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Multiple myeloma trial readout boosts AbbVie’s bispecific bid
AbbVie reported Phase 3 success for etentamig, its dual-acting T cell engager for multiple myeloma, meeting the main trial goal to improve outcomes versus standard therapy. Company data indicate a...
Angelman syndrome setbacks reshape the rare neuro pipeline
Ultragenyx disclosed that its Phase 3 Angelman syndrome trial Aspire, evaluating apazunersen (GTX-102), missed both key goals, reigniting debate about how to develop and sequence next-generation...
Cardiovascular risk-targeting misses in pivotal trial
Novartis’ pelacarsen failed to reduce cardiovascular death or emergencies such as heart attack or stroke in the Phase 3 HORIZON trial, dealing a blow to a closely watched strategy aimed at...
Obesity GLP-1 expansion via Menarini and Gan & Lee licensing
Menarini signed its largest ex-China licensing agreement for Gan & Lee’s obesity candidate bofanglutide (GZR-18), securing rights across 39 European countries in a deal valued at up to €726...
Neurology and specialty ophthalmology pipeline: gene therapy and dosing momentum
Sensorion received authorization from France’s ANSM to initiate a Phase I/II trial of SENS-601 (GJB2-GT) for GJB2-related hearing loss, bringing the company’s lead gene therapy candidate into...
Oncology M&A and platform-building around antibody-targeted therapy conjugates
HUTCHMED inked a large licensing deal with GSK for worldwide rights to HMPL-A830, an antibody-targeted therapy conjugate combining an EGFR-directed antibody with a KRAS inhibitor payload. The...
Clinical-stage biotech financing and early clinical push in obesity
Superluminal Medicines secured a $60 million Series B to advance its obesity program into first-in-human testing. The financing is designed to support Phase 1 development of next-generation...
Drug discovery company adds UK funding for chronic autoimmune programs
Medicines Discovery Catapult (MDC) invested £500,000 each in two U.K. biotechs, funding Flip Therapeutics and Nascent Therapeutics through an Innovate UK-linked scheme. Flip is developing in vivo...
Regulatory and platform signals in CNS therapy pipelines
After Ultragenyx’s negative Phase 3 Angelman readout, rare neuro investors are tracking remaining RNA-targeted or related experimental programs for signals on next study design. Parallel attention...
FDA approval: first disease-modifying Alexander disease therapy
The FDA has approved Ionis Pharmaceuticals’ antisense therapy Zanvastro (zilganersen) for Alexander disease in pediatric and adult patients, marking the first disease-modifying treatment for the...
Phase 3 readouts: multiple myeloma T-cell engager etentamig posts survival benefit
AbbVie reported that its dual-acting bispecific antibody etentamig met a Phase 3 primary goal in relapsed or refractory multiple myeloma, improving outcomes versus standard therapy. In the study,...
Phase 3 setback: Novartis pelacarsen misses cardiovascular outcomes in HORIZON
Novartis said its experimental cardiovascular drug pelacarsen failed to reduce cardiovascular death or emergency events in a pivotal Phase 3 trial, the company announced. The study, HORIZON,...
Clinical pipeline funding: NeuShen lands $80M Series B for brain-health drugs
NeuShen Therapeutics, a Shanghai and Boston biotech led by a veteran transpacific drug developer, raised more than $80 million in a Series B financing to advance three clinical-stage brain-health...
Regulatory approvals: China clears Everest heart spray and Simcere RSV antibody
China’s National Medical Products Administration approved two new differentiated therapies aimed at lowering acute and seasonal disease burdens. Everest Medicines’ Cardamyst received clearance as...
Drug development pivots: Ultragenyx Angelman Phase 3 fails, prompting cost review
Ultragenyx disclosed that its Phase 3 trial Aspire in Angelman syndrome failed to meet the study’s primary and key secondary endpoints for apazunersen. The company reported that Bayley-4 Cognitive...
Big Pharma deal: GSK licenses Hutchmed’s KRAS/EGFR antibody-targeted therapy conjugate
GSK agreed to license Hutchmed’s HMPL-A830, a dual-action antibody-targeted therapy conjugate designed to combine an EGFR-targeting antibody with a KRAS inhibitor payload. The deal, valued at up...
Big Pharma technology deal: Novartis expands access to Alteogen’s subcutaneous delivery platform
Novartis entered a licensing agreement with Alteogen for its hyaluronidase-based subcutaneous drug delivery platform, centered on ALT-B4 (berahyaluronidase alfa). The deal allows Novartis to...
Recommender systems: graph-attention model improves personalization by modeling interaction history
Researchers proposed a graph-attention-based recommender approach that adjusts predictions by weighting a user’s past interactions rather than treating history uniformly. The method targets the...
Gene therapy pipeline: FDA IND clearance for first U.S. clinical trial in mucolipidosis type IV
The Mucolipidosis Type IV (ML4) Foundation announced that the FDA cleared an Investigational New Drug application for an experimental gene therapy program targeting mucolipidosis type IV, the...
Cardiometabolic / GLP-1 partnerships and regional expansion
Menarini struck a large European licensing deal for Gan & Lee’s biweekly GLP-1 obesity candidate, bofanglutide, extending the drug into 39 European countries. The agreement is structured around an...