{"id":1014555,"date":"2026-10-28T08:00:30","date_gmt":"2026-10-28T12:00:30","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/palvella-announces-fda-acceptance-and-priority-review-of-qtorin-rapamycin-nda-february-28-2027-pdufa-target-action-date-set\/"},"modified":"2026-10-28T08:00:30","modified_gmt":"2026-10-28T12:00:30","slug":"palvella-announces-fda-acceptance-and-priority-review-of-qtorin-rapamycin-nda-february-28-2027-pdufa-target-action-date-set","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/palvella-announces-fda-acceptance-and-priority-review-of-qtorin-rapamycin-nda-february-28-2027-pdufa-target-action-date-set\/","title":{"rendered":"Palvella Announces FDA Acceptance and Priority Review of QTORIN\u2122 Rapamycin NDA; February 28, 2027 PDUFA Target Action Date Set"},"content":{"rendered":"
\n

\n QTORIN\u2122 rapamycin could become the first FDA-approved therapy for microcystic lymphatic malformations, a serious, lifelong rare disease affecting an estimated more than 30,000 diagnosed children and adults in the U.S.<\/em>\n <\/p>\n

\n Phase 3 SELVA study achieved highly statistically significant results across all six prespecified efficacy endpoints (all p<0.001), with 95% of participants aged 6 years and older who completed the efficacy evaluation period demonstrating improvement on the mLM-IGA primary endpoint<\/em>\n <\/p>\n

\n Palvella preparing for a potential standalone U.S. commercial launch in the first half of 2027, supported by experienced commercial leadership and established medical affairs and patient services capabilities<\/em>\n <\/p>\n

WAYNE, Pa., Oct. 28, 2026 (GLOBE NEWSWIRE) — Palvella Therapeutics, Inc.<\/a>\u00a0(Nasdaq: PVLA) (\u201cPalvella\u201d or the \u201cCompany\u201d), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies for serious, rare skin diseases and vascular anomalies for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced that the FDA has accepted for filing and granted Priority Review to the Company\u2019s New Drug Application (NDA) for QTORIN\u2122 3.9% rapamycin anhydrous gel (QTORIN\u2122 rapamycin) for the treatment of microcystic lymphatic malformations (microcystic LMs). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2027.<\/p>\n

\u201cFDA acceptance of our NDA and granting of Priority Review represent significant milestones in the development of QTORIN\u2122 rapamycin as a potential first FDA-approved therapy for microcystic lymphatic malformations,\u201d said Wes Kaupinen, Founder and Chief Executive Officer of Palvella Therapeutics. \u201cPalvella was founded to serve rare disease patients by developing and commercializing first-in-disease therapies that meaningfully improve their lives. With compelling Phase 3 SELVA results and a February 28, 2027 PDUFA target action date, we believe we are closer than ever to delivering on that mission. We have assembled an exceptional team across our medical and commercial organizations as we prepare for a potential U.S. launch and work toward bringing QTORIN\u2122 rapamycin to patients who currently have no FDA-approved therapies.\u201d<\/p>\n

The NDA is supported by an evidence package that includes results from the Phase 3 SELVA study, which achieved statistical significance across all six prespecified efficacy endpoints (all p<0.001), and Phase 2 clinical results that supported FDA\u2019s decision to grant Breakthrough Therapy designation. The application also includes published literature and other evidence regarding the clinical use of off-label rapamycin in microcystic LMs. QTORIN\u2122 rapamycin was well tolerated in SELVA, with no drug-related serious adverse events reported and systemic rapamycin concentrations below 2 ng\/mL at all measured timepoints for all participants.<\/p>\n

If approved, QTORIN\u2122 rapamycin would become the first FDA-approved therapy for children and adults with microcystic LMs, a serious, lifelong condition associated with persistent leaking, bleeding, recurrent infections, and functional impairment.<\/p>\n

QTORIN\u2122 rapamycin has received Breakthrough Therapy, Fast Track, and Orphan Drug designations from the FDA for the treatment of microcystic lymphatic malformations. The development program has also received grant funding from the FDA Office of Orphan Products Development.<\/p>\n

\n Preparing for Potential U.S. Commercial Launch in 2027<\/strong>\n <\/p>\n

Palvella is preparing for a potential standalone U.S. commercial launch of QTORIN\u2122 rapamycin in the first half of 2027, subject to FDA approval. The Company has established key commercial and medical capabilities, including experienced rare disease commercial leadership, a field-based medical science liaison team deployed across the United States, and a dedicated patient services organization. Current launch preparations include disease education, engagement with treating specialists, patient identification, market access planning, and patient support readiness, with the objective of facilitating timely access to QTORIN\u2122 rapamycin following potential FDA approval.
FDA approval of QTORIN\u2122 rapamycin would mark Palvella\u2019s transition to a commercial-stage rare disease biopharmaceutical company.<\/p>\n

\n Advancing a Broad Pipeline of Potential First-in-Disease Therapies<\/strong>\n <\/p>\n

Beyond microcystic LMs, Palvella continues to advance QTORIN\u2122 rapamycin for cutaneous venous malformations and clinically significant angiokeratomas, as well as QTORIN\u2122 pitavastatin for disseminated superficial actinic porokeratosis. These programs reflect Palvella\u2019s strategy to leverage the repeatability and scalability of its QTORIN\u2122 platform to develop multiple first-in-disease therapies for serious, rare skin diseases and vascular anomalies.<\/p>\n

\n About Microcystic Lymphatic Malformations<\/strong>\n <\/p>\n

Microcystic LMs are a rare, chronically debilitating genetic disease driven by dysregulation of the PI3K\/mTOR pathway. Malformed lymphatic vessels can protrude through the skin, persistently leak and bleed, and cause recurrent infections, cellulitis and hospitalization. Published natural history data demonstrate that microcystic LMs are persistent and progressive and do not spontaneously regress. Surgery, sclerotherapy and laser can be limited by recurrence and repeated procedures, while systemic PI3K\/mTOR inhibitors may be constrained by chronic safety and tolerability considerations, particularly in children, and by challenges in achieving sufficient exposure in affected skin. Advances in molecular genetics have established dysregulated PI3K\/mTOR signaling as a central disease driver, supporting precision, mechanism-based treatment. There are no FDA-approved treatments for the estimated 30,000 or more people diagnosed with microcystic LMs in the United States.<\/p>\n

\n About Palvella Therapeutics<\/strong>\n <\/p>\n

Founded and led by rare disease biotech veterans, Palvella Therapeutics, Inc. (Nasdaq: PVLA) is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients living with serious, rare skin diseases and vascular anomalies for which there are no FDA-approved therapies. Palvella is developing a broad pipeline of product candidates based on its patented QTORIN\u2122 platform, with an initial focus on serious, rare skin diseases and vascular anomalies, many of which are lifelong in nature. Palvella\u2019s lead product candidate, QTORIN\u2122 3.9% rapamycin anhydrous gel (QTORIN\u2122 rapamycin), is currently being developed for the treatment of microcystic lymphatic malformations, cutaneous venous malformations, and clinically significant angiokeratomas. Palvella\u2019s second product candidate, QTORIN\u2122 pitavastatin, is currently being developed for the treatment of disseminated superficial actinic porokeratosis. For more information, please visit\u00a0www.palvellatx.com<\/a>\u00a0or follow Palvella on\u00a0LinkedIn<\/a>\u00a0or\u00a0X<\/a>\u00a0(formerly known as Twitter).<\/p>\n

QTORIN\u2122 rapamycin and QTORIN\u2122 pitavastatin are for investigational use only and neither has been approved by the FDA or by any other regulatory agency for any indication.<\/p>\n

\n Forward-Looking Statements<\/strong>
\n
This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended (Securities Act)). These statements may discuss goals, intentions, and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Palvella, as well as assumptions made by, and information currently available to, the management of Palvella. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as \u201cmay,\u201d \u201cwill,\u201d \u201cshould,\u201d \u201cwould,\u201d \u201cexpect,\u201d \u201canticipate,\u201d \u201cplan,\u201d \u201clikely,\u201d \u201cbelieve,\u201d \u201cestimate,\u201d \u201cproject,\u201d \u201cintend,\u201d and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding the expected timing of the presentation of data from clinical trials, Palvella\u2019s clinical development plans and related anticipated development milestones and anticipated timing of regulatory submissions, Palvella\u2019s expectations with respect to the potential approval of the NDA for QTORIN\u2122 rapamycin, the potential impact of Priority Review on the FDA\u2019s review timeline, any delays in the FDA\u2019s review of Palvella\u2019s accepted NDA, Palvella\u2019s commercial preparedness and the timing and execution of a potential launch following regulatory approval, Palvella\u2019s plans to pursue Breakthrough Therapy Designation, Palvella\u2019s plans to meet with regulatory authorities, Palvella\u2019s expectations regarding the benefits of orphan drug designation and potential benefit of orphan drug exclusivity for QTORIN\u2122 rapamycin for the treatment of microcystic lymphatic malformations, Palvella\u2019s cash, financial resources and expected runway, Palvella\u2019s expectations regarding its programs, including QTORIN\u2122 rapamycin and QTORIN\u2122 pitavastatin, and its research-stage opportunities, including its expected therapeutic potential and market opportunity. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the ability to raise additional capital to finance operations; the ability to advance product candidates through preclinical and clinical development; the ability to make regulatory submissions on anticipated timelines; the ability to obtain regulatory approval for, and ultimately commercialize, Palvella\u2019s product candidates, including QTORIN\u2122 rapamycin and QTORIN\u2122 pitavastatin; the outcome of early clinical trials for Palvella\u2019s product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements; the fact that data and results from clinical studies may not necessarily be indicative of future results; Palvella\u2019s limited experience in designing clinical trials and lack of experience in conducting clinical trials; Palvella\u2019s limited experience in commercial manufacturing; the ability to identify and pivot to other programs, product candidates, or indications that may be more profitable or successful than Palvella\u2019s current product candidates; the substantial competition Palvella faces in discovering, developing, or commercializing products; the negative impacts of global events on operations, including ongoing and planned clinical trials and ongoing and planned preclinical studies; the ability to attract, hire, and retain skilled executive officers and employees; the ability of Palvella to protect its intellectual property and proprietary technologies; reliance on third parties, contract manufacturers, and contract research organizations; and the risks and uncertainties described in the filings made by Palvella with the Securities and Exchange Commission (SEC), including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the SEC and available at\u00a0www.sec.gov<\/a>. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that Palvella may face. Except as required by applicable law, Palvella does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release.<\/p>\n

\n Contact Information<\/strong>\n <\/p>\n

\n Investors<\/u>\n <\/p>\n

Wesley H. Kaupinen
Founder and CEO
Palvella Therapeutics
wes.kaupinen@palvellatx.com<\/a><\/p>\n

Media<\/u><\/p>\n

Marcy Nanus
Vice President of Investor Relations and Corporate Affairs
Palvella Therapeutics
marcy.nanus@palvellatx.com<\/a><\/p>\n

\"\"
\n
\n \"\"\n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

QTORIN\u2122 rapamycin could become the first FDA-approved therapy for microcystic lymphatic malformations, a serious, lifelong rare disease affecting an estimated more than 30,000 diagnosed children and adults in the U.S. Phase 3 SELVA study achieved highly statistically significant results across all six prespecified efficacy endpoints (all p<0.001), with 95% of participants aged 6 years and older who completed the efficacy evaluation period demonstrating improvement on the mLM-IGA primary endpoint Palvella preparing for a potential standalone U.S. commercial launch in the first half of 2027, supported by experienced commercial leadership and established medical affairs and patient services capabilities WAYNE, Pa., Oct. 28, 2026 (GLOBE NEWSWIRE) — Palvella Therapeutics, Inc.\u00a0(Nasdaq: PVLA) (\u201cPalvella\u201d or the \u201cCompany\u201d), a clinical-stage biopharmaceutical company focused on developing … <\/p>\n

Continue reading “Palvella Announces FDA Acceptance and Priority Review of QTORIN\u2122 Rapamycin NDA; February 28, 2027 PDUFA Target Action Date Set”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-1014555","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nPalvella Announces FDA Acceptance and Priority Review of QTORIN\u2122 Rapamycin NDA; February 28, 2027 PDUFA Target Action Date Set - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/palvella-announces-fda-acceptance-and-priority-review-of-qtorin-rapamycin-nda-february-28-2027-pdufa-target-action-date-set\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Palvella Announces FDA Acceptance and Priority Review of QTORIN\u2122 Rapamycin NDA; 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