First Tracks Biotherapeutics Stock Climbs Nearly 8% as Celiac Drug Hopes Push Shares Up 160% in a Year

Shares of First Tracks Biotherapeutics Inc. rose nearly 8% on Tuesday, extending a long rally fueled by early clinical data on its experimental celiac disease drug.

The stock gained $3.87 to $53.57 in morning trading on the Nasdaq, above its previous high of just over $50. The company is valued at about $2.2 billion, and the shares are up about 160% over the past 52 weeks. Volume was about 269,000 shares by midmorning, compared with a three-month daily average of about 828,000.

The company did not announce any new information alongside Tuesday's gain, and it was not immediately clear what drove the move. The stock has climbed steadily since the company reported positive results last month from a key early-stage trial of its lead drug, ANB033.

First Tracks, based in San Diego, is a clinical-stage biotechnology company that develops antibody therapies for autoimmune and inflammatory diseases. It was spun off from AnaptysBio and began trading on April 20 under the ticker "TRAX," with about $180 million in cash. The stock opened its public life at about $17 and fell to a low of $14.72 in early June before starting to climb.

ANB033 is an injectable drug that blocks CD122, a receptor that two immune signaling proteins, IL-15 and IL-2, use to activate immune cells. In celiac disease, those signals drive the immune response that damages the small intestine when patients eat gluten. Celiac disease has no approved drug treatment, and patients must follow a strict gluten-free diet.

On Oct. 12, First Tracks reported results from the first group of patients in a Phase 1b trial. Thirty-two patients, 17 on ANB033 and 15 on placebo, received three doses over four weeks. They then ate about 6 grams of gluten a day, roughly two slices of bread, for 14 days.

At week six, ANB033 showed statistically significant protection against intestinal damage compared with placebo on all key tissue measures. Patients on the drug also had no increase in symptoms during the gluten challenge. Only 6% of patients taking ANB033 used medicine to relieve stomach symptoms, compared with 47% of those on placebo. There were no serious adverse events.

Chief Executive Daniel Faga said the drug met all of the study's goals. "ANB033 achieved every single one," he said of the trial's aims.

"These data support our plans to progress ANB033 into late-stage development in 2027 in celiac disease as a potential treatment to prevent both acute symptoms and intestinal damage from gluten exposure despite general adherence to a gluten-free diet," Faga said in the company's third-quarter report on Nov. 3.

Chief Medical Officer Paul Lizzul said: "For people living with celiac disease, these findings suggest that ANB033 may one day offer an additional layer of protection against both intestinal damage and symptoms from accidental gluten exposure." He added that the results are early and more research is needed.

The stock rose as much as 20% the day the data came out. Three days later, First Tracks announced a $200 million private placement, adding to its cash for late-stage development.

The U.S. Food and Drug Administration has granted ANB033 Fast Track designation for celiac disease, which can speed up the review process. Results from a second group of patients, focused on healing of the intestinal lining, are expected in the first quarter of 2027. Data from a separate Phase 1b trial in eosinophilic esophagitis, an allergic inflammatory disease of the esophagus, are expected in the third quarter of 2027. The company also plans to start Phase 2 trials in vitiligo and one more disease in the first half of next year.

First Tracks is competing with larger drugmakers. Teva Pharmaceuticals and Argenx both have celiac drugs in clinical testing with encouraging early results. One analyst said First Tracks' data compared "favorably" with Teva's, although the drugs have not been tested against each other.

The company reported a third-quarter net loss of $31.4 million, or 88 cents per share, compared with a loss of $41.9 million a year earlier. It has no product revenue.

Some analysts have cautioned that much of the good news may already be in the price after the stock's big run. Early-stage biotech results often fail to hold up in larger trials, and investors will watch the next round of celiac data early next year to see whether the protective effect holds.