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Kyverna Therapeutics Highlights Potential of KYV-101 in Multiple Sclerosis with Data from Phase 1 Investigator-Initiated Trials to be Presented at ECTRIMS

Kyverna Therapeutics Highlights Potential of KYV-101 in Multiple Sclerosis with Data from Phase 1 Investigator-Initiated Trials to be Presented at ECTRIMS

✨ Onyx Summary Kyverna Therapeutics reported updated Phase 1 data from investigator-initiated trials of its CD19 CAR T-cell therapy, KYV-101, in progressive multiple sclerosis, showing favorable safety, CNS penetration, and early signs of disease stabilization or improvement. The data, presented by Stanford and UCSF at the 2025 ECTRIMS Congress, reinforce KYV-101’

Advanced Clinical Announces Leadership Transition

Advanced Clinical Announces Leadership Transition

✨ Onyx Summary Advanced Clinical announced that CEO Julie Ross has departed to pursue a new opportunity, with Founder and Owner Leo Sheridan assuming the role of Chief Executive Officer. Supported by a seasoned leadership team, the transition underscores the company’s continued focus on global growth, operational excellence, and delivering

Lexicon Pharmaceuticals Announces Update on Submission of Additional Data to U.S. FDA Supporting the Benefit-Risk Profile of Zynquista® in Type 1 Diabetes

Lexicon Pharmaceuticals Announces Update on Submission of Additional Data to U.S. FDA Supporting the Benefit-Risk Profile of Zynquista® in Type 1 Diabetes

✨ Onyx Summary Lexicon Pharmaceuticals announced that the FDA will require additional time to review newly submitted clinical data supporting the potential resubmission of its New Drug Application for Zynquista® (sotagliflozin) as an adjunct therapy for adults with type 1 diabetes, with feedback now expected in Q4 2025. The update follows

Pilavapadin Provides Meaningful Pain Reduction in Adults with Diabetic Peripheral Neuropathic Pain (DPNP) in Data Presented at the European Association for the Study of Diabetes (EASD) and NEUROdiab Annual Meetings

Pilavapadin Provides Meaningful Pain Reduction in Adults with Diabetic Peripheral Neuropathic Pain (DPNP) in Data Presented at the European Association for the Study of Diabetes (EASD) and NEUROdiab Annual Meetings

✨ Onyx Summary Lexicon Pharmaceuticals presented new Phase 2b PROGRESS study data for its investigational AAK1 inhibitor, pilavapadin, at the NEUROdiab and EASD 2025 meetings, showing that the 10 mg once-daily dose achieved a statistically and clinically meaningful reduction in diabetic peripheral neuropathic pain while maintaining strong tolerability. The findings strengthen

Piramal Pharma Solutions Augments Formulation Capabilities with the Addition of New Korsch XM-12 Bilayer Tablet Press at its Morpeth, UK Facility

Piramal Pharma Solutions Augments Formulation Capabilities with the Addition of New Korsch XM-12 Bilayer Tablet Press at its Morpeth, UK Facility

✨ Onyx Summary Piramal Pharma Solutions announced the acquisition of a Korsch XM-12 bilayer tablet press for its Morpeth, UK facility, enhancing its capabilities in oral solid and hormonal drug product development and manufacturing. The investment strengthens precision, flexibility, and containment in tablet production, supporting Piramal’s commitment to advanced drug

SpyGlass Pharma Appoints Anand Sundaram as Head of Commercial

SpyGlass Pharma Appoints Anand Sundaram as Head of Commercial

✨ Onyx Summary SpyGlass Pharma appointed Anand Sundaram as Vice President, Head of Commercial, to lead launch strategy and build its commercial organization ahead of two planned Phase III trials for its sustained drug delivery platform. Sundaram brings extensive ophthalmic commercialization experience from Opthea, Iveric Bio, Novartis, and Genentech, strengthening SpyGlass’

Perspective Therapeutics Progresses Dose Finding for [212Pb]VMT01 in Combination with Nivolumab in its Ongoing Phase 1/2a Study of MC1R-Positive Metastatic Melanoma

Perspective Therapeutics Progresses Dose Finding for [212Pb]VMT01 in Combination with Nivolumab in its Ongoing Phase 1/2a Study of MC1R-Positive Metastatic Melanoma

✨ Onyx Summary Perspective Therapeutics has dosed the first patient in a new Phase 1/2a cohort evaluating [212Pb]VMT01, its targeted alpha-particle therapy, in combination with Bristol Myers Squibb’s nivolumab (Opdivo®) for patients with metastatic melanoma. The expansion to a higher 3.0 mCi dose and combination arm marks

Lexicon Pharmaceuticals Announces Submission of Additional Data to U.S. FDA Supporting the Benefit-Risk Profile of Zynquista® in Type 1 Diabetes

Lexicon Pharmaceuticals Announces Submission of Additional Data to U.S. FDA Supporting the Benefit-Risk Profile of Zynquista® in Type 1 Diabetes

✨ Onyx Summary Lexicon Pharmaceuticals submitted new clinical data to the FDA from three investigator-initiated studies supporting a potential resubmission of its New Drug Application for Zynquista® (sotagliflozin) as an adjunct to insulin therapy for adults with type 1 diabetes. The submission follows a 2024 FDA complete response letter citing safety

Keros Therapeutics Presents Additional Clinical Data from its KER-065 Program at the American Society of Bone and Mineral Research 2025 Annual Meeting

Keros Therapeutics Presents Additional Clinical Data from its KER-065 Program at the American Society of Bone and Mineral Research 2025 Annual Meeting

✨ Onyx Summary Keros Therapeutics presented additional Phase 1 data for KER-065 showing strong bone anabolic activity and increased bone mineral density in healthy volunteers, with the treatment well-tolerated across all dose levels. The results reinforce KER-065’s dual potential in Duchenne muscular dystrophy and bone disorders, supporting its continued clinical