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In vivo CRISPR moves to regulatory track in hereditary angioedema
Intellia Therapeutics said its in vivo CRISPR therapy lonvoguran ziclumeran (lonvo-z) hit a Phase 3 primary endpoint in hereditary angioedema, prompting the company to begin a rolling submission...
Big Pharma dealmaking targets next-gen blood cancer biology
Eli Lilly agreed to buy Ajax Therapeutics in a deal valued at up to $2.3 billion, seeking breakthroughs in myelofibrosis and other myeloproliferative neoplasms. Ajax’s lead program, AJ1-11095, is...
Therapeutic IL-23 competition intensifies after Oruka psoriasis Phase 2 data
Oruka Therapeutics reported Phase 2 results for ORKA-001 in plaque psoriasis, showing complete skin clearance (PASI 100) in 40 of 63 treated patients (63.5%) at 16 weeks versus 1 of 21 placebo...
Portfolio reshaping: Thermo Fisher exits microbiology with Astorg buy
Thermo Fisher Scientific agreed to sell its microbiology business to Astorg for about $1.075 billion, with expected closing in the second half of 2026. The divestiture covers the microbiology unit...
Pipeline reset at Astellas after gene therapy safety history
Astellas said it will pause development of AT132 (resamirigene bilparvovec), a gene therapy for X-linked myotubular myopathy after prior safety concerns including four deaths tied to liver failure...
Hair-loss drug reaches late-stage readout for oral therapy
Veradermics reported positive results from a late-stage Phase 2/3 trial of its oral hair-loss therapy VDPHL01 in men with mild-to-moderate pattern hair loss. The company said participants taking...
FDA submission pathway opens after Intellia’s in vivo CRISPR filing momentum
Intellia’s Phase 3 win for its in vivo CRISPR treatment is also accelerating planning for the regulatory timeline. Following the Phase 3 results, Intellia said it is racing toward an FDA rolling...
Lilly and other large deals reshape hematology and women’s health
In parallel dealmaking, Sun Pharmaceuticals announced plans to acquire Organon and expand its women’s health and biosimilars portfolio. The all-cash $11.75 billion transaction would make Sun one...
Oncology update: Compass Therapeutics’ trial misses overall survival
Compass Therapeutics’ stock dropped after the company reported negative overall survival (OS) results tied to its bispecific antibody in a Phase 2/3 trial of second-line biliary tract cancer. The...
Diagnostics and regulation: IVDR amendments spotlight access and workflow strain in Europe
At ESCMID, clinical microbiologists raised concerns that implementation of the EU In Vitro Diagnostic Regulation (IVDR) is restricting patient access to tests and tightening development timelines....
CRISPR gene editing—hereditary angioedema Phase 3 and regulatory path
Intellia reported Phase 3 results for lonvo-z, its in vivo CRISPR medicine for hereditary angioedema (HAE), showing attack rates fell 87% versus placebo in an 80-patient pivotal study. More than...
Oruka’s psoriasis program—long-acting dosing intent after Phase 2
Oruka Therapeutics disclosed Phase 2 psoriasis data for its long-acting injectable candidate, ORKA-001, with 63% of patients achieving complete skin clearance in a mid-stage readout. The company...
Lilly expands oncology pipeline—acquisition of Ajax Therapeutics for up to $2.3B
Eli Lilly announced it will acquire Ajax Therapeutics for up to $2.3 billion, extending its M&A run into oncology. Ajax’s lead asset is a next-generation JAK2 inhibitor being evaluated in a Phase...
Sun Pharma’s women’s health push—acquires Organon for $11.75B
Sun Pharma agreed to buy Merck’s spinoff Organon in an all-cash transaction valued at $11.75 billion, aiming to expand its presence in women’s health and biosimilars. The deal is structured to...
Thermo Fisher divests microbiology—Microbiology business sold to Astorg
Thermo Fisher Scientific announced it will sell its microbiology business to private equity firm Astorg for about $1.08 billion. The company said the transaction is expected to close in the second...
Emerging immunotherapy trial signal—tremelimumab plus durvalumab in MSI-high gastric cancer
At AACR Annual Meeting 2026, investigators presented updated cohort results from the INFINITY phase 2 trial evaluating tremelimumab plus durvalumab as an organ-preserving option for resectable...
UK biotech fundraising—early recovery signs without IPO rebound yet
A report cited by industry stakeholders indicates British biotech equity funding showed early signs of recovery after a mid-2025 lull. In the first quarter of 2026, British biotechs reportedly...
IVDR implementation at ESCMID—lab access concerns rise in Europe
At ESCMID, clinical microbiologists highlighted growing concerns that EU’s In Vitro Diagnostic Regulation (IVDR) may be constricting access to tests and slowing diagnostic development....
Oral Rogaine—Veradermics’ Phase 2/3 hair loss win
Veradermics reported success for its oral hair-loss candidate in a late-stage study, supporting the company’s transition as a public entity. In the trial, men with mild-to-moderate pattern hair...
AI-enabled microscopy—sharper real-time imaging in live cells
Researchers at the University of California San Diego reported an AI-enhanced microscopy approach that captures real-time video inside living cells with higher clarity than conventional imaging....