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. Chief Operating Officer Kathleen Goin reported option exercises and share sales in the company’s stock. On May 20, 2026, she exercised stock options for 2,154 shares at $7.14 per share and 2,148 shares at $9.08 per share, acquiring 4,302 shares of common stock.
That same day, she sold a total of 4,302 common shares in open‑market transactions at weighted average prices of about $110.35, $111.30, and $111.90. The filing shows she held 0 common shares directly after these transactions. The sales were made under a pre‑arranged Rule 10b5‑1 trading plan adopted on August 19, 2025, during an open trading window.
Palvella Therapeutics filed a Rule 144 notice reporting the proposed sale of Common Stock on 05/20/2026 associated with a stock option exercise to the issuer for cash. The filing lists broker details and transaction references including $475,630.84 and an aggregate figure 14,342,844 alongside prior sale entries by Kathleen Goin on 03/18/2026 and 04/15/2026 with amounts $507,611.05 and $547,398.96.
Palvella Therapeutics, Inc. reported new clinical data from its Phase 3 SELVA and Phase 2 TOIVA studies of QTORIN™ 3.9% rapamycin gel in serious, rare vascular malformations. In SELVA, all 13 participants aged 6–11 years were rated “Much Improved” or “Very Much Improved” on the Microcystic Lymphatic Malformation Investigator Global Assessment at Week 24, with a mean improvement of +2.46 and p<0.001. Among 23 patients with moderate or worse leaking or bleeding at baseline, 87% achieved these top response categories with a mean improvement of +2.48. All 43 SELVA participants completing the efficacy period were at least somewhat satisfied on the TSQM-9, and 84% reported high satisfaction levels. Blinded review showed minimal change during the 8-week run-in and a 3.4-point mean mLM-MCSS improvement after 24 weeks, representing 48% of the maximum potential improvement. TOIVA showed statistically significant reductions in cVM-MCSS Height and Appearance at all time points, with Week 24 mean reductions of 1.50 and 1.43 points (p<0.001). Palvella plans to submit a New Drug Application for microcystic lymphatic malformations in the second half of 2026, targeting potential approval in the first half of 2027, and to start a Phase 3 trial in cutaneous venous malformations in the second half of 2026. QTORIN™ rapamycin holds FDA Breakthrough Therapy, Orphan Drug, and Fast Track designations for microcystic lymphatic malformations and Fast Track for cutaneous venous malformations.
Palvella Therapeutics reported new efficacy and patient-experience data from its Phase 2 TOIVA trial of QTORIN™ rapamycin in cutaneous venous malformations. Among patients who had bleeding at baseline, 100% (4/4) showed statistically significant improvement on the clinician-rated cVM-IGA Bleeding scale at Week 12, with a mean change of +2.5 points (p=0.003), and all were rated “Much Improved” or “Very Much Improved.” At the same time point, 100% of these patients reported being “satisfied” or “very satisfied” with treatment. Baseline qualitative interviews highlighted substantial pain, functional limitations, social and work impacts, and emotional distress, underscoring the broad quality-of-life burden in this rare disease where there are currently no FDA-approved therapies.
Palvella Therapeutics, Inc. has received approval from the Nasdaq Listing Qualifications Department to transfer the listing of its common stock from the Nasdaq Capital Market to the Nasdaq Global Market. The change will be effective with the open of business on May 13, 2026.
The company’s common stock will continue to trade under the ticker symbol “PVLA”, and no change to the symbol accompanies this exchange tier transfer.
Palvella Therapeutics reported a wider first quarter 2026 loss while significantly strengthening its balance sheet and advancing its rare-disease pipeline. Net loss was $15.8 million, or $1.20 per share, compared with $8.2 million, or $0.74 per share, a year earlier, driven by higher research, manufacturing and public-company costs.
The company completed an upsized, oversubscribed equity financing in February 2026, generating $230.0 million in gross proceeds and $215.8 million in net proceeds. Cash, cash equivalents and short-term investments were $261.9 million as of March 31, 2026, compared with $59.6 million in total assets at year-end 2025, positioning Palvella to fund key clinical and commercial initiatives.
Palvella is preparing a New Drug Application for QTORIN™ rapamycin in microcystic lymphatic malformations, with a pre-NDA FDA meeting granted for the second quarter of 2026 and NDA submission on track for the second half of 2026, targeting a potential U.S. launch in the first half of 2027. It is also progressing QTORIN™ programs in cutaneous venous malformations, clinically significant angiokeratomas and disseminated superficial actinic porokeratosis, and has expanded its leadership team and board to support commercialization.
Palvella Therapeutics, Inc. reported a net loss of $15.8 million for the three months ended March 31, 2026, compared with $8.2 million a year earlier, as it increased investment in late-stage rare dermatology programs. Research and development expenses nearly doubled to $9.3 million, and general and administrative costs rose to $5.5 million.
The company significantly strengthened its balance sheet through a February 2026 equity financing, issuing 1,840,000 shares and lifting total cash and cash equivalents to $206.4 million, plus $55.5 million of short-term U.S. Treasury investments. Total assets were $263.8 million and stockholders’ equity was $232.3 million. Management expects existing cash resources to fund operations for at least one year while advancing QTORIN rapamycin and QTORIN pitavastatin through clinical development.
Palvella Therapeutics, Inc. is asking stockholders to vote at its 2026 virtual annual meeting on June 10, 2026, including an amendment to the 2024 Equity Incentive Plan to add 750,000 shares for future awards. Investors will also elect three Class III directors, ratify Ernst & Young LLP as auditor, and cast advisory votes on executive pay and how often to hold future say‑on‑pay votes. The board, which has seven members and six independents with an independent chair, recommends voting “FOR” all six proposals, including a potential adjournment if support for the equity plan is insufficient.
Palvella Therapeutics, Inc. Chief Operating Officer Kathleen Goin exercised stock options and sold shares in pre-planned trades. On April 15, 2026, she exercised options for 2,154 shares of common stock at $7.14 per share and 2,148 shares at $9.08 per share, acquiring a total of 4,302 shares.
That same day, she executed open-market sales totaling 4,302 shares of common stock in multiple transactions, at weighted average prices including $125.9647, $127.1254, $128.2349, $129.1692, and $130.33 per share, with underlying trade ranges from $125.53 to $129.70 as disclosed. The filing states these transactions were carried out under a Rule 10b5-1 trading plan adopted on August 19, 2025 during an open trading window. After these transactions, the report shows 0 shares of common stock held directly by Goin, and no remaining option positions are listed.