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Regulatory decision and access for a next-wave gene therapy
The FDA has granted accelerated approval to Regeneron’s Otarmeni (lunsotogene parvec-cwha), positioning it as the first gene therapy designed to restore neurosensory function to normal levels in...
Moderna’s reported hantavirus vaccine effort
Moderna began early-stage work on a hantavirus vaccine, according to reports that sparked a notable investor reaction. The Boston Globe and other outlets described the program as still in its...
Cardiovascular and metabolic signal from a niche respiratory drug
Researchers at the Medical University of South Carolina (MUSC) reported that the asthma medication formoterol may reverse fatty liver disease biology, including metabolic dysfunction-associated...
Sequencing platform competition heats up with a patent infringement suit
10x Genomics filed a lawsuit against Element Biosciences, alleging that Element’s Aviti24 multiomic analysis platform infringes multiple spatial technology patents licensed from Harvard...
Immunology financing and early clinical push for tolerance
Tr1X is advancing an off-the-shelf type 1 regulatory T cell platform after raising attention for its approach to inducing long-term immune tolerance. The San Diego biotech’s lead program, built...
Public market momentum for immunology biotech with IPO proceeds
Odyssey Therapeutics raised $304 million through an IPO and concurrent private placement, positioning the company to advance immunology programs tied to its lead ulcerative colitis asset, OD-001....
Oncologic diagnostics boost guidance after strong quarterly traction
Guardant Health reported Q1 2026 revenue growth of 48% year over year, lifting its full-year guidance after strong performance in oncology and screening. The company posted $301.7 million in Q1...
AI-guided protein design partnership
Twist Bioscience and LenioBio announced a partnership aimed at accelerating AI-guided protein design using real-world protein molecules. The collaboration focuses on enabling rapid data generation...
Nasdaq debut for a neuromodulation stroke therapy maker
Mobia Medical began trading on Nasdaq under ticker MOBI after completing an IPO priced at $15 per share, raising about $150 million. The company sold 10 million shares at the midpoint of its...
Sparking enzyme-precise control of engineered microbes with CRISPR pulses
Seoul National University researchers developed a next-generation CRISPR biocontainment approach designed to control engineered bacterial survival without DNA cleavage. The work, published in...
FDA gene therapy approval
Regeneron’s Otarmeni (lunsotogene parvec-cwha) won FDA accelerated approval as the first in vivo gene therapy for OTOF-related severe-to-profound sensorineural hearing loss. The FDA based its...
Infectious disease vaccine R&D signals
Moderna’s reported early-stage hantavirus vaccine work triggered investor attention after reports surfaced that the company has started research on a potential jab. The project is described as in...
Cell therapy company funding
Odyssey Therapeutics priced an upsized IPO and concurrent private placement to raise $304 million as it advances its lead Phase II program for ulcerative colitis and plans further development...
FDA/biopharma regulatory and access decisions
Regulatory timelines shifted for Alzheimer’s therapy lecanemab (Leqembi) as the FDA delayed a decision on the company’s proposed subcutaneous route. Biogen and Eisai said the decision date was...
Oncology molecule diagnostics and reimbursement momentum
Guardant Health beat expectations with a Q1 2026 revenue surge, raised full-year guidance, and pointed to continued momentum in oncology and screening. The company reported Q1 revenue of $301.7...
Biotech IPOs and early-stage market access
Mobia Medical began trading on Nasdaq after pricing its IPO at $15 per share, raising about $150 million. The company sold 10 million shares at the midpoint of its $14–$16 target range and ended...
Spatial biology platform expansion and guidance outlook
10x Genomics forecast dimmed spatial biology sales as it rolls out its Atera in situ spatial platform and reiterated full-year guidance. In a business update tied to the platform launch, the...
Spatial technology patent litigation
10x Genomics sued Element Biosciences over alleged patent infringement involving Element’s Aviti24 multiomic analysis platform. The complaint, filed in the District of Delaware, alleges Aviti24...
Therapeutic antibody development pipeline milestone
Arrivent Biopharma received FDA IND clearance for ARR-002 (AV-P138-ADC), an antibody-drug conjugate targeting MUC16 and NaPi2b. The IND clearance enables initiation of a Phase I trial expected to...
Biopharma diagnostics expansion
Amplified Sciences initiated patient enrollment for PanAMP, a multicenter clinical utility study designed to evaluate how its PanCystPro assay influences clinical decision-making for early...