clinical trials

Revolution Medicines (RVMD) received a non-transferrable FDA Commissioner’s National Priority Voucher (CNPV) for daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor. Daraxonrasib is in Phase 3 trials: RASolute 302 for pancreatic cancer and RASolve 301 for non-small cell lung cancer. Data from RASolute 302 is expected in 2026. While the CNPV can expedite FDA review, RVMD stated timelines remain unchanged. The voucher acknowledges the potential of daraxonrasib, but approval is not guaranteed.

Spyre Therapeutics (SYRE) announced the pricing of its public offering of 14,864,865 shares at $18.50 per share, projecting $275.0 million in gross proceeds. Underwriters have a 30-day option to purchase an additional 2,229,729 shares. The offering is expected to close around October 15, 2025, pending customary conditions. Funds will support research and development of antibody therapies for IBD and other immune-mediated conditions. Jefferies, TD Securities, Leerink Partners, and Stifel acted as joint book-running managers.

Upstream Bio (UPB) presented data at the European Respiratory Society Congress showcasing verekitug’s mechanism of action. Verekitug prevents TSLP binding by occupying receptor sites and outcompetes TSLP even with preformed receptor complexes. This supports its potential for treating TSLP-driven respiratory diseases. Phase 2 data in CRSwNP showed significant improvements. A Phase 2 readout in severe asthma is expected in Q1 2026. Verekitug’s high affinity and inhibition of the TSLP receptor could lead to less frequent dosing than current therapies.

MoonLake Immunotherapeutics announced Phase 3 VELA program results for sonelokimab in moderate to severe hidradenitis suppurativa (HS). The combined trials showed statistically significant improvements in primary and key secondary endpoints. VELA-1 achieved statistical significance, while VELA-2 missed its primary endpoint due to a higher placebo response. Both trials showed noteworthy HiSCR75 results using a pre-specified treatment policy strategy. Sonelokimab exhibited a favorable safety profile. MoonLake plans regulatory discussions and continues clinical studies in multiple indications.

Reviva Pharmaceuticals (RVPH) announced a $9 million public offering of 27 million shares/equivalents, plus Series E & F warrants, priced at $0.335 per share. Proceeds will fund R&D and corporate purposes. The Series E warrants expire in 5 years, Series F in 12 months, both exercisable at $0.335. Expected closing is around Sept. 22, 2025. The offering, led by A.G.P./Alliance Global Partners, may lead to shareholder dilution, with potential for 54 million additional warrant shares.

Lobe Sciences will participate in the Clusterbusters 20th Annual U.S. Patient Conference (Sept 11-14, 2025) to present research on L-130, Conjugated Psilocin™, a potential treatment for chronic cluster headaches. The company recently secured $6 million in funding, with a potential $20 million more, to complete FDA submission for L-130. Lobe aims to connect with patients, form an advocacy team, and gather input for clinical trial design, leveraging patient experiences provided by Clusterbusters, a supporting advocacy group.

Brain-computer interfaces (BCIs) are gaining traction, exemplified by Neuralink’s progress, where an implanted chip enabled a user to control devices and regain a sense of purpose. Neuralink trials are expanding, and are exploring applications like restoring sight. Simultaneously, Chinese researchers are conducting multi-center trials for neurocritical care. The global BCI market is projected to grow, fueled by both clinical and consumer applications, highlighting the integration of BCIs with robotics and AI, and the growing importance for governments to address related policies.

Genentech announced topline results from the Phase IIb ALIENTO and Phase III ARNASA trials evaluating astegolimab for COPD. ALIENTO met its primary endpoint, demonstrating a statistically significant reduction in the annualized exacerbation rate (AER) at 52 weeks. However, ARNASA did not meet its primary endpoint, despite a numerical reduction in AER. Astegolimab’s safety profile remained consistent with prior data. Genentech will discuss the data with regulatory authorities and present it at a future medical meeting. The trials included diverse COPD patients.

Lilly announced positive Phase 3 trial results for once-weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes. The QWINT-1, QWINT-3, and QWINT-4 trials demonstrated non-inferior A1C reduction compared to daily basal insulin. The company plans to submit efsitora for regulatory review by the end of the year.

Lipella Pharmaceuticals Inc. is delisted from the Nasdaq Capital Market due to rule violations regarding private placement transactions. The delisting, involving the issuance of convertible preferred stock and warrants, led to the suspension of trading. While disappointed, the company is exploring alternative markets, remains focused on its clinical development plans for LP-10 and LP-310, and is pressing forward with its mission to address unmet medical needs.