The FDA has granted the program Fast Track status, aiming to address rashes that affect roughly 150,000 U.S. patients each year.
Azitra had its best trading day in more than seven months on Wednesday after disclosing that the first patient had been dosed in its Phase 1/2 trial of ATR04-484, a topical live biotherapeutic being developed to treat rashes caused by EGFR inhibitor (EGFRi) cancer therapies.
The stock closed Wednesday up 35.9% at $1.03, before slipping 2.4% in after-hours trading.
ATR04-484, which has a fast-track designation from the FDA, is designed to address EGFRi-associated rash, a side effect that affects an estimated 150,000 people in the U.S. each year.
These rashes are one of the most common and disruptive side effects of EGFRi cancer drugs, occurring in up to 80% of patients and often severe enough to interrupt treatment.
“Dosing the first patient is an important milestone in the advancement of ATR04-484 as a potential treatment for EGFRi-associated rash,” said CEO Francisco Salva. He noted the therapy could help reduce the dermatologic toxicities that limit the use of targeted cancer therapies such as those for lung and colorectal cancers.
The randomized, double-blind, vehicle-controlled Phase 1/2 study will evaluate ATR04-484’s safety, tolerability, and efficacy in adult patients, measuring endpoints such as rash severity, itch, and pain.
The drug is based on an engineered strain of Staphylococcus epidermidis, designed to reduce IL-36γ and S. aureus levels, both of which are elevated in EGFRi-related rashes.
Beyond ATR04-484, Azitra is also advancing ATR-12 for Netherton syndrome, a rare and life-threatening genetic skin disease with no approved therapies. Both programs stem from the company’s dermatology platform, which leverages a microbial strain library and artificial intelligence to identify new drug candidates.
On Stocktwits, retail sentiment was ‘extremely bullish’ amid a 4,657% surge in 24-hour message volume.
One user said that Azitra shares had been “holding pretty strong,” while others pointed to the surge in trading activity.
Wednesday’s turnover reached 110.7 million shares, more than 800 times the stock’s average daily volume of about 132,000.
Azitra’s stock has declined 63.7% so far in 2025.
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