Palvella Therapeutics Launches "BEYOND mLM" Disease Awareness Campaign for Microcystic Lymphatic Malformations in Collaboration with Leading Lymphatic, Vascular, and Dermatology Nonprofit Organizations

campaign designed to educate, engage, and empower patients, caregivers, and healthcare professionals

Campaign developed and launched in close collaboration with leading nonprofit organizations, including , , the , , and

Microcystic lymphatic malformations (microcystic LMs) are a rare, chronically debilitating and lifelong disease affecting an estimated more than 30,000 diagnosed patients in the United States, with no FDA-approved therapies available

WAYNE, Pa., March 10, 2026 (GLOBE NEWSWIRE) -- (Nasdaq: PVLA) (Palvella or “the Company”), 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 launch of "BEYOND mLM," a new disease state awareness campaign and website, , designed to educate, engage, and empower patients, caregivers, and healthcare professionals about microcystic lymphatic malformations (microcystic LMs).

Microcystic LMs are a rare, chronically debilitating disease characterized by malformed lymphatic vessels that can protrude through the skin and persistently leak lymph fluid (lymphorrhea) and bleed, often leading to recurrent serious infections resulting in hospitalization. is an educational website created to help patients, caregivers, and healthcare professionals better understand its underlying biology and full functional and psychosocial impact. The multi-stakeholder campaign is being developed in partnership with leading nonprofit organizations and experts across the dermatology and lymphatic malformation communities, including:

• , a multi-institutional research consortium founded by a group of pediatric hematologist-oncologists and patient advocacy groups to address the rare nature of vascular anomalies.
• , a nonprofit organization dedicated to improving the lives of patients affected by complex lymphatic anomalies.
• , an internationally recognized nonprofit organization dedicated to fighting lymphatic disease and lymphedema through education, research, and advocacy.
• , a collaborative research network dedicated to improving the lives of children affected by skin disease by accelerating research and advancing effective therapies.
• a multidisciplinary clinical resource and expert network focused on improving care coordination for patients with vascular anomalies.  
  
  

Collectively, these partners bring deep expertise, advocacy leadership, and a shared commitment to improving outcomes for those affected by microcystic LMs.

“We are delighted to see Palvella bring together experts and organizations who share a commitment for improving the lives of patients with microcystic lymphatic malformations,” said Dr. Michael Kelly, pediatric hematologist-oncologist at the Cleveland Clinic’s Vascular Anomalies Program and Executive Director of the LGDA. “Patients with microcystic lymphatic malformations often lack access to educational materials written in a way that is accessible and practical. This effort will help provide valuable resources not only for patients and caregivers, but also for healthcare providers seeking to deepen their understanding of this complex condition.”

Through the planned addition of patient stories, expert insights, and tailored resources, Palvella and its nonprofit collaborators aim to strengthen support for the microcystic LM community by improving disease understanding, facilitating care navigation, and fostering meaningful community connections.

“Microcystic lymphatic malformations are rare, complex, and often misunderstood, yet they have a profound impact on patients and families due to their chronically debilitating nature and lifelong disease course," said Ashley Kline, Chief Commercial Officer of Palvella Therapeutics. “Beyond mLM brings together clear, accessible information on the disease and its real-world impact. We are proud to partner with leading nonprofit organizations and experts to support the community through meaningful, evidence-based education and engagement.”

About Microcystic Lymphatic Malformations

Microcystic LMs is a rare, chronically debilitating genetic disease resulting in the activation of the phosphatidylinositol 3-kinase (PI3K)/mammalian target of rapamycin (mTOR) growth pathway. The condition is characterized by malformed lymphatic vessels that can protrude through the skin and persistently leak lymph fluid (lymphorrhea) and bleed, often leading to recurrent serious infections resulting in hospitalization. Microcystic LMs often present in childhood and are persistent and progressive without spontaneous resolution. Over time, there is an increase in the number and size of malformed lymphatic vessels, leading to worsening symptoms and complications and lifetime morbidity. There are currently no FDA-approved treatments for the estimated more than 30,000 children and adults diagnosed with microcystic LMs in the United States.



About Palvella Therapeutics

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 participants 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, 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 topical treatment of disseminated superficial actinic porokeratosis. For more information, please visit  or follow Palvella on  or  (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 ongoing clinical trials, including the TOIVA study, 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

Media

Marcy Nanus

Managing Partner, Trilon Advisors LLC