Core Viewpoint - Palvella Therapeutics is advancing its QTORIN™ 3.9% rapamycin anhydrous gel program to address the unmet medical need for treatments of angiokeratomas, a rare skin disease affecting over 50,000 patients in the U.S. [1][6] Company Developments - The company plans to initiate a Phase 2 trial for QTORIN rapamycin in the latter half of 2026, with a meeting scheduled with the FDA in early 2026 to discuss the study design [1][3][6] - CEO Wes Kaupinen expresses optimism about QTORIN rapamycin's potential to become the first FDA-approved therapy for angiokeratomas, as current treatment options are limited and often involve painful procedures [2][6] Financial Analysis - H.C. Wainwright upgraded Palvella's stock rating to "Buy" on September 25, 2025, raising the price target from $75 to $95, while Stifel Nicolaus set a price target of $80, indicating a potential increase of approximately 33.62% from the stock price at that time [4] - Despite a negative price-to-earnings (P/E) ratio of -26.45 and a negative enterprise value to operating cash flow ratio of -42.71, the company maintains a strong liquidity position with a current ratio of 7.67, indicating sufficient current assets to cover liabilities [5][6]

Core Viewpoint - Palvella Therapeutics is expanding its QTORIN™ rapamycin development program to include clinically significant angiokeratomas, a rare skin disease with no FDA-approved therapies available for over 50,000 diagnosed patients in the U.S. [1][2] Company Overview - Palvella Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies for serious, rare skin diseases without FDA-approved treatments [5] - The company is led by veterans in rare disease drug development and is developing a pipeline based on its patented QTORIN™ platform [5] Product Development - The company plans to initiate a Phase 2 trial for QTORIN™ rapamycin targeting clinically significant angiokeratomas in the second half of 2026, following a meeting with the FDA in the first half of 2026 [3] - QTORIN™ rapamycin is also being evaluated in ongoing clinical trials for microcystic lymphatic malformations (Phase 3 SELVA study) and cutaneous venous malformations (Phase 2 TOIVA study) [3] Disease Context - Clinically significant angiokeratomas are characterized by lymphatic-derived skin lesions that can cause bleeding, pain, and functional impairment, with no tendency for spontaneous regression [2] - Current treatment options are limited and involve potentially destructive procedures that carry significant risks [2]