Bio News
Gossamer Bio has ended its $486 million (approximately 729 billion won) agreement with Chiesi after reclaiming worldwide rights to seralutinib, a pulmonary arterial hypertension treatment that failed to meet the primary endpoint in a phase 3 trial. Seralutinib improved the 6-minute walk distance by 13.3 meters versus placebo after 24 weeks in the phase 3 trial, but its P value of 0.032 did not meet the prespecified statistical significance threshold of P<0.025. Gossamer plans to submit a new drug application (NDA) in September and is targeting approval in the third quarter of 2027 after the US Food and Drug Administration (FDA) determined that the results represented a matter for review rather than a barrier to submission.
BIOBOOK TEAM
biobookmedia@biobook.co.krRoche’s New Drug for Uveitic Macular Edema Faces FDA Decision in July 2027
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MFDS Begins Distribution of Internationally Certified Reference Materials, Including 24 New Items, for a Total of 882
