WAYNE, Pa., Aug. 4, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or the Company) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company developing and commercializing therapies for serious, rare skin diseases and vascular malformations with no U.S. Food and Drug Administration (FDA)-approved treatments, reported second-quarter 2026 financial results and provided a corporate update.

The company said it completed its pre-New Drug Application (NDA) meeting with the FDA and submitted the first module of the rolling NDA for QTORIN™ rapamycin in microcystic lymphatic malformations. Palvella said completion of the NDA submission remains on track for the second half of 2026. The company is also preparing for a planned standalone U.S. commercial launch of QTORIN™ rapamycin in the first half of 2027, if approved. Microcystic lymphatic malformations are rare, debilitating vascular anomalies for which treatment options have historically been limited to surgical and interventional procedures that often prove incomplete or temporary.

“We made significant progress during the second quarter, completing our pre-NDA meeting with FDA and initiating the rolling NDA submission for QTORIN™ rapamycin in microcystic lymphatic malformations,” said Wes Kaupinen, Founder and Chief Executive Officer of Palvella. “We are working closely with FDA under the program’s Breakthrough Therapy and Fast Track designations to expedite development and review, with the objective of potentially introducing the first approved therapy to pediatric and adult patients living with this serious, lifelong disease. Completion of the NDA submission remains on track for the second half of 2026, and we are preparing for a planned standalone commercial launch in the first half of 2027, if approved. We have recruited commercial and medical affairs leaders with deep experience in rare disease and dermatology who are now in the field executing key pre-launch activities, while we continue to advance our other rare disease programs and pursue additional opportunities across the QTORIN™ platform.”

Recent research and development highlights

QTORIN™ rapamycin for microcystic lymphatic malformations

James Treat, M.D., of Children’s Hospital of Philadelphia presented additional Phase 3 SELVA data during a late-breaking session at the International Society for the Study of Vascular Anomalies World Congress (ISSVA). The presentation included a statistically significant improvement in the 6–11-year-old cohort and other supportive findings showing improvements in clinical signs and patient-reported outcomes with QTORIN™ rapamycin.

Palvella also completed an in-person pre-NDA meeting with the FDA that addressed nonclinical, clinical pharmacology, clinical information, and the planned evidence package for the NDA. Following that meeting, the FDA granted Palvella’s request for Rolling Review of the QTORIN™ rapamycin NDA for microcystic lymphatic malformations, allowing the agency to begin reviewing completed portions of the application before submission of the full NDA. The program holds both Breakthrough Therapy Designation, which the FDA grants for serious conditions when preliminary clinical evidence may indicate substantial improvement over available therapies, and Fast Track Designation, which facilitates more frequent FDA interaction during development.

The company submitted the first module of its rolling NDA to the FDA and said it remains on track to complete the submission in the second half of 2026.

QTORIN™ rapamycin for cutaneous venous malformations

In May 2026, at the 83rd Annual Meeting of the Society for Investigative Dermatology (SID), Palvella presented data from its Phase 2 TOIVA trial of QTORIN™ rapamycin for cutaneous venous malformations. The company said the findings showed that 100% of patients with bleeding at baseline demonstrated improvement on the Cutaneous Venous Malformations Investigator Global Assessment Bleeding scale at Week 12.

Dr. Treat also presented additional Phase 2 TOIVA data, including 24-week results, at ISSVA. Those data showed statistically significant improvements in both cVM-MCSS Height/Engorgement and cVM-MCSS Appearance at all measured time points, with increasing clinical response observed with longer duration of QTORIN™ rapamycin therapy.

Palvella said Phase 3 trial initiation remains on track for the fourth quarter of 2026, following completion of the planned End-of-Phase 2 meeting.

QTORIN™ rapamycin for clinically significant angiokeratomas

Palvella dosed the first patients in LOTU, a multicenter Phase 2 trial evaluating Fast Track-designated QTORIN™ rapamycin for clinically significant angiokeratomas. The company described angiokeratomas as a rare, chronic and debilitating isolated lymphatic malformation affecting an estimated more than 50,000 diagnosed patients in the U.S., with no FDA-approved therapies.

Topline results from LOTU are expected in the second half of 2027.

QTORIN™ pitavastatin for disseminated superficial actinic porokeratosis

Palvella’s second product candidate, QTORIN™ pitavastatin, is being developed for disseminated superficial actinic porokeratosis (DSAP), a premalignant genetic skin disease characterized by persistent, often extensive lesions that enlarge and increase in size, number and extent over time. The company said the condition can cause chronic loss of skin integrity and severely affect quality of life, and that no FDA-approved therapies currently exist for the estimated more than 50,000 diagnosed patients in the U.S.

Palvella said it strengthened the intellectual property position supporting QTORIN™ pitavastatin through the issuance of U.S. Patent No. 12,636,273, exclusively licensed from Yale University and building on pioneering work by Keith Choate, M.D., Ph.D. The issued claims cover the topical administration of HMG-CoA reductase inhibitors, including pitavastatin, for the treatment of porokeratosis, including DSAP, and provide protection into 2043.

The company said Phase 2 trial initiation is expected in the second half of 2026.

QTORIN™ platform expansion

Palvella said it plans to announce the fourth target clinical indication for QTORIN™ rapamycin in the second half of 2026. The company said expansion of QTORIN™ rapamycin into additional indications is supported by a growing body of published literature highlighting the potential of rapamycin in difficult-to-treat, mTOR-driven skin diseases and supporting targeted topical approaches intended to improve tolerability and safety. Rapamycin, also known as sirolimus, is an mTOR inhibitor with an established systemic safety profile dating to its original FDA approval as an immunosuppressant in 1999, and topical delivery aims to concentrate the drug at the site of disease while limiting systemic exposure.

Palvella also plans to announce the third product candidate from the QTORIN™ platform in a serious, rare disease with no FDA-approved therapies in the second half of 2026.

Recent corporate highlights

Palvella appointed rare disease biotech executive and commercial leader Matt Pauls, J.D., M.B.A., to its Board of Directors. The company said the appointment adds experience in rare disease drug development, commercialization and corporate strategy from executive and board roles at Savara Inc., Soleno Therapeutics, Strongbridge Biopharma and Insmed Incorporated.

Palvella was named “Healthcare & Life Sciences Company of the Year” at the 2026 Philadelphia Alliance for Capital and Technology Ecosystem Awards, which the company said recognized its work advancing therapies for rare diseases and its contributions to the regional life sciences ecosystem.

The company also completed its uplisting to the Nasdaq Global Market, which it said provides increased visibility within the investment community and reflects its continued growth and corporate milestones.

Second-quarter 2026 financial results

Palvella said cash, cash equivalents and short-term investments totaled $250.6 million as of June 30, 2026.

Research and development expenses for the three months ended June 30, 2026 were $12.5 million, compared with $5.1 million for the same period in 2025. The company attributed the increase primarily to higher manufacturing spending, clinical development of QTORIN™ rapamycin for angiokeratomas, costs related to the first module of the rolling NDA submission, and higher headcount and consulting services in 2026.

General and administrative expenses were $8.9 million for the quarter, compared with $4.1 million a year earlier. Palvella said the increase was primarily due to higher headcount in 2026 and increased professional services associated with operating as a publicly traded company.

Net loss was $21.9 million, or $1.52 per basic and diluted share, for the quarter, compared with a net loss of $9.5 million, or $0.86 per basic and diluted share, in the second quarter of 2025.

Weighted average shares outstanding for earnings per share calculations were 14,356,219 in Q2 2026 and 13,724,256 year to date. Shares outstanding were 15,802,768 as of July 31, 2026, including 14,408,007 shares of common stock and 1,394,761 common share equivalents assuming conversion of outstanding pre-funded warrants.

Conference call details

Palvella said it will host a conference call and live audiovisual webcast at 8:30 a.m. ET today to discuss second-quarter 2026 financial results and provide a corporate update. The live webcast, including presentation slides, can be accessed through the company’s website in the “Events & Presentations” section. Phone registration details are available through the company’s conference call link. A replay of the webcast will be available about two hours after the call and will remain archived for 90 days on the company’s website at www.palvellatx.com.

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 for patients with serious, rare skin diseases and vascular malformations for which there are no FDA-approved therapies. The company is developing a 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 conditions.

Palvella’s lead product candidate, QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin), is being developed for microcystic lymphatic malformations, cutaneous venous malformations and clinically significant angiokeratomas. Its second product candidate, QTORIN™ pitavastatin, is being developed for disseminated superficial actinic porokeratosis.

For more information, visit www.palvellatx.com or follow Palvella on LinkedIn or X (formerly known as Twitter).

QTORIN™ rapamycin and QTORIN™ pitavastatin are for investigational use only and have not been approved by the FDA or any other regulatory agency for any indication.

Forward-looking statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934 and Section 27A of the Securities Act of 1933. These statements reflect current beliefs and assumptions of Palvella’s management and are subject to risks and uncertainties that could cause actual results to differ materially. Forward-looking statements include, among other things, expected timing of clinical data presentations, clinical development plans, regulatory submissions, FDA review processes, expectations for QTORIN™ rapamycin and QTORIN™ pitavastatin, cash resources and runway, and research-stage opportunities.

The company said risks include, among other things, the ability to raise additional capital; advance product candidates through preclinical and clinical development; make regulatory submissions on anticipated timelines; obtain regulatory approval and commercialize product candidates; the outcome of early clinical trials; limited experience in clinical development and commercial manufacturing; competition; the impact of global events on operations; the ability to attract and retain employees; protection of intellectual property; and reliance on third parties, contract manufacturers and contract research organizations. Palvella said it does not intend to publicly update forward-looking statements except as required by law.

Contact information

Investors: Wesley H. Kaupinen, Founder and CEO, Palvella Therapeutics, wes.kaupinen@palvellatx.com

Media: Marcy Nanus, Vice President of Investor Relations and Corporate Affairs, Palvella Therapeutics, marcy.nanus@palvellatx.com