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FDA rejection of Replimune melanoma therapy
The FDA again rejected Replimune’s oncolytic virus therapy for advanced melanoma after the company failed to resolve trial-related doubts, according to the agency’s renewed decision. Replimune...
Gilead and Kymera deepen molecular-glue degrader pipeline
Gilead exercised its option to exclusively license KT-200, a preclinical oral CDK2 molecular-glue degrader developed by Kymera Therapeutics. The move follows an earlier June 2025 option and comes...
China NMPA approval for MGI’s DNBSeq-T1+ sequencer
MGI Tech said its DNBSeq-T1+ sequencer received medical device registration from China’s NMPA, enabling deployment in the Chinese clinical market. The benchtop instrument targets applications...
Pre-IPO funding for Oricell’s solid-tumor CAR-T push
Oricell Therapeutics secured a pre-IPO venture financing worth more than $110 million to advance CAR-T programs aimed at solid tumors. The company’s lead asset, Ori-C101, is a GPC3-targeted...
Avalyn Pharma targets IPO to fund Phase 3 inhaled IPF programs
Avalyn Pharma filed to pursue an IPO to fund Phase 3 trials for inhaled respiratory therapies for idiopathic pulmonary fibrosis. The biotech’s lead program, AP01, is an inhaled formulation of...
FDA policy shift: America First PDUFA becomes reward-based
A BIOCentury report says the FDA is shifting from a punitive model to a reward-based “America First” PDUFA policy, changing incentives tied to where first-in-human trials are conducted. Under the...
Roche and C4 Teraputics expand into degrader-antibody conjugates
Roche signed a new pact with C4 Therapeutics to develop degrader-antibody conjugates (DACs), blending antibody delivery with targeted protein degradation payloads. The collaboration includes $20...
AI and multiomics push into hospital operations
Luminai raised $38 million in Series B funding to scale an AI platform that automates healthcare administrative workflows, starting with referral management. The company said it is working with...
Seeding the next wave of single-cell toxicity prediction
DeepCyte launched with $1.5 million in seed funding, positioning its single-cell metabolomics platform and AI software to predict drug toxicity and mechanisms at single-cell resolution. The...
Bioanalytical expansion: Seer to apply proteomics tech to Singapore cohort study
Seer said the PRECISE-SG100K population proteomics initiative will use its Proteograph platform to profile plasma proteomes of about 10,000 participants. The proteomics data will be combined with...
Biotech IPO plans and late-stage funding for inhaled pulmonary fibrosis assets
Avalyn Pharma has filed for an IPO to fund Phase 3 development of inhaled therapies aimed at idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis. The company’s lead candidate,...
China CAR-T financing ahead of public-market push
Oricell Therapeutics raised additional capital in a pre-IPO round as the Shanghai-based CAR-T developer accelerates plans for a public listing. The company said it has raised more than $110...
Protein degradation partnerships expand in cancer pipelines
Gilead exercised an option to license Kymera Therapeutics’ preclinical molecular glue degrader targeting CDK2, injecting another candidate into a rapidly expanding oncology pipeline. Under the...
R&D platform funding: Stipple Bio emerges with $100M Series A for ADC epitope selection
Stipple Bio came out of stealth with a $100 million Series A focused on advancing an ADC program and scaling its epitope-selection platform. The company’s lead asset, STP-100, is an antibody-drug...
Biopharma commercialization data: Tempus expands Gilead real-world AI collaboration
Tempus expanded its data-and-AI collaboration with Gilead, adding access to broader multimodal datasets and Tempus’ AI platform for oncology drug development. Tempus said the expanded deal builds...
CAR-T response in autoimmune disease with a long-running clinical case
A five-year follow-up narrative highlights how CAR-T therapy continues to surprise investigators in autoimmune disease, centered on a case treated around Georg Schett’s research program. The story...
FDA payment and policy pressure: Shift to reward-based America First PDUFA rules
A policy update described by BioCentury says the FDA is moving from a punitive approach to a reward-based “America First” framework under PDUFA. The reauthorization is framed as reducing fees by...
Single-cell toxicity startup DeepCyte launches with seed funding
DeepCyte launched with $1.5 million in seed funding to commercialize single-cell drug toxicity prediction tools. The company said its MetaCore platform pairs laser-based single-cell sampling with...
Neurodegeneration biomarker: Plasma p-tau217 links to amyloid-β in synuclein disease
Researchers reported in npj Parkinson’s Disease that plasma phosphorylated tau 217 (p-tau217) can detect amyloid-β accumulation in neurodegenerative diseases marked by synuclein pathology. The...
Women’s health evidence gap and market imbalance in menopause care
A new report argues that menopause remains underserved by evidence-based therapeutics despite growing consumer attention and a rapidly expanding menopause market. The piece highlights structural...