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Patent risk around RAS cancer programs
Revolution Medicines’ lawyers issued a legal threat targeting Erasca’s RAS program, setting up the risk of a dispute over patents and efficacy claims. Erasca said it received the threat after a...
CRISPR gene editing reaches Phase 3 milestone for hereditary angioedema
Intellia’s in vivo CRISPR therapy lonvo-z succeeded in a Phase 3 trial for hereditary angioedema, sharply reducing attack rates in patients with the rare swelling disorder. Intellia said it...
AI-designed gene therapy delivery improvements (eVLP production)
Researchers from Whitehead Institute reported a genome-wide screening approach to identify producer-cell modifications that improve production and delivery potency of engineered virus-like...
Oncology dealmaking: Lilly expands JAK portfolio with Ajax buy
Eli Lilly agreed to acquire Ajax Therapeutics for up to $2.3B in cash to gain access to next-generation JAK2 inhibitor assets in myeloproliferative neoplasms. Lilly will receive Ajax’s lead...
Immunotherapy failure signal in biliary cancer
Compass Therapeutics released additional results from its Companion-002 phase II/III study of tovecimig in combination with paclitaxel in second-line biliary tract cancer. The new update included...
Psoriasis competition heats up with Oruka’s IL-23 long-acting data
Oruka Therapeutics reported mid-stage results for ORKA-001, a long-acting IL-23 monoclonal antibody, in plaque psoriasis and also provided updated exposure analysis supporting once-per-year...
Biomarker tech financing for coronary artery disease
PlaqueTec raised $5M in an oversubscribed round to expand its work on intracoronary blood-protein biomarkers for coronary artery disease. The company’s BIOPATTERN clinical trial uses a device that...
Diagnostics regulation pressure in Europe (IVDR concerns)
Clinical microbiologists warned at ESCMID that Europe’s IVDR implementation may reduce patient access to diagnostic tests and constrain development of new assays. Stakeholders cited real-world...
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...