October 2026 FDA Calendar: After a Clean September, the Risk Sits in Two Filings

Key Highlights

• Four of the six FDA actions due in October are label expansions for marketed products, a lower-variance mix than September's first-in-disease candidates.
• Bepirovirsen for chronic hepatitis B and INO-3107 for recurrent respiratory papillomatosis are the two original applications and carry most of the month's binary regulatory risk.
• Inovio's cash runway, guided into late first quarter 2027, sits alongside an open FDA question on accelerated approval eligibility.
• An October 30 advisory committee revisits a rejected pediatric myopia application, testing how the agency weighs statistical and clinical evidence.
• Novo Nordisk's CagriSema and two oncology applications hold fourth-quarter windows with no fixed date.

A Lighter Calendar After a Clean September

September set a high bar. Eight applications with September goal dates were approved, five of them ahead of their goal dates, among them UX111 from Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE), zilganersen from Ionis Pharmaceuticals Inc. (NASDAQ:IONS), apitegromab from Scholar Rock Holding Corp. (NASDAQ:SRRK) and Ameluz from Biofrontera Inc. (NASDAQ:BFRI). Zilganersen cleared on September 3 against a September 22 goal date, apitegromab on September 11 against September 30, and Ameluz on September 14 against September 28. Praxis Precision Medicines Inc. (NASDAQ:PRAX) was the exception, with its relutrigine review extended to December 27.

October is quieter and built differently. Six FDA actions carry October goal dates: four are supplemental applications for marketed products and two are original applications. A seventh date, an advisory committee meeting, is not a decision at all. The agency works under an acting commissioner, Kyle Diamantas, and the nominee, Heidi Overton, faced a Senate committee hearing on September 24, adding a leadership transition to the regulatory environment institutional investors weigh.

Label Expansions: Roche's Double Week and Two Others

Roche Holding AG (OTCQX:RHHBY). Two priority-review supplements have goal dates six days apart. The first, due by October 9, would add Tecentriq and Tecentriq Hybreza plus chemotherapy as adjuvant treatment for stage III colon cancer with deficient mismatch repair or high microsatellite instability. The ATOMIC study enrolled 712 patients and showed a 50 percent reduction in the risk of recurrence or death against chemotherapy alone, with 36-month disease-free survival of 86 percent versus 76 percent. The second, due October 15, would extend Enspryng to thyroid eye disease. In the two SatraGO studies, which enrolled 258 patients, proptosis response was 53 percent versus 23 percent on placebo in SatraGO-2, a statistically significant result, and 49 percent versus 31 percent in SatraGO-1, which Roche says did not reach statistical significance. That split is the analytical question. Roche calls Enspryng a potential first at-home subcutaneous option, though the FDA approved Lumvoa (veligrotug) for thyroid eye disease on June 26.

Opus Genetics Inc. (NASDAQ:IRD) and Viatris Inc. (NASDAQ:VTRS). The goal date for Ryzumvi (phentolamine ophthalmic solution 0.75 percent) in presbyopia is October 17, a Saturday, so action may come earlier. Ryzumvi has been approved since September 2023 for reversing pharmacologically induced mydriasis, and Viatris, its commercialization licensee, filed the supplement. In the VEGA-3 trial, 27.2 percent of treated participants gained at least 15 letters of near visual acuity, with less than a five-letter loss in distance acuity, 12 hours after dosing on day 8, against 11.5 percent on placebo. No treatment-related serious adverse events were reported in that study.

Sun Pharmaceutical Industries Ltd. (NSE:SUNPHARMA). Ilumya (tildrakizumab-asmn) faces an action date by October 29 for adults with active psoriatic arthritis. It has been approved since 2018 for plaque psoriasis. The application rests on INSPIRE-1 and INSPIRE-2, 52-week randomized, placebo-controlled trials of the 100 mg dose. Sun Pharma reported topline findings in July 2025 and said in March that fuller detail would follow at a medical congress, so the efficacy case is less visible than for the other supplements.

Original Filings Carry the Binary Risk

GSK plc (NYSE:GSK). Bepirovirsen, an antisense oligonucleotide for adults with chronic hepatitis B, has an October 26 goal date under priority review and breakthrough therapy designation. GSK licensed it from Ionis. GSK's May 28 data release, published in the New England Journal of Medicine, reported week-72 functional cure in 19 percent of patients with baseline surface antigen up to 3,000 IU/mL on bepirovirsen versus 0 of 614 on placebo, against about 1 percent on standard therapy. Grade 3 or higher adverse events hit 16 percent versus 3 percent, mostly ALT increases. Bepirovirsen is not approved anywhere, so a first-in-class decision is the distinguishing feature of this date.

Inovio Pharmaceuticals Inc. (NASDAQ:INO). INO-3107, a DNA medicine for adults with recurrent respiratory papillomatosis, has an October 30 goal date under standard review, and the FDA indicated in December that it was not planning an advisory committee. Inovio filed under the accelerated approval pathway, but the FDA's file-acceptance letter noted a preliminary conclusion that the company had not submitted adequate information to justify eligibility. At an informal meeting the FDA did not discuss that comment and said feedback on a confirmatory trial design would follow. Inovio says the late-cycle review meeting and pre-licensure inspections are complete.

The efficacy data come from a Phase 1/2 trial of 32 participants, in which 72 percent had a 50 to 100 percent reduction in surgeries after the first year, and a retrospective follow-up of 28 participants in which 86 percent did at the end of the second year. Funding is a second variable. Inovio held $36.7 million in cash, equivalents and short-term investments at June 30, down from $58.5 million at the end of 2025, and raised about $18.3 million net in July. It guides to a third-quarter burn of about $18 million and runway into late first quarter 2027, with stockholders' equity of $4.4 million. Approval would start a planned launch, while a restrictive outcome could change the funding timeline.

An Advisory Panel and a Pending Verdict

Sydnexis (privately held). The FDA's Dermatologic and Ophthalmic Drugs Advisory Committee meets on October 30 to discuss SYD-101, atropine 0.01 percent, for slowing myopia progression in children aged three and older. The FDA issued a complete response letter on October 23, 2025, acknowledging that the STAR trial met its primary endpoint but concluding the data did not support effectiveness. Sydnexis filed a formal dispute resolution request, and in July the agency said it would convene the committee. STAR enrolled more than 800 children and reported p-values of 0.0226 on the primary endpoint and 0.0002 on the key secondary endpoint. The committee's vote would be non-binding.

GRAIL Inc. (NASDAQ:GRAL). Galleri's September 23 panel voted 7 to 2, with one abstention, that its benefits outweigh its risks, unanimously on safety and 6 to 4 on effectiveness. The vote is also non-binding, and the company expects a final FDA decision in the coming months.

What Has Already Resolved

Three items on October calendars no longer await action.

Merck & Co. Inc. (NYSE:MRK). Welireg with lenvatinib won approval on September 24, ahead of an October 4 goal date.

Pharming Group N.V. (NASDAQ:PHAR). Joenja won approval on September 11 for children aged 4 to 11 weighing at least 27 kilograms.

Daiichi Sankyo Co. Ltd. (TSE:4568). Daiichi Sankyo and Merck withdrew their ifinatamab deruxtecan application on September 25, ahead of an October 10 goal date, after FDA feedback that Phase 2 data did not meet criteria for accelerated approval. Inovio filed under the same pathway.

Fourth-Quarter Candidates Without a Fixed Date

Three applications carry fourth-quarter windows rather than disclosed dates.

Pfizer Inc. (NYSE:PFE). Talzenna plus Xtandi is under priority review in HRR gene-mutated metastatic castration-sensitive prostate cancer. The TALAPRO-3 trial, which enrolled 599 patients, reported a 52 percent reduction in the risk of progression or death.

AstraZeneca PLC (NYSE:AZN). Imfinzi with enfortumab vedotin holds priority review in cisplatin-ineligible muscle-invasive bladder cancer, supported by the VOLGA trial.

Novo Nordisk A/S (NYSE:NVO). CagriSema, a once-weekly GLP-1 and amylin analogue combination for weight management, was filed on December 18, 2025. Novo's August presentation expects a US decision in the fourth quarter of 2026 and gives no exact date. REDEFINE 1, in 3,417 adults without type 2 diabetes, showed weight loss of about 20 to 23 percent depending on the analysis method, against about 3 percent on placebo.

What the Month Tests

October poses two questions. The first is timing. September's early actions covered new applications and supplements alike, so some of the dates above may resolve early while others may not, and the fourth-quarter candidates are better read as windows than as dates. The second is evidence at the margin. SatraGO-1, the accelerated pathway for INO-3107 and the STAR trial's statistical result each ask whether the agency will treat evidence short of a clean result as sufficient. A calendar that lists these as equivalent dates would understate how different their risk profiles are.