WAYNE, PA — Palvella Therapeutics Inc. (Nasdaq: PVLA) Chief Scientific Officer Jeffrey Martini will address evidence gaps and regulatory barriers affecting drug repurposing at an Aug. 5 FDA public workshop in Washington, D.C., as regulators examine ways to accelerate new uses for approved medicines.
The hybrid meeting, organized by the Reagan-Udall Foundation in collaboration with the Food and Drug Administration, will focus on how regulators, researchers and clinicians identify and prioritize approved drugs for potential use in serious, chronic and rare diseases.
Martini is expected to discuss barriers that can prevent promising repurposing programs from advancing, including gaps in clinical evidence and uncertainty over regulatory requirements.
“The combination of an established safety profile and emerging evidence from real-world use suggesting potential clinical benefit can provide a strong foundation for accelerating the development of repurposed therapies,” Martini stated.
He added that advances in genetics and disease biology can identify approved medicines that may act on the underlying causes of previously untreatable conditions.
The workshop builds on an FDA drug repurposing initiative launched in May 2026. Participants will include representatives from federal agencies, patient organizations, clinical research groups and the medical community.
The meeting will examine selection criteria for repurposing candidates, the evidence needed to support development and the regulatory pathways available for advancing therapies efficiently.
Palvella develops treatments for rare skin diseases and vascular malformations that currently lack FDA-approved therapies. The company’s development strategy includes adapting established molecules for new indications and creating formulations intended for specific diseases.
Founder and Chief Executive Officer Wes Kaupinen described repurposing as a potential route for applying known compounds to newly identified disease mechanisms, particularly in rare conditions.
Martini’s public comments are scheduled to address the question: “What evidence gaps or policy/regulatory barriers most commonly hinder the advancement of promising repurposing opportunities?”
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