{"id":905780,"date":"2025-11-05T06:27:12","date_gmt":"2025-11-05T11:27:12","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/palvella-therapeutics-announces-new-qtorin-product-candidate-qtorin-pitavastatin-for-the-treatment-of-disseminated-superficial-actinic-porokeratosis-dsap-a-rare-chronic-and-pr\/"},"modified":"2025-11-05T06:27:12","modified_gmt":"2025-11-05T11:27:12","slug":"palvella-therapeutics-announces-new-qtorin-product-candidate-qtorin-pitavastatin-for-the-treatment-of-disseminated-superficial-actinic-porokeratosis-dsap-a-rare-chronic-and-pr","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/palvella-therapeutics-announces-new-qtorin-product-candidate-qtorin-pitavastatin-for-the-treatment-of-disseminated-superficial-actinic-porokeratosis-dsap-a-rare-chronic-and-pr\/","title":{"rendered":"Palvella Therapeutics Announces New QTORIN\u2122 Product Candidate, QTORIN\u2122 Pitavastatin, for the Treatment of Disseminated Superficial Actinic Porokeratosis (DSAP), a Rare, Chronic, and Pre-Cancerous Genetic Skin Disease with No FDA-Approved Therapies"},"content":{"rendered":"
\n

\n DSAP is a premalignant, progressive disease characterized by numerous expanding lesions which significantly impact quality-of-life; no FDA-approved therapies exist for the estimated more than 50,000 diagnosed U.S. patients<\/em>\n <\/p>\n

\n QTORIN\u2122 pitavastatin has the potential to be the first pathogenesis-directed therapy designed to directly inhibit the mevalonate pathway, the causal driver of DSAP, in the pathogenic skin tissue<\/em>\n <\/p>\n

\n Company plans to initiate a Phase 2 trial evaluating QTORIN\u2122 pitavastatin for DSAP in the second half of 2026<\/em>\n <\/p>\n

\n Company to host webcast conference call today,\u00a0November 5, 2025\u00a0at\u00a08:30am ET<\/em>\n <\/p>\n

WAYNE, Pa., Nov. 05, 2025 (GLOBE NEWSWIRE) — (Nasdaq: PVLA) Palvella Therapeutics, Inc. (Palvella or \u201cthe Company\u201d), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced a new product candidate, QTORIN\u2122 pitavastatin, for the treatment of disseminated superficial actinic porokeratosis (DSAP). QTORIN\u2122 pitavastatin was developed leveraging QTORIN\u2122, the company’s patented platform for reproducibly generating novel, topical product candidates for the targeted treatment of serious, rare skin diseases.<\/p>\n

DSAP is a genetic skin disease that results from mutations in the mevalonate pathway, leading to the accumulation of toxic intermediates. Clinically, DSAP presents as persistent, often extensive lesions that enlarge and increase in size, number, and extent over time. These lesions cause chronic loss of skin integrity, which can severely impact quality-of-life. DSAP is premalignant, with potential transformation to squamous cell carcinoma, particularly in long-standing or widespread cases. Spontaneous regression is extremely rare, and no FDA-approved therapies currently exist for the estimated more than 50,000 diagnosed patients in the United States.<\/p>\n

“QTORIN\u2122 pitavastatin has the potential to be the first pathogenesis-directed therapy for the treatment of DSAP, a serious, rare skin disease which currently has no FDA-approved therapies,\u201d said Wes Kaupinen, Founder and Chief Executive Officer. \u201cRecent breakthrough scientific discoveries further characterizing the genetics and biology of DSAP, as well as published case studies on the use of off-label topical statins, provide strong scientific rationale for advancing the development of QTORIN\u2122 pitavastatin. With its superior potency relative to other mevalonate pathway inhibitors, pitavastatin represents a next-generation statin ideally suited for QTORIN\u2122 development in DSAP.\u201d<\/p>\n

Palvella plans to meet with the FDA in the first half of 2026 to discuss the proposed design of a Phase 2 clinical trial evaluating QTORIN\u2122 pitavastatin in subjects with disseminated superficial actinic porokeratosis. Trial initiation is anticipated in the second half of 2026.<\/p>\n

\n Webcast Conference Call Details<\/strong><\/p>\n

Palvella will host a conference call and live audiovisual webcast to discuss its new clinical candidate QTORIN\u2122 pitavastatin at 8:30 a.m. ET today. The conference call format will be presentation only. To access the live webcast of the call with slides, please click here<\/a>\u00a0or visit the \u201cEvents & Presentations\u201d section of Palvella\u2019s website. A replay of the webcast will be available approximately 2 hours after the conclusion of the call and archived for 90 days under the \u201cEvents & Presentations\u201d section of the Company’s website at\u00a0www.palvellatx.com<\/u><\/a>.<\/p>\n

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

Founded and led by rare disease drug development veterans, Palvella Therapeutics, Inc. (Nasdaq: PVLA) is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases 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, 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<\/u><\/a>\u00a0or follow Palvella on\u00a0LinkedIn<\/u><\/a>\u00a0or\u00a0X<\/u><\/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 or cleared by the FDA or by any other regulatory agency for any indication.<\/p>\n

\n Forward-Looking Statements<\/strong><\/p>\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 ongoing clinical trials, Palvella\u2019s clinical development plans and related anticipated development milestones, 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 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; 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 www.sec.gov. 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\u00a0Information<\/strong>\n <\/p>\n

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

\n Media<\/u>
\n
Marcy Nanus
Managing Partner, Trilon Advisors LLC
mnanus@trilonadvisors.com<\/u><\/a><\/p>\n

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

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

DSAP is a premalignant, progressive disease characterized by numerous expanding lesions which significantly impact quality-of-life; no FDA-approved therapies exist for the estimated more than 50,000 diagnosed U.S. patients QTORIN\u2122 pitavastatin has the potential to be the first pathogenesis-directed therapy designed to directly inhibit the mevalonate pathway, the causal driver of DSAP, in the pathogenic skin tissue Company plans to initiate a Phase 2 trial evaluating QTORIN\u2122 pitavastatin for DSAP in the second half of 2026 Company to host webcast conference call today,\u00a0November 5, 2025\u00a0at\u00a08:30am ET WAYNE, Pa., Nov. 05, 2025 (GLOBE NEWSWIRE) — (Nasdaq: PVLA) Palvella Therapeutics, Inc. (Palvella or \u201cthe Company\u201d), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare … <\/p>\n

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