Biotech · Clinical setback
SION-719 did not produce a clinically meaningful improvement when added to Vertex's Trikafta, leading Sionna to end the program and reassess its remaining pipeline.
The BioPharma Docket 5 · Monday, August 10
SION-719 did not produce a clinically meaningful improvement when added to Vertex's Trikafta, leading Sionna to end the program and reassess its remaining pipeline.
The 15-patient crossover study produced a placebo-adjusted sweat chloride reduction of 1.0 mmol/L. Sionna had identified a 10 mmol/L improvement as its goal before the readout.
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The acquisition adds ABS-1230, an experimental precision medicine for KCNT1-related epilepsy, to Jazz Pharmaceuticals' neurology portfolio.
Jazz will pay $820 million upfront and could pay another $500 million tied to regulatory and commercial milestones. ABS-1230 is in phase 1b/2a testing.
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The company expects the new site to employ nearly 500 people and manufacture small molecules, biologics and antibody drug conjugates.
Construction is expected to finish in 2030. The investment forms part of Bristol Myers Squibb's five-year, $40 billion United States investment program.
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Sonelokimab met the primary endpoint and all reported secondary clinical endpoints in biologic-naive patients with active psoriatic arthritis.
At week 16, 42.1 percent of patients achieved an ACR50 response. The company has not yet disclosed comparative treatment-arm data, which remain blinded until the study is completed.
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The complete response letter for ITM-11 did not identify concerns with the submitted clinical efficacy or safety data, according to the company.
FDA cited chemistry, manufacturing and controls issues and deficiencies at a third-party commercial facility. ITM plans to address the findings and resubmit the application.
Read full articleBioPharma Docket reporting is based on company announcements, regulatory documents and the linked coverage. Last updated August 10, 2026 at 11:45 AM ET.
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