✨ Onyx Summary enGene Holdings appointed Hussein Sweiti, M.D., MSc, as Chief Medical Officer, effective September 29, 2025. Dr. Sweiti, formerly Global Medical Head of Oncology Clinical Development at Johnson & Johnson, joins enGene as it transitions detalimogene voraplasmid toward regulatory filing and potential commercialization in high-risk, BCG-unresponsive
✨ Onyx Summary Saama announced the launch of modular Clinical AI Agents built on its Agentic AI platform, enabling sponsors to drive efficiency and innovation across the clinical development lifecycle through partial autonomy and human-in-the-loop oversight. The purpose-built system addresses integration and compliance failures seen in generalist
✨ 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
✨ 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
✨ 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
✨ Onyx Summary Adverum Biotechnologies announced it will complete screening by September 30 for ARTEMIS, its first pivotal Phase 3 trial of Ixo-vec in wet age-related macular degeneration (AMD), with full enrollment of at least 284 patients expected in 4Q 2025 and data readout in 1Q 2027. The ARTEMIS
✨ Onyx Summary Geron Corporation granted inducement equity awards to 16 new hires totaling 966,000 shares—644,000 stock options at a $1.27 exercise price and 322,000 RSUs—under Nasdaq Listing Rule 5635(c)(4), with grants dated September 17, 2025 and four-year vesting schedules. The move
✨ 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
✨ 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
✨ 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’
✨ 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
✨ Onyx Summary Kyverna Therapeutics will present interim Phase 2 data from the KYSA-6 study of its CD19 CAR T-cell therapy KYV-101 in generalized myasthenia gravis at the 2025 AANEM Annual Meeting. The results, part of a registrational Phase 2/3 study, will include efficacy and safety data
✨ Onyx Summary Belite Bio completed the last subject visit in its global Phase 3 DRAGON trial of tinlarebant for Stargardt disease type 1, which enrolled 104 adolescents across 11 jurisdictions (94 completed); the primary endpoint is the growth rate of atrophic lesions with safety/tolerability assessed. Top-line data are
✨ Onyx Summary Lexicon Pharmaceuticals will present clinical data for its investigational AAK1 inhibitor, pilavapadin, at three meetings: NeuroDiab (Sept. 13, 2025, Bucharest), EASD (Sept. 17, 2025, Vienna), and Arrowhead’s Pain Therapeutics Summit (Oct. 13–14, 2025, San Diego), with sessions led by Dr. Rodica Pop-Busui and Dr. Suma
✨ 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
✨ 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
![Perspective Therapeutics Progresses Dose Finding for [212Pb]VMT01 in Combination with Nivolumab in its Ongoing Phase 1/2a Study of MC1R-Positive Metastatic Melanoma](https://storage.ghost.io/c/89/48/8948ce11-5e2a-481d-9f95-cf8a6b32a75a/content/images/size/w1304/format/webp/2025/10/Perspective-1.png)
