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Current Report · Items 8.01, 9.01 · 8-K

Liquidia Corporation

LQDANASDAQEQUITYCurrent

Other Events

Item 8.01 Other Events. On September 3, 2026, Liquidia Corporation, a Delaware corporation (the “Company”), issued a press release announcing that the U.S. Food and Drug Administration has granted Fast Track Designation to YUTREPIA® (treprostinil) inhalation powder for the treatment of Raynaud’s phenomenon associated with systemic sclerosis.…

Filed Sep 3, 2026Accepted Sep 3, 2026, 8:00 AM EDTCIK 1819576Accession 0001104659-26-104929
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Company context

Liquidia Corporation is a biopharmaceutical company driven by science and compassion to revolutionize care for patients with challenging respiratory and vascular diseases. The company's current focus spans the development and commercialization of products in pulmonary hypertension and other applications of its proprietary PRINT® Technology. PRINT enabled the creation of YUTREPIA® (treprostinil) inhalation powder, a drug approved for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). YUTREPIA is currently under development for other indications, including SSc-RP. The company is also developing L606, an investigational extended-release formulation of treprostinil administered twice daily with a next-generation nebulizer, and currently markets generic Treprostinil Injection for the treatment of PAH. To learn more about Liquidia, please visit www.liquidia.com.

Current securities

Recent company filings

  1. 4 filingSep 15, 2026
  2. 4 filingAug 25, 2026
  3. 4 filingAug 21, 2026
  4. 10-Q filingAug 12, 2026
  5. Results of Operations and Financial Condition · Other EventsAug 12, 2026

Disclosure sections

Items 8.01, 9.01

Select an item to read the extracted section. The as-filed document remains the primary evidence.

Item 8.01Item 8.01 - Other Events
Item 8.01 Other Events. On September 3, 2026, Liquidia Corporation, a Delaware corporation (the “Company”), issued a press release announcing that the U.S. Food and Drug Administration has granted Fast Track Designation to YUTREPIA® (treprostinil) inhalation powder for the treatment of Raynaud’s phenomenon associated with systemic sclerosis. A copy of the press release is filed as Exhibit 99.1 hereto and is incorporated by reference into this Item 8.01.
Filed exhibits (1)
EX-99.1 (by filename) tm2624724d1_ex99-1.htm

EX-99.1 2 tm2624724d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 FDA Grants Fast Track Designation to YUTREPIA® for the Treatment of Raynaud's Phenomenon Associated with Systemic Sclerosis Fast Track designation underscores the significant unmet need for patients with systemic sclerosis-associated Raynaud's phenomenon (SSc-RP), a debilitating manifestation affecting up to 90% of SSc patients No therapy is currently approved in the U.S. to treat SSc-RP and management options are limited and often inadequate for patients with more severe disease Liquidia plans to initiate RE-WARM, a Phase 2a dose-finding study of YUTREPIA in SSc-RP, in the fourth quarter of 2026 ───────────────────────────────────────────────────────────────────────────────── MORRISVILLE, N.C., Sept. 3, 2026 (GLOBE NEWSWIRE) -- Liquidia Corporation (Nasdaq: LQDA), a biopharmaceutical company driven by science and compassion to revolutionize care for patients with challenging respiratory and vascular diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to YUTREPIA® (treprostinil) inhalation powder for the treatment of Raynaud's phenomenon associa…

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