Seven FDA Decisions Due by Christmas, and the Trials Behind Them

The last quarter of 2026 is crowded at the US Food and Drug Administration. Below are the decisions with a goal date that the sponsoring company confirmed in its own announcement, under the Prescription Drug User Fee Act, the PDUFA date. A PDUFA date is the FDA's target to finish its review. The agency can act earlier, ask for more time, or say no. This piece makes no forecast about any outcome. It records what each pivotal trial measured, because that is what the agency is weighing.

October and November

October 26: bepirovirsen, chronic hepatitis B (GSK, licensed from Ionis). GSK announced on April 28 that the FDA accepted the application under priority review with a goal date of October 26. The drug is an antisense oligonucleotide given for six months on top of standard antiviral pills. In the two phase 3 B-Well trials, pooled, 19% of treated patients reached functional cure, meaning the virus and its surface antigen were undetectable six months after stopping all treatment: 233 of 1,220, against 0 of 614 on placebo. Among patients with lower baseline surface antigen, the rate was 26%. Results were published in the New England Journal of Medicine. The open question is durability beyond the trial window. November 14: ivonescimab, lung cancer with EGFR mutations (Summit Therapeutics). The goal date was set when the FDA accepted the application in January. The phase 3 HARMONi trial tested the drug, which blocks PD-1 and VEGF at once, plus chemotherapy against chemotherapy alone after a targeted EGFR drug stopped working. It met its progression free survival endpoint: median 6.8 months against 4.4, hazard ratio 0.52. Overall survival, the other primary endpoint, did not reach statistical significance at the primary analysis (hazard ratio 0.79, p=0.057). Later cuts with longer follow up showed a hazard ratio of 0.76, but those p values are nominal, not confirmatory. How the FDA weighs that survival result is the heart of this file. November 22: deramiocel, Duchenne muscular dystrophy (Capricor). The original date of August 22 was pushed back three months after Capricor filed what the FDA classified as a major amendment. In the phase 3 HOPE-3 trial of 106 participants, published in The Lancet, the cell therapy slowed decline in upper limb function by 54% against placebo on the PUL 2.0 scale (p=0.029). On July 29, an FDA advisory committee voted 9 to 3 that the evidence did not support effectiveness for Duchenne cardiomyopathy, a narrower question than Capricor had proposed. Capricor now seeks an indication focused on upper limb function. Advisory votes are not binding. November 30: povetacicept, IgA nephropathy (Vertex). Vertex used a priority review voucher and announced acceptance on June 1. The request is for accelerated approval, which rests on a surrogate marker. At a planned week 36 interim analysis of the phase 3 RAINIER trial, protein in the urine fell 52.0% from baseline and 49.8% more than placebo. The final analysis, on kidney function measured as eGFR slope over two years, is still to come. November 30: giredestrant, early breast cancer (Roche). In the phase 3 lidERA trial of more than 4,100 patients with estrogen receptor positive, HER2 negative disease, the pill reduced the risk of invasive disease recurrence or death by 30% against standard hormone therapy (hazard ratio 0.70). At three years, 92.4% were alive and free of invasive disease, against 89.6%. Overall survival data were immature.

December

December 18: giredestrant plus everolimus, advanced breast cancer with ESR1 mutations (Roche). A second file for the same molecule. In the phase 3 evERA trial, published in the New England Journal of Medicine, median progression free survival was 10.0 months against 5.5 in patients with ESR1 mutations (hazard ratio 0.38). Overall survival was again immature. December 23: anitocabtagene autoleucel, multiple myeloma after at least three prior lines (Gilead and Kite). The date appeared when Gilead announced in February that it would buy Arcellx for about $7.8 billion, a deal completed in April. This CAR T cell therapy rests on the single arm phase 2 iMMagine-1 study. At a median follow up of 15.9 months, 96% of 117 patients responded and 74% reached a complete or stringent complete response. There is no control group, which is common for late line myeloma but limits comparison.

What was left out

Novo Nordisk's CagriSema for weight management is often listed in this window. Novo filed in December 2025 and says only that a decision is expected in the fourth quarter of 2026; it has not published a goal date, so it is not in the calendar above. Its main trial, REDEFINE 1, showed 20.4% weight loss at 68 weeks against 3.0% on placebo, published in the New England Journal of Medicine. Head to head data against tirzepatide are in our read of the CagriSema and EloraTZP trials.

I would watch the two files where the evidence and the request do not line up neatly. Ivonescimab asks for approval with a survival result that missed significance at the planned analysis, and deramiocel comes after a negative advisory vote on a question it no longer asks. The other five rest on clean primary endpoints. Those two will say more about how today's FDA reads borderline evidence than any approval of a clear win.