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QTORIN rapamycin

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 5:03 AM ET

QTORIN rapamycin is a Palvella Therapeutics, Inc. program in microcystic lymphatic malformations. Its PDUFA date is Feb 28, 2027, the FDA's goal date to complete review of the application. Every date links its source.

PVLA catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Indication under review: Microcystic lymphatic malformations. Sponsor: Palvella Therapeutics, Inc. (PVLA). Market-cap tier at the time we tracked it: Mid. We track 1 catalyst event for this program: 1 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

PDUFA · Feb 28, 2027PVLA

Specialist biotech funds holding PVLA, 13F for the quarter ended June 30, 2026

FundSharesValue at quarter endFiling
BVF Inc.672,789$102.8 millionfiled August 14, 2026
OrbiMed Advisors292,360$44.7 millionfiled August 14, 2026

13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.

Questions

When is QTORIN rapamycin's next FDA decision or readout?

QTORIN rapamycin's PDUFA date is Feb 28, 2027. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.

What happened at QTORIN rapamycin's most recent FDA decision?

No FDA decision for QTORIN rapamycin is in our archive yet.

What is QTORIN rapamycin used for?

In our records QTORIN rapamycin is under review or in development for Microcystic lymphatic malformations.

Who makes QTORIN rapamycin?

Palvella Therapeutics, Inc. (PVLA).

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.