Press Releases - Onyx Newsroom (Page 20)

Initial Data Shows 100% Disease Control in 5 Out of 5 Patients With Recurrent Glioblastoma With Two Patients in Near Complete Response Treated With ImmunityBio’s ANKTIVA®, NK Cell Therapy Plus Optune Gio® Device

✨ Onyx Summary ImmunityBio announced early pilot data in recurrent glioblastoma showing that all five patients treated with its combination of ANKTIVA® (an IL-15 agonist), NK cell therapy, and Optune Tumor Treating Fields achieved disease control, including two near-complete responses. Glioblastoma is among the most aggressive brain cancers, with limited treatment

August 26, 2025

Guardant Health to Participate in the Morgan Stanley 23rd Annual Global Healthcare Conference

✨ Onyx Summary Guardant Health will present in a fireside chat at the Morgan Stanley 23rd Annual Global Healthcare Conference on September 8, 2025—an appearance that underscores its prominence as a leader driving the future of precision oncology and cancer screening innovation. PALO ALTO, Calif.– Guardant Health, Inc. (Nasdaq: GH)

August 26, 2025

Piramal Pharma Publishes FY2025 Sustainability Report, Outlining Performance and Decarbonization Glidepath

✨ Onyx Summary Piramal Pharma Limited released its FY2025 Sustainability Report, detailing measurable progress across governance, climate action, diversity, and community impact under its four sustainability pillars. The report highlights a 6% cut in Scope 1 and 2 emissions, expanded renewable energy use to 20%, and strengthened DE&I representation,

August 26, 2025

Phathom Pharmaceuticals to Participate in Upcoming Investor Conferences

✨ Onyx Summary Phathom Pharmaceuticals announced that its management team will present at the Cantor Global Healthcare Conference on September 3 and the H.C. Wainwright Global Investment Conference on September 8, 2025, with live webcasts and replays available on the company’s website. Management will also participate in one-on-one investor

August 25, 2025

Kyverna Therapeutics to Present at Upcoming Investor Conferences in September

✨ Onyx Summary Kyverna Therapeutics announced that CEO Warner Biddle will participate in fireside chats at the 2025 Wells Fargo, Morgan Stanley, and H.C. Wainwright Global Healthcare Conferences in early September. The presentations will be webcast live via Kyverna’s investor relations website, with replays available for 90 days. EMERYVILLE,

August 25, 2025

Phathom Pharmaceuticals Clarifies That There Is No Reduction in Lead Shareholder’s Ownership Following Administrative Change to 13D Filing

✨ Onyx Summary Phathom Pharmaceuticals clarified that an upcoming Schedule 13D filing by Frazier Life Sciences reflects only administrative reporting changes and does not reduce Frazier’s ownership in the company. By affirming that no shares have been sold, Phathom underscores continued investor commitment at a pivotal time in advancing its

August 20, 2025

Keros Announces U.S. FDA Orphan Drug Designation Granted to KER-065 for the Treatment of Duchenne Muscular Dystrophy

✨ Onyx Summary Keros Therapeutics received U.S. FDA Orphan Drug designation for KER-065 for the treatment of Duchenne muscular dystrophy, recognizing its potential to address a rare and serious condition with limited therapies. The designation provides regulatory and financial incentives as Keros advances KER-065 toward a planned Phase 2 trial

August 20, 2025

Rocket Pharmaceuticals Announces FDA Has Lifted the Clinical Hold on the Pivotal Phase 2 Trial of RP-A501 for the Treatment of Danon Disease

✨ Onyx Summary Rocket Pharmaceuticals announced that the FDA has lifted the clinical hold on its pivotal Phase 2 trial of RP-A501 for Danon disease, allowing the study to resume at a recalibrated lower dose with updated safety protocols. The swift resolution marks a key milestone for one of the most

August 20, 2025

Nucleus RadioPharma Appoints Former FDA Commissioner Dr. Stephen Hahn as CEO to Scale Patient Access to Radiopharmaceutical Therapies

✨ Onyx Summary Nucleus RadioPharma appointed former FDA Commissioner Dr. Stephen M. Hahn as chief executive officer to lead its expansion in radiopharmaceutical manufacturing and infrastructure. Backed by $72 million in funding and partnerships with Eclipse, Mayo Clinic, and AstraZeneca, Hahn will focus on scaling GMP readiness, expanding R&D,

August 20, 2025

SpyGlass Pharma Appoints Elizabeth O’Farrell to its Board of Directors

✨ Onyx Summary SpyGlass Pharma appointed Elizabeth (Liz) O’Farrell, former Eli Lilly executive, to its Board of Directors as Independent Director and Chair of the Audit Committee. O’Farrell’s extensive background in finance, governance, and global operations strengthens SpyGlass’s leadership as it advances its long-acting ophthalmic drug delivery

August 19, 2025

ImmunityBio Announces Phase 2 Study of ANKTIVA® in Patients with Long COVID

✨ Onyx Summary ImmunityBio has launched a Phase 2 clinical trial to evaluate ANKTIVA®, its IL-15–based immunotherapy, in patients with long COVID, a condition affecting an estimated 1 in 5 U.S. adults after SARS-CoV-2 infection. The exploratory study will primarily assess safety, with secondary and exploratory measures including effects

August 19, 2025

Legend Biotech Appoints Carlos Santos as Chief Financial Officer

✨ Onyx Summary Legend Biotech appointed Carlos Santos as Chief Financial Officer, succeeding interim CFO Jessie Yeung. Santos, formerly CFO for U.S. Oncology at AstraZeneca, brings global finance leadership across pharma and tech sectors to support Legend’s goal of achieving profitability in 2026 while advancing its CAR-T franchise, including

August 18, 2025

Geron Corporation Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

✨ Onyx Summary Geron Corporation granted inducement equity awards to 11 new hires covering 522,000 shares—348,000 stock options with a $1.45 exercise price and 10-year term, and 174,000 RSUs—granted on August 15, 2025 under Nasdaq Listing Rule 5635(c)(4), with options and RSUs vesting

August 18, 2025

Guardant Health Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

✨ Onyx Summary Guardant Health announced the grant of 239,565 restricted stock units to 189 new employees and stock options for 23,542 shares to two additional hires under its 2023 Employment Inducement Incentive Award Plan. These equity awards not only serve as a material inducement for attracting top talent

August 15, 2025

VeriSIM Life CEO Dr. Jo Varshney Wins Prestigious 2025 International Women Entrepreneur Award in Information Technology

✨ Onyx Summary VeriSIM Life announced that its Founder and CEO, Dr. Jo Varshney, received the 2025 International Women Entrepreneur Award in IT from Great Companies, recognizing her leadership in applying AI-driven biosimulation to transform drug development. Dr. Varshney’s work with the company’s BIOiSIM® platform—capable of predicting human

August 14, 2025

Ocugen, Inc. Announces Positive Scientific Advice from the European Medicines Agency Related to the Approval Pathway for OCU410ST—Modifier Gene Therapy for Stargardt Disease

✨ Onyx Summary Ocugen announced that the EMA’s CHMP has accepted the design of its ongoing Phase 2/3 GARDian3 trial of OCU410ST for Stargardt disease as sufficient to support both U.S. and European regulatory filings. Early Phase 1 data showed the therapy slowed lesion growth by 48% and

August 13, 2025