✨ 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 marks
✨ 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 for six patients
✨ 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 expected
✨ 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 Gopinathan.
✨ 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
✨ 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
✨ Onyx Summary Belite Bio entered an upsized PIPE financing led by RA Capital with participation from Eventide, Marshall Wace, RTW, Soleus, and Vestal Point, raising ~$125M upfront and issuing two-year warrants exercisable at a 20% premium ($76.80) for up to an additional ~$150M. The company will sell 1,953,
✨ Onyx Summary Adverum Biotechnologies granted inducement equity awards to two new employees, consisting of stock options to purchase 16,860 shares and 8,430 restricted stock units under its 2017 Inducement Plan. The awards, made in accordance with Nasdaq Listing Rule 5635(c)(4), align new hires’ incentives with shareholder
✨ Onyx Summary Lexicon Pharmaceuticals will present preclinical data at NeuPSIG 2025 showing pilavapadin (AAK1 inhibitor) reduced neuropathic pain in models of chemotherapy-induced peripheral neuropathy and multiple sclerosis, with a separate poster on the Phase 2b PROGRESS study design. The update broadens pilavapadin’s potential beyond diabetic peripheral neuropathic pain, aligning
✨ Onyx Summary Perspective Therapeutics has appointed Joel Sendek as Chief Financial Officer, effective immediately. Sendek, a veteran biotech finance executive with over $2.5 billion raised across prior CFO roles and a top-ranked equity research background, succeeds Juan Graham and is expected to strengthen the company’s financial and strategic
✨ Onyx Summary Lexicon Pharmaceuticals will present patient-reported outcomes on the impact of diabetic peripheral neuropathic pain at PAINWeek 2025 (Poster #53, Sept. 4, 4:00–5:30 p.m. PT, Las Vegas) led by Belinda Hardin, PharmD, BCPS, and Suma Gopinathan, Ph.D. The findings are intended to inform late-stage
✨ Onyx Summary ✨ Onyx Summary enGene Holdings announced it has reached target enrollment of 100 patients in the pivotal cohort of its Phase 2 LEGEND trial evaluating detalimogene voraplasmid in high-risk, BCG-unresponsive non-muscle invasive bladder cancer. The company plans to overenroll the cohort and now anticipates submitting a Biologics License Application
✨ Onyx Summary Perspective Therapeutics has appointed Maya Martinez-Davis, President of GSK’s U.S. Commercial business, to its Board of Directors as an independent director. Martinez-Davis brings over two decades of biopharma leadership across GSK, Merck KGaA, and Pfizer, strengthening the company’s strategic and commercial expertise as it advances
✨ Onyx Summary Allucent expanded its executive team, appointing Patrick Phillips as COO, Rachel Page as CCO, and Nate Thompson as CIO to strengthen operations, commercial execution, and technology/AI strategy. The hires aim to scale delivery for small and mid-sized biopharma clients, accelerating program execution and reinforcing Allucent’s position
✨ Onyx Summary Lexicon reported a pooled post-hoc analysis of the SCORED and SOLOIST-WHF trials presented at ESC 2025 showing sotagliflozin reduced total CV death and HF events and lowered total MACE versus placebo consistently across age, including ≥65 and ≥75 years. The dataset (~12,000 participants; median age 69) supports
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