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Q32 sells complement asset to Akebia — $12M upfront for rare kidney program
Q32 Bio sold rights to its Phase II complement inhibitor ADX‑097 to Akebia Therapeutics for $12 million upfront, with up to $592 million in potential milestones, extending Q32’s cash runway and...
CRAFT CAR T and CAR T for CNS tumors: engineering safer, broader cell therapies
Researchers and companies presented advances in allogeneic CAR T approaches designed to reduce off‑target CRISPR risks (CRAFT CAR T) and to extend CAR T therapy into central nervous system (CNS)...
Regeneron bets $150M on Tessera: gene writing for AATD
Regeneron entered a global collaboration with Tessera Therapeutics to co-develop TSRA-196, a near-clinic in vivo gene-writing candidate for alpha-1 antitrypsin deficiency (AATD). The deal includes...
Belite posts Phase 3 win — Stargardt drug meets primary endpoint
Belite Bio reported positive topline results from the Phase 3 DRAGON trial of tinlarebant in adolescents with Stargardt disease type 1, meeting the primary endpoint with a clinically meaningful...
Protego raises $130M — pushes AL amyloidosis program to pivotal
Protego Biopharma closed an oversubscribed $130 million Series B to advance PROT‑001, its oral candidate for AL (light‑chain) amyloidosis, toward a pivotal study. The financing was led by...
US vaccine path under rebuild — Prasad memo sparks policy firestorm
Federal vaccine policy is in flux after internal CBER memos and agency planning signalled a stricter evidentiary bar for vaccine approvals, prompting public debate and scrutiny. FDA leadership has...
Lundbeck exits Avadel chase — Alkermes cleared to acquire
Lundbeck withdrew from a bidding contest for Avadel Pharmaceuticals, locking in Alkermes’ path to acquire the sleep‑disorder drug developer under a roughly $2.37 billion bid that includes...
Q32 sells complement asset to Akebia: cash runway extended
Q32 Bio sold rights to its phase II complement inhibitor ADX‑097 to Akebia Therapeutics, generating upfront proceeds that materially extend Q32’s cash runway and let the small developer focus...
UK‑US pharma price pact: U.K. loosens rules to avoid U.S. tariffs
The U.K. agreed to relax certain drug‑pricing rules and increase spending on medicines in exchange for a U.S. decision not to impose tariffs on British‑origin pharmaceuticals, ingredients and...
Janux data shuffle: JANX007 shows mixed early‑stage prostate results
Janux Therapeutics released a new data cut from an ongoing Phase 1 study of JANX007, a T‑cell engager for metastatic castration‑resistant prostate cancer, showing response rates around 30% in the...
Recursion leadership change: Najat Khan to take CEO baton
Recursion announced a planned leadership transition: long‑time CEO Chris Gibson will become board chair and Najat Khan, PhD, the company’s chief R&D and commercial officer, will assume CEO...
Scaled lung organoids: stirred bioreactor enables bulk production
Researchers at the University of Duisburg‑Essen developed an automated stirred‑tank bioreactor process to generate large quantities of iPSC‑derived lung organoids, producing complex...
Regeneron makes $150M bet on gene writing: Tessera tie-up
Regeneron Pharmaceuticals struck a $150 million collaboration with Tessera Therapeutics to develop and commercialize TSRA-196, a near-clinic in vivo gene-writing candidate for alpha-1 antitrypsin...
Protego raises $130M to push amyloidosis drug into pivotal test
Protego Biopharma closed a $130 million oversubscribed Series B led by Novartis Venture Fund and Forbion to advance its first-in-class oral program for light‑chain (AL) amyloidosis into a...
Belite’s pill meets Phase 3 endpoint: FDA filing next?
Belite Bio reported topline success from its 104-subject Phase 3 DRAGON trial: tinlarebant produced a statistically significant 36% reduction in the growth rate of retinal lesions versus placebo...
FDA clears intrathecal SMA gene therapy... while DMD hits fresh hurdles
The FDA approved Novartis’ intrathecally delivered SMA gene therapy Itvisma (onasemnogene abeparvovec), offering a new delivery route intended to broaden access beyond the intravenous label of...
UK ups drug spending to dodge U.S. tariffs: pricing deal struck
The U.K. government agreed to loosen drug-price controls and increase medicine spending in return for a three‑year exemption from potential U.S. tariffs on British pharmaceuticals under Section...
China approves Innovent’s picankibart: first domestic IL‑23p19
China’s National Medical Products Administration authorized Innovent Biologics’ picankibart (IBI‑112), branded Pecondle, for moderate to severe plaque psoriasis—marking the country’s first...
Generate:Biomedicines moves TSLP antibody into Phase 3
Generate:Biomedicines announced initiation of two large Phase 3 trials for its lead TSLP antibody, advancing the company’s first program from discovery to pivotal development. The move underscores...
FDA clears Ideaya IND for IDE‑034: bispecific ADC enters clinic
Ideaya Biosciences received FDA clearance to begin a Phase I trial of IDE‑034, a bispecific antibody‑drug conjugate targeting B7H3/PTK7 linked to a TOP1 payload, for solid tumors. The...