Welcome to our dedicated page for Palvella Therapeutics SEC filings (Ticker: PVLA), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Palvella Therapeutics, Inc. (Nasdaq: PVLA) SEC filings page on Stock Titan provides access to the company’s official disclosures as a clinical-stage biopharmaceutical issuer. Palvella’s filings describe a business focused on developing investigational topical therapies for serious, rare skin diseases and vascular malformations with no FDA-approved therapies, built around its patented QTORIN™ platform.
Through documents such as Form 8-K current reports, investors can review how Palvella communicates material events, including topline results from the Phase 2 TOIVA trial of QTORIN™ rapamycin for cutaneous venous malformations, updates on the Phase 3 SELVA trial in microcystic lymphatic malformations, and announcements of new product candidates like QTORIN™ pitavastatin for disseminated superficial actinic porokeratosis. Other 8-K filings furnish earnings press releases, corporate presentations, and information about conference calls related to quarterly financial results and corporate updates.
These filings also confirm key structural details, such as Palvella’s incorporation in Nevada, its listing of common stock on The Nasdaq Capital Market under the symbol PVLA, and its description as a clinical-stage company. Regulation FD disclosures provide slide decks and presentations that elaborate on the company’s pipeline, regulatory designations, and development plans, while results-of-operations filings supply context on research and development spending and general and administrative costs associated with advancing QTORIN™ programs.
On Stock Titan, users can combine real-time updates from EDGAR with AI-assisted views of Palvella’s filings to more quickly understand the significance of new 8-Ks and related exhibits. This includes identifying which filings discuss clinical data, regulatory interactions, or financial performance, and how those disclosures relate to the company’s investigational product candidates, all while recognizing that QTORIN™ rapamycin and QTORIN™ pitavastatin remain unapproved therapies.
Palvella Therapeutics, Inc. is offering $150,000,000 of common stock and, in lieu of common stock to certain investors, pre‑funded warrants to purchase common stock. The Pre‑Funded Warrants carry a $0.001 exercise price, do not expire and are exercisable subject to an ownership limitation.
The prospectus supplement relates to shares issuable upon exercise of the Pre‑Funded Warrants and grants underwriters a 30‑day option to purchase up to an additional $22,500,000 of common stock. Palvella’s common stock trades on the Nasdaq Capital Market under the symbol PVLA (last reported sale price $87.84 on February 23, 2026). The supplement discloses preliminary cash, cash equivalents and marketable securities of approximately $55.9 million as of December 31, 2025 (unaudited).
Clinical updates highlight positive pivotal Phase 3 SELVA topline results for QTORIN rapamycin (primary and key secondary endpoints met with p<0.001), and other program advances. The prospectus lists 11,088,329 shares outstanding as of September 30, 2025 and summarizes dilution, use of proceeds for R&D and general corporate purposes, and standard underwriting arrangements.
Palvella Therapeutics, Inc. furnished an update on its cash position, stating that as of December 31, 2025 it had approximately $55.9 million in cash, cash equivalents and marketable securities. This figure is a preliminary management estimate.
The company has not completed its year-end financial close, so the final audited amount for this date may differ materially. The preliminary data has not been audited, reviewed, compiled or otherwise examined by Ernst & Young LLP and is provided solely as furnished information under a current report on Form 8-K.
Palvella Therapeutics released topline Phase 3 SELVA data for QTORIN 3.9% rapamycin gel in microcystic lymphatic malformations, showing a large treatment effect in a serious, currently untreated disease. The primary endpoint, the mLM-IGA score, improved by a mean of +2.13 at Week 24 with p<0.001, indicating highly statistically significant benefit.
Key secondary and all additional secondary endpoints, including blinded mLM-MCSS, patient and clinician global assessments, also met significance with p<0.001. Among patients aged 6 and older, 95% completed the efficacy period and 86% were rated “Much Improved” or “Very Much Improved.” Safety was favorable, with treatment-related adverse events in 34% of participants, no related serious or severe events, and rapamycin blood levels below 2 ng/mL in all samples.
Palvella plans an NDA submission in the second half of 2026 and is targeting potential U.S. approval in the first half of 2027, positioning QTORIN as a potential first FDA-approved therapy in this indication and supporting a stated U.S. peak sales opportunity of $1–$3 billion across microcystic lymphatic malformations and related venous malformations.
Palvella Therapeutics reported positive topline Phase 3 SELVA results for its topical QTORIN™ 3.9% rapamycin gel in microcystic lymphatic malformations, a rare disease with no FDA-approved treatments. The study met its primary endpoint with a mean +2.13 point improvement on a clinician-rated severity scale (p<0.001).
Among participants aged ≥6 who completed 24 weeks, 95% improved and 86% were rated “Much” or “Very Much Improved.” QTORIN™ rapamycin was well-tolerated with no drug-related serious adverse events and low systemic levels. Palvella plans to submit a New Drug Application in the second half of 2026, positioning QTORIN™ as a potential first FDA-approved therapy for an estimated 30,000 U.S. patients.
Palvella Therapeutics Chief Operating Officer Kathleen Goin reported option exercises and share sales in Common Stock of PALVELLA THERAPEUTICS, INC. On February 18, 2026, she exercised stock options for 4,302 shares at exercise prices of $7.14 and $9.08 per share, converting derivative awards into common shares.
That same day, she sold 4,302 common shares in open-market transactions at weighted average prices of $79.1569 and $79.9651 per share, with individual trades ranging from $78.75 to $80.00. After these sales, her directly held common stock position reported in this filing was 0 shares. All transactions were executed under a pre-established Rule 10b5-1 trading plan adopted on August 19, 2025, and the stock option referenced is disclosed as fully vested.
Palvella Therapeutics submitted an amended Form 144/A reporting multiple dispositions of Common Stock by Kathleen Goin. The filing lists sales of 370,965 shares on 11/19/2025, 415,022 shares on 12/17/2025, and 419,983 shares on 01/21/2026. The notice also shows a planned transaction dated 02/18/2026 described as a Stock Option Exercise with cash proceeds and identifies Piper Sandler & Co. as the broker.
PVLA submitted a Form 144 notice for the proposed sale of common shares scheduled 02/18/2026, identified as an option exercise to be settled for cash. The filing lists prior sales by Kathleen Goin, including 419,983 shares on 01/21/2026 and 415,022 shares on 12/17/2025.
Palvella Therapeutics, Inc. received a Schedule 13G reporting that First Light Asset Management, LLC and its managing member Mathew P. Arens beneficially own 887,031 shares of Palvella common stock, representing 7.49% of the outstanding class as of 12/31/2025.
The shares are held in separately managed accounts and private funds advised by First Light, with both First Light and Arens sharing voting and dispositive power over all 887,031 shares and no sole voting or dispositive power. The filing certifies the position was acquired and is held in the ordinary course of business and not for the purpose of changing or influencing control of Palvella.
Palvella Therapeutics, Inc. received an amended Schedule 13G/A (Amendment No. 3) reporting that funds and entities associated with Biotechnology Value Fund and Mark N. Lampert beneficially owned 879,009 shares of Palvella common stock as of December 31, 2025.
These shares represent approximately 7.1% of Palvella’s outstanding common stock, based on 11,836,490 shares outstanding as of November 7, 2025 plus 535,839 shares issued to the reporting persons and a managed account upon exercise of certain pre-funded warrants.
Ownership is spread across BVF, BVF2, Biotechnology Value Trading Fund OS and related general partners and managers, all of which report shared voting and dispositive power. The group certifies the position is not held for the purpose of changing or influencing control of Palvella.
Palvella Therapeutics, Inc. received an amended Schedule 13G/A from several Frazier Life Sciences entities reporting passive ownership of its common stock. Frazier Life Sciences Public Fund, L.P. directly holds 706,360 shares, representing 6.0% of the common stock, based on 11,836,490 shares outstanding as of November 7, 2025. Other affiliated Frazier funds hold smaller positions of 4,730, 7,517 and 3,793 shares. The group also holds prefunded warrants for additional shares that are subject to a 4.99% beneficial ownership cap upon exercise. The reporting persons certify the securities were not acquired to change or influence control of Palvella.