Pharminent · Daily Brief
September 29, 2026
Regulatory & Approvals
Merck and Daiichi drop accelerated approval plan for I-DXd
Merck and Daiichi Sankyo ended plans to seek accelerated approval of ifinatamab deruxtecan in small cell lung cancer after the FDA indicated the data generated so far would not support an accelerated clearance.
BioPharma Dive →$DSNKY$MRK
FDA approves Egetis’ first treatment for MCT8 deficiency
Sweden’s Egetis won US approval for the first-ever treatment for people living with the ultra-rare genetic disease MCT8 deficiency.
Pharmaphorum →
FDA approves Lilly’s Olumiant, AbbVie’s Juvmo and Mirum and Incyte’s Atebrioz
The FDA approved Lilly’s Olumiant, AbbVie’s Juvmo, and Mirum and Incyte’s Atebrioz.
PharmExec →$ABBV$LLY
DreaMed wins FDA clearance for CGM-based insulin dosing app
DreaMed Diabetes received FDA 510(k) clearance for MODI, a mobile app that uses continuous glucose monitoring data to provide insulin dosing recommendations for people with type 2 diabetes who need both basal insulin and fast-acting injections.
MedCity News →
Clinical Data
Kodiak shares jump on Phase 3 data for two eye drugs
Kodiak reported positive Phase 3 findings for two eye drugs, including tabirafusp in wet AMD, adding more than $3 billion to the company’s market value.
BioPharma Dive →
Adicet’s off-the-shelf gamma delta cell therapy shows early lupus data
Data from an early trial of Adicet’s “off-the-shelf” gamma delta cell therapy in lupus showed it surpassed benchmarks set by personalized CAR-T treatments tested in the disease.
BioPharma Dive →
Lilly says Zepbound beat Wegovy HD in indirect comparison
Lilly reported a new indirect treatment comparison in which Zepbound 15 mg was associated with 4.5% greater weight loss than Wegovy HD (semaglutide injection 7.2 mg) in adults with obesity, and participants on Zepbound 15 mg had more than three times the odds of achieving at least 20% body-weight reduction.
Eli Lilly →$LLY
Lilly’s Foundayo beat oral semaglutide in indirect comparison
In a new indirect treatment comparison, Lilly’s Foundayo (orforglipron) 17.2 mg was associated with 1.5% greater weight loss and 0.3% greater A1C reduction than oral semaglutide 25 mg at 52 weeks in adults with type 2 diabetes, building on the head-to-head ACHIEVE-3 study.
Eli Lilly →$LLY
Deals & Partnerships
AstraZeneca takes 10% Summit stake in $2B deal
AstraZeneca has acquired a roughly 10% stake in Summit Therapeutics and signed a deal worth about $2 billion to test CLDN18.2-targeting sone-ve with the PD-1xVEGF bispecific ivonescimab.
Pharmaphorum →$AZN
Merck licenses SciBrunch’s KRAS G12D inhibitor for $400M upfront
MSD signed a license agreement for a KRAS G12D inhibitor from China’s SciBrunch, paying $400 million upfront for the preclinical candidate.
Pharmaphorum →$MRK
Merck licenses SPR2015 in $2.13 billion deal
Merck acquired rights to SPR2015 in a licensing deal valued at $2.13 billion.
PharmExec →$MRK
GSK to acquire Chimagen’s trispecific T cell-engager for myeloma
GSK announced on September 15, 2026 that it agreed to acquire a trispecific T cell-engager from privately held Chimagen Biosciences, and plans to develop and commercialize the asset for multiple myeloma with Phase 1 trials expected to begin in 2027.
Big Molecule Watch →$GSK
Tolerance Bio licenses TLB-33 from Tanabe Pharma for $560M
Tolerance Bio signed an agreement securing an exclusive license from Tanabe Pharma for TLB-33 in a worldwide deal worth up to around $560 million.
Pharmaceutical Technology →
Dualitas and Roche partner on bispecific antibodies for immunology
Dualitas Therapeutics announced on September 17, 2026 a research collaboration and license agreement with Roche to advance novel bispecific antibodies for immunology and inflammation diseases, under which Dualitas will functionally screen over 300,000 novel bispecific combinations using its DualScreen Bispecific Discovery Engine.
Big Molecule Watch →$RHHBY
Business & Finance
USPTO institutes four IPRs against Janssen’s golimumab patents
On September 9, 2026, the USPTO issued a Notice of Decisions on Institution granting institution in four inter partes review proceedings challenging Janssen Biotech’s golimumab method-of-treatment patents: IPR2026-00256, IPR2026-00257, IPR2026-00258 and IPR2026-00259.
Big Molecule Watch →
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