PDUFA for rusfertide in polycythemia vera
The FDA’s decision on Takeda Pharmaceutical Company’s Rusfertide (hepcidin mimetic; with Protagonist Therapeutics) for Polycythemia vera was due in Q3 2026 (Jul–Sep). 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
- Takeda Pharmaceutical Company Limited TAK
- Drug
- Rusfertide (hepcidin mimetic; with Protagonist Therapeutics)
- For
- Polycythemia vera
- Stage
- NDA under Priority Review, Breakthrough Therapy
- When
- Q3 2026 · the company gave a window, not a day; the calendar never invents one
- Source note
- Takeda/Protagonist announced FDA acceptance with Priority Review on March 2, 2026; the company release states a PDUFA goal date in Q3 2026 (some trade coverage reports August 2026). Decision is imminent as of August 20, 2026 — verify status before publishing.
- Checked
- Checked by a person when it was added
- Source: takeda.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
- TAK headlines on this site
Zasocitinib regulatory submissions in plaque psoriasis (US NDA and other authorities), expected during 2026 (no exact date yet). A company milestone for Takeda Pharmaceutical Company (Zasocitinib (TAK-279) for Moderate-to-severe plaque psoriasis): a step in the program rather than a decision or a data readout.
More details
- Entry
- Zasocitinib regulatory submissions in plaque psoriasis (US NDA and other authorities) · Company milestone
- Drug
- Zasocitinib (TAK-279)
- For
- Moderate-to-severe plaque psoriasis
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- 2026 · the company gave a window, not a day
- Source note
- Takeda Q1 FY2026 results PR (Jul 30, 2026); slides frame it as NDA submission in FY2026 with launch H1 FY2027. Launch/H1 2027 item already tracked.
- Checked
- Checked by a person when it was added
- Verify it
- Source: takeda.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
- TAK headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
Takeda Capital Markets Day in Tokyo, expected on Dec 11, 2026. A company milestone for Takeda Pharmaceutical Company (Pipeline (oveporexton, rusfertide, zasocitinib, mezagitamab, fazirsiran, elritercept) for Corporate/pipeline strategy): a step in the program rather than a decision or a data readout.
More details
- Entry
- Takeda Capital Markets Day in Tokyo · Company milestone
- Drug
- Pipeline (oveporexton, rusfertide, zasocitinib, mezagitamab, fazirsiran, elritercept)
- For
- Corporate/pipeline strategy
- Stage
- n/a
- When
- Dec 11, 2026
- Source note
- Takeda Q1 FY2026 results PR (Jul 30, 2026).
- Checked
- Checked by a person when it was added
- Verify it
- Source: takeda.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
- TAK headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
Zasocitinib psoriasis US filing in FY2026; launch targeted H1 2027, expected in the first half of 2027 (no exact date yet). A company milestone for Takeda Pharmaceutical Company (Zasocitinib (TAK-279, oral TYK2 inhibitor) for Moderate-to-severe plaque psoriasis): a step in the program rather than a decision or a data readout.
More details
- Entry
- Zasocitinib psoriasis US filing in FY2026; launch targeted H1 2027 · Company milestone
- Drug
- Zasocitinib (TAK-279, oral TYK2 inhibitor)
- For
- Moderate-to-severe plaque psoriasis
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H1 2027 · the company gave a window, not a day
- Source note
- BioSpace (citing Takeda) reports the zasocitinib application is slated within Takeda's current fiscal year (ends March 2027) with launch expected in H1 2027, implying an FDA decision by then. Timing is company guidance at year/half precision, not a confirmed PDUFA date.
- Checked
- Checked by a person when it was added
- Verify it
- Source: biospace.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
- TAK headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page