$PVLA

PALVELLA THERAPEUTICS, INC.

No enriched coverage for $PVLA in the last 7 days.

$4.9M
JENKINS GEORGE M
93%
See all $PVLA insider activity →
Med

JENKINS GEORGE M sold $4.2M of PVLA

JENKINS GEORGE M sold 27,500 shares of PALVELLA THERAPEUTICS, INC. (PVLA) at an average of $151.53 ($149.38–$153.10, $4.17M total) across 9 trades over 2026-09-11 to 2026-09-15 under a Rule 10b5-1 trading plan.

Palvella Completes Rolling NDA For QTORIN Rapamycin In Microcystic Lymphatic Malformatios

Palvella Therapeutics (PVLA) completed its NDA submission to the FDA for QTORIN 3.9% rapamycin anhydrous gel, a potential treatment for microcystic lymphatic malformations (microcystic LMs). The NDA includes Phase 3 SELVA trial results, which met primary and secondary endpoints. The therapy has received Breakthrough Therapy, Fast Track, and Orphan Drug designations. Palvella anticipates a potential commercial launch in early 2027, pending approval.

Goin Kathleen sold $655K of PVLA

Goin Kathleen (Chief Operating Officer) sold 4,302 shares of PALVELLA THERAPEUTICS, INC. (PVLA) at an average of $152.21 ($151.39–$156.77, $0.65M total) across 5 trades on 2026-08-19 under a Rule 10b5-1 trading plan.

PVLA sentiment & insider activity

Recent PVLA coverage spans insider activity, regulation and market movers.

In the last 30 days, PVLA insiders filed 15 SEC Form 4 transactions — no purchases and 15 sales ($4.9M). The most active reporter was JENKINS GEORGE M with 9 filings. 93% of those filings were made under pre-arranged Rule 10b5-1 plans.

What's driving PVLA

  • The sizable insider sale may signal reduced confidence and could pressure the stock short term.

    SEC EDGAR · Sep 16, 2026

  • Positive NDA filing and strong Phase 3 data could trigger a sharp price rally if approval is granted.

    rttnews.com · Aug 31, 2026

  • Insider sell may signal lack of confidence and adds supply pressure.

    SEC EDGAR · Aug 20, 2026

  • Near-term catalyst is FDA rolling-review progress plus a defined NDA completion window, with follow-on upside tied to potential approval and planned standalone launch.

    SEC EDGAR 8-K · Aug 4, 2026

  • Rolling NDA progress is a tangible regulatory milestone that can re-rate risk for a clinical-stage biotech.

    rttnews.com · Jul 22, 2026

AlphAI scores every news story that mentions PVLA with an AI model for sentiment and relevance, and aggregates insider trades from PALVELLA THERAPEUTICS, INC.'s SEC EDGAR Form 4 filings. Figures refresh continuously.

News on $PVLA

Score
$PVLAHighAI 9/10

Palvella Completes Rolling NDA For QTORIN Rapamycin In Microcystic Lymphatic Malformatios

Palvella Therapeutics (PVLA) completed its NDA submission to the FDA for QTORIN 3.9% rapamycin anhydrous gel, a potential treatment for microcystic lymphatic malformations (microcystic LMs). The NDA includes Phase 3 SELVA trial results, which met primary and secondary endpoints. The therapy has received Breakthrough Therapy, Fast Track, and Orphan Drug designations. Palvella anticipates a potential commercial launch in early 2027, pending approval.

PALVELLA THERAPEUTICS, INC. (PVLA): Results of Operations and Financial Condition

PALVELLA THERAPEUTICS, INC. (PVLA) filed an SEC Form 8-K — Results of Operations and Financial Condition. Palvella Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update First module of the rolling NDA for QTORIN™ rapamycin for microcystic lymphatic malformations submitted to FDA, with completion of the NDA submission on track for the second half of

$DYAIMed

Top Biotech Gainers: WGRX Rebrands, PVLA Nears FDA Milestone, ASBP On Track For NDA Filing

Biotech stocks rose as several companies issued updates. Wellgistics Health (WGRX) completed a rebrand to DataMEDS AI and will trade as MEDS; it reported Q1 2026 revenue of $0.929M and expects $1.775M in Q2. Dyadic (DYAI) saw a major shareholder sell. Palvella (PVLA) submitted the first NDA module for QTORIN. Sol-Gel (SLGL) expects SGT-610 Phase 3 data in Q4 2026.

$PVLAMed

Palvella Therapeutics (PVLA) Submits Initial Module of NDA For QTORIN

Palvella Therapeutics (NASDAQ:PVLA) said it filed the initial module of its FDA NDA for QTORIN 3.9% rapamycin anhydrous gel to treat microcystic lymphatic malformations. The company plans to submit remaining NDA modules in late 2026 and prepare for a potential independent U.S. launch in early 2027. QTORIN has Orphan Drug, Fast Track, and Breakthrough Therapy designations.

$PVLALow

PALVELLA THERAPEUTICS, INC. (PVLA): Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers

PALVELLA THERAPEUTICS, INC. (PVLA) filed an SEC Form 8-K — Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers. false 0001583648 0001583648 2026-06-29 2026-06-29 iso4217:USD xbrli:shares iso4217:USD xbrli:shares UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Repor

$PVLALow

PALVELLA THERAPEUTICS, INC. (PVLA): Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers

PALVELLA THERAPEUTICS, INC. (PVLA) filed an SEC Form 8-K — Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers. false 0001583648 0001583648 2026-06-10 2026-06-10 iso4217:USD xbrli:shares iso4217:USD xbrli:shares UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Repor

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