Every material Form 8-K PALVELLA THERAPEUTICS, INC. has filed with the SEC since August 04, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
Palvella Therapeutics reported a third-quarter 2026 net loss of $24.6 million, or $1.70 per share, up from $11.3 million, or $1.03 per share, a year earlier, as research and development and general and administrative expenses rose sharply. The company said the FDA accepted its NDA for QTORIN rapamycin for microcystic lymphatic malformations with Priority Review and a February 28, 2027 PDUFA target action date, and it ended the quarter with $236.7 million in cash, cash equivalents and short-term investments.
Net loss of $24.6 million ($1.70 per share) for the quarter ended September 30, 2026, versus $11.3 million ($1.03 per share) a year earlier
R&D expenses rose to $10.8 million from $6.5 million; G&A expenses rose to $11.9 million from $3.6 million
FDA accepted the NDA for QTORIN rapamycin with Priority Review; PDUFA target action date is February 28, 2027
Cash, cash equivalents and short-term investments were $236.7 million as of September 30, 2026
Palvella Therapeutics said the FDA accepted for filing and granted Priority Review to its New Drug Application for QTORIN 3.9% rapamycin anhydrous gel for microcystic lymphatic malformations, with a Prescription Drug User Fee Act target action date of February 28, 2027. The company says the drug could be the first FDA-approved therapy for this condition and is preparing for a potential U.S. launch in the first half of 2027, but approval is not assured.
FDA accepted the NDA and granted Priority Review for QTORIN 3.9% rapamycin anhydrous gel
PDUFA target action date set for February 28, 2027
Phase 3 SELVA study met all six prespecified efficacy endpoints (all p<0.001)
Potential standalone U.S. commercial launch planned for the first half of 2027, subject to FDA approval
Palvella Therapeutics reported a second-quarter 2026 net loss of $21.9 million, or $1.52 per share, up from $9.5 million, or $0.86 per share, a year earlier. The company said it submitted the first module of its rolling NDA for QTORIN rapamycin in microcystic lymphatic malformations and ended the quarter with $250.6 million in cash, cash equivalents and short-term investments.
Net loss for the three months ended June 30, 2026 was $21.9 million, or $1.52 per share, versus $9.5 million, or $0.86 per share, a year earlier.
Research and development expenses rose to $12.5 million from $5.1 million; general and administrative expenses rose to $8.9 million from $4.1 million.
Cash, cash equivalents and short-term investments were $250.6 million as of June 30, 2026.
The company expects to complete the NDA submission in the second half of 2026 and plans a standalone U.S. launch in the first half of 2027, if approved.
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