✨ Onyx Summary enGene Holdings amended its loan and security agreement with Hercules Capital to secure access to up to $125 million in non-dilutive capital, strengthening its balance sheet ahead of a planned BLA filing in the second half of 2026 for detalimogene voraplasmid in BCG-unresponsive non-muscle invasive bladder cancer. The
✨ Onyx Summary Novo Nordisk and Aspect Biosystems are advancing their diabetes cell therapy collaboration, with Aspect acquiring key stem cell–derived islet and hypoimmune technologies and taking the lead on development, manufacturing, and commercialization, while Novo Nordisk expands its equity investment and retains downstream rights, milestones, and royalties. The deal
✨ Onyx Summary ImmunityBio held a Type B End-of-Phase meeting with the U.S. Food and Drug Administration to align on a regulatory path for resubmission of its supplemental BLA for ANKTIVA plus BCG in BCG-unresponsive papillary non-muscle-invasive bladder cancer. Supported by more than five years of follow-up data showing durable
✨ Onyx Summary Guardant Health announced a multi-year collaboration with Merck to support the development and commercialization of Merck’s oncology pipeline using Guardant’s Infinity™ Smart platform, including clinical trial enrollment, companion diagnostics, and global commercialization. The partnership underscores the growing centrality of liquid biopsy–driven biomarkers in oncology drug
✨ Onyx Summary ImmunityBio reported that enrollment in its registrational QUILT-2.005 trial evaluating ANKTIVA plus BCG in BCG-naïve non-muscle-invasive bladder cancer has surpassed 85%, with full enrollment expected by Q2 2026 and a planned BLA submission to the U.S. Food and Drug Administration by year end 2026. Interim data
✨ Onyx Summary ImmunityBio reported updated data from its ongoing QUILT-106 study showing durable complete responses of up to 15 months with an off-the-shelf CD19 CAR-NK cell therapy combined with rituximab in patients with Waldenström lymphoma, with 100% disease control observed to date. The chemotherapy-free, lymphodepletion-free outpatient regimen highlights the potential
✨ Onyx Summary ImmunityBio, Inc. reported preliminary fourth-quarter 2025 net product revenue of approximately $38.3 million, up 20% sequentially and more than fourfold year over year, reflecting accelerating adoption of ANKTIVA and continued commercial momentum. The update also highlighted expanding global regulatory approvals for ANKTIVA and a strengthened cash position
MALVERN, Pa., Jan. 15, 2026 – Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced positive preliminary 12-month data (~50% of patients evaluated to date) from the Phase 2 ArMaDa clinical trial evaluating OCU410 (AAV5-RORA), its novel modifier gene therapy
✨ Onyx Summary Sun Pharmaceutical Industries Limited announced that UNLOXCYT™ (cosibelimab-ipdl) is now commercially available in the U.S. for adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation. The launch follows an FDA label update reflecting long-term clinical trial data
✨ Onyx Summary ImmunityBio, Inc. announced that Saudi Arabia’s Saudi Food and Drug Authority has approved ANKTIVA plus BCG for adult patients with BCG-unresponsive non-muscle invasive bladder cancer, expanding the therapy’s regulatory footprint beyond the U.S., U.K., and EU. The approval supports ImmunityBio’s international commercial strategy,
✨ Onyx Summary ImmunityBio, Inc. reported positive clinical results for its investigational immunotherapy ANKTIVA in non-small cell lung cancer, demonstrating statistically significant immune restoration and an association between lymphocyte recovery and improved survival in checkpoint-experienced patients. Data from the QUILT-2.023 and QUILT-3.055 studies support a potential shift beyond chemotherapy
✨ Onyx Summary Foghorn Therapeutics Inc. closed a $50 million registered direct financing priced at a 30% premium, backed by existing institutional shareholders, strengthening its balance sheet. The capital is expected to support continued advancement of the company’s chromatin regulatory oncology pipeline without the use of an underwriter. WATERTOWN, Mass.
✨ Onyx Summary Ocugen, Inc. announced it will host a conference call and webcast on January 15, 2026, to review one-year data from the first cohort of patients in the Phase 2 ArMaDa trial of OCU410 for geographic atrophy secondary to dry age-related macular degeneration. The event will feature key opinion
✨ Onyx Summary NantWorks, LLC and ImmunityBio, Inc. announced the inaugural U.S.–Saudi Biotech Alliance Summit, to be held alongside the J.P. Morgan Healthcare Conference on January 14, 2026, bringing together U.S. and Saudi leaders across biotechnology, healthcare, manufacturing, AI, and finance. The invitation-only summit is structured to
✨ Onyx Summary Cellares announced that the FDA has cleared an IND amendment allowing Cabaletta Bio to use Cellares’ automated Cell Shuttle and Cell Q platforms to manufacture and release its investigational autoimmune CAR T therapy rese-cel, with first patient dosing expected in the first half of 2026. The clearance marks
✨ Onyx Summary Cellares has secured a long-term lease for a new European IDMO Smart Factory at Leiden Bio Science Park, establishing its European headquarters and adding regional automated manufacturing capacity. The move strengthens Cellares’ global network to support time-sensitive, patient-specific cell therapy programs with standardized, scalable production as partners advance
