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Gene‑therapy advances: SynGAP1 restoration and SPAST‑AAV9 prevent HSP in models
Two gene‑therapy reports outlined translational progress in distinct neurological disorders. Researchers demonstrated that restoring SynGAP1 expression via gene therapy rescued epilepsy and...
New tumor immune‑evasion mechanisms challenge PD‑L1 therapies
Two studies revealed tumor‑intrinsic mechanisms that blunt immune checkpoint efficacy. Zhao et al. (Cell Research, 2026) reported that tumor PD‑L1 can trigger beta‑2 microglobulin (β2m)...
Vanda wins FDA nod: first motion-sickness drug in 40 years
The U.S. Food and Drug Administration approved Nereus (tradipitant) from Vanda Pharmaceuticals, marking the first new prescription treatment for motion sickness in more than four decades. Approval...
Axsome gets priority review: agitation in Alzheimer’s heads to April PDUFA
The FDA accepted Axsome Therapeutics’ supplemental NDA for AXS-05 to treat agitation in Alzheimer’s disease and granted priority review, assigning a PDUFA date of April 30. The agency’s acceptance...
FDA issues complete response for relacorilant — Corcept pivots to ovarian cancer
The FDA issued a complete response letter (CRL) to Corcept Therapeutics for relacorilant in patients with hypertension secondary to hypercortisolism (Cushing syndrome), requesting additional...
FDA clears two robotic platforms: more options for hospitals
The U.S. FDA cleared Medtronic’s Hugo robotic-assisted surgery (RAS) system and CMR Surgical’s Versius Plus system, expanding the pool of cleared robotic platforms for soft-tissue procedures. The...
Shenzhen Edge files HKEX IPO: $154 million to scale surgical-robotics push
Shenzhen Edge Medical announced a HKEX initial public offering to raise HKD1.19 billion (about US$154 million) to fund R&D and international expansion of its surgical robotics pipeline. The...
BioAtla and GATC fund registrational push for Ozuriftamab vedotin
BioAtla and AI-driven partner GATC Health announced a $40 million special purpose vehicle transaction to advance ozuriftamab vedotin (Oz‑V), a CAB-ROR2 antibody‑drug conjugate, into a Phase 3...
NMPA accepts three Helius solid‑tumor INDs: China trial window opens
Shanghai Henlius Biotech reported acceptance by China’s National Medical Products Administration (NMPA) of IND applications for three differentiated solid‑tumor candidates. IND acceptance in China...
Engineered viral RNA editors treat sepsis in vivo: macrophages targeted
Researchers published a Nature Communications study describing bioengineered viral vectors that enable in vivo RNA editing in macrophages to treat sepsis. The chemogenetic system allows targeted...
AAV9 silence‑and‑replace prevents hereditary spastic paraplegia in models
A silence‑and‑replace gene therapy using AAV9 reported prevention of hereditary spastic paraplegia (HSP) symptoms in recent preclinical studies published in Molecular Therapy. The approach...
SynGAP1 gene therapy restores function and rescues epilepsy phenotypes
A new gene‑therapy study reported functional restoration of SynGAP1 and rescue of epilepsy and associated behavioral deficits in preclinical models. SynGAP1‑related disorders cause intellectual...
FDA greenlights Nereus: Vanda lands first motion‑sickness drug in 40 years
The U.S. Food and Drug Administration approved Nereus (tradipitant), Vanda Pharmaceuticals’ oral neurokinin‑1 receptor agent, marking the first new prescription treatment for motion sickness in...
FDA gives priority review to AXS‑05 – Axsome targets Alzheimer’s agitation
The U.S. FDA accepted Axsome Therapeutics’ supplemental new drug application for AXS‑05 (Auvelity) to treat agitation in Alzheimer’s disease and granted priority review, setting a PDUFA goal date...
FDA issues CRL to Corcept – relacorilant setback in Cushing, pivot to ovarian cancer
The FDA issued a complete response letter for Corcept Therapeutics’ relacorilant in hypertension secondary to hypercortisolism (Cushing syndrome), requesting additional evidence of efficacy. The...
AbbVie inks DLL3 T‑cell engager deal in China – Zelgen supplies clinical‑stage asset
AbbVie struck a licensing and development arrangement with Zelgen Biopharmaceuticals for a clinical‑stage bispecific T‑cell engager targeting DLL3 in China. The deal expands AbbVie’s oncology...
BioAtla, GATC raise $40M SPV – Oz‑V moves toward registrational OPSCC trial
BioAtla and GATC Health announced a $40 million special purpose vehicle to fund advancement of ozuriftamab vedotin (Oz‑V), a CAB‑ROR2 antibody‑drug conjugate, into a registrational Phase 3 study...
NMPA accepts INDs for three Henlius solid‑tumor candidates: China trials to start
Shanghai Henlius Biotech reported that China’s National Medical Products Administration (NMPA) accepted investigational new drug applications for three differentiated candidates targeting solid...
Engineered virus edits macrophage RNA in vivo: new sepsis strategy
Researchers reported a bioengineered viral system capable of performing targeted RNA editing in macrophages in vivo, demonstrating therapeutic activity in preclinical sepsis models. Published in...
NIH launches OligoTox challenge: $500K prizes to map oligonucleotide toxicity
The National Center for Advancing Translational Sciences (NCATS) announced the OligoTox Open Data Challenge, a two‑phase NIH prize competition offering up to $500,000 to generate high‑quality open...