Palvella Strengthens Leadership Ahead of Rare Disease Therapy Launch

Palvella Therapeutics has appointed Jennifer J. McDonough as its new Senior Vice President of Market Access and Patient Services. The company, which specialises in rare skin diseases and vascular malformations, is preparing for the potential launch of its lead treatment, QTORINTM rapamycin, in the near future. McDonough's arrival strengthens Palvella's push toward commercial readiness as it awaits FDA approval for its key therapy.

McDonough brings extensive experience in rare disease therapies, having previously worked at Krystal Biotech. There, she played a key role in the launch and expansion of VYJUVEK®, a treatment for dystrophic epidermolysis bullosa. Her expertise in access strategy and patient support will now support Palvella's commercial plans.

Palvella's lead product, **QTORINTM rapamycin**, is an anhydrous gel designed to treat microcystic lymphatic malformations. The therapy is also being developed for cutaneous venous malformations and angiokeratomas. The FDA is expected to review the company's Biologics License Application (BLA) in the second half of 2026, following a priority review designation granted in late 2025. In addition to QTORINTM rapamycin, Palvella is advancing a second candidate, **QTORINTM pitavastatin**, for disseminated superficial actinic porokeratosis. McDonough's appointment comes at a critical time as the company builds its commercial infrastructure. Her role will focus on securing market access and ensuring robust patient services ahead of the planned U.S. launch.

The hiring of McDonough signals Palvella's commitment to a smooth market entry for its therapies. With FDA approval for QTORINTM rapamycin anticipated in 2026, the company is positioning itself for commercial success. Her leadership in access and patient support will be vital in bringing these treatments to patients with rare and serious conditions.