Palvella Therapeutics Inc 8-K Filings

Palvella Therapeutics is advancing its QTORIN platform for rare dermatologic and vascular malformation diseases. Lead candidate QTORIN 3.9% rapamycin anhydrous gel achieved highly statistically significant Phase 3 SELVA results in microcystic lymphatic malformations, supporting a rolling New Drug Application (NDA) submission planned for completion in 2H 2026 and potential U.S. approval and launch in 1H 2027. The program holds Breakthrough, Fast Track and Orphan designations and targets an estimated >30k diagnosed U.S. patients, with internal research indicating potential U.S. peak sales of >$1 billion at orphan-level pricing.

The same formulation is being developed for cutaneous venous malformations, where positive Phase 2 TOIVA data and Fast Track status underpin a planned Phase 3 initiation in Q4 2026, and for clinically significant angiokeratomas (Phase 2 initiated in April 2026). A second key program, QTORIN pitavastatin, is being advanced for DSAP with Phase 2 initiation expected in 2H 2026. Palvella reports an oversubscribed $230mm financing in Q1 2026 and $262 million in cash as of March 31, 2026, with 2026 cash expenses estimated at [~$90-95mm], which it states provides potential funding through multiple regulatory filings, an initial launch and several Phase 2 readouts.

Palvella Therapeutics, Inc. expanded its Board of Directors from seven to eight members and appointed Matthew Pauls as a Class I director, with his initial term running until the company’s 2027 annual meeting of stockholders.

Pauls, 56, is currently Chief Executive Officer of Savara, Inc. and holds multiple other biopharmaceutical board roles, bringing extensive rare disease and commercialization experience. As a non-employee director, he will receive customary cash retainers under Palvella’s director compensation policy and was granted an option to purchase 6,000 shares of common stock, vesting in equal monthly installments over 36 months, subject to continued service. The Board determined he is independent under Nasdaq listing rules, and there are no related party transactions or family relationships requiring disclosure.

Palvella Therapeutics, Inc. stockholders approved an amendment to the company’s 2024 Equity Incentive Plan, increasing the authorized shares issuable under the plan by 750,000 shares. This amendment had been previously approved by the Board of Directors, subject to stockholder approval, and became effective immediately at the 2026 Annual Meeting.

As of April 13, 2026, there were 14,323,686 outstanding common shares entitled to vote. Stockholders elected three Class III directors—George M. Jenkins, Todd C. Davis and John Doux, M.D.—to serve until the 2029 Annual Meeting. They also ratified Ernst & Young LLP as independent registered public accounting firm for the 2026 fiscal year.

Stockholders approved, on an advisory basis, 2025 compensation for named executive officers and chose to hold future advisory votes on executive compensation every year. They approved both the equity plan amendment and a potential adjournment proposal, although adjournment was ultimately unnecessary.

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. expanded its Board of Directors from six to seven members and appointed John Doux, M.D. as a Class III director, with his term ending at the 2026 Annual Meeting of Stockholders. The Board determined that he is independent under applicable Nasdaq listing rules.

Dr. Doux is a board-certified dermatologist and long-time healthcare investment analyst at Palo Alto Investors LP, with prior board experience at Palvella and several biotechnology companies. Under the company’s Non-Employee Director Compensation Policy, he received an option to purchase 6,000 shares of common stock, vesting in equal monthly installments over 36 months, subject to continued service.

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 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, 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. 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, Inc. filed a current report to note that it has posted a new corporate presentation on its website. The presentation, dated January 29, 2026 and filed as Exhibit 99.1, will be used by company representatives in various investor meetings.

The filing does not introduce new financial results or major transactions, but formally makes the investor presentation part of the public record by incorporating it by reference into the report.

Palvella Therapeutics, Inc. filed a current report to note that on January 12, 2026 it posted a new corporate presentation on its website. Company representatives plan to use this presentation in meetings with investors from time to time. The presentation is also included as Exhibit 99.1 to the report, making the same information available through the SEC’s system.

Palvella Therapeutics, Inc. reported a key clinical update for its dermatology program. On December 15, 2025, the company scheduled an investor conference call to present topline results from its Phase 2 TOIVA study of QTORIN 3.9% rapamycin anhydrous gel for treating cutaneous venous malformations, a vascular skin condition. The call is accompanied by an online slide presentation, provided as Exhibit 99.1.

Palvella also issued a press release, filed as Exhibit 99.2, announcing positive topline results from this ongoing Phase 2 study. Together, the call, slides, and press release highlight progress in the clinical development of QTORIN for this indication, giving investors more detail on how the program is advancing.

Palvella Therapeutics, Inc. furnished an update that it will announce its financial results for the quarter ended September 30, 2025 and hold an earnings call on November 11, 2025. The company attached its press release as Exhibit 99.1 and an earnings call slide presentation as Exhibit 99.2.

The materials are furnished under Items 2.02 and 7.01 and are not deemed “filed” for liability purposes under the Exchange Act, except as expressly incorporated by reference. Palvella’s common stock trades on the Nasdaq Capital Market under the symbol PVLA.

Palvella Therapeutics (PVLA) announced a new product candidate, QTORIN™ pitavastatin, for disseminated superficial actinic porokeratosis (DSAP). The company is hosting an investor call on November 5, 2025 at 8:30 a.m. Eastern Time, with materials available via a webcast link.

An investor presentation was furnished as Exhibit 99.1 and a press release as Exhibit 99.2. The information was furnished under Item 7.01 and is not deemed filed under the Exchange Act.

Palvella Therapeutics disclosed on September 24, 2025 that it is expanding the development program for QTORIN™ 3.9% rapamycin anhydrous gel into Clinically Significant Angiokeratomas. The filing notes a press release describing this expansion has been furnished as Exhibit 99.1 and is being made under Regulation FD disclosure standards.

The notice is procedural in form: it confirms the program expansion but does not provide clinical data, trial design, timelines, or cost information. The filing is signed by the company’s Chief Financial Officer, indicating formal corporate disclosure rather than new regulatory approvals or completed clinical results.

Palvella Therapeutics, Inc. furnished a Regulation FD disclosure on September 3, 2025 indicating the company has posted a corporate presentation to its website for use in investor meetings. The presentation is furnished as Exhibit 99.1 and is incorporated by reference into this report. The filing states the presentation may be used in meetings with investors and clarifies that, except where expressly referenced, the presentation will not be deemed incorporated by reference into other securities filings. The report is signed by Matthew Korenberg, Chief Financial Officer.

Palvella Therapeutics, Inc. reported that on August 14, 2025 it announced financial results for the quarter ended June 30, 2025. The company furnished a press release and an earnings-call slide presentation as Exhibits 99.1 and 99.2 to this Current Report, and will hold an earnings call using the presentation on the same date. The filing explicitly states that the materials are being furnished rather than "filed," so they are not subject to the liabilities of Section 18 of the Exchange Act and are not automatically incorporated by reference into other SEC filings.

The report provides notice of the release and the investor presentation but does not include financial figures, results detail, or forward-looking guidance within the 8-K text itself; investors must consult the furnished press release and presentation for substantive financial information.