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Latest Biotech News

Recursion leadership change: Najat Khan to take CEO baton

December 02, 2025

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

December 02, 2025

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

December 01, 2025

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

December 01, 2025

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?

December 01, 2025

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

December 01, 2025

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

December 01, 2025

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

December 01, 2025

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

December 01, 2025

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

December 01, 2025

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...

Singapore’s PRECISE taps pharma majors: Asian genomics alliance

December 01, 2025

Precision Health Research, Singapore (PRECISE) formalized a precompetitive partnership with Alnylam, Bayer, Boehringer Ingelheim and Novo Nordisk to analyze data from PRECISE‑SG100K, a population...

Janux reports 30% response rate in early JANX007 prostate data

December 01, 2025

Janux Therapeutics disclosed a new data cut from its Phase 1 study of JANX007, a T‑cell engager for prostate cancer, showing a 30% objective response rate in the evaluated cohort. The company...

Protego raises $130M — gears up for pivotal AL amyloidosis trial

December 01, 2025

Protego Biopharma closed an oversubscribed $130 million financing to advance its first‑in‑class oral program for light‑chain (AL) amyloidosis into a potential pivotal study next year. The round...

Regeneron commits $150M... Tessera deal targets gene writing for AATD

December 01, 2025

Regeneron Pharmaceuticals and Tessera Therapeutics struck a collaboration valued at $150 million to develop and commercialize TSRA‑196, Tessera’s in‑vivo gene‑writing candidate for alpha‑1...

Belite’s Phase 3 win — tinlarebant clears primary endpoint in Stargardt

December 01, 2025

Belite Bio reported topline results from the global Phase 3 DRAGON trial showing that tinlarebant met the study’s primary endpoint in adolescents with Stargardt disease type 1 (STGD1). The company...

Generate:Biomedicines launches Phase 3 — TSLP antibody moves to registrational studies

December 01, 2025

Generate:Biomedicines announced the start of two large Phase 3 trials for its lead TSLP (thymic stromal lymphopoietin) antibody, marking a key clinical inflection for the AI‑driven biotech. The...

Circular Genomics closes $15M Series A — circRNA blood biomarker for Alzheimer’s

December 01, 2025

Circular Genomics raised $15 million in a Series A round led by Mountain Group Partners to advance a circular RNA (circRNA)‑based biomarker platform for early detection of Alzheimer’s disease. The...

Morphocell extends Series A with $50M — scales tissue‑engineered liver programs

December 01, 2025

Morphocell Technologies announced a $50 million Series A financing extension — a $10 million add‑on to its earlier $40 million close — led by Investissement Québec with participation from CDP...

Analysts initiate coverage on BillionToOne — banks set bullish price targets

December 01, 2025

JP Morgan, BTIG and Jefferies initiated analyst coverage on molecular diagnostics firm BillionToOne, assigning a range of ratings and price targets that reflect optimism about the company’s...

Ideaya wins IND clearance — IDE‑034 poised for first‑in‑human solid tumor study

December 01, 2025

Ideaya Biosciences received FDA IND clearance to begin a Phase I study of IDE‑034, a bispecific antibody‑drug conjugate targeting B7H3/PTK7 coupled to a TOP1 payload, in patients with advanced...