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 filed an 8‑K to share an updated corporate presentation highlighting progress in its rare disease pipeline. The lead candidate, QTORIN™ 3.9% rapamycin gel for microcystic lymphatic malformations, delivered highly statistically significant Phase 3 SELVA results, with a mean +2.13 improvement on the mLM‑IGA primary endpoint and p<0.001 across primary, key secondary, and all four secondary endpoints. The program has Breakthrough, Fast Track, and Orphan Designations, with a U.S. NDA submission targeted for the second half of 2026 and potential FDA approval in the first half of 2027. Palvella also reported positive Phase 2 data in cutaneous venous malformations, Fast Track designation and planned Phase 2 initiation for angiokeratomas, and a QTORIN™ pitavastatin program for DSAP. Following an oversubscribed February 2026 equity financing, the company cites approximately $274 million in pro forma cash to support regulatory filings, potential U.S. launch, and multiple Phase 2 readouts.
PALVELLA THERAPEUTICS, INC. director George M. Jenkins made an open-market purchase of common stock. On March 30, 2026, he bought 445 shares of Palvella Therapeutics common stock at $112.30 per share. Following this trade, he directly holds 187,616 shares and has an additional 13,516 shares reported as indirectly held through the Eagles Mere Air Museum Foundation.
Palvella Therapeutics, Inc. describes its transformation into a clinical-stage rare disease biopharma after merging with Legacy Palvella and adopting a new focus on serious, rare skin diseases and vascular malformations with no FDA-approved therapies. The company’s lead topical candidate, QTORIN 3.9% rapamycin gel, showed strong Phase 3 results in microcystic lymphatic malformations, with a mean mLM-IGA improvement of +2.13 at Week 24 and statistically significant gains on all key secondary endpoints. A Phase 2 study in cutaneous venous malformations also achieved nominally significant improvements on multiple clinician- and patient-reported measures. Palvella is preparing a Section 505(b)(2) NDA for microcystic LMs in the second half of 2026 and planning a Phase 3 cutaneous VM trial. The company is expanding its QTORIN platform into clinically significant angiokeratomas and disseminated superficial actinic porokeratosis via QTORIN pitavastatin, targeting U.S. patient populations each estimated above 50,000, and highlights extensive patent coverage into the 2038–2046 timeframe.
Palvella Therapeutics reported a larger 2025 net loss while advancing its rare‑disease pipeline and bolstering its balance sheet. The company’s lead candidate QTORIN™ rapamycin showed highly positive Phase 3 SELVA results in microcystic lymphatic malformations, with a mean mLM-IGA improvement of +2.13 (p<0.001) and strong responder rates, supporting plans for a New Drug Application in the second half of 2026 and a potential first FDA approval in the first half of 2027.
Palvella is also expanding QTORIN™ rapamycin into cutaneous venous malformations and clinically significant angiokeratomas and advancing QTORIN™ pitavastatin for disseminated superficial actinic porokeratosis. Pro forma cash was about $274 million as of December 31, 2025, reflecting net proceeds of $215.8 million from a February 2026 equity financing, compared with cash and cash equivalents of $58.0 million at year-end. For 2025, research and development expenses rose to $22.8 million and general and administrative expenses to $15.8 million, driving a net loss attributable to common stockholders of $41.7 million, or $3.71 per share.
Palvella Therapeutics Chief Operating Officer Kathleen Goin exercised stock options to acquire 4,302 shares of common stock on March 18, 2026 at exercise prices of $7.14 and $9.08 per share. She then sold 4,302 shares in three open-market transactions at weighted average prices of $117.5632, $118.3681, and $119.0817, as disclosed in the footnotes. The filing states these trades were executed under a pre-arranged Rule 10b5-1 trading plan adopted on August 19, 2025. Following the transactions, the report shows she holds no shares of Palvella Therapeutics common stock directly and no remaining derivative positions from these options.
PVLA reports Rule 144 sales of Common Stock by an insider and a planned sale under a stock option. The filing lists a planned sale dated 03/18/2026 described as Stock Option for Common stock to be sold for cash.
The filing also discloses prior reported dispositions by Kathleen Goin: 415,022 on 12/17/2025, 419,983 on 01/21/2026, and 341,563 on 02/18/2026. The transactions list NASDAQ as the market.
Palvella Therapeutics director George M. Jenkins bought 4,000 shares of common stock at $125 per share in an underwritten offering that closed on February 27, 2026. This purchase, reported as an open-market or private transaction, increased his direct holdings to 187,171 shares. He also reports indirect ownership of 13,516 shares held by Eagles Mere Air Museum Foundation.
Palvella Therapeutics director Elaine J. Heron reported buying 2,400 shares of common stock in an underwritten offering at $125 per share on February 27, 2026. This open-market purchase increased her direct holdings to 47,812 shares of Palvella Therapeutics.
The Form 4 also reports 5,879 shares of common stock held indirectly by a trust associated with Heron, reflecting additional ownership beyond her directly held shares.
Palvella Therapeutics, Inc. entered an underwriting agreement to sell 1,600,000 shares of common stock at $125.00 per share in a public offering. The underwriters also have a 30-day option to buy up to an additional 240,000 shares at the same public price, less underwriting discounts and commissions.
Palvella expects to receive approximately $187.3 million in net proceeds after underwriting discounts, commissions and estimated expenses. The company plans to use these funds, together with existing cash, cash equivalents and marketable securities, to support development of its programs, including QTORIN rapamycin and QTORIN pitavastatin, and for working capital and other general corporate purposes, including research and development expenses.
The offering is being made under an effective Form S-3 shelf registration statement and a prospectus supplement dated February 25, 2026. The transaction is expected to close on or about February 27, 2026, subject to customary closing conditions, and all shares in the deal are being sold by Palvella.
Palvella Therapeutics, Inc. is conducting a registered primary offering of 1,600,000 shares of its common stock at a public offering price of $125.00 per share, with gross proceeds of $200,000,000 and net proceeds to the company of approximately $187.3 million before expenses. The underwriters have a 30-day option to purchase up to 240,000 additional shares.
The offering prospectus notes directors have indicated non‑binding interest in purchasing shares on the same terms as other investors. The company expects to use proceeds to support development of its QTORIN programs, including QTORIN rapamycin and QTORIN pitavastatin, and for working capital and general corporate purposes.
Separately, Palvella disclosed positive topline Phase 3 SELVA results for QTORIN rapamycin in microcystic lymphatic malformations, meeting its primary and multiple secondary endpoints (p<0.001), and reported preliminary cash, cash equivalents and marketable securities of approximately $55.9 million as of December 31, 2025.