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Eye care Phase 3 readouts strengthen Kodiak’s dosing-durability thesis
Kodiak Sciences reported back-to-back progress in wet age-related macular degeneration, with Phase 3 results showing its anti-VEGF prospect tarcocimab tedromer (Zenkuda) met primary endpoints...
Regulatory approvals expand Mirum’s hepatitis delta franchise
Mirum Pharmaceuticals scored major momentum for its hepatitis delta portfolio, landing a U.S. FDA approval for its once-daily, oral ALK2 inhibitor Atebrioz (zilurgisertib) as the company positions...
Big Pharma bets on Summit’s PD-1xVEGF bispecific for ADC combinations
AstraZeneca moved from collaboration talk to capital commitment, investing $2 billion in Summit Therapeutics to accelerate development of ivonescimab, its PD-1xVEGF bispecific. The companies plan...
Adicet’s allogeneic CAR-T reports lupus signal as shares slide
Adicet Bio reported early clinical results for prula-cel, an off-the-shelf CAR-T approach, in lupus and said key kidney outcomes improved in an early-stage study with the company planning a...
FDA clears DreaMed’s CGM-driven insulin automation for Type 2
DreaMed Diabetes received FDA 510(k) clearance for MODI, a mobile software tool that uses continuous glucose monitoring (CGM) data to generate insulin dosing recommendations for people with Type 2...
Merck locks KRAS G12D licensing rights from SciBrunch
Merck moved deeper into KRAS G12D with an exclusive global licensing deal with SciBrunch Therapeutics for a preclinical oral inhibitor, including a $400 million upfront payment. The agreement...
Novo expands its pipeline via $2.6B GLP-1/GIP preclinical deal with Hengrui
Novo strengthened its pipeline rebuild through a preclinical business move, agreeing to pay $2.6 billion for rights tied to a GLP-1/GIP drug program from Hengrui. The transaction reflects...
Nutshell wins FDA IND clearance for NRF2 degrader NTS-231
Nutshell Therapeutics (Shanghai) obtained FDA IND clearance for NTS-231, a covalent allosteric molecular glue degrader of NRF2 discovered using its Allostar AI-driven platform. The program centers...
Vasomune completes enrollment in Phase 2a pegevongitide program for pneumonia/ARDS
Vasomune Therapeutics completed enrollment in a randomized, double-blind, placebo-controlled Phase 2a study evaluating pegevongitide (AV-001) in patients hospitalized with pneumonia requiring...
Veeva launches AI agent to accelerate clinical trial study configuration
Veeva Systems unveiled Study Builder, an AI agent designed to speed clinical trial study configuration for sponsors using Veeva’s EDC and Data Quality System. The tool ingests trial protocols and...
AstraZeneca deepens bet on Summit’s PD-1xVEGF bispecific and triggers ADC combo plans
AstraZeneca has agreed to invest $2 billion in Summit Therapeutics to accelerate development of ivonescimab (PD-1xVEGF) and advance ADC combination strategies. The partners plan to begin by...
FDA clears DreaMed CGM-driven insulin dosing tool for Type 2 dual regimens
DreaMed Diabetes received FDA 510(k) clearance for MODI, a mobile software tool that uses continuous glucose monitoring data to generate insulin dosing recommendations for people with Type 2...
Egetis wins FDA approval for tiratricol in a rare X-linked genetic disease
Egetis Therapeutics secured US FDA approval for its emcitate/ tiratricol therapy for a rare X-linked genetic condition. The approval is a milestone for the company’s effort to bring a treatment...
Kodiak’s Phase 3 readout restores Eylea-equivalent durability claims in wet AMD
Kodiak Sciences reported a double Phase 3 win for its wet age-related macular degeneration candidates, saying the Phase 3 primary endpoints were met versus Regeneron’s Eylea (aflibercept). The...
FDA approval and Phase 3 momentum for Mirum’s Atebrioz and brelovitug in hepatitis delta
Mirum Pharmaceuticals delivered a two-part catalyst in fibrodysplasia ossificans progressiva and chronic hepatitis delta virus. The company reported FDA approval for its once-daily oral ALK2...
CAR-T in lupus: Adicet’s off-the-shelf prula-cel shows complete kidney responses in early data
Adicet Bio reported early human data for its donor-derived, off-the-shelf CAR-T approach prula-cel in lupus nephritis, including kidney response outcomes after roughly a year of follow-up. The...
Merck strikes a $2.13B KRAS G12D license deal with SciBrunch
Merck & Co. closed a global licensing agreement with China-based SciBrunch Therapeutics for a preclinical oral KRAS G12D (on) inhibitor. The deal includes $400 million upfront and additional...
Vasomune completes enrollment for Fast Track-pegevongitide Phase 2a in pneumonia/ARDS
Vasomune Therapeutics completed enrollment in AV001-004, a randomized, double-blind, placebo-controlled Phase 2a study evaluating pegevongitide (AV-001) in hospitalized pneumonia patients...
Veeva launches an AI agent to generate faster EDC and study build configurations
Veeva Systems unveiled an agentic AI system called Study Builder Agent to speed clinical study configuration across EDC and data quality systems. The plugin ingests a protocol and uses CDISC...
Scynexis wins BARDA contract for antifungal development of SCY-247
BARDA awarded Scynexis a $214 million contract to develop SCY-247, an investigational treatment for serious drug-resistant fungal infections. The funding supports the program’s advancement, adding...