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What’s in Today’s Brief? (September 29th Preview)
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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 against Regeneron’s Eylea. Kodiak said both vision gains were noninferior and more than half of patients could follow an individualized dosing approach with injections every six months versus every eight weeks for Eylea.
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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 for broader commercial uptake. The company also disclosed Phase 3 data for brelovitug, reporting a positive virologic response and ALT normalization primary endpoint in a recently acquired program.
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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 to start by testing ivonescimab in combination with AstraZeneca’s CLDN18.2-directed ADC in gastrointestinal cancers, aiming to translate a dual immune-engagement and angiogenesis approach into combination regimens.
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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 pivotal trial. The readout included complete kidney response and remission metrics among evaluable lupus nephritis patients at about one year, with Adicet also highlighting low rates of serious cytokine release syndrome and no reported neuro side effects.
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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 diabetes requiring both basal insulin and fast-acting injections. The clearance advances a CGM-driven insulin automation pathway that can reduce manual dosing decisions while keeping clinicians and patients in control through software guidance.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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