Regulatory Daily Summary: What Happened on November 3, 2026

Voceryq wins accelerated approval, with follow-up evidence and device review ahead

The FDA approved Voceryq to reduce surgery frequency in adults with recurrent respiratory papillomatosis, which causes growths in the airway.12 Patients use the treatment with INOVIO’s Cellectra 5PSP delivery device.48

In a single-arm study, seven of 26 efficacy-evaluable patients had no surgery during the 12 months after treatment.34 These patients had undergone a median of 4.5 surgical excisions in the preceding year.39

The FDA granted accelerated approval based on reduced surgery frequency, an intermediate measure considered reasonably likely to predict clinical benefit.4 INOVIO must conduct a confirmatory study and submit its final report by August 30, 2032. The FDA may withdraw approval if the study fails to verify benefit or is not pursued diligently.4

The agency directed INOVIO to reassess human-factors data for the delivery device and test its sharps-injury protection.4 INOVIO expects orders and shipments to begin in about 60 days, with full commercial launch anticipated in the first quarter of 2027.34

FDA sets May 1, 2027, target date for uniQure’s Huntington’s gene therapy

The FDA accepted uniQure’s application for AMT-130 and granted priority review under the accelerated approval pathway.56 The target action date is May 1, 2027. The agency is tentatively considering an advisory committee meeting.56

AMT-130 is a one-time gene therapy delivered by MRI-guided brain surgery to the striatum, where it is designed to silence the huntingtin gene.56

The application draws on 36-month results from Phase 1/2 studies compared with an external control built from Enroll-HD data.5

At four years, results from 12 high-dose participants showed 44% less decline on a composite disease scale than an updated external control, but the difference was not statistically significant.56 The same analysis showed 61% less decline in functional capacity, with a nominal p-value of 0.008.6

The FDA had questioned whether earlier data could support approval and initially sought a prospective randomized study. It later accepted the three-year analysis as the primary basis for an accelerated-approval application.56

uniQure plans a randomized confirmatory trial of about 200 participants. Screening in the United States is expected to start by the end of 2026.56

Court upholds rejection of Taiho’s late LYTGOBI patent-extension filing

A New Jersey federal court upheld the government’s decision that Taiho missed the deadline to seek a patent-term extension for LYTGOBI.7 Taiho filed on November 29, 2022, one day after the Patent and Trademark Office’s November 28 deadline.7

The FDA issued LYTGOBI’s initial approval on September 30, 2022, then sent a corrected letter on October 5 that retained September 30 as the effective action date.7 The court held that the 60-day filing period starts on and includes the day FDA transmits marketing permission. It found no basis to use October 5 as the approval date.7

The court said the loss of patent rights was severe, but the statute and administrative record left it no discretion to reach another result.7

Also worth knowing

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  The UK Medicines and Healthcare products Regulatory Agency and Health Research Authority published findings from a six-month pilot in 2025 involving seven studies, and updated guidance for preparing clinical-trial Inclusion and Diversity Plans.10

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