PALVELLA THERAPEUTICS (PVLA) Company Report

Palvella Therapeutics, Inc. entered into an underwriting agreement on February 25, 2026, to sell 1,600,000 shares of its common stock at a public offering price of $125.00 per share.
The underwriters have an option to purchase up to an additional 240,000 shares of common stock for a period of 30 days.
The company estimates net proceeds from this offering to be approximately $187.3 million.
The net proceeds, along with existing cash, will be used to support the development of programs, including QTORIN rapamycin and QTORIN pitavastatin, and for working capital and other general corporate purposes.
The offering is expected to close on or about February 27, 2026.

1 day ago

8-K

Palvella Therapeutics Announces Pricing of Upsized Public Offering

PVLA

New Projects/Investments

Palvella Therapeutics (PVLA) priced an upsized public offering of 1,600,000 shares of its common stock at $125.00 per share.
The offering is expected to generate $200 million in aggregate gross proceeds, before deducting underwriting discounts and commissions and other offering expenses, assuming no exercise of the underwriters’ option.
Palvella has granted the underwriters a 30-day option to purchase up to an additional 240,000 shares of its common stock.
The net proceeds from this offering are intended to support the development of its programs, including QTORIN rapamycin and QTORIN pitavastatin, and for working capital and other general corporate purposes.
The offering is expected to close on or about February 27, 2026.

2 days ago

Press Release

Palvella Therapeutics Announces Positive Phase 3 SELVA Study Results for QTORIN Rapamycin

PVLA

Product Launch

Guidance Update

Palvella Therapeutics announced positive Phase 3 SELVA study results for QTORIN rapamycin in microcystic lymphatic malformations (mLM), demonstrating a highly statistically significant outcome on the primary endpoint with a +2.13 improvement on the mLM-IGA scale and a p-value of less than 0.001.
The study showed 95% of participants improved on the primary endpoint, with 86% rated as much or very much improved, and QTORIN rapamycin was well-tolerated. A high 98% of completers elected to continue into the extension study.
The company plans to submit a New Drug Application (NDA) in the second half of 2026 under expedited FDA programs, aiming for QTORIN rapamycin to be the first FDA-approved therapy for mLM.
Palvella estimates peak U.S. sales potential of $1 billion-$3 billion for QTORIN rapamycin across its first two indications, with pricing guidance between $100,000-$200,000 per patient per year.

4 days ago

Transcript

Palvella Therapeutics Reports Positive Top-Line Phase 3 Data for QTORIN in Microcystic Lymphatic Malformations

PVLA

Product Launch

Guidance Update

New Projects/Investments

Palvella Therapeutics announced positive top-line results from its Phase 3 SELVA study of QTORIN 3.9% rapamycin in hydrogel for microcystic lymphatic malformations (mLM), a condition for which there are currently no FDA-approved therapies.
QTORIN rapamycin demonstrated a highly statistically significant outcome on the primary endpoint, showing a +2.13 improvement on the microcystic lymphatic malformation Investigator Global Assessment Scale (mLM-IGA) with a p-value of less than 0.001.
At week 24, 95% of participants improved on the mLM-IGA primary endpoint, and 86% were rated as much improved or very much improved. The drug was well-tolerated in both children and adults, with minimal systemic exposure, and 98% of completers elected to roll into the extension period.
The company plans to submit a New Drug Application (NDA) in the second half of 2026 under multiple expedited FDA programs, including Breakthrough Therapy and Fast Track designations.
Palvella estimates peak U.S. sales potential between $1 billion and $3 billion for QTORIN rapamycin across its first two indications, with an estimated price range of $100,000-$200,000 per patient per year.

4 days ago

Transcript

Palvella Therapeutics Announces Positive Phase III SELVA Study Results for QTORIN Rapamycin

PVLA

Product Launch

New Projects/Investments

Guidance Update

Palvella Therapeutics announced positive top-line results from its Phase III SELVA study for QTORIN 3.9% rapamycin in hydrogel for microcystic lymphatic malformations (mLM), demonstrating a highly statistically significant outcome on the primary endpoint (mLM-IGA improvement of +2.13, p-value < 0.001).
At week 24, 95% of participants improved on the mLM-IGA primary endpoint, with 86% rated as much improved or very much improved, and QTORIN rapamycin was well-tolerated.
The company plans an NDA submission in the second half of 2026 under Breakthrough Therapy and Fast Track designations, aiming for a label for patients three years and older.
Palvella estimates peak U.S. sales potential between $1 billion and $3 billion for QTORIN rapamycin across its first two indications, with a planned pricing of $100,000-$200,000 per patient per year.
A fourth indication for QTORIN rapamycin is expected to be announced in the second half of this year, expanding the pipeline.

4 days ago

Transcript

Palvella Therapeutics announces positive Phase 3 SELVA study results for QTORINT™ Rapamycin

PVLA

New Projects/Investments

Guidance Update

Palvella Therapeutics announced highly statistically significant topline data from its Phase 3 SELVA study for QTORINT™ Rapamycin in Microcystic Lymphatic Malformations (mLM), with all primary, key secondary, and secondary endpoints achieving statistical significance (all p<0.001).
The study demonstrated a mean improvement of +2.13 on the mLM-IGA primary endpoint (p<0.001), with 95% of participants aged ≥ 6 improving and 86% being "Much Improved" or "Very Much Improved".
QTORINT™ Rapamycin exhibited a well-tolerated and favorable safety profile.
Palvella plans to proceed with an NDA filing in 2H:2026, targeting potential FDA approval in 1H:2027, and estimates $1-$3 billion U.S. peak sales potential for mLM and CVM.

4 days ago

Presentation

Palvella Therapeutics Announces Positive Phase 3 SELVA Study Topline Results for QTORIN™

PVLA

Product Launch

Palvella Therapeutics, Inc. announced highly statistically significant topline results from its Phase 3 SELVA study of QTORIN™ 3.9% rapamycin anhydrous gel for microcystic lymphatic malformations (mLM) on February 24, 2026.
The study demonstrated a mean improvement of +2.13 on the mLM-IGA primary endpoint (p<0.001), with 95% of participants aged ≥ 6 showing improvement and 86% rated "Much Improved" or "Very Much Improved".
QTORIN™ was well-tolerated across adult and pediatric patients, and 98% of Week 24 completers rolled over to the Extension period.
The company plans to file an NDA in 2H:2026 with potential FDA approval in 1H:2027, estimating a potential $1-$3 billion U.S. peak sales potential for QTORIN™ in mLM and cVM.

4 days ago

8-K

Palvella Therapeutics announces positive Phase 3 SELVA study results for QTORIN™ rapamycin

PVLA

Product Launch

Palvella Therapeutics, Inc. announced positive topline results from its Phase 3 SELVA study of QTORIN™ 3.9% rapamycin anhydrous gel for microcystic lymphatic malformations. The study met its primary endpoint with a statistically significant improvement (mean change of +2.13; p<0.001) on the mLM-IGA, and also achieved statistical significance on all secondary endpoints.
QTORIN™ rapamycin was well-tolerated, with no drug-related serious adverse events reported.
The company plans to submit a New Drug Application (NDA) to the FDA in the second half of 2026, with potential U.S. approval in the first half of 2027, aiming to be the first FDA-approved therapy for this condition which affects over 30,000 individuals in the U.S..

4 days ago

8-K

Palvella Therapeutics to Discuss Topline Phase 3 SELVA Clinical Trial Results

PVLA

Palvella Therapeutics will host a conference call and webcast on February 24, 2026, at 8:00 am ET to discuss topline results from its Phase 3 SELVA clinical trial.
The trial assessed the efficacy and safety of QTORIN™ 3.9% rapamycin anhydrous gel for the treatment of microcystic lymphatic malformations.
A press release sharing these topline results is scheduled for approximately 6:30 am ET on February 24, 2026, prior to the call.

4 days ago

Press Release

Palvella Therapeutics Provides Update on Late-Stage Pipeline and Financial Position

PVLA

New Projects/Investments

Guidance Update

Palvella is focused on developing first-in-disease therapies for serious, rare skin diseases and vascular malformations, with its lead product candidate, QTORIN™ rapamycin, having a $1-$3 billion+ peak U.S. sales potential.
The company anticipates several key milestones in 2026, including Phase 3 topline data for Microcystic Lymphatic Malformations (mLMs) in March 2026, an NDA submission for mLMs in 2H 2026, and the initiation of Phase 3 for Cutaneous Venous Malformations (cVMs) and Phase 2 studies for clinically significant angiokeratomas and Disseminated Superficial Actinic Porokeratosis (DSAP) in 2H 2026.
Palvella reported a cash position of $63.6 million as of September 30, 2025, with a projected cash of ~$55 million at year-end, providing a runway into 2H 2027.