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What’s in Today’s Brief? (July 11th Preview)
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Roche/Ionis terminate Huntington’s programs
Roche has discontinued two Ionis-partnered antisense therapy programs in Huntington’s disease after failing to meet key efficacy and safety objectives. In a letter to Huntington’s disease community groups, Roche said the Phase 2 GENERATION HD2 study for tominersen will stop after the drug did not achieve its primary efficacy goal. Roche also ended a separate trial for RG6496 after new data from a parallel animal study triggered a stop decision.
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AstraZeneca/Ionis stumble in ATTR-CM
A Phase 3 readout for AstraZeneca and Ionis’ Wainua (eplontersen) has failed in transthyretin amyloid cardiomyopathy, further constricting development options for TTR-silencing approaches in ATTR-CM. Coverage of the decision and ensuing analysis highlighted how Wall Street is parsing whether the failure reflects knockdown versus stabilizer synergy—or the modality itself—after the Cardio-TTRansform program reduced TTR levels but did not clear its clinical endpoint.
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FDA resumes CRL releases after transparency pause
The FDA has resumed issuing complete response letters (CRLs) to pharmaceutical companies after citing a renewed focus on transparency, according to reporting on newly posted decision letters. The shift follows a pause tied to an internal governance discussion, and comes as multiple late-stage programs face manufacturing, labeling, or clinical package issues.
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FDA rejects Hengrui-Elevar liver cancer combo again
The FDA has rejected an investigational liver cancer regimen combining HLB Co.’s rivoceranib with Jiangsu Hengrui’s camrelizumab for a third time, citing manufacturing deficiencies tied to a facility inspection. The repeated complete response letter underscores continued regulatory friction for checkpoint–TKI combinations in HCC, even as sponsors seek revised submissions to address the underlying quality issues.
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GSK’s B7-H3 ADC posts Phase 3 overall survival win in China
GSK and Hansoh reported Phase 3 success in China for risvutatug rezetecan (ris-rez), a B7-H3-targeted antibody-drug conjugate in advanced or relapsed small cell lung cancer. The program met its primary endpoint of overall survival versus standard chemotherapy with topotecan, and GSK said the results were statistically significant and clinically meaningful, with consistent benefits in secondary measures including time to tumor progression.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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