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FDA gene therapy approval
Regeneron won FDA accelerated approval for Otarmeni (lunsotogene parvec-cwha), positioned as the first in vivo gene therapy to restore neurosensory hearing for children and adults with...
AI-enabled liquid biopsy demand surge
Natera raised its 2026 revenue guidance after Q1 results showed a sharp acceleration across oncology and women’s health testing. The company increased full-year guidance to $2.74 billion to $2.82...
Big pharma partnership and pipeline expansion in ophthalmology
Bayer moved to expand its ophthalmology portfolio by acquiring Perfuse Therapeutics for $2.45 billion, gaining full rights to PER-001, a Phase II endothelin receptor antagonist for glaucoma and...
Clinical trial update in cancer of unknown primary
Researchers reported promising Phase II data for cancer of unknown primary (CUP) using a second-line regimen combining an anti–PD-1 immune checkpoint inhibitor with nab-paclitaxel. The study, led...
Biotech platform launch and competitive spatial market
10x Genomics launched Atera, a new in situ spatial biology platform aimed at whole-transcriptome mapping with single-cell sensitivity at scale. The company said Atera is engineered to work across...
Genomic testing access expansion via state authorization
Caris Life Sciences submitted an application to the New York State Department of Health’s Clinical Laboratory Evaluation Program for authorization to perform Caris Assure in-state. The review will...
New public equity raises for immunology and stroke
Odyssey Therapeutics completed an upsized IPO and concurrent private placement, raising $304 million to fund clinical-stage autoimmune and inflammatory pipeline development. The company priced...
IND clearance for next ADC programs
Arrivent Biopharma received FDA IND clearance for ARR-002 (AV-P138-ADC), marking a step toward initiating a Phase I trial focused first on ovarian and endometrial cancers and expanding across...
Funding: durable mRNA platform and in vivo CAR T
ParcelBio raised $13 million in seed financing to build its APEXm platform for durable protein expression and to advance an in vivo CAR T program for autoimmune disease. The round was led by...
Public finance and guidance for sequencing and diagnostics
Pacific Biosciences trimmed the high end of its 2026 revenue guidance after lower-than-anticipated instrument demand and continued softness in academic funding, particularly in the Americas. The...
FDA approvals and regulatory momentum in gene therapy
The FDA granted accelerated approval to Regeneron’s Otarmeni (lunsotogene parvec-cwha), positioning it as the first gene therapy designed to restore neurosensory function for OTOF-related...
Infectious disease vaccine pipeline signals: Moderna’s early hantavirus work
Reports say Moderna has begun early-stage research into a hantavirus vaccine, a development that immediately moved investor expectations and reignited interest in unmet infectious-disease...
Biomarkers and diagnostics: Guardant and Natera reset growth outlooks
Guardant Health and Natera both reported quarter-strength diagnostics momentum tied to oncology testing—signals that continue to push liquid biopsy adoption beyond early-stage research. Guardant...
Oncology development: new Phase 2 combo for cancer of unknown primary
Researchers reported promising Phase II results for a second-line regimen in cancer of unknown primary (CUP), pairing an anti-PD-1 immune checkpoint inhibitor with nab-paclitaxel. The study frames...
Cell and gene therapy funding and early execution: Odyssey’s Nasdaq IPO
Odyssey Therapeutics completed an upsized IPO and secured $304 million in gross proceeds to advance immunology-driven pipeline programs. The company priced 15.5 million shares at $18 each and...
ADC and T-cell engager pipeline: FDA IND clearance for Harbour Biomed’s HBM-7004
Harbour Biomed received FDA IND clearance for HBM-7004, enabling first-in-human evaluation of the company’s B7H4 x CD3 bispecific antibody. The program is expected to start a Phase I trial in...
Diagnostics market expansion: Caris seeks New York authorization for Assure genomic profiling
Caris Life Sciences filed an application with the New York State Department of Health for authorization to run its Caris Assure blood-based genomic profiling assay on specimens from New York. The...
Spending and litigation in molecular tools: 10x Genomics sues Element over Aviti24 spatial tech
10x Genomics sued Element Biosciences, alleging Element’s Aviti24 multiomic analysis platform infringes spatial technology patents licensed from Harvard University. The complaint was filed in US...
Company financings: ParcelBio raises seed funding to advance durable mRNA and CAR-T
ParcelBio secured $13 million in seed financing to develop its Amplified and Prolonged EXpression mRNA (APEXm) platform and advance an in vivo CAR T program for autoimmune disease. The round was...
Preclinical therapeutic mechanisms: CRISPR biocontainment without DNA cleavage
Seoul National University researchers published a next-generation CRISPR biocontainment technology intended to control engineered bacterial survival without DNA cleavage. The approach uses a...