✨ 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
✨ 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,
✨ 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
✨ 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
✨ 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
✨ 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
✨ 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
✨ 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
✨ 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
✨ Onyx Summary ImmunityBio reported early Phase I results from its QUILT-106 trial showing complete responses in the first two patients with relapsed Waldenström macroglobulinemia treated with its investigational CD19 CAR-NK therapy, given alone or with rituximab. Both heavily pretreated patients achieved remission without significant toxicities, and the therapy was delivered
✨ Onyx Summary Ocugen, Inc. (Nasdaq: OCGN) closed a $20 million registered direct offering with Janus Henderson Investors, issuing 20 million shares of common stock and accompanying warrants to purchase an equal number of shares at $1.50 each. The company expects the proceeds, along with potential warrant exercises totaling up
✨ Onyx Summary Belite Bio reported Q2 2025 results alongside key milestones: completion of enrollment in the Phase 3 PHOENIX trial in geographic atrophy, FDA Breakthrough Therapy Designation for Tinlarebant in Stargardt disease, and the DRAGON Phase 3 trial tracking to complete in Q4 2025. As of June 30, Belite had
✨ Onyx Summary ImmunityBio announced that the Michael E. DeBakey VA Medical Center in Houston has become one of the first VA hospitals in the U.S. to administer ANKTIVA®, its FDA-approved IL-15–based immunotherapy, to a veteran with bladder cancer. ANKTIVA is approved with BCG for patients with BCG-unresponsive non-muscle
✨ Onyx Summary Ocugen entered into a $20 million registered direct offering with Janus Henderson Investors, selling 20 million shares at $1.00 each along with warrants for another 20 million shares exercisable at $1.50. The warrants are valid for two years and callable if Ocugen’s stock trades above
✨ Onyx Summary Belite Bio entered a registered direct offering with a single large existing institutional shareholder to sell 230,770 ADSs and accompanying five-year warrants for another 230,770 ADSs at $65 per unit, for gross proceeds of about $15M (with up to an additional ~$15M possible upon warrant exercise)
✨ Onyx Summary Phathom Pharmaceuticals reported Q2 2025 net revenue of $39.5 million, up from $7.3 million a year earlier, driven by continued adoption of its acid blocker VOQUEZNA, which has surpassed 580,000 prescriptions. The company reduced operating expenses through restructuring and expects to achieve profitability in 2026,
