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What’s in Today’s Brief? (January 1st Preview)
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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 more than four decades. The approval was supported by three pivotal studies, including two phase III trials conducted in real‑world maritime settings. Vanda plans a commercial launch in early 2026. Investors reacted quickly: the company’s stock surged on the approval, reflecting both the narrow competitive landscape for motion‑sickness therapeutics and potential near‑term revenue. The clinical program’s emphasis on vomiting prevention in real‑world conditions provided the agency with data aligned to the indication requested. Hospital pharmacies, travel medicine clinics and military procurement groups are immediate commercial targets.
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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 of April 30. The agency’s acceptance follows submission of pivotal data arguing clinical benefit in a high‑unmet‑need population. Axsome’s shares rose sharply on the news, reflecting the market’s view of a potential blockbuster opportunity in dementia behavioral symptoms. Priority review accelerates the regulatory timeline and signals the agency sees potential for significant patient benefit, but the company will still need to demonstrate a favorable risk‑benefit profile in an older, comorbid population.
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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 agency’s decision prompted a steep selloff in Corcept shares and forced the company to reassess its regulatory pathway for that indication. Corcept said it will meet with the FDA to define next steps while shifting focus to a July 2026 PDUFA target for relacorilant in platinum‑resistant ovarian cancer, where the company believes the benefit‑risk calculus differs. The CRL underscores the agency’s demand for robust efficacy data in endocrinologic indications and leaves the commercial timeline for the Cushing population uncertain.
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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 immunotherapy footprint in the region and gives the company an asset aimed at DLL3‑expressing tumors. The partnership illustrates Big Pharma’s continued strategy of sourcing T‑cell engager programs from regional developers to accelerate localized clinical development and commercialization. The agreement will likely combine AbbVie’s clinical development resources with Zelgen’s regional regulatory knowledge as the program advances through Chinese trials.
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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 for second‑line-plus oropharyngeal squamous cell carcinoma (OPSCC). The financing targets a planned registrational pathway and supports late‑stage operations. The SPV structure pools investor capital specifically for the Oz‑V program, allowing BioAtla to retain broader corporate flexibility while securing dedicated funds for the registrational study. The move underscores investor appetite for targeted ADC programs and for CAB (conditionally active biologic) platforms aimed at improving tumor selectivity.
...and 5 more selected Biotech stories in today’s full edition.
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