Curated news and analysis on clinical trials, drug approvals, and medical research.
MicroOrganoSpheres predicted treatment success in 83% of 21 advanced colorectal cancer cases, reaching 100% accuracy with primary-tumor samples. The automated test can be performed within days.
A securities class action alleges Corcept misled investors about the regulatory prospects for relacorilant. The suit cites an FDA Complete Response Letter, a 50.4% stock drop, and an April 21, 2026 lead plaintiff deadline.
VYLOY (zolbetuximab-clzb) remains the only approved CLDN18.2-targeted therapy for first-line HER2-negative gastric or gastroesophageal junction adenocarcinoma with CLDN18.2-positive tumors. The pipeline is focused on next-generation antibodies, ADCs, CAR-T, NK-cell and bispecific approaches aiming to build on zolbetuximab benchmark data.
Xenon Pharmaceuticals reported positive Phase III X-TOLE2 results for azetukalner in focal onset seizures. The company plans an FDA new drug application in Q3 2026.
Compass Pathways reported positive late-stage COMP360 psilocybin data in treatment-resistant depression and plans FDA talks ahead of a filing between October and December. The update lifted shares across several psychedelics developers.
A cost-effectiveness analysis found home-based anal cancer screening increased participation versus clinic-based screening among sexual and gender minority individuals. The approach remained investigational because the FDA has not approved self-sampling for anal cancer screening.
The Trump administration has agreed to release federal funding for the $16 billion Gateway rail tunnel and Second Avenue Subway Phase 2, ending months-long suspensions that halted work and caused layoffs. Gateway funding had been suspended for over four months, leaving $205 million owed and forcing 1,000 layoffs, while Second Avenue Subway funds were withheld for seven months pending compliance reviews.
India Pharma 2026 will be held April 13-14 in New Delhi with the theme "Discover in India: Leapfrogging Life-Sciences Innovation." The event will focus on R&D, regulation, AI, CRDMO and financing.
Psyence Biomedical Ltd. completes a $5 million share-for-share equity investment in PsyLabs through put option exercise, strengthening their strategic supply relationship. The transaction involves no cash exchange but gives PsyLabs approximately 50% ownership of PBM. The deal aims to secure pharmaceutical-grade psychedelic compound supply for clinical programs.
Oncotelic Therapeutics announced expanded international intellectual property coverage for OT-101 across neurology, oncology and CNS drug-delivery technologies. The company also highlighted biotech valuation trends tied to clinical progress and its 45% stake in GMP Bio.
Kansas City, Missouri, approved a 13-0 ordinance banning synthetic 7-OH and limiting natural kratom sales to adults 21 and older. The law adds sales restrictions, licensing requirements and fines as scrutiny of 7-OH products increases.
LENZ Therapeutics submitted a UK marketing authorization application for VIZZ for presbyopia on April 20, 2026. The filing follows FDA approval in July 2025 and EMA validation in March 2026.
Kyverna Therapeutics reports positive long-term follow-up results for its CAR-T therapy miv-cel in generalized myasthenia gravis, with plans to submit a biologics license application in the first half of 2026. The company has $279.3 million in cash providing runway into 2028 to fund launch and Phase 3 trials.
Nektar said extended rezpeg treatment promoted greater hair growth in severe alopecia areata and reported durable 52-week efficacy for rezpegaldesleukin in atopic dermatitis. The company said it has FDA alignment on Phase 3 design and is targeting a BLA submission by 2029.
Asahi Kasei has started a Phase I clinical trial in Japan for AK1940, a peptide-based investigational compound for autoimmune diseases. The study will assess pharmacokinetics, safety and tolerability in healthy volunteers.
Phase 3 OCEANIC-STROKE data showed asundexian plus antiplatelet therapy reduced recurrent ischemic stroke versus placebo. Major bleeding rates were similar between groups.
New data from the American Cancer Society shows the U.S. cancer death rate has dropped 34% since 1991, preventing nearly five million deaths. More than 18 million Americans are living after a cancer diagnosis, with that number expected to surpass 22 million by 2030.
Bayer’s sevabertinib has obtained domestic approval as an imported rare drug for HER2-mutant non-small cell lung cancer. The oral reversible HER2-targeted TKI was previously approved by the FDA for previously treated patients.
Galux completed a $29 million Series B financing and entered an MOU with OliX Pharmaceuticals to jointly develop a next-generation AI-based siRNA delivery platform. The funding will support GaluxDesign, R&D expansion and preclinical validation.
Genflow Biosciences has entered a technology collaboration with Acuitas Therapeutics to formulate Genflow's SIRT6 mRNA payload using Acuitas' lipid nanoparticle platform for preclinical evaluation. The collaboration is fully funded by Acuitas, with no cash payable by Genflow and no dilution to existing shareholders.
