Press Releases - Onyx Newsroom (Page 17)

Cellares Selects Five Best-in-Class Technology Providers, Tecan, Advanced Instruments, Cytek Biosciences, Slingshot Biosciences and AltemisLab, to Expand Cell Q’s Capabilities in Meeting Demands for Commercial Scale Cell Therapy Quality Control

✨ Onyx Summary Cellares announced multiple technology partnerships to advance Cell Q™, the first fully automated, modular quality control platform designed to handle the commercial-scale throughput required for cell therapy manufacturing. By integrating best-in-class systems from partners like Tecan, Cytek, and Advanced Instruments, Cell Q sets a new standard for compliance,

September 17, 2025

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

September 16, 2025

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’

September 16, 2025

2025 Eisai R&D Day: Deepening Connections

✨ Onyx Summary MassBio will host the 2025 Eisai R&D Day on October 20 at Eisai’s G2D2 Center in Cambridge, featuring panel discussions, poster sessions, and networking to showcase Eisai’s R&D priorities in neuroscience, oncology, and global health. By fostering direct engagement between Eisai and

September 16, 2025

Avidity Biosciences, Inc. Announces Closing of Upsized Public Offering of Common Stock, Including Full Exercise of Underwriters' Option to Purchase Additional Shares

✨ Onyx Summary Avidity Biosciences closed a $690 million public offering of 17.25 million shares at $40 each, including the full exercise of underwriters’ option to purchase additional shares. The proceeds will support late-stage clinical development of its Antibody Oligonucleotide Conjugates (AOCs), preparation for multiple product launches, expansion of commercial

September 15, 2025

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

September 15, 2025

Ocugen, Inc. and Kwangdong Pharmaceutical Co., Ltd. Complete License Agreement of OCU400 Modifier Gene Therapy for Retinitis Pigmentosa in Korea

✨ Onyx Summary Ocugen has licensed exclusive rights to its investigational gene therapy OCU400 for retinitis pigmentosa to Kwangdong Pharmaceutical in South Korea, with upfront and milestone payments of up to $7.5 million, sales milestones tied to $180 million in projected 10-year sales, and a 25% royalty on net sales.

September 15, 2025

Alex M. Azar II Joins Guardant Health Board of Directors

✨ 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

September 15, 2025

Kyverna Therapeutics to Highlight Interim Phase 2 Data from KYV-101 KYSA-6 Study in Myasthenia Gravis at AANEM 2025

✨ 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

September 15, 2025

Belite Bio Announces Completion of DRAGON, a 2-Year, Phase 3 Trial of Oral Tinlarebant in the Treatment of Stargardt Disease

✨ 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

September 12, 2025

Lexicon Pharmaceuticals to Present Additional Clinical Data on Pilavapadin at Three Upcoming Medical Meetings

✨ 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.

September 11, 2025

Avidity Biosciences Announces Pricing of Upsized Public Offering of Common Stock

✨ 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,

September 11, 2025

Guardant Health Expands Access to Shield CRC Blood Test to Senior Living Communities with LabFlorida Partnership

✨ 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

September 11, 2025

Avidity Biosciences' Del-zota Demonstrated Reversal of Disease Progression Across Key Functional Endpoints in EXPLORE44® and EXPLORE44-OLE™ Phase 1/2 Trial in People Living with DMD44

✨ 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

September 10, 2025

Avidity Biosciences Announces Proposed Public Offering of Common Stock

✨ 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

September 10, 2025

Guardant Health Announces Partnership with PathGroup Bringing Shield Blood Test to 250+ Hospitals and Health Systems in 25 States

✨ 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’

September 8, 2025