JAGX Stock Soars Over 10% Premarket After Best Day In Over 8 Years: What’s Driving The Surge?

• JAGX's latest rally followed a 1-for-15 reverse split that took effect last week to support Nasdaq compliance.
• The FDA waived fiscal 2027 fees for Mytesi, an HIV-related diarrhea drug, and Canalevia-CA1, a treatment for chemotherapy-induced diarrhea in dogs.
• All randomized children in Jaguar’s MVID trial are continuing into an extension phase.

Shares of Jaguar Health (JAGX) soared 11% in premarket trading on Wednesday following their best session in over eight years as FDA fee waivers for two drugs and a surge in retail interest put the commercial-stage pharmaceutical company’s rare-disease plans in focus.

JAGX stock closed Tuesday at $34.46, rocketing 1,191%, less than a week after a 1-for-15 reverse stock split took effect to support compliance with Nasdaq’s listing standards.

What The FDA Waived For Jaguar

Jaguar said on Tuesday that the FDA waived its fiscal 2027 program fee for Mytesi, an approved treatment for noninfectious diarrhea in adults with HIV/AIDS taking antiretroviral therapy. The agency’s Center for Veterinary Medicine separately waived the fiscal 2027 fee for Canalevia-CA1, a conditionally approved treatment for chemotherapy-induced diarrhea in dogs.

Both drugs are marketed in the U.S. by Future Pak under a licensing agreement. The waivers reduce fees associated with the existing products.

Jaguar Eyes 2027 Filing For Pediatric Intestinal Failure 

Jaguar is developing a powder formulation of Crofelemer, the active ingredient in Mytesi and Canalevia-CA1, for rare intestinal-failure disorders. Its lead target is microvillus inclusion disease (MVID), which can leave children dependent on intravenous nutrition and fluids. The company aims to file a new drug application for MVID in mid-2027 and is also pursuing short bowel syndrome.

Earlier this month, Jaguar said all randomized children in its MVID trial would continue into a single-blind extension phase. The company also reported that one patient’s weekly need for intravenous support, adjusted for body weight, fell by up to 48% after more than 12 months of crofelemer treatment. 

On an August investor call, CEO Lisa Conte said: “We are now fully a rare disease GI company with 100% of our human development efforts sharply and strategically focused on our rare disease program.” She said Jaguar was seeking a development and commercialization partner for the intestinal-failure program.

How Jaguar Is Funding Its Rare-Disease Push

Jaguar licensed U.S. commercialization of Mytesi and Canalevia-CA1 to Future Pak in January, receiving $16 million at closing and a further $2 million after satisfying conditions for a holdback payment. Jaguar still manufactures and supplies the products, while U.S. sales revenue from the two brands goes to Future Pak.

The deal also changed how Jaguar’s sales appear in its results. Second-quarter net prescription product revenue was about $1.2 million, primarily from supplying Mytesi to Future Pak. Its net loss attributable to common stockholders widened to $12.7 million from $10.4 million a year earlier.

How Do Retail Traders Feel About JAGX?

On Stocktwits, JAGX retail sentiment surged from ‘neutral’ a day earlier to a record 95 out of 100, placing it in ‘extremely bullish’ territory amid ‘extremely high’ message volume. 

One user said, “$JAGX no-one is entering today without a stop loss in place because the mm and 'predatory lenders like Mark Fife/toxic debt funds' are, imo, creating "exit liquidity" to dump the next wave of dilution on new bagholders (sec filings).”

Another user said, “$JAGX the low float after multiple rs was the catalyst. Now the window of opportunity and just how high they choose to run it up before switching the atm on with a vengeance.”

JAGX stock has plunged 93% year to date.

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