✨ Onyx Summary Guardant Health announced the appointment of former U.S. Health and Human Services Secretary Alex M. Azar II to its board of directors, bringing extensive leadership experience from both government and the private sector. His addition underscores Guardant’s ambition to pair policy expertise with scientific innovation, strengthening
✨ 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 Avidity Biosciences priced an upsized public offering of 15 million shares at $40 each, expected to raise $600 million before expenses, with underwriters granted a 30-day option to purchase up to 2.25 million additional shares. Proceeds will be used to advance its three late-stage RNA therapeutic programs,
✨ Onyx Summary Guardant Health announced a strategic agreement with LabFlorida/SunDx Labs to make its FDA-approved Shield™ blood test for colorectal cancer screening available to residents of senior living communities across Florida. By extending Shield to this high-risk, underserved population, the partnership could transform preventive care in aging communities—removing
✨ Onyx Summary Avidity Biosciences reported new one-year data from the EXPLORE44 program showing that its exon 44–skipping therapy del-zota not only slowed but reversed disease progression in Duchenne muscular dystrophy patients, with improvements across multiple functional measures compared to natural history. Treatment led to sustained dystrophin production, normalization of
✨ Onyx Summary Avidity Biosciences (Nasdaq: RNA) announced plans to raise approximately $500 million through an underwritten public offering of its common stock, with an additional $75 million available to underwriters via a 30-day option. The company intends to use the proceeds to advance its three late-stage clinical programs, prepare for
✨ Onyx Summary Guardant Health has announced a partnership with PathGroup to expand access to its FDA-approved Shield™ blood test for colorectal cancer (CRC) screening. The collaboration will bring Shield to more than 250 hospitals and health systems, 15,000+ affiliated physicians, and millions of patients across 25 states through PathGroup’
✨ 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 ImmunityBio reported Phase 2 data showing that ANKTIVA® (nogapendekin alfa inbakicept) can reverse therapy-induced lymphopenia in patients with checkpoint inhibitor–resistant advanced non-small cell lung cancer, with reversal linked to longer median overall survival (15.8 vs. 11.5 months; p=0.0057). The study suggests that restoring
✨ Onyx Summary Guardant Health announced a strategic partnership with PathGroup to expand access to its FDA-approved Shield™ blood test for colorectal cancer screening across 250+ hospitals, 15,000 physicians, and millions of patients in 25 states. By integrating Shield into PathGroup’s vast network and workflows, the collaboration represents a
✨ 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
