MedPharm Welcomes Palvella Therapeutics’ Positive Topline Results from its Phase 3 study of QTORIN™ Rapamycin in Microcystic Lymphatic Malformations

DURHAM, N.C., March 17, 2026 - MedPharm, a global leader in topical and transdermal contract drug development and manufacturing, today welcomed the news that its partner, Palvella Therapeutics, Inc. (“Palvella”) (Nasdaq: PVLA), recently announced positive topline results from its Phase 3 SELVA study of QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin), an investigational therapy under development for the treatment of microcystic lymphatic malformations (microcystic LMs).

MedPharm was selected by Palvella to support the development of QTORIN™ rapamycin, with MedPharm’s scientists working closely alongside Palvella’s research and development team and leadership to advance the formulation strategy from initial concept through clinical development and preparation for commercial manufacturing, including:

·         Collaborating with Palvella to advance the formulation strategy for rapamycin, an inherently challenging molecule due to its large molecular weight, poor solubility, chemical instability, and complex physicochemical properties.

·         Supporting the development of a dermal-targeted, room temperature stable anhydrous gel with a high drug load, designed to locally inhibit the mammalian target of rapamycin (mTOR) pathway within affected skin tissue across multiple mTOR-driven diseases while minimizing systemic exposure.

·         Conducting an intensive, multi-year formulation development program, involving complex physicochemical optimization to achieve the performance characteristics required by Palvella, including applying MedPharm’s specialized expertise to conduct in vitro skin permeation testing (IVPT) and in vitro release testing (IVRT) to refine the formulations for release and targeted delivery to the site of action.

·         Incorporating patient-informed insights into formulation design, including hosting a patient with a rare skin disease at MedPharm’s UK laboratories to inform key product attributes.

·         Supporting scale-up and manufacturing readiness, including enabling production of clinical trial supply and preparation for anticipated near-term commercial-scale manufacturing.

Palvella 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 U.S. FDA-approved therapies. Palvella’s QTORIN™ rapamycin has received Breakthrough Therapy, Orphan Drug, and Fast Track designations from the FDA for the treatment of microcystic LMs, as well as an FDA Orphan Products Development grant. QTORIN™ rapamycin is also under development for cutaneous venous malformations and clinically significant angiokeratomas.

“I am delighted that MedPharm has been able to contribute to Palvella reaching this important milestone,” said Bill Humphries, Chief Executive Officer of MedPharm. “As global leaders in the development of semi-solid drug formulations, MedPharm looks forward to supporting Palvella with their vision to become the leading rare disease biopharma company serving patients with serious, rare skin diseases and vascular malformations.”

MedPharm has also been selected by Palvella to advance the development of QTORIN™ pitavastatin for porokeratosis, a serious, rare genetic skin disease characterized by chronic, often pruritic lesions and an increased risk of progression to skin cancer. There are currently no FDA-approved therapies for porokeratosis. If approved, QTORIN™ pitavastatin could become the first therapy specifically targeted to treat this condition, addressing a significant unmet medical need for patients.

From its facilities in Durham, North Carolina, and Guildford in the United Kingdom, MedPharm provides a full suite of services for creams, gels, ointments, liquids, lotions, and pastes. With over two decades of experience, the company is able to develop and optimize semi-solid dosage forms to ensure maximized drug delivery and stability, enhanced patient adherence, and regulatory compliance.