✨ Onyx Summary Belite Bio completed enrollment of 60 patients in its global Phase 2/3 DRAGON II trial evaluating tinlarebant for the treatment of Stargardt disease type 1, including adolescent participants across the U.S., U.K., and Japan. The milestone keeps Belite Bio on track to submit a New
✨ Onyx Summary Lexicon Pharmaceuticals announced it will ring the Nasdaq Closing Bell on January 27, 2026, marking its 30th anniversary as a publicly traded biopharmaceutical company. The event highlights Lexicon’s evolution from a genomics pioneer to a company advancing a diversified pipeline of small-molecule therapies in cardiometabolic disease and
✨ Onyx Summary Ocugen closed a registered direct offering of 15 million shares at $1.50 per share, generating $20.85 million in net proceeds to fund operations and extend its cash runway into the fourth quarter of 2026. Led by RTW Investments, the financing provides near-term balance sheet support as
✨ Onyx Summary ImmunityBio reported updated Phase 2 data from its QUILT-3.078 study showing that 19 of 23 patients with recurrent or progressive glioblastoma remain alive, with median overall survival not yet reached, following a chemotherapy-free combination immunotherapy regimen. The results suggest potential survival beyond historical benchmarks in a heavily
✨ Onyx Summary Guardant Health announced that the U.S. Food and Drug Administration approved Guardant360 CDx as a companion diagnostic to identify patients with BRAF V600E–mutant metastatic colorectal cancer eligible for treatment with BRAFTOVI in combination therapy. Supported by Phase 3 BREAKWATER trial data, the approval expands non-invasive access
✨ Onyx Summary Legend Biotech will present six posters at the 2026 ASTCT/CIBMTR Tandem Meetings highlighting additional clinical and real-world analyses for CARVYKTI in multiple myeloma, including data on neurologic events, bridging therapy, manufacturing outcomes, and long-term progression-free survival. The updates build the evidence base for optimizing CARVYKTI use—particularly
✨ Onyx Summary Lexicon Pharmaceuticals completed a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration for pilavapadin in diabetic peripheral neuropathic pain, with the FDA raising no objections to advancing the program into Phase 3 registrational studies. The outcome clears a regulatory path toward late-stage development of
✨ Onyx Summary Ocugen priced an underwritten public offering of 15 million shares at $1.50 per share, raising $22.5 million in gross proceeds to support general corporate purposes and operations. Led by RTW Investments, the financing strengthens Ocugen’s balance sheet as it advances its gene therapy programs for
✨ Onyx Summary MassBio outlined the agenda for its 2026 State of Possible Conference on March 26 in Boston, convening senior biotech CEOs, investors, policymakers, and ecosystem leaders to examine how scientific discovery translates into patient impact amid long development timelines and shifting economic pressures. The program features keynote leaders including
✨ 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
