Ascelia refuses new trial for Orviglance after FDA meeting
The public is reading the company's summary of the minutes, not the FDA complete response letter or the minutes themselves, which is the gap Commissioner Makary has described on camera as corporate spin.
The public is reading the company's summary of the minutes, not the FDA complete response letter or the minutes themselves, which is the gap Commissioner Makary has described on camera as corporate spin.
On October 11, 2026, Ascelia Pharma said FDA's Type A minutes still require a new clinical study for Orviglance, and the company said it will not run one.
Why it matters: People with severe kidney impairment who need liver imaging are waiting on whether a manganese contrast gets a U.S. approval path, and investors are waiting on a date the company has not set.
Date to watch: No next FDA date is posted. Ascelia scheduled a webcast for October 12, 2026, at 8:30 a.m. CEST, and named a cash runway into 2027.
Sources:
- Ascelia Pharma — Orviglance update after FDA Type A meeting minutes (2026-10-11)
https://www.ascelia.com/mfn_news/ascelia-pharma-provides-orviglance-update-following-fda-type-a-meeting/ - Ascelia Pharma — Complete Response Letter on the Orviglance NDA (2026-07-03)
https://www.ascelia.com/mfn_news/ascelia-pharma-provides-update-on-the-orviglance-nda/ - Ascelia Pharma — FDA set the Type A meeting for September 9, 2026 (2026-08-17)
https://www.ascelia.com/mfn_news/ascelia-pharma-announces-fda-has-scheduled-type-a-meeting-for-orviglance-nda-on-september-9-2026/ - Ascelia Pharma — Type A meeting held September 9, 2026 (2026-09-10)
https://www.ascelia.com/mfn_news/ascelia-pharma-completes-fda-type-a-meeting-on-orviglance-nda/ - Ascelia Pharma — Orviglance update on the SPARKLE re-read (2026-07-12)
https://www.ascelia.com/mfn_news/ascelia-pharma-provides-orviglance-update/ - FDA — publishing complete response letters (2025-07-10)
https://www.fda.gov/news-events/press-announcements/fda-embraces-radical-transparency-publishing-complete-response-letters - eCFR — 21 CFR 314.110 Complete response letter to the applicant (2008-07-10)
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-314/subpart-D/section-314.110 - FDA — Type A meeting timetable drawn from the PDUFA meetings guidance (2026-10-08)
https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/otp-type-meetings - openFDA — Complete Response Letters database (2026-10-09)
https://open.fda.gov/apis/transparency/completeresponseletters/ - STAT News — FDA releasing rejection letters after they are issued (2025-09-04)
https://www.statnews.com/pharmalot/2025/09/04/fda-crls-rejection-letters-transparency-makary/ - FDA — PDUFA formal meetings guidance (2026-08-13)
https://www.fda.gov/media/172311/download - Bloomberg Television — Marty Makary on publishing decision letters (2025-07-10)
https://www.youtube.com/watch?v=sUbfQy9AAL0 - CNBC Television — Marty Makary, July 30, 2025 (2025-07-30)
https://www.youtube.com/watch?v=7gKOa1ugYMA - CNBC Television — Marty Makary, July 11, 2025 (2025-07-11)
https://www.youtube.com/watch?v=uk6tD64OpHk - Bloomberg Television — Marty Makary, December 15, 2025 (2025-12-15)
https://www.youtube.com/watch?v=UZovDzgNdZE - New York Stock Exchange — Marty Makary, February 10, 2026 (2026-02-10)
https://www.youtube.com/watch?v=DH9-nXOqGf4 - CNBC Television — Marty Makary with David Faber, May 5, 2026 (2026-05-05)
https://www.youtube.com/watch?v=0E6lqGqbm7o
The Throughline decodes today's headline — with receipts. Every claim is sourced; links below.
Subscribe and stand the watch. — Last Bastion