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Biotech cost cuts and late-stage clinical failures
Neumora Therapeutics announced it is discontinuing navacaprant, its kappa opioid receptor antagonist for major depressive disorder, after two Phase 3 failures. The KOASTAL-2 and KOASTAL-3 studies...
Depression drug developer restructures alongside Phase 3 setbacks
As part of a broader wave of 2026 cost-saving moves, the layoff tracker reports that enGene Therapeutics is halving its workforce while preparing an eventual BLA submission for its sole clinical...
Cardiometabolic pipeline accelerates toward registrational study
Edgewise Therapeutics said it plans to move its heart disease candidate into Phase 3 after an update to its Phase 2 data package. The company is advancing a genetic cardiomyopathy program, framing...
Germany backs away from variable drug discount pricing
Germany has reportedly scrapped a plan to introduce variable discount pricing for branded pharmaceuticals after strong pushback from drugmakers, according to Reuters. The initiative was part of a...
PBM and pharmacy access litigation over FAIR Rx Act
Express Scripts and the PBM trade group PCMA have filed suit to block implementation of Tennessee’s FAIR Rx Act, following complaints similar to those submitted by CVS Caremark. The legislation,...
Merck gains adjuvant kidney cancer label expansion with Welireg-Keytruda combo
The FDA approved Merck & Co.’s Welireg plus Keytruda combination as an adjuvant treatment for intermediate-high or high-risk clear cell renal cell carcinoma following kidney removal surgery. The...
Adaptive Biotechnologies restructures immune medicine business
Adaptive Biotechnologies said it will shed its immune medicine business and offer up to $287.5 million in senior notes, aiming to recalibrate toward its MRD-focused platform. The company expects...
Drug pricing and reimbursement negotiations: Medicare proposal closes evergreening loophole
A proposed CMS rule would clarify and tighten how Medicare Drug Price Negotiation applies to fixed combination therapies, potentially affecting lifecycle management strategies used by large...
AI drug design funding: DeepMind-linked Isomorphic Labs raises mega-round
Isomorphic Labs, an Alphabet-affiliated AI drug design company with ties to DeepMind, raised $2.1 billion in a Series B round led by Thrive Capital with participation from Alphabet. The financing...
FDA prepares once-weekly HIV PrEP pill decision for lenacapavir
Gilead said the FDA accepted its supplemental New Drug Application for Yeztugo (lenacapavir) 300-mg tablets as a potential once-weekly oral pre-exposure prophylaxis (PrEP) option. The agency...
Merck scores adjuvant combo approval in kidney cancer with Welireg plus Keytruda
Merck & Co. received FDA approval for Welireg (belzutifan) combined with Keytruda (pembrolizumab) as adjuvant treatment for adults with intermediate-high or high-risk clear cell renal cell...
FDA greenlights Tzield for stage 3 type 1 diabetes with accelerated CD3-based therapy
Sanofi’s Tzield (teplizumab) gained FDA clearance for stage 3 type 1 diabetes in a move that expands the CD3-directed monoclonal antibody’s disease-modifying use. The accelerated approval follows...
Adaptive Biotechnologies plans to spin out immune medicine and issue up to $287.5M in notes
Adaptive Biotechnologies outlined a strategic shift to separate its immune medicine business and re-center on minimal residual disease (MRD) operations. The company also said it expects to offer...
Eli Lilly expands oncology and signals acquisition momentum with Ajax-sourced blood cancer data
Eli Lilly advanced its blood cancer strategy by presenting early clinical data for AJ1-11095, a type II JAK2 inhibitor in development for myelofibrosis that originated from its acquisition of Ajax...
Regulatory framework shift: FDA guidance on Bayesian methods could speed complex trials
A new FDA guidance on Bayesian statistics is poised to broaden how sponsors design clinical trials, particularly for diseases where uncertainty, heterogeneity, and rare-event dynamics complicate...
Neumora drops depression program after additional Phase 3 failures
Neumora Therapeutics announced it will discontinue its navacaprant program after failing two additional Phase 3 trials in major depressive disorder. The Koastal-2 and Koastal-3 studies did not...
HMNC Brain Health banks $50M Series B and ties up with MEDICE for depression therapies
HMNC Brain Health, a clinical-stage neuroscience company, raised its first $50 million tranche of a Series B and secured a commercialization partnership with family-owned German healthcare firm...
Illumina scales ‘unsolved rare cases’ sequencing study with European and Middle East sites
Illumina launched a multi-center study called Beyond GiICS to re-analyze and extend rapid whole-genome sequencing efforts in infants and children with rare diseases whose neonatal or pediatric...
Radical Numerics raises $50M seed to build multimodal AI models from DNA, RNA and proteins
Radical Numerics launched with $50 million in seed funding to build integrated AI models trained directly on biological data across DNA, RNA, and proteins. The round was led by Emergence Capital...
Regulatory approvals and FDA actions (oncology)
Merck’s Welireg (belzutifan) combined with Keytruda (pembrolizumab) won FDA approval for an adjuvant setting in clear cell renal cell carcinoma (ccRCC), aiming to reduce recurrence risk after...