASI...
Diagnostics—FDA Breakthrough Device for mRNA blood test in psychiatry
Laguna Diagnostics said its mRNA Gene Biomarker blood test for differentiating schizophrenia from bipolar I disorder received FDA Breakthrough Device Designation. The assay is intended to generate...
Acquisition—Sun Pharma to buy Organon for $11.75B
Sun Pharmaceuticals agreed to acquire Organon & Co. in an all-cash deal valued at $11.75 billion, aiming to expand its women’s health portfolio and strengthen its biosimilar business. Organon’s...
Immuno-oncology platform deal—Kahimmune and Gustave Roussy
Kahimmune Therapeutics partnered with Gustave Roussy to use patient samples from treated individuals to generate neoantigen data for Kahimmune’s first mRNA therapeutic candidate. The collaboration...
Clinical development—Faron hires Parexel for bexmarilimab Phase 2 in HR-MDS
Faron selected Parexel to run its Phase 2 program for bexmarilimab in higher-risk myelodysplastic syndromes, covering sites in the US, UK, and Europe. The study, described as BEXERA Phase 2b, is...
Funding—AI protein design startup Fathom raises $47M Series A
Fathom Therapeutics, formerly Atommap, raised a $47 million oversubscribed Series A to advance its Microcosmos drug design engine. The platform uses physics-based simulations and AI to model...
Regulatory action and enforcement moves
The FDA escalated its effort to remove Tavneos (amgen) from the market, alleging trial manipulation that tainted the data supporting approval. The agency’s action adds a new layer of regulatory...
AI-enabled molecular medicine deals
Eli Lilly struck a collaboration with AI-focused biotech Profluent to develop next-generation gene editors that could enable insertion of entire genes. The companies did not detail the number of...