U.S. Food and Drug Administration Awards Year Two Proceeds from Orphan Products Grant Supporting Palvella Therapeutics' Phase 3 SELVA Trial of QTORIN™ Rapamycin for Microcystic Lymphatic M...
Palvella Therapeutics, Inc. (PVLA)
Company Research
Source: Yahoo! Finance
Second year proceeds granted following FDA review of annual performance progress report on Phase 3 SELVA single-arm, baseline-controlled trial; up to $2.6 million in non-dilutive funding anticipated over the grant period Top-line data from SELVA expected in the first quarter of 2026; New Drug Application (NDA) submission planned for second half of 2026 WAYNE, Pa., Oct. 13, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: PVLA) Palvella Therapeutics, Inc. (Palvella), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced it has received the second year of funding under its FDA Office of Orphan Products Development grant. The grant provides up to $2.6 million in non-dilutive funding over its full 4-year term and supports Palvella's ongoing Phase 3 SELVA trial of QTORIN™ 3.9% rapamycin anhydrous
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News
- Palvella Therapeutics (NASDAQ:PVLA) is now covered by analysts at BTIG Research. They set a "buy" rating on the stock.MarketBeat
- Palvella Therapeutics (NASDAQ:PVLA) is now covered by analysts at Craig Hallum. They set a "buy" rating on the stock.MarketBeat
- Palvella Therapeutics (NASDAQ:PVLA) had its "sell (d)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- Palvella Therapeutics (NASDAQ:PVLA) was given a new $145.00 price target on by analysts at Stifel Nicolaus.MarketBeat
- Palvella Therapeutics (NASDAQ:PVLA) was upgraded by analysts at Raymond James Financial, Inc. from an "outperform" rating to a "strong-buy" rating. They now have a $143.00 price target on the stock, up previously from $92.00.MarketBeat
PVLA
Earnings
- 11/11/25 - Miss
PVLA
Sec Filings
- 11/21/25 - Form 4
- 11/19/25 - Form 144
- 11/14/25 - Form SCHEDULE
- PVLA's page on the SEC website