Also lined up are target action dates for Sanofi’s Gaucher disease therapy, GSK’s lung cancer medicine and BridgeBio’s muscular dystrophy drug.
November is shaping up to be a busy month for the FDA, which has at least 11 target action dates on its docket in the coming weeks.
Among the agency’s biggest upcoming decisions is one for Summit Therapeutics and Akeso’s bispecific antibody ivonescimab, which some have dubbed the Keytruda killer after a Phase 3 victory over the PD-1 giant in September 2024. Ivonescimab is currently being proposed for the treatment of a certain type of non-small cell lung cancer (NSCLC) but has been hailed as a potential backbone therapy in the future of oncology.
Also on the docket is Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy, which has been through the regulatory wringer already, and a drug from Vertex Pharmaceuticals that could launch the company into the renal space.
November will also see FDA decisions for Sanofi’s brain-penetrant drug for a rare lysosomal disorder; a therapy from BridgeBio that could be the first disease-modifying medicine for limb-girdle muscular dystrophy; and a cancer treatment that GSK picked up in its $10.6 billion acquisition of Nuvalent Bio.
Here, BioSpace looks at some of the most potentially impactful FDA decisions slated for this month.
Summit, Akeso could bring first PD-1xVEGF bispecific to US shelves
By Nov. 14, the FDA is expected to release its verdict on Summit Therapeutics and Akeso’s ivonescimab, which the companies are proposing for EGFR-mutated NSCLC. An approval could introduce the U.S. market to its first PD-1xVEGF bispecific antibody.
Summit, which holds U.S. rights to ivonescimab, is supporting the application with data from the global Phase 3 HARMONi trial. Data released in May 2025 showed that ivonescimab plus chemotherapy significantly improved progression-free survival versus placebo plus chemotherapy, meeting one of the study’s primary endpoints.
Overall survival (OS) at the time fell short of statistical significance, however, casting doubts on the asset’s approvability in the U.S. The FDA had previously told Summit that a significant OS benefit would be needed for approval. Findings from an additional analysis, presented in September, showed a nominally significant OS benefit in the overall global population.
Having seen ivonescimab’s body of data thus far, Dara Azar, associate vice president of Biotech Equity Research at Stifel, told BioSpace earlier this month that he doesn’t expect the asset to hit any major regulatory snags. Ivonescimab is already approved in China for various NSCLC indications.
After delay, Capricor nears decision date for Duchenne cell therapy
The regulatory rollercoaster for Capricor Therapeutics’ cell therapy deramiocel is potentially nearing its end. An FDA decision for the asset’s use in Duchenne muscular dystrophy is scheduled for Nov. 22.
Deramiocel is backed by data from the Phase 3 HOPE III trial, which in December 2025 showed that the cell therapy met the primary endpoint of improvements in upper-limb function. Capricor also claimed that deramiocel hit the key secondary endpoint of slowing the deterioration of cardiac function decline, though this was later disputed by the FDA.
Earlier this year, Capricor beefed up deramiocel’s data package with 24-month open-label data from HOPE-3, while also refining the proposed indication for the investigational therapy to focus on upper limb function instead of cardiac function. These amendments triggered a three-month delay, pushing the decision back from Aug. 22 to Nov. 22.
If the therapy does secure approval, it would be the end of a very long and winding regulatory road for deramiocel. Capricor’s first attempt for an approval in DMD cardiomyopathy was met with a rejection in July 2025 after a canceled advisory committee meeting that blindsided CEO Linda Marbán. In its rejection letter, the FDA cited manufacturing issues as well as the need for additional data to support the therapy.
Armed with HOPE-3 data, Capricor returned to the FDA with a resubmission, which the FDA accepted in March. This time, the agency did hold an adcomm—but it didn’t go well for Capricor. In July, the biotech suffered a frustrating 9–3 vote from the FDA’s advisors after a contentious discussion that left Marbán open to the possibility of legal action against the agency. The independent experts found Capricor’s data supporting deramiocel’s efficacy to be “very fragile,” but Marbán told BioSpace that the issues revolved around the statistical analysis plan the agency used in its review of deramiocel.
Vertex awaits IgAN decision for potentially ‘iconic’ next stage of portfolio
Vertex Pharmaceuticals is proposing the fusion protein therapy povetacicept for the treatment of IgA nephropathy. The application is under regulatory review with a decision expected on or before Nov. 30.
Povetacicept is backed by the placebo-controlled Phase 3 RAINIER study, which in March showed a significant reduction in urine protein-to-creatinine ratio, a biomarker of kidney function and the trial’s primary outcome, at 36 weeks. In a May 4 note, BMO Capital Markets called RAINIER’s data “strong.”
The firm is bullish about povetacicept, writing in that same note that an approval for the asset would kick off Vertex’s renal business and usher in “an evolution of Vertex that may be nothing short of iconic.”
BMO doubled down in a July 17 note, writing that the recent approvals in the IgAN space only serve to build the group’s conviction in povetacicept. These competitors include Novartis, which in July expanded its complement blocker Fabhalta into IgAN, and Vera Therapeutics, which just days before secured an IgAN nod for atacicept, now named Trutakna.
“Vertex may not be first to the game,” the analysts wrote, “but it is likely to benefit from ongoing educational/awareness-enhancing efforts from competing manufacturers.”
