✨ Onyx AI Summary Massachusetts biotech leaders emphasized the importance of balancing drug affordability initiatives with the need to sustain innovation that drives future cures. As federal policymakers weigh new cost-control measures, the statement underscores that safeguarding both access and discovery is vital to ensure patients benefit not only from lower
✨ Onyx Summary MassBio CEO Kendalle Burlin O’Connell emphasized Massachusetts’s global leadership in advanced therapies and the importance of policies like Governor Maura Healey’s proposed $400 million DRIVE initiative to accelerate early-stage innovation and workforce development. She argues that by reigniting the state’s life sciences flywheel, Massachusetts
✨ Onyx Summary Guardant Health announced FDA approval of its Guardant360® CDx as a companion diagnostic for Eli Lilly’s Inluriyo (imlunestrant), enabling identification of advanced or metastatic ER+, HER2– breast cancer patients with ESR1 mutations who may benefit from the therapy. This marks the test’s sixth FDA-approved companion diagnostic
✨ Onyx AI Summary Belite Bio completed the last patient visit in DRAGON, its pivotal Phase 3 trial of oral tinlarebant in adolescents with Stargardt disease type 1 (104 enrolled across 11 regions; primary endpoint is growth rate of atrophic lesions), with topline results slated for Q4 2025. Tinlarebant aims to
✨ Onyx Summary Guardant Health and Quest Diagnostics announced a multi-year strategic collaboration to make Guardant’s FDA-approved Shield™ blood test for colorectal cancer screening available through Quest’s vast provider network, patient service centers, and phlebotomy teams nationwide starting in early 2026. By pairing Shield’s simplicity with Quest’s
✨ Onyx Summary Cellares appointed Chris McDonald, former SVP and Global Head of Technical Operations at Kite (a Gilead Company), to its Advisory Board. McDonald brings more than 35 years of experience scaling global biomanufacturing operations at Kite, Amgen, Novartis, and AstraZeneca, expertise that will support Cellares’ international expansion of its
✨ Onyx Summary MassBio and Google co-hosted the 2025 AI for Drug Discovery Training in Cambridge, bringing together more than 60 life sciences professionals from start-ups, academia, and pharma for hands-on sessions with Google’s Gemini and Vertex AI platforms. By equipping the Massachusetts biotech community with AI-driven skills, the program
✨ Onyx Summary MassBio, SCbio, Venture Carolina, VentureSouth, and the South Carolina Department of Commerce launched the Palmetto Beacon Venture Fellowship, a program designed to educate and empower the next generation of biotech investors through immersive sessions in Charleston, John’s Island, and Boston. By bridging ecosystems from the Southeast to
✨ 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,
✨ 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
✨ 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
✨ 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.
✨ 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 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 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
