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Late-stage oncology—B7-H3 ADCs press forward in relapsed small-cell lung cancer
Chinese phase III data strengthen the case for B7-H3 antibody-drug conjugates in relapsed small-cell lung cancer, with two programs from MediLink showing overall survival benefits versus...
Oncology—Akeso and Summit move to shore up ivonescimab survival case
Akeso and Summit Therapeutics released new overall survival data for ivonescimab (HARMONi-2), aiming to address analyst skepticism about trial generalizability beyond China. The companies reported...
Regulatory—FDA seeks input on rare-disease trial criteria and endpoint selection
The FDA said it is looking for additional outside input as it reassesses criteria used for rare disease drug development, including how much efficacy and safety evidence is sufficient to support...
Clinical failure—AstraZeneca’s oral SERD Etcamah misses in first-line breast cancer
AstraZeneca reported that SERENA-4 failed to show statistically significant benefit for Etcamah (camizestrant) as a first-line treatment in advanced ER-positive, HER2-negative breast cancer. The...
Regulatory/market access—pediatric priority review vouchers near record highs
The U.S. pediatric priority review voucher (PRV) program hit a new high, with three additional vouchers issued since August for drugs targeting rare pediatric diseases. The tally places pediatric...
AI and regulatory operations—nPhase promises faster clinical submissions
nPhase launched an AI platform aimed at accelerating the generation of regulatory submissions for clinical trials. The company says the tool can convert raw study data into submission-ready...
Biotech funding—Nara Health secures $14M for third-party administration platform
Nara Health raised $14 million to expand its third-party administration platform, focused on streamlining coverage and benefits administration workflows. The round was led by Khosla Ventures, with...
Platform buildout—Single Cell Discoveries acquires TATAA Biocenter
Single Cell Discoveries (SCD) completed the acquisition of TATAA Biocenter, expanding capabilities across target validation and assay development. Terms were not disclosed, but the deal combines...
Business realignment—Cellectis exits CAR-T to pivot to in vivo gene editing
Cellectis said it is quitting CAR-T programs and shifting resources toward ‘in vivo’ gene editing after assessing a changing competitive and development landscape. The company’s decision includes...
Regulatory actions in neuro/rare disease
FDA has granted approval to Scholar Rock’s Isembyld (apitegromab), marking the first muscle-targeted treatment for spinal muscular atrophy and arriving after prior manufacturing setbacks. The drug...
Oncology trial signals: wins, misses, and pipeline readouts
Oncologists saw a mixed bag of late-breaking data as companies reported both setbacks and trial progress across solid tumors and targeted approaches. AstraZeneca also posted disappointing...
FDA study clearance and IND moves in gene/cell therapy
New FDA clearance actions pushed several platform and investigational programs closer to human testing. The FDA cleared the University of Colorado Anschutz to run a CAR T-cell study in adults...
Biotech pivot and strategic transformation
Cellectis announced a strategic transformation that affects its entire development posture, shifting away from allogeneic CAR-T into in vivo gene editing. The company cited the momentum of its...
Clinical neuroscience and gene/epigenome editing collaborations
Modalis and Exegenesis Bio expanded their collaboration to push MDL-201 toward the clinic for Duchenne muscular dystrophy. The program uses Modalis’ epigenome editing technology to sustainably and...
Regulatory and commercial stakes in obesity pharmacology
Corbus Pharmaceuticals reported Phase 1b obesity data for its CB1 inverse agonist, arguing that its mechanism may reduce neuropsychiatric side effects seen with earlier CB1-targeting efforts. The...
IND-enabling translational immunology and targeted platforms
Preclinical and translational immunotherapy work continued to target hard-to-treat cancer biology. Researchers presented preclinical characterization of DMR-001, a long-acting monoclonal antibody...
Immunotherapy delivery and dosing optimization signals
Dosing logistics and patient convenience drove updates in immunotherapy delivery. In small-cell lung cancer, subcutaneous tarlatamab (from the DeLLphi-308 Phase 1b study) showed safety and early...
Corporate strategy and manufacturing capacity shift in vaccines
GSK moved to reduce capacity in Germany as demand for egg-based flu vaccines declined, telling a spokesperson Endpoints News it is closing a factory and laying off about 650 workers. The decision...
Psychedelics in anxiety: late-stage readouts and FDA path
Definium Therapeutics reported additional Phase 3 progress for its oral LSD candidate DT120 as the company moves toward an FDA submission. In one late-stage readout, DT120 showed an anxiety...
SMA drug approval: apitegromab (Isembyld)
FDA has approved Scholar Rock’s spinal muscular atrophy treatment apitegromab, branded as Isembyld, following delays tied to manufacturing issues at a troubled factory. The injectable is...