{"success":true,"data":{"pressRelease":{"id":"134956","rtpr_id":"nGNXbJVrDS","ticker":"LQDA","exchange":"NASDAQ","all_tickers":["LQDA"],"title":"FDA Grants Fast Track Designation to YUTREPIA® for the Treatment of Raynaud's Phenomenon Associated with Systemic Sclerosis","author":"Globe Newswire","published_at":"2026-09-03T11:30:00.185Z","article_body":"* Fast Track designation underscores the significant unmet need for patients\nwith systemic sclerosis-associated Raynaud's phenomenon (SSc-RP), a\ndebilitating manifestation affecting up to 90% of SSc patients\n* No therapy is currently approved in the U.S. to treat SSc-RP and management\noptions are limited and often inadequate for patients with more severe disease\n* Liquidia plans to initiate RE-WARM, a Phase 2a dose-finding study of\nYUTREPIA in SSc-RP, in the fourth quarter of 2026\nMORRISVILLE, N.C., Sept. 03, 2026 (GLOBE NEWSWIRE) -- Liquidia Corporation\n(Nasdaq: LQDA), a biopharmaceutical company driven by science and compassion\nto revolutionize care for patients with challenging respiratory and vascular\ndiseases, today announced that the U.S. Food and Drug Administration (FDA) has\ngranted Fast Track designation to YUTREPIA® (treprostinil) inhalation powder\nfor the treatment of Raynaud's phenomenon associated with systemic sclerosis\n(SSc-RP). The potential use of YUTREPIA in SSc-RP is currently under clinical\ndevelopment, and its safety and efficacy for this indication have not been\nevaluated by any regulatory authority.\n\nSystemic sclerosis (SSc) is a rare, chronic autoimmune disease marked by\nwidespread vasculopathy and fibrosis of the skin and internal organs, and it\ncarries the highest mortality of any systemic rheumatic disease. Raynaud's\nphenomenon (RP) consists of recurrent, often severe vasospastic episodes that\ncause pain, numbness and color change in the fingers and toes. Affecting up to\n90% of SSc patients, these attacks are more frequent, prolonged and severe\nthan primary Raynaud's, often progressing to digital ischemic ulcers in an\nestimated 40% to 60% of patients and, in recurrent cases, digital amputation.\nAt a 2020 FDA Patient-Focused Drug Development meeting, SSc patients\nidentified Raynaud's attacks as among the disease's most bothersome and\nimpactful symptoms, citing pain, functional limitation and considerable\nemotional distress tied to fear of ulceration and tissue loss. A central\ndriver of SSc-RP is deficient endogenous prostacyclin production, which\ncontributes to the vasospasm, platelet activation and vascular remodeling\nunderlying the disease. Liquidia estimates the addressable population of\nSSc-RP patients with moderate to severe symptoms to be approximately 30,000\npatients in the United States.\n\nDr. Rajeev Saggar, Chief Medical Officer, said: \"Fast Track designation\nreflects the seriousness of this condition and the need for new options. No\ntherapy is currently approved by the FDA specifically for SSc-RP. We are\nencouraged by the opportunity to evaluate whether YUTREPIA can reduce the\ncomplications of moderate to severe Raynaud’s that most affect patients'\nquality of life, and we are committed to advancing this program with urgency,\nstarting with the RE-WARM study later this year.\"\n\nThe FDA's Fast Track program is designed to facilitate the development and\nexpedite the review of drugs intended to treat serious conditions and fill an\nunmet medical need. Fast Track designation provides Liquidia with the\nopportunity for more frequent interactions with the FDA throughout\ndevelopment, the potential for rolling review of a New Drug Application, and,\nif relevant criteria are met, potential eligibility for Priority Review and/or\nAccelerated Approval.\n\nAbout RE-WARM\n\nLiquidia plans to initiate RE-WARM (NCT07748000), a Phase 2a, randomized,\nopen-label, dose-finding study of YUTREPIA in approximately 75 adults with SSc\nexperiencing symptomatic Raynaud's phenomenon attacks, at up to approximately\n30 sites in the United States. RE-WARM is designed to characterize the safety\nand pharmacodynamics of YUTREPIA in this population. The study also explores\nwhether treatment reduces the number, severity and impact of RP attacks. The\nstudy is expected to begin in October 2026, with primary completion targeted\nfor February 2027.\n\nAbout YUTREPIA® (treprostinil) Inhalation Powder\n\nYUTREPIA is an inhaled dry-powder formulation of treprostinil delivered\nthrough a convenient, low-effort, palm-sized device. YUTREPIA was designed\nusing Liquidia's PRINT® technology, which enables the development of drug\nparticles that are precise and uniform in size, shape and composition, and\nthat are engineered for enhanced deposition in the lung following oral\ninhalation. YUTREPIA is approved for the treatment of pulmonary arterial\nhypertension (PAH) and pulmonary hypertension associated with interstitial\nlung disease (PH-ILD). YUTREPIA is not approved for the treatment of Raynaud's\nphenomenon associated with systemic sclerosis, and there is no guarantee that\nthe FDA will ultimately approve YUTREPIA for this use, even with Fast Track\ndesignation.\n\nINDICATION\n\nYUTREPIA (treprostinil) inhalation powder is a prostacyclin analog indicated\nfor the treatment of:\n* Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise\nability. Studies establishing effectiveness predominately included patients\nwith NYHA Functional Class III symptoms and etiologies of idiopathic or\nheritable PAH (56%) or PAH associated with connective tissue diseases (33%).\n* Pulmonary hypertension associated with interstitial lung disease (PH-ILD;\nWHO Group 3) to improve exercise ability. The study establishing effectiveness\npredominately included patients with etiologies of idiopathic interstitial\npneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF),\ncombined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3\nconnective tissue disease (22%).\nSELECTED SAFETY INFORMATION: WARNINGS AND PRECAUTIONS\n* Treprostinil is a pulmonary and systemic vasodilator. In patients with low\nsystemic arterial pressure, treatment with treprostinil may produce\nsymptomatic hypotension.\n* Treprostinil inhibits platelet aggregation and increases the risk of\nbleeding.\n* Co-administration of a cytochrome P450 (CYP) 2C8 enzyme inhibitor (e.g.,\ngemfibrozil) may increase exposure (both Cmax and AUC) to treprostinil.\nCo-administration of a CYP2C8 enzyme inducer (e.g., rifampin) may decrease\nexposure to treprostinil. Increased exposure is likely to increase adverse\nevents associated with treprostinil administration, whereas decreased exposure\nis likely to reduce clinical effectiveness.\n* Like other inhaled prostaglandins, YUTREPIA may cause acute bronchospasm.\nPatients with asthma or chronic obstructive pulmonary disease (COPD), or other\nbronchial hyperreactivity, are at increased risk for bronchospasm. Ensure that\nsuch patients are treated optimally for reactive airway disease prior to and\nduring treatment.\n* Most common adverse reactions with YUTREPIA (≥10%) are cough, headache,\nthroat irritation and dizziness.\nPrescribing Information and Instructions for Use for YUTREPIA (treprostinil)\ninhalation powder are available at\nhttps://www.yutrepia.com/full-prescribing-information.pdf.\n\nAbout Liquidia Corporation\n\nLiquidia Corporation is a biopharmaceutical company driven by science and\ncompassion to revolutionize care for patients with challenging respiratory and\nvascular diseases. The company's current focus spans the development and\ncommercialization of products in pulmonary hypertension and other applications\nof its proprietary PRINT® Technology. PRINT enabled the creation of\nYUTREPIA® (treprostinil) inhalation powder, a drug approved for the treatment\nof pulmonary arterial hypertension (PAH) and pulmonary hypertension associated\nwith interstitial lung disease (PH-ILD). YUTREPIA is currently under\ndevelopment for other indications, including SSc-RP. The company is also\ndeveloping L606, an investigational extended-release formulation of\ntreprostinil administered twice daily with a next-generation nebulizer, and\ncurrently markets generic Treprostinil Injection for the treatment of PAH. To\nlearn more about Liquidia, please visit www.liquidia.com.\n\nCautionary Statements Regarding Forward-Looking Statements\n\nThis press release may include forward-looking statements within the meaning\nof the Private Securities Litigation Reform Act of 1995. All statements\ncontained in this press release other than statements of historical facts,\nincluding statements regarding our future results of operations and financial\nposition, our strategic and financial initiatives, our business strategy and\nplans and our objectives for future operations, are forward-looking\nstatements. Such forward-looking statements, including statements regarding\nclinical trials, clinical studies and other clinical work (including the\nfunding therefor, anticipated patient enrollment, safety data, study data,\ntrial outcomes, timing or associated costs), regulatory applications and\nrelated submission contents and timelines, the receipt, timing and\ncontinuation of Fast Track designation and any benefits thereof, and our\nability to successfully develop and, if approved, commercialize YUTREPIA for\nSSc-RP or any other product candidate, involve significant risks and\nuncertainties and actual results could differ materially from those expressed\nor implied herein. Fast Track designation does not guarantee that YUTREPIA\nwill receive FDA approval for the treatment of SSc-RP, that development will\nproceed on the anticipated timeline, or that RE-WARM or any future study will\nproduce favorable results. The words “anticipate,” “believe,”\n“continue,” “could,” “estimate,” “expect,” “intend,”\n“may,” “plan,” “potential,” “predict,” “project,”\n“should,” “target,” “would,” and similar expressions are intended\nto identify forward-looking statements. We have based these forward-looking\nstatements largely on our current expectations and projections about future\nevents and financial trends that we believe may affect our financial\ncondition, results of operations, business strategy, short-term and long-term\nbusiness operations and objectives and financial needs. These forward-looking\nstatements are subject to a number of risks discussed in our filings with the\nSEC, as well as a number of uncertainties and assumptions. Moreover, we\noperate in a very competitive and rapidly changing environment and our\nindustry has inherent risks. New risks emerge from time to time. It is not\npossible for our management to predict all risks, nor can we assess the impact\nof all factors on our business or the extent to which any factor, or\ncombination of factors, may cause actual results to differ materially from\nthose contained in any forward-looking statements we may make. In light of\nthese risks, uncertainties and assumptions, the future events discussed in\nthis press release may not occur and actual results could differ materially\nand adversely from those anticipated or implied in the forward-looking\nstatements. Nothing in this press release should be regarded as a\nrepresentation by any person that these goals will be achieved, and we\nundertake no duty to update our goals or to update or alter any\nforward-looking statements, whether as a result of new information, future\nevents or otherwise.\n\nContact Information\n\nInvestors:\nJason Adair\nChief Business Officer\n919.328.4350\n\nMedia:\nmedia@liquidia.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/f7659070-cc55-4e68-ae70-33013e7df72c)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNXbJVrDS","title":"FDA Grants Fast Track Designation to YUTREPIA® for the Treatment of Raynaud's Phenomenon Associated with Systemic Sclerosis","author":"Globe Newswire","ticker":"LQDA","created":"2026-09-03T11:30:00.185Z","tickers":["LQDA"],"exchange":"NASDAQ","article_body":"* Fast Track designation underscores the significant unmet need for patients\nwith systemic sclerosis-associated Raynaud's phenomenon (SSc-RP), a\ndebilitating manifestation affecting up to 90% of SSc patients\n* No therapy is currently approved in the U.S. to treat SSc-RP and management\noptions are limited and often inadequate for patients with more severe disease\n* Liquidia plans to initiate RE-WARM, a Phase 2a dose-finding study of\nYUTREPIA in SSc-RP, in the fourth quarter of 2026\nMORRISVILLE, N.C., Sept. 03, 2026 (GLOBE NEWSWIRE) -- Liquidia Corporation\n(Nasdaq: LQDA), a biopharmaceutical company driven by science and compassion\nto revolutionize care for patients with challenging respiratory and vascular\ndiseases, today announced that the U.S. Food and Drug Administration (FDA) has\ngranted Fast Track designation to YUTREPIA® (treprostinil) inhalation powder\nfor the treatment of Raynaud's phenomenon associated with systemic sclerosis\n(SSc-RP). The potential use of YUTREPIA in SSc-RP is currently under clinical\ndevelopment, and its safety and efficacy for this indication have not been\nevaluated by any regulatory authority.\n\nSystemic sclerosis (SSc) is a rare, chronic autoimmune disease marked by\nwidespread vasculopathy and fibrosis of the skin and internal organs, and it\ncarries the highest mortality of any systemic rheumatic disease. Raynaud's\nphenomenon (RP) consists of recurrent, often severe vasospastic episodes that\ncause pain, numbness and color change in the fingers and toes. Affecting up to\n90% of SSc patients, these attacks are more frequent, prolonged and severe\nthan primary Raynaud's, often progressing to digital ischemic ulcers in an\nestimated 40% to 60% of patients and, in recurrent cases, digital amputation.\nAt a 2020 FDA Patient-Focused Drug Development meeting, SSc patients\nidentified Raynaud's attacks as among the disease's most bothersome and\nimpactful symptoms, citing pain, functional limitation and considerable\nemotional distress tied to fear of ulceration and tissue loss. A central\ndriver of SSc-RP is deficient endogenous prostacyclin production, which\ncontributes to the vasospasm, platelet activation and vascular remodeling\nunderlying the disease. Liquidia estimates the addressable population of\nSSc-RP patients with moderate to severe symptoms to be approximately 30,000\npatients in the United States.\n\nDr. Rajeev Saggar, Chief Medical Officer, said: \"Fast Track designation\nreflects the seriousness of this condition and the need for new options. No\ntherapy is currently approved by the FDA specifically for SSc-RP. We are\nencouraged by the opportunity to evaluate whether YUTREPIA can reduce the\ncomplications of moderate to severe Raynaud’s that most affect patients'\nquality of life, and we are committed to advancing this program with urgency,\nstarting with the RE-WARM study later this year.\"\n\nThe FDA's Fast Track program is designed to facilitate the development and\nexpedite the review of drugs intended to treat serious conditions and fill an\nunmet medical need. Fast Track designation provides Liquidia with the\nopportunity for more frequent interactions with the FDA throughout\ndevelopment, the potential for rolling review of a New Drug Application, and,\nif relevant criteria are met, potential eligibility for Priority Review and/or\nAccelerated Approval.\n\nAbout RE-WARM\n\nLiquidia plans to initiate RE-WARM (NCT07748000), a Phase 2a, randomized,\nopen-label, dose-finding study of YUTREPIA in approximately 75 adults with SSc\nexperiencing symptomatic Raynaud's phenomenon attacks, at up to approximately\n30 sites in the United States. RE-WARM is designed to characterize the safety\nand pharmacodynamics of YUTREPIA in this population. The study also explores\nwhether treatment reduces the number, severity and impact of RP attacks. The\nstudy is expected to begin in October 2026, with primary completion targeted\nfor February 2027.\n\nAbout YUTREPIA® (treprostinil) Inhalation Powder\n\nYUTREPIA is an inhaled dry-powder formulation of treprostinil delivered\nthrough a convenient, low-effort, palm-sized device. YUTREPIA was designed\nusing Liquidia's PRINT® technology, which enables the development of drug\nparticles that are precise and uniform in size, shape and composition, and\nthat are engineered for enhanced deposition in the lung following oral\ninhalation. YUTREPIA is approved for the treatment of pulmonary arterial\nhypertension (PAH) and pulmonary hypertension associated with interstitial\nlung disease (PH-ILD). YUTREPIA is not approved for the treatment of Raynaud's\nphenomenon associated with systemic sclerosis, and there is no guarantee that\nthe FDA will ultimately approve YUTREPIA for this use, even with Fast Track\ndesignation.\n\nINDICATION\n\nYUTREPIA (treprostinil) inhalation powder is a prostacyclin analog indicated\nfor the treatment of:\n* Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise\nability. Studies establishing effectiveness predominately included patients\nwith NYHA Functional Class III symptoms and etiologies of idiopathic or\nheritable PAH (56%) or PAH associated with connective tissue diseases (33%).\n* Pulmonary hypertension associated with interstitial lung disease (PH-ILD;\nWHO Group 3) to improve exercise ability. The study establishing effectiveness\npredominately included patients with etiologies of idiopathic interstitial\npneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF),\ncombined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3\nconnective tissue disease (22%).\nSELECTED SAFETY INFORMATION: WARNINGS AND PRECAUTIONS\n* Treprostinil is a pulmonary and systemic vasodilator. In patients with low\nsystemic arterial pressure, treatment with treprostinil may produce\nsymptomatic hypotension.\n* Treprostinil inhibits platelet aggregation and increases the risk of\nbleeding.\n* Co-administration of a cytochrome P450 (CYP) 2C8 enzyme inhibitor (e.g.,\ngemfibrozil) may increase exposure (both Cmax and AUC) to treprostinil.\nCo-administration of a CYP2C8 enzyme inducer (e.g., rifampin) may decrease\nexposure to treprostinil. Increased exposure is likely to increase adverse\nevents associated with treprostinil administration, whereas decreased exposure\nis likely to reduce clinical effectiveness.\n* Like other inhaled prostaglandins, YUTREPIA may cause acute bronchospasm.\nPatients with asthma or chronic obstructive pulmonary disease (COPD), or other\nbronchial hyperreactivity, are at increased risk for bronchospasm. Ensure that\nsuch patients are treated optimally for reactive airway disease prior to and\nduring treatment.\n* Most common adverse reactions with YUTREPIA (≥10%) are cough, headache,\nthroat irritation and dizziness.\nPrescribing Information and Instructions for Use for YUTREPIA (treprostinil)\ninhalation powder are available at\nhttps://www.yutrepia.com/full-prescribing-information.pdf.\n\nAbout Liquidia Corporation\n\nLiquidia Corporation is a biopharmaceutical company driven by science and\ncompassion to revolutionize care for patients with challenging respiratory and\nvascular diseases. The company's current focus spans the development and\ncommercialization of products in pulmonary hypertension and other applications\nof its proprietary PRINT® Technology. PRINT enabled the creation of\nYUTREPIA® (treprostinil) inhalation powder, a drug approved for the treatment\nof pulmonary arterial hypertension (PAH) and pulmonary hypertension associated\nwith interstitial lung disease (PH-ILD). YUTREPIA is currently under\ndevelopment for other indications, including SSc-RP. The company is also\ndeveloping L606, an investigational extended-release formulation of\ntreprostinil administered twice daily with a next-generation nebulizer, and\ncurrently markets generic Treprostinil Injection for the treatment of PAH. To\nlearn more about Liquidia, please visit www.liquidia.com.\n\nCautionary Statements Regarding Forward-Looking Statements\n\nThis press release may include forward-looking statements within the meaning\nof the Private Securities Litigation Reform Act of 1995. All statements\ncontained in this press release other than statements of historical facts,\nincluding statements regarding our future results of operations and financial\nposition, our strategic and financial initiatives, our business strategy and\nplans and our objectives for future operations, are forward-looking\nstatements. Such forward-looking statements, including statements regarding\nclinical trials, clinical studies and other clinical work (including the\nfunding therefor, anticipated patient enrollment, safety data, study data,\ntrial outcomes, timing or associated costs), regulatory applications and\nrelated submission contents and timelines, the receipt, timing and\ncontinuation of Fast Track designation and any benefits thereof, and our\nability to successfully develop and, if approved, commercialize YUTREPIA for\nSSc-RP or any other product candidate, involve significant risks and\nuncertainties and actual results could differ materially from those expressed\nor implied herein. Fast Track designation does not guarantee that YUTREPIA\nwill receive FDA approval for the treatment of SSc-RP, that development will\nproceed on the anticipated timeline, or that RE-WARM or any future study will\nproduce favorable results. The words “anticipate,” “believe,”\n“continue,” “could,” “estimate,” “expect,” “intend,”\n“may,” “plan,” “potential,” “predict,” “project,”\n“should,” “target,” “would,” and similar expressions are intended\nto identify forward-looking statements. We have based these forward-looking\nstatements largely on our current expectations and projections about future\nevents and financial trends that we believe may affect our financial\ncondition, results of operations, business strategy, short-term and long-term\nbusiness operations and objectives and financial needs. These forward-looking\nstatements are subject to a number of risks discussed in our filings with the\nSEC, as well as a number of uncertainties and assumptions. Moreover, we\noperate in a very competitive and rapidly changing environment and our\nindustry has inherent risks. New risks emerge from time to time. It is not\npossible for our management to predict all risks, nor can we assess the impact\nof all factors on our business or the extent to which any factor, or\ncombination of factors, may cause actual results to differ materially from\nthose contained in any forward-looking statements we may make. In light of\nthese risks, uncertainties and assumptions, the future events discussed in\nthis press release may not occur and actual results could differ materially\nand adversely from those anticipated or implied in the forward-looking\nstatements. Nothing in this press release should be regarded as a\nrepresentation by any person that these goals will be achieved, and we\nundertake no duty to update our goals or to update or alter any\nforward-looking statements, whether as a result of new information, future\nevents or otherwise.\n\nContact Information\n\nInvestors:\nJason Adair\nChief Business Officer\n919.328.4350\n\nMedia:\nmedia@liquidia.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/f7659070-cc55-4e68-ae70-33013e7df72c)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-09-03T11:30:00.225215412Z","server_sent_at_ms":1788435000225},"received_at":"2026-09-03T11:30:00.359Z","source_url":null},"analysis":{"id":"123846","press_release_id":"134956","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["Fast Track designation does not guarantee FDA approval of YUTREPIA for SSc-RP; the indication remains investigational","SSc-RP program is early-stage — only an open-label Phase 2a dose-finding study, with primary completion not expected until February 2027"],"eventType":"regulatory","narrative":"The FDA granted Fast Track designation to Liquidia's YUTREPIA (treprostinil) inhalation powder for Raynaud's phenomenon associated with systemic sclerosis (SSc-RP), an indication with no currently approved therapy in the United States.\n\nLiquidia plans to initiate RE-WARM, a Phase 2a dose-finding study of YUTREPIA in approximately 75 adults with SSc-RP at up to 30 U.S. sites, starting in October 2026 with primary completion targeted for February 2027.\n\nThe company estimates roughly 30,000 U.S. patients with moderate to severe SSc-RP. Fast Track status provides more frequent FDA interactions, potential rolling NDA review, and possible eligibility for Priority Review or Accelerated Approval, though the designation does not guarantee eventual approval for this use.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Fast Track designation opens a label-expansion path for YUTREPIA into SSc-RP, an indication with no FDA-approved therapy and roughly 30,000 addressable U.S. patients."},"keyFigures":{"customDimensions":{"nct_id":"NCT07748000","rewarm_sites":"up to approximately 30 U.S. sites","rewarm_start":"October 2026","rewarm_enrollment":"approximately 75 adults","ssc_rp_prevalence":"up to 90% of SSc patients","addressable_population_us":30000,"digital_ulcer_progression":"40% to 60% of SSc-RP patients","rewarm_primary_completion":"February 2027"}},"quotedText":"reflects the seriousness of this condition and the need for new options.","namedEntities":{"people":[{"name":"Dr. Rajeev Saggar","role":"Chief Medical Officer"},{"name":"Jason Adair","role":"Chief Business Officer (investor contact)"}],"products":["YUTREPIA (treprostinil) inhalation powder","PRINT technology","L606","generic Treprostinil Injection"],"companies":[{"name":"Liquidia Corporation","ticker":"LQDA","relationship":"filer"},{"name":"U.S. Food and Drug Administration (FDA)","relationship":"regulatory agency"}],"dollarAmounts":[]},"materialImpact":{"score":3,"reasoning":"FDA Fast Track designation for a new SSc-RP indication of Liquidia's commercial product, paired with a planned Phase 2a trial, is a genuine regulatory catalyst — but it is non-binary, early-stage, and years from any potential approval decision."},"tickerRelevance":{"others":[],"primary":"LQDA"},"globalImportance":30,"audienceRelevance":25,"eventTypeSecondary":["clinical_trial"],"importanceComponents":{"tickerTier":"small-cap biotech","binaryEvent":false,"eventGravity":"FDA Fast Track designation (non-binary regulatory milestone)","issuerAuthored":true,"indicationExpansion":"new indication with no approved U.S. therapy and ~30,000 addressable patients","retailFavoriteBoost":false}},"event_type":"regulatory","event_type_secondary":["clinical_trial"],"sentiment":"bullish","material_impact_score":3,"narrative":"The FDA granted Fast Track designation to Liquidia's YUTREPIA (treprostinil) inhalation powder for Raynaud's phenomenon associated with systemic sclerosis (SSc-RP), an indication with no currently approved therapy in the United States.\n\nLiquidia plans to initiate RE-WARM, a Phase 2a dose-finding study of YUTREPIA in approximately 75 adults with SSc-RP at up to 30 U.S. sites, starting in October 2026 with primary completion targeted for February 2027.\n\nThe company estimates roughly 30,000 U.S. patients with moderate to severe SSc-RP. Fast Track status provides more frequent FDA interactions, potential rolling NDA review, and possible eligibility for Priority Review or Accelerated Approval, though the designation does not guarantee eventual approval for this use.","key_figures":{"customDimensions":{"nct_id":"NCT07748000","rewarm_sites":"up to approximately 30 U.S. sites","rewarm_start":"October 2026","rewarm_enrollment":"approximately 75 adults","ssc_rp_prevalence":"up to 90% of SSc patients","addressable_population_us":30000,"digital_ulcer_progression":"40% to 60% of SSc-RP patients","rewarm_primary_completion":"February 2027"}},"named_entities":{"people":[{"name":"Dr. Rajeev Saggar","role":"Chief Medical Officer"},{"name":"Jason Adair","role":"Chief Business Officer (investor contact)"}],"products":["YUTREPIA (treprostinil) inhalation powder","PRINT technology","L606","generic Treprostinil Injection"],"companies":[{"name":"Liquidia Corporation","ticker":"LQDA","relationship":"filer"},{"name":"U.S. Food and Drug Administration (FDA)","relationship":"regulatory agency"}],"dollarAmounts":[]},"model_name":"glm-4.7","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-09-03T11:34:11.007Z","global_importance":30,"audience_relevance":25,"importance_components":{"tickerTier":"small-cap biotech","binaryEvent":false,"eventGravity":"FDA Fast Track designation (non-binary regulatory milestone)","issuerAuthored":true,"indicationExpansion":"new indication with no approved U.S. therapy and ~30,000 addressable patients","retailFavoriteBoost":false}},"durationMs":89313,"modelName":"glm-4.7"}}