Estimated FDA action date for Mim8 (denecimig) in hemophilia A
The FDA’s decision on Novo Nordisk’s Denecimig (Mim8, FVIIIa-mimetic bispecific) for Hemophilia A prophylaxis, with or without inhibitors was due on Sep 30, 2026. The outcome isn’t recorded here yet — the linked source has the latest.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- Novo Nordisk A/S NVO
- Drug
- Denecimig (Mim8, FVIIIa-mimetic bispecific)
- For
- Hemophilia A prophylaxis, with or without inhibitors
- Stage
- BLA under review (FRONTIER program)
- When
- Sep 30, 2026
- Source note
- BLA submitted September 2025 (company release); pdufa.bio lists a September 30, 2026 action date. Novo has not publicly confirmed the exact PDUFA date, so treated as tracker-reported.
- Checked
- Checked by a person when it was added
- Source: pdufa.bio ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- NVO headlines on this site
Phase 3 starts: oral zenagamtide (Q3), SC zenagamtide CVOT and high-dose cagrilintide (Q4), expected in the second half of 2026 (no exact date yet). A company milestone for Novo Nordisk (Zenagamtide (amycretin); cagrilintide for Obesity / cardiovascular outcomes): a step in the program rather than a decision or a data readout.
More details
- Entry
- Phase 3 starts: oral zenagamtide (Q3), SC zenagamtide CVOT and high-dose cagrilintide (Q4) · Company milestone
- Drug
- Zenagamtide (amycretin); cagrilintide
- For
- Obesity / cardiovascular outcomes
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Novo H1 2026 anticipated R&D milestones table; CagriSema REIMAGINE SWITCH Phase 3 initiation also guided for Q3 2026.
- Checked
- Checked by a person when it was added
- Verify it
- Source: ml-eu.globenewswire.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- NVO headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
Novo Nordisk presents data on CagriSema for Obesity / weight management (1.0/1.0 and 1.7/1.7 mg doses) at a medical meeting in the second half of 2026 (no exact date yet). New numbers at a conference can move the stock as much as a formal announcement.
More details
- Entry
- CagriSema REDEFINE 9 lower-dose Phase 3 detailed results at a scientific congress · Data presented at a medical meeting
- Drug
- CagriSema
- For
- Obesity / weight management (1.0/1.0 and 1.7/1.7 mg doses)
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Novo H1 2026 report: REDEFINE 9 completed with superior weight loss vs placebo at both lower doses.
- Checked
- Checked by a person when it was added
- Verify it
- Source: ml-eu.globenewswire.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- NVO headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
The FDA is expected to decide in Q4 2026 (Oct–Dec) (no exact date yet) whether to approve Novo Nordisk’s CagriSema (cagrilintide + semaglutide) for Chronic weight management (obesity/overweight). Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.
More details
- Entry
- Expected FDA decision on CagriSema for weight management · FDA decision due (PDUFA date)
- Drug
- CagriSema (cagrilintide + semaglutide)
- For
- Chronic weight management (obesity/overweight)
- Stage
- Phase 2 · the stage that tests whether the drug actually works
- When
- Q4 2026 · the company gave a window, not a day
- Source note
- Novo filed the NDA December 18, 2025 and said the FDA is expected to review the application in 2026; catalyst trackers and coverage put the action date in Q4 2026 under a standard review clock. No exact PDUFA date has been made public.
- Checked
- Checked by a person when it was added
- Verify it
- Source: pdufa.bio ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- NVO headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
The FDA is expected to decide in Q4 2026 (Oct–Dec) (no exact date yet) whether to approve Novo Nordisk’s Ozempic pill (oral semaglutide 25 mg) for Type 2 diabetes. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.
More details
- Entry
- FDA decision on Ozempic pill 25 mg dose (oral semaglutide) in T2D · FDA decision due (PDUFA date)
- Drug
- Ozempic pill (oral semaglutide 25 mg)
- For
- Type 2 diabetes
- Stage
- sNDA under FDA review
- When
- Q4 2026 · the company gave a window, not a day
- Source note
- Novo Nordisk H1 2026 financial report (company announcement 48/2026, Aug 4, 2026); also listed as 'Oral semaglutide 25 mg US decision' in Q4 2026 in the anticipated R&D milestones table.
- Checked
- Checked by a person when it was added
- Verify it
- Source: ml-eu.globenewswire.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- NVO headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
The FDA is expected to decide in Q4 2026 (Oct–Dec) (no exact date yet) whether to approve Novo Nordisk’s Sogroya (somapacitan) for Short stature in Turner syndrome. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.
More details
- Entry
- FDA decision on Sogroya for Turner syndrome · FDA decision due (PDUFA date)
- Drug
- Sogroya (somapacitan)
- For
- Short stature in Turner syndrome
- Stage
- sBLA under review
- When
- Q4 2026 · the company gave a window, not a day
- Source note
- Novo Nordisk H1 2026 report; EU/Japan TS decisions H1 2027.
- Checked
- Checked by a person when it was added
- Verify it
- Source: ml-eu.globenewswire.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- NVO headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
Etavopivat US and EU submissions in sickle cell disease, expected in Q4 2026 (Oct–Dec) (no exact date yet). A company milestone for Novo Nordisk (Etavopivat for Sickle cell disease): a step in the program rather than a decision or a data readout.
More details
- Entry
- Etavopivat US and EU submissions in sickle cell disease · Company milestone
- Drug
- Etavopivat
- For
- Sickle cell disease
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- Q4 2026 · the company gave a window, not a day
- Source note
- Novo H1 2026 report: HIBISCUS Phase 3 completed, meeting both co-primary endpoints.
- Checked
- Checked by a person when it was added
- Verify it
- Source: ml-eu.globenewswire.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- NVO headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page