Macimorelin Acetate

Ms. McDonough previously served as Senior Vice President of Patient Access, Analytics, and Operations at Krystal Biotech (Nasdaq: KRYS), where she helped lead the U.S. launch of VYJUVEK®, supporting its growth from FDA approval in 2023 to $389 million in annual sales in 2025 Ms. McDonough to lead Palvella’s Market Access and Patient Services organizations, advancing payer engagement, patient support, specialty distribution, and access strategy for the Company’s QTORIN™ programs targeting serious, rare skin diseases and vascular malformations WAYNE, Pa., March 23, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or “the Company”) (Nasdaq: PVLA ), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular malformations for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced the appointment of Jennifer J. McDonough as Senior Vice President of Market Access and Patient Services. “As we prepare for a potential near-term U.S. launch of QTORIN™ rapamycin for microcystic lymphatic malformations, building strong market access and patient services capabilities is a key priority for Palvella,” said Wes Kaupinen, Founder and Chief Executive Officer of Palvella. “Jennifer brings deep expertise in rare disease access strategy and patient support, as well as valuable rare skin disease experience from Krystal Biotech, where she contributed to the successful launch of VYJUVEK®, a first-in-disease topical therapy for dystrophic epidermolysis bullosa, a serious, rare genetic skin disease. We are excited to welcome her to the Palvella team as we work to support patients, caregivers, and providers from day one of our planned U.S. launch. We believe the exceptional talent we’re recruiting to Palvella provides a strong foundation for several new product launches as we advance our deep pipeline of therapies for serious, rare skin diseases and vascular malformations.” Ms. McDonough is an accomplished commercial leader with more than 25 years of experience supporting the launch and growth of rare disease and specialty therapies, including first-in-disease therapies for serious, rare skin diseases. She brings deep expertise in market access strategy, reimbursement, patient services, specialty distribution, and commercial operations, with a strong track record of building integrated commercial infrastructure to enable timely patient access and provide comprehensive support for innovative therapies that are new to physicians and their patients. Prior to joining Palvella, Ms. McDonough worked at Krystal Biotech from 2021 to 2026, most recently serving as Senior Vice President, Patient Access, Analytics & Operations. In this role, she led patient access, patient services, analytics, and distribution strategy and contributed to the successful launch and rapid uptake of VYJUVEK®, a re-dosable topical gene therapy for dystrophic epidermolysis bullosa, supporting its growth to $389 million in annual sales by 2025 following FDA approval in 2023. Previously, she held senior leadership roles at Strongbridge Biopharma (acquired by Xeris Biopharma), where she led market access, patient services, and specialty distribution across three rare disease products, including Keveyis®, Macrilen®, and Recorlev®. Earlier in her career, she held senior roles at Cencora (formerly AmerisourceBergen), EMD Serono, and CVS Health, with a focus on commercialization strategy, specialty pharmacy contracting, patient services, and market access across rare and specialty therapies. Ms. McDonough holds a Bachelor of Science in Computer Science and Mathematics and a Master of Arts in Education from the University of Pittsburgh. “I am thrilled to join Palvella at such an exciting and pivotal moment, following positive Phase 3 SELVA results for QTORIN™ rapamycin in microcystic lymphatic malformations and progressing towards potential FDA approval and U.S. launch,” said Ms. McDonough. “What inspires me most is Palvella’s unwavering patient-first approach and dedication to building a leading rare disease company that truly places patients and their families at the center. I am passionate about ensuring that QTORIN™ rapamycin reaches patients quickly and efficiently, while helping to create the infrastructure needed to support future therapies while bringing hope to patients living with serious, rare skin diseases and vascular malformations.” About Palvella Therapeutics 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 suffering from serious, rare skin diseases and vascular malformations for which there are no FDA-approved therapies. Palvella is developing a broad pipeline of product candidates based on its patented QTORIN™ platform, with an initial focus on serious, rare skin diseases and vascular malformations, many of which are lifelong in nature. Palvella’s lead product candidate, QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin), is currently being developed for the treatment of microcystic lymphatic malformations, cutaneous venous malformations, and clinically significant angiokeratomas. Palvella’s second product candidate, QTORIN™ pitavastatin, is currently being developed for the treatment of disseminated superficial actinic porokeratosis. For more information, please visit or follow Palvella on LinkedIn or X (formerly known as Twitter). QTORIN™ rapamycin and QTORIN™ pitavastatin are for investigational use only and neither has been approved by the FDA or by any other regulatory agency for any indication. Forward-Looking Statements 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 “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” 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’s clinical development plans and related anticipated development milestones, Palvella’s plans to pursue Breakthrough Therapy Designation, Palvella’s plans to meet with regulatory authorities, Palvella’s cash, financial resources and expected runway, Palvella’s expectations regarding its programs, including QTORIN™ rapamycin and QTORIN™ 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’s product candidates, including QTORIN™ rapamycin and QTORIN™ pitavastatin; the outcome of early clinical trials for Palvella’s 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’s 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’s 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 . 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. Contact Information Investors Wesley H. Kaupinen Founder and CEO, Palvella Therapeutics wes.kaupinen@palvellatx.com Media Marcy Nanus Managing Partner, Trilon Advisors LLC mnanus@trilonadvisors.com