FDA action expected on Tyvaso IPF sNDA
United expects the FDA to decide on Tyvaso (nebulized treprostinil) for Idiopathic pulmonary fibrosis during 2027 (no exact date yet). An approval lets the company start selling it in that market.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- United Therapeutics Corporation UTHR
- Drug
- Tyvaso (nebulized treprostinil)
- For
- Idiopathic pulmonary fibrosis
- Stage
- sNDA under review
- When
- 2027 · the company gave a window, not a day; the calendar never invents one
- Source note
- sNDA submitted June 2026 with priority review requested, based on positive TETON-1 and TETON-2. PDUFA date not yet publicly announced; company anticipates potential 2027 approval (launch possibly as early as Q1 2027).
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- Source: seekingalpha.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
- UTHR headlines on this site
Ralinepag NDA submission for PAH, expected in the second half of 2026 (no exact date yet). A company milestone for United (Ralinepag for Pulmonary arterial hypertension): a step in the program rather than a decision or a data readout.
More details
- Entry
- Ralinepag NDA submission for PAH · Company milestone
- Drug
- Ralinepag
- For
- Pulmonary arterial hypertension
- 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
- Company PR (May 17, 2026): intends to submit an NDA for ralinepag in PAH to FDA by the second half of 2026, after ADVANCE OUTCOMES met its primary endpoint (55% risk reduction in clinical worsening).
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- Source: businesswire.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
- UTHR headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
NDA submission for treprostinil SMI (soft mist inhaler) by year-end 2026, expected in Q4 2026 (Oct–Dec) (no exact date yet). A company milestone for United (treprostinil SMI for PAH / pulmonary hypertension): a step in the program rather than a decision or a data readout.
More details
- Entry
- NDA submission for treprostinil SMI (soft mist inhaler) by year-end 2026 · Company milestone
- Drug
- treprostinil SMI
- For
- PAH / pulmonary hypertension
- Stage
- NDA
- When
- Q4 2026 · the company gave a window, not a day
- Source note
- Q2 2026 earnings release (Aug 5, 2026). Company guides 'planned filings later this year' / 'by the end of this year'; mapped to 2026-Q4 as outer bound.
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- Source: ir.unither.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
- UTHR headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
United expects the FDA to decide on ralinepag for pulmonary arterial hypertension during 2027 (no exact date yet). An approval lets the company start selling it in that market.
More details
- Entry
- Potential FDA approval of ralinepag tablets in PAH · Regulatory approval
- Drug
- ralinepag
- For
- pulmonary arterial hypertension
- Stage
- NDA under review
- When
- 2027 · the company gave a window, not a day
- Source note
- Q2 2026 earnings release (Aug 5, 2026). NDA submitted June 2026; no PDUFA date disclosed yet (acceptance not yet announced as of Aug 21). Companion Tyvaso IPF 2027 approval already tracked.
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- Checked by a person when it was added
- Verify it
- Source: ir.unither.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
- UTHR headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page