Get the Daily Brief
Latest Biotech News
Ulcerative colitis – Abivax obefazimod shows high remission, cancer cases trigger caution
Abivax reported strong efficacy from its Phase 3 maintenance study of obefazimod (a daily oral therapy) in ulcerative colitis, but disclosed a small number of cancer cases among treated patients...
Regulatory approvals – FDA greenlights FoundationOne CDx companion tests for Talzenna + Xtandi
The FDA approved Foundation Medicine’s FoundationOne CDx assays as companion diagnostics for Pfizer’s Talzenna plus Xtandi in metastatic castration-resistant prostate cancer with homologous...
CDx commercialization – Veracyte launches Prosigna LDT after OPTIMA trial data at ASCO
Veracyte launched its Prosigna Breast Risk of Recurrence assay as a laboratory-developed test (LDT) in the US after ASCO 2026 presentations tied to the Phase 3 OPTIMA trial. Company executives...
Dealmaking – Servier buys Edgewise muscular dystrophy assets for up to $2.65B
Servier agreed to acquire Edgewise Therapeutics’ muscular dystrophy business for $1.55 billion upfront, with total deal value potentially reaching $2.65 billion including milestone payments. The...
Deals – Eli Lilly licenses Hanmi’s GLP-2 therapy sonefpeglutide in $1.26B agreement
Eli Lilly inked a licensing agreement with Hanmi Pharmaceutical for sonefpeglutide, a long-acting GLP-2 analog in development for short bowel syndrome and other indications. The deal includes $75...
Oncology biopharma – Avenzo reverse-merger with Rallybio clears path to Nasdaq
Rallybio will merge with Avenzo Therapeutics in a reverse merger designed to bring Avenzo to the Nasdaq market after Rallybio’s prior reverse-merger path was disrupted by UCB’s acquisition of...
Biotech ecosystem – Organ-on-chip advances toward regulatory tool qualification
The FDA’s ISTAND program is moving organ-on-chip systems closer to qualified “drug development tools,” with Emulate’s liver-chip approach highlighted as a key example of progress. The coverage...
Technology partnerships – IDT links Illumina DRAGEN to oncology library prep workflows
Integrated DNA Technologies and Illumina partnered to connect Illumina’s DRAGEN secondary analysis pipeline with IDT oncology library preparation workflows. The collaboration focuses on DRAGEN...
Non-small-cell lung cancer – PD-1/VEGF bispecifics deliver OS benefit
Akesos ivonescimab and Summit Therapeutics’ development partner’s ivonescimab regimen extended survival in a key squamous non-small-cell lung cancer trial conducted entirely in China. In the...
ASCO pancreatic cancer breakthrough – daraxonrasib reshapes second-line outcomes
Revolution Medicines’ daraxonrasib produced striking survival gains in RAS-driven metastatic pancreatic cancer, with detailed Phase 3 RASolute 302 results presented at ASCO and simultaneously...
Colorectal cancer – American Cancer Society lowers screening age and expands at-home molecular options
The American Cancer Society updated colorectal cancer screening guidance in CA: A Cancer Journal for Clinicians, reaffirming a diversified testing strategy while emphasizing an expanded menu of...
Regulatory – FDA clears Prostate CDx for Talzenna plus Xtandi in HRR-mutated mCRPC
The FDA approved Foundation Medicine CDx assays as companion diagnostics for Pfizer’s Talzenna (talazoparib) plus Xtandi (enzalutamide) in metastatic castration-resistant prostate cancer (mCRPC)...
Biopharma deals – Servier expands into muscular dystrophy with Edgewise assets
Servier is acquiring Edgewise Therapeutics’ muscular dystrophy business, stepping into neurology and muscular dystrophy with a deal structured around an upfront cash payment and performance...
Clinical pipeline – CRISPR R&D advances in blood stem cells with a new editing workflow
A research team led by Luigi Naldini at SR-Tiget developed a new strategy to make CRISPR-Cas9 genome editing in human hematopoietic stem cells more efficient and safer. The approach is reported to...
Regulatory and company action – Replimune resubmits melanoma biologic after FDA leadership shakeup
Replimune will resubmit its biologics license application for RP1, a melanoma therapy, after two prior FDA rejections. The company said it expects to refile its application in the coming days,...
Cancer diagnostics – Veracyte launches Prosigna LDT in the U.S. after OPTIMA readout
Veracyte launched its Prosigna Breast Risk of Recurrence assay as a laboratory-developed test (LDT) in the U.S. after clinical trial data presented at ASCO supported its use in guiding adjuvant...
Company pivots after late-stage setback – Oculis shifts pipeline after Phase 3 DME disappointment
Oculis’ Phase 3 program for diabetic macular edema did not meet endpoints, prompting the company to shift pipeline priorities. The setback delays the prospect of a topical eye-drop option for DME...
M&A and corporate structure – Avenzo to take Nasdaq listing via reverse merger with RallyBio
RallyBio is pursuing another path to a Nasdaq listing through a reverse merger with Avenzo Therapeutics after the earlier reverse-merger route with Candid fell apart following a UCB acquisition....
Pancreatic cancer clinical breakthrough at ASCO
Revolution Medicines disclosed full Phase 3 results for daraxonrasib in previously treated, metastatic pancreatic ductal adenocarcinoma at ASCO 2026, with the data simultaneously published in The...
FDA diagnostics: new CDx path for Talzenna plus Xtandi
The FDA approved Foundation Medicine’s FoundationOne CDx assays as a companion diagnostic for Pfizer’s Talzenna plus Xtandi regimen in metastatic castration-resistant prostate cancer. The coverage...