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Latest Biotech News

Crescent inks two‑way Kelun pact — PD‑1/VEGF bispecific program set for parallel US‑China readouts

December 06, 2025

Crescent Biopharma struck a bilateral deal with Sichuan Kelun‑Biotech to generate parallel datasets for its PD‑1/VEGF bispecific CR‑001 and to test combination strategies with antibody‑drug...

Praxis halts pivotal seizure trial early for efficacy — relutrigine draws investor focus

December 06, 2025

Praxis Precision Medicines stopped its Phase 2/3 EMBOLD study in developmental and epileptic encephalopathies early after an interim analysis showed strong efficacy for the sodium‑channel...

Bristol Myers extends Breyanzi label: CAR‑T cleared for marginal zone lymphoma

December 06, 2025

Bristol Myers Squibb received regulatory approval to expand the indication for its CAR‑T therapy Breyanzi to include third‑line marginal zone lymphoma, marking the first CAR‑T approval for this...

Syntax Bio publishes CRISPR Cellgorithm: programmable control trims stem‑cell timelines

December 06, 2025

Syntax Bio reported research in Science Advances on its Cellgorithm platform, a CRISPR‑based system that programs gene activity in human stem cells to accelerate and standardize differentiation....

Anti‑SFRP2 antibody suppresses TNBC growth and metastasis in mice — preclinical proof‑of‑concept

December 06, 2025

Researchers at MUSC Hollings Cancer Center published preclinical data showing that a monoclonal antibody targeting secreted frizzled‑related protein 2 (SFRP2) reduced primary triple‑negative...

Triana closes $120M Series B to push molecular glue degraders toward clinic

December 06, 2025

Triana Biomedicines announced an oversubscribed $120 million Series B to advance its molecular glue degrader pipeline, including lead candidate TRI‑611 aimed at ALK‑driven non‑small cell lung...

Freenome to go public: $330M SPAC backs blood-based cancer test push

December 05, 2025

Freenome agreed to merge with a SPAC to take the Bay Area liquid‑biopsy developer public with roughly $330 million in proceeds, including a $240 million PIPE commitment. The deal accelerates...

CDC panel scraps universal birth dose: ACIP shifts hepatitis B guidance

December 05, 2025

The Advisory Committee on Immunization Practices voted to remove the long‑standing universal hepatitis B vaccine recommendation at birth for infants whose mothers test negative, instead urging...

FDA upheaval escalates: Høeg named to run CDER as ex‑chiefs criticize vaccine policy

December 05, 2025

The FDA named Tracy Beth Høeg as acting director of the Center for Drug Evaluation and Research amid rapid leadership turnover at CDER. Høeg, an epidemiologist who worked on high‑profile vaccine...

Natera buys Foresight: $275M acquisition to boost MRD sensitivity

December 05, 2025

Natera agreed to acquire Foresight Diagnostics for $275 million upfront plus up to $175 million in earnouts to integrate PhasED‑Seq phased‑variant technology into Natera’s Signatera MRD platform....

Denali taps royalty financing as FDA action and holds cloud approval timeline

December 05, 2025

Royalty Pharma agreed to provide up to $275 million to Denali tied to potential approval of tividenofusp alfa, giving Denali contingent capital while the FDA delays a regulatory decision. The...

Triana nets $120M: molecular‑glue degrader program advances to clinic

December 05, 2025

Triana Biomedicines closed an oversubscribed $120 million Series B to advance TRI‑611, a molecular‑glue degrader targeting ALK‑driven non‑small cell lung cancer, into clinical development. The...

Praxis halts pivotal seizure trial early: relutrigine posts strong efficacy

December 05, 2025

Praxis Precision Medicines stopped its Phase 2/3 EMBOLD trial early after an interim analysis showed statistically robust efficacy for relutrigine in a rare epilepsy indication. The company said...

Encoded ties ETX101 to 78% seizure drop — pivotal trial on track

December 05, 2025

Encoded Therapeutics reported Phase 1/2 Dravet syndrome gene‑therapy data showing a 78% reduction in seizures linked to ETX101, moving the program toward a pivotal study next year. The company...

Terray hits BMS milestone: AI‑chip platform delivers discovery breakthrough

December 05, 2025

Terray Therapeutics announced it achieved the first discovery milestone under its multi‑target collaboration with Bristol Myers Squibb, validating its Experimentation Meets Machine Intelligence...

Ginkgo wins $47M DOE‑linked contract to automate phenotyping at PNNL

December 05, 2025

Ginkgo Bioworks secured a four‑year, $47 million contract to design and build an automated phenotyping platform for the Pacific Northwest National Laboratory and its Environmental Molecular...

ACIP in disarray: hepatitis B birth-dose vote delayed then reversed

December 05, 2025

An advisory swirl over newborn hepatitis B vaccinations culminated this week in procedural chaos and a contentious policy shift. Early in the week the CDC’s Advisory Committee on Immunization...

Ex-FDA chiefs lambaste vaccine policy—agency taps Høeg to run CDER

December 05, 2025

Twelve former FDA commissioners publicly condemned proposed vaccine-policy changes and accused the agency’s biologics chief of threatening longstanding regulatory standards, publishing their...

Capricor’s DMD win ignites rally—company prices $150M follow-on

December 05, 2025

Capricor Therapeutics reported positive top-line Phase III data for its cell therapy deramiocel in Duchenne muscular dystrophy, prompting a dramatic market reaction and a strategic financing push....

FDA pauses Denali trial... company secures $275M royalty financing

December 05, 2025

Regulatory friction and financing maneuvers converged for Denali Therapeutics this week. The FDA placed a hold on Denali’s planned Phase 1 study for a Pompe-disease candidate, requesting protocol...