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Palvella Therapeutics Receives Third Year Grant from FDA
Palvella Therapeutics announced that the Company has received a third year of grant funding from the FDA Office of Orphan Products Development. The funding supports the Phase 3 SELVA trial and ongoing open-label extension study of QTORIN 3.9% rapamycin anhydrous gel for the treatment of microcystic lymphatic malformations. The award follows FDA review of Palvella's annual performance progress report, which included results from the Phase 3 SELVA trial.
Palvella Therapeutics Completes NDA Submission for Qtorin
Palvella Therapeutics announced that the company has completed the rolling submission of its new drug application, or NDA, to the FDA seeking approval of Qtorin 3.9% rapamycin anhydrous gel for the treatment of microcystic lymphatic malformations, a serious, rare, and chronically debilitating genetic disease for which there are currently no FDA-approved therapies.
Palvella Completes NDA Submission Preparation for QTORIN
"We made significant progress during the second quarter, completing our pre-NDA meeting with FDA and initiating the rolling NDA submission for QTORIN rapamycin in microcystic lymphatic malformations," said Wes Kaupinen, Founder and Chief Executive Officer of Palvella. "We are working closely with FDA under the program's Breakthrough Therapy and Fast Track designations to expedite development and review, with the objective of potentially introducing the first approved therapy to pediatric and adult patients living with this serious, lifelong disease. Completion of the NDA submission remains on track for the second half of 2026, and we are preparing for a planned standalone commercial launch in the first half of 2027, if approved. We have recruited commercial and medical affairs leaders with deep experience in rare disease and dermatology who are now in the field executing key pre-launch activities, while we continue to advance our other rare disease programs and pursue additional opportunities across the QTORIN platform."
Bob's Discount Furniture Short Interest Rises to 29%
Welcome to this week's installment of "The Short Interest Report" - The Fly's weekly recap of short interest trends among some of the most widely followed high-short-float stocks. Using the data from our partner, which utilizes the latest information from stock lenders to estimate short interest changes for thousands of publicly traded companies, this report will screen for some of biggest changes in short interest as a percentage of free float and days-to-cover ratios while also considering the short interest data on some of the more volatile and heavier-traded names of the week. Based on the availability of data from Ortex, the report tracks the trading period that covers prior Friday through Thursday of this week, excluding holidays. As a basis of comparison for stocks discussed below, the S&P 500 index was down 1.7%, the Nasdaq Composite was down 2.9%, the Russell 2000 index was down 1.2%, the Russell 2000 Growth ETFwas down 0.9% and the Russell 2000 Value ETFwas down 1.6% in the five-day trading session range through July 23.SHORT INTEREST GAINERSOrtex-reported short interest in Bob's Discount Furniturehas steadily rebuilt over the past several months as the stock recovered from its late-March lows, with bearish positioning climbing alongside the shares rather than retreating. In the five-day period covered, short interest as a percentage of free float has risen from roughly 25% to 29%, matching July 9th all-time highs, while days-to-cover on the name nudged higher from 6.7 to 7.9 – also a match of the highs two weeks ago. The stock was down 11% in the five-session range through Thursday, though shares are up more than 50% from all-time lows below $10 on May 5 – three months after the stock priced its IPO at $17 per share.Ortex-reported short interest in Palvella Therapeuticstroughed just below 20% on June 10 as the stock found support around the $100 level for the second time in three weeks. Since then, shares have surged nearly 40%, yet bearish positioning has continued to build rather than unwind, with estimated short interest climbing above 27% of free float. This week alone, short interest increased from 25.2% to a four-month high of 27.2%, even as the stock slipped about 3% over the five-day period covered through Thursday. The recent rise in bearish positioning follows a volatile stretch in which Palvella plunged roughly 20% on July 20 after the FDA declined to grant Breakthrough Therapy Designation for QTORIN in cVMs, though several sell-side firms defended the investment thesis in the wake of the decision, underscoring the divide between bullish analysts and increasingly aggressive short sellers.Ortex-reported short interest in Array Technologieshas continued to build even as the stock has fallen to its lowest level of 2025, signaling that bearish conviction remains elevated despite the prolonged selloff. This week, estimated short interest as a percentage of free float increased from 21.4% to 22.5%, while days to cover edged higher from 5.4 to 5.6. In the five-day period covered through Thursday, Array shares fell about 10%, followed by another 5% decline on Friday, leaving the stock down roughly 42% year-to-date and trading at its lowest level since the start of 2025. The weakness has persisted despite generally constructive commentary surrounding the company's $203M acquisition of Affordable Wire Management announced on July 17, with Roth Capital lowering its price target to $6 from $9 but that the deal adds a high-margin, capital-light wire management platform that should deepen Array's utility-scale market opportunity.SHORT INTEREST DECLINERSOrtex-reported short interest in Celcuityhad troughed at roughly 28% of free float on April 23 before rebuilding steadily to record highs near 43% over the ensuing three months just as the stock attempted to recover. That trend reversed this week, with estimated short interest falling sharply from 42.6% to 35.9%, the lowest level in nearly two months, as bears appeared to lock in profits following the stock's recent decline. Days to cover also eased from 7.6 to 7.0, a more modest retreat given the heightened trading volumes and volatility seen throughout July. In the five-day period covered through Thursday, Celcuity shares were essentially flat, but the stock fell another 6.5% on Friday, extending its slide to the lowest level of 2026. The recent bout of profit-taking by short sellers follows a nearly 20% one-day decline on July 14, when the company announced FDA approval for breast cancer therapy drug Revtorpyk while simultaneously indicating a commercial launch in late Q3, a timeline that disappointed investors relative to expectations.Ortex-reported short interest in STAAR Surgicaldeclined sharply over the five-day period covered through Thursday as bears appeared to take profits following the stock's recent weakness. Estimated short interest as a percentage of free float fell from 21.5% to 19.6%, the lowest level since March 12, while days to cover dropped from 6.9 to 5.8, reflecting both reduced bearish positioning and higher liquidity. Selling pressure accelerated and trading volume spiked after the company pre-announced second-quarter results on July 17, sending the shares down roughly 9% in a single session and prompting at least some short sellers to cover into the decline. The pullback in short interest came as STAA shares fell 16.5% during the period, though the stock remains up about 1.3% year to date.
Palvella Therapeutics Stock Drops 13.6% to $135.88
Palvella Therapeutics is down -13.6%, or -$21.36 to $135.88.
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