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What’s in Today’s Brief? (April 16th Preview)
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GLP-1 obesity-to-diabetes expansion with cardiovascular and liver safety data
Eli Lilly’s oral GLP-1 obesity drug Foundayo (orforglipron) cleared a key heart-safety hurdle in people with diabetes, meeting non-inferiority versus insulin glargine in a cardiovascular outcomes study while showing no greater risk of liver harm. The company also signaled plans to submit Foundayo for FDA review in diabetes by the end of the second quarter under a National Priority Review Voucher.
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FDA priority review for B7-H3 ADC in extensive-stage small-cell lung cancer
The FDA granted priority review to Daiichi Sankyo and Merck’s ifinatamab deruxtecan, a B7-H3-directed antibody-drug conjugate, for advanced extensive-stage small-cell lung cancer. The accelerated timeline underscores regulators’ focus on new ADCs targeting solid-tumor surface markers, with ifinatamab deruxtecan now moving through the BLA review at heightened speed.
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Groundbreaking Phase 3 setback recovery effort for Elevidys in Europe
Roche will start a new global Phase 3 trial for Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy Elevidys after Europe delivered a negative opinion. The study plans to randomize about 100 early ambulatory boys to Elevidys or placebo over 72 weeks, using “time to rise” as the primary objective and aiming to produce evidence for a revised European submission.
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Major next-generation diagnostics deal: Foundation Medicine to acquire Saga Diagnostics’ Pathlight MRD platform
Roche subsidiary Foundation Medicine agreed to buy Saga Diagnostics to expand its molecular residual disease (MRD) portfolio, paying up to $595 million. The acquisition brings Saga’s Pathlight tumor-informed MRD platform into Foundation’s mix, with plans to leverage Roche sequencing and Digital LightCycler PCR technologies to enable decentralized MRD testing globally.
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RNA epigenetics momentum: Storm raises Series C and treats first patient in sarcoma Phase 2
Storm Therapeutics secured a $56 million Series C to advance STC-15, its RNA enzyme inhibitor targeting myo- and liposarcomas, and reported that the first patient has been treated in a new Phase 2 program. The funding and patient dosing mark a shift from preclinical promise toward clinical evidence generation for an underexplored RNA epigenetics mechanism in solid tumors.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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