Latest Biotech News

The FDA escalated scrutiny of Capricor’s Duchenne muscular dystrophy cell therapy, deramiocel, ahead of its Cellular, Tissue and Gene Therapies Advisory Committee meeting. In briefing materials...

Freenome won FDA approval for its SimpleScreen blood-based colorectal cancer test, a step designed to bring AI-enhanced cfDNA methylation screening into routine care. The company said Abbott will...

Argenx agreed to buy Forte Biosciences in an all-cash $2.2 billion deal, securing the Phase 2-stage autoimmune candidate FB102. Argenx will pay $77 per share, a premium to Forte’s pre-announcement...

GSK and the GOG Foundation initiated a Phase 3 global trial evaluating mocertatug rezetecan in platinum-resistant ovarian cancer, with enrollment of the first patient. The study,...

Lucid Genomics and the Genetic Alliance announced a collaboration to expand access to Lucid’s AI-powered sequencing analysis platform for underserved rare disease patients. Under the agreement,...

Germany’s genomics-guided precision medicine national pilot project, genomeDE, is expanding after putting reimbursement and data storage infrastructure in place. The initiative has enrolled nearly...

Tidalsense raised $19 million to scale N-Tidal Diagnose, its AI-powered platform for identifying chronic obstructive pulmonary disease (COPD) in about five minutes. The funding round is positioned...

Pairidex secured seed financing of $4.89 million to accelerate commercialization of FusionMRD, an RNA-based droplet digital PCR blood test for monitoring minimal residual disease in gene...

Scribe priced a $128.7 million IPO, funding progress across its in vivo gene-silencing and lipid-targeting pipeline. The California biotech priced 8.58 million shares at $15.00 and also sold an...

RA Capital-backed Oak Hill Bio plans to enter the Nasdaq through a SPAC merger with Research Alliance Corporation III, extending the rare-disease funding pipeline. The strategy is aimed at...

Freenome won FDA approval for its blood-based SimpleScreen colorectal cancer test, the company said Monday, marking a new commercial milestone for cfDNA methylation analytics. The test is cleared...

Argenx agreed to acquire Forte Biosciences in a deal valued up to $2.2 billion, extending the Dutch-Belgian immunology leader’s acquisition spree into earlier-stage autoimmune assets. Argenx will...

MapLight Therapeutics reported positive Phase 2 results for its schizophrenia medicine but the market response underscored how endpoint details can dominate clinical narratives. In a mid-stage...

FDA scientists flagged concerns about the efficacy of Capricor’s deramiocel ahead of an advisory committee meeting, according to Monday’s update. The agency said the stem-cell treatment for...

Legend Biotech said CEO Ying Huang resigned with no permanent replacement named, appointing Alan Bash as interim CEO and initiating a search process for a successor. The company said Huang’s...

Quantum-Si disclosed that it received a Nasdaq delisting notification after its shares traded below the $1 minimum bid price for 30 consecutive business days. The Branford, Connecticut-based...

RA Capital led a $175 million investment behind Oak Hill Bio, a startup developing an Angelman syndrome drug that Roche shelved and aiming to compete with late-stage programs from Ultragenyx and...

Pairidex raised a $4.89 million seed round to accelerate FusionMRD, an RNA-based droplet digital PCR blood test targeting minimal residual disease in gene-fusion driven blood cancers. The company...

Veraxa Biotech moved its bispecific antibody-drug conjugate program VXA-222 into the next collaboration phase after achieving a technical milestone with Omniab. The update signals advancement of...

InnoCare Pharma said its oral TYK2 inhibitor fadeucravacitinib met the primary endpoint in a Phase 3 trial for adults with moderate-to-severe plaque psoriasis. The company positioned the result as...