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Latest Biotech News

Biotech IPOs return with heavy immunology and Nasdaq filings

May 09, 2026

Odyssey Therapeutics priced an upsized IPO and concurrent private placement to fund autoimmune and inflammatory pipeline assets and complete its return to public markets. The company raised $304...

Oncology and diagnostics capital flows: Caris and Guardant operational momentum

May 09, 2026

Caris Life Sciences took a step to expand access to its blood-based genomic profiling assay by submitting an application to the New York State Department of Health (NYSDOH) for authorization to...

Guardant Health Boosts Guidance on Q1 Growth – Minimal Residual Disease Momentum Continues

May 09, 2026

Guardant Health reported Q1 2026 revenue of $301.7 million, up 48% year over year, and increased its full-year outlook to $1.30 billion–$1.32 billion. Company executives pointed to volume growth...

Precision diagnostics expansion: TGen launches 3-day whole-genome multiple myeloma test

May 09, 2026

Translational Genomics Research Institute (TGen), part of City of Hope, launched JAYseq™, a clinical whole-genome sequencing test for multiple myeloma designed to deliver results in about three...

Digital pathology deal accelerates AI-powered diagnostics scale at Roche

May 09, 2026

Roche agreed to acquire PathAI for up to $1.05 billion to expand its digital pathology capabilities and strengthen AI-powered diagnostic workflows. Under the terms announced, Roche will pay $750...

Patent fight heats up in spatial genomics and prenatal sequencing

May 09, 2026

10x Genomics sued Element Biosciences, alleging the Aviti24 multiomic spatial platform infringes spatial-technology patents licensed from Harvard University. In its Delaware complaint, 10x cites...

Illumina Takes Action Against BillionToOne on NIPT Patent Claims

May 09, 2026

Illumina filed a complaint in U.S. District Court for the District of Delaware against BillionToOne, alleging infringement of multiple patents covering non-invasive prenatal testing technologies....

Cell-free DNA fragmentomics gains momentum for tumor detection

May 09, 2026

Researchers highlighted a cell-free DNA fragmentomics technique designed to detect tumor-linked nucleosomal patterns by analyzing the size distribution of circulating DNA fragments. The approach,...

Regulatory decision reroutes for gene therapy approvals

May 09, 2026

The FDA agreed to reconsider an approval path for Atara Biotherapeutics and Pierre Fabre Pharmaceuticals’ EBV-specific T-cell therapy Ebvallo (tabelecleucel), following the agency’s earlier shock...

New FDA authorization for a first-in-class hearing gene therapy

May 09, 2026

Regeneron won accelerated approval from the FDA for Otarmeni (lunsotogene parvec-cwha), described as the first gene therapy to restore neurosensory function for OTOF-associated sensorineural...

Oncology trial readout moves in unknown primary cancer

May 09, 2026

Researchers reported phase II results for a combination intended to treat cancers of unknown primary (CUP) with a regimen that pairs an anti-PD-1 immune checkpoint inhibitor with nab-paclitaxel....

New clinical enrollment for pancreatic cancer diagnostic utility

May 09, 2026

Amplified Sciences started patient enrollment for PanAMP, a multicenter real-world clinical utility study assessing how its PanCystPro assay influences clinical decision-making for early...

Caris expands access to genomic profiling testing through New York review

May 09, 2026

Caris Life Sciences submitted an application to New York State Department of Health’s Clinical Laboratory Evaluation Program to authorize Caris Assure for specimens originating in the state. The...

Precision diagnostics demand lifts major liquid biopsy player guidance

May 09, 2026

Guardant Health reported strong Q1 2026 revenue growth and raised full-year guidance after oncology testing volumes and minimal residual disease (MRD) demand accelerated. The company posted Q1...

Biotech IPOs raise cash to fund autoimmune and cell therapy pipelines

May 09, 2026

Odyssey Therapeutics returned to the public markets with an upsized IPO and concurrent private placement, bringing $304 million in gross proceeds to fund its autoimmune and inflammatory pipeline....

M&A and platform bets in digital pathology

May 09, 2026

Roche agreed to acquire PathAI in a deal valued at up to $1.05 billion to expand its digital pathology and companion diagnostics capabilities. Roche will pay $750 million upfront, with as much as...

Spatial genomics patent dispute escalates

May 09, 2026

10x Genomics sued Element Biosciences, alleging Element’s Aviti24 multiomic platform infringes 10x spatial technology patents licensed from Harvard University. The complaint was filed in the US...

Cell-free DNA fragmentomics moves into tumor-linked pattern detection

May 09, 2026

Researchers reported a fragmentomics approach designed to detect tumor-linked nucleosomal patterns by analyzing size distributions of circulating cell-free DNA. The technique connects fragment...

Gene therapy approval

May 08, 2026

The FDA granted accelerated approval to Regeneron’s in vivo gene therapy Otarmeni (lunsotogene parvec-cwha), making it the first gene therapy designed to restore neurosensory function in...

Regulatory reconsideration for cell therapy

May 08, 2026

The FDA agreed to reconsider Ebvallo (tabelecleucel) after a surprise rejection earlier in 2026, giving Pierre Fabre Pharmaceuticals and Atara Biotherapeutics a new potential path toward review....