Palvella Therapeutics Inc (PVLA)

Palvella Shares Advance After FDA Grants Rolling Review for Rare Disease TherapyJune 22, 2026 8:49 AM
IH Market News Palvella Therapeutics Inc (NASDAQ:PVLA) shares gained 5% in premarket trading on Monday after the company announced that the U.S. Food and Drug Administration had granted rolling review status to its New Drug Application (NDA) for QTORIN rapamycin, a treatment for microcystic lymphatic malformations. The regulatory development marks another step forward in the company’s efforts to bring the therapy to market and could potentially accelerate the review process. Rolling Review Expected to Streamline NDA Evaluation Under the FDA’s rolling review framework, Palvella can submit completed sections of its NDA as they are finalized rather than waiting for the entire application package to be completed. This approach allows regulators to begin reviewing portions of the submission earlier, potentially shortening the overall assessment timeline. The company said it remains on schedule to complete the full NDA submission during the second half of 2026. Potential First Approved Treatment for a Rare Condition If approved, QTORIN rapamycin would become the first FDA-authorized therapy specifically indicated for microcystic lymphatic malformations. The rare genetic disorder is estimated to affect more than 30,000 people across the United States. Patients with the condition develop abnormal lymphatic vessels that can extend through the skin, leading to chronic leakage, bleeding, recurring infections and, in some cases, repeated hospitalizations. Multiple FDA Designations Support Development QTORIN rapamycin has already received several regulatory designations intended to support and accelerate its development. The therapy has been awarded Breakthrough Therapy Designation, Orphan Drug Designation and Fast Track Designation by the FDA for the treatment of microcystic lymphatic malformations. Rolling review eligibility is reserved for therapies that have received Fast Track or Breakthrough Therapy status and are targeting serious diseases with significant unmet medical needs. Targeted Delivery Approach Aims to Improve Treatment Outcomes QTORIN rapamycin has been developed to deliver rapamycin directly to affected skin tissue, targeting the abnormal mTOR signaling pathway that drives disease progression. The localized delivery strategy is designed to maximize therapeutic activity at the site of disease while reducing systemic exposure to the drug. Currently, there are no FDA-approved treatment options available for patients with microcystic lymphatic malformations in the United States, highlighting the potential significance of the therapy if it successfully completes the regulatory review process. Palvella Therapeutics stock priceThe post Palvella Shares Advance After FDA Grants Rolling Review for Rare Disease Therapy appeared first on US Editors. Original: Palvella Shares Advance After FDA Grants Rolling Review for Rare Disease Therapy

$PVLA, nice job, keep it up

Palvella Therapeutics shares surge on positive Phase 3 trial resultsFebruary 24, 2026 10:20 AM
IH Market News
Palvella Therapeutics (NASDAQ:PVLA) shares climbed about 15% on Tuesday after the company announced positive topline data from its Phase 3 SELVA clinical trial evaluating QTORIN 3.9% rapamycin anhydrous gel for the treatment of microcystic lymphatic malformations (mLM).The late-stage study achieved its primary endpoint, demonstrating a statistically significant improvement on the Microcystic Lymphatic Malformation Investigator Global Assessment, with a mean change of +2.13 points (p

$PVLA there we go!

$PVLA, Steifel maintains buy on Palvella raises price target to $145.00

$PVLA, Raymond James upgraded the stock from outperform to strong buy and raised it's price target from $92.00 to $143.00.

$PVLA, more analysts upgrades up to $105.00 price target.

$PVLA, TD Cowen maintains buy on Palvella Therapeutics raises price target to $97.00

$PVLA, Cantor Fitzgerald maintains overweight on Palvella Therapeutics and raises price target to $200

Sold PVLA @ $77.38 for a cool 400%

$PVLA, wonder if we'll see another analyst upgrade after recent news?

$PVLA, still hummin along.

$PVLA, Stifel maintains buy and raises price target to $80.

$PVLA Canaccord Genuity raises PT to $66.00 from $52.00

PVLA headed towards first analyst price target. Still a ways to go but...

$PVLA, Scotia bank initiates coverage on PVLA with sector outperform rating price target $50.00.

$PVLA, analyst price target $39.00

$PVLA nice move today. Clear sailing ahead if they want.

$PIRS heavy volume day

PIRS under $20

$PIRS low O/S merger. Held on to a few of these just for giggles.

PIRS under $10

PIRS: Effective April 23,2024 a one for 80 reverse split:

https://hedgefollow.com/upcoming-stock-splits.php

Mine went off at .265. Back on watch again.

Wash trade in progress

$PIRS no resistance up to .27 imo and a large gap above that.

PIRS...................................https://stockcharts.com/h-sc/ui?s=PIRS&p=W&b=5&g=0&id=p86431144783

Big sale PM

Someone picked up a nice size at the close

Agreed. Picked up more shares today

Jep, nice consolidation and may explode again on further updates

Anyone still watching this?

There was one in the high 0.30´s, looks like it gets successfully taken down, but still could get rejected to 0.33 again. Gap in the high 0.70´s, and am not a pumper to talk about even more... I like this stock most because it takes every single step up perfectly and draws a perfect chart!

What resistance levels $1-1.20?

Break that resistance and we gonna have the best play of the month…

Hope some of you loaded with me under 0.25. It’s go time, support at the 50ma, maybe it’s possible to go for the 0.40 break this week…

Break these 0.40‘s to the 0.78 gap. On the expected updates everything possible…

PIRS....................https://stockcharts.com/h-sc/ui?s=PIRS&p=W&b=5&g=0&id=p86431144783

Interesting news. https://www.otcmarkets.com/stock/PIRS/news/story?e&id=2608442

Time for the final loading before the big bang...

They got a patent renewed - but still no real PR on it while similar stocks moved 100%+ on it. Still holding…

Hey, are you able to share what the patent news is that you mentioned?

Golden opp.here - patent news and still under radar

PIRS.........................https://stockcharts.com/h-sc/ui?s=PIRS&p=W&b=5&g=0&id=p86431144783

.22 settle

$PIRS nice 70% pop!

Off .25

PIRS.....................https://stockcharts.com/h-sc/ui?s=PIRS&p=W&b=5&g=0&id=p86431144783

PIRS......................https://stockcharts.com/h-sc/ui?s=PIRS&p=W&b=5&g=0&id=p86431144783

PIRS .20 https://finance.yahoo.com/news/were-little-worried-pieris-pharmaceuticals-142856056.html