Nasus Pharma's IND Application For NS002 Gets FDA Clearance

September 14, 2026 — 08:30 am EDT

Written by RTTNews.com for RTTNews

(RTTNews) - Monday, Nasus Pharma Ltd. (NSRX) announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for NS002, an investigational intranasal epinephrine powder for the treatment of anaphylaxis.

The FDA clearance represents a significant milestone for the company, which plans to initiate its pivotal study in the fourth quarter of 2026, evaluating NS002 as a needle-free alternative to EpiPen and will compare self-administration to administration by a health care professional.

The company anticipates topline data readout from the study in the first quarter of 2027.

Nasus added that NS002 has achieved the critical 100 pg/mL plasma epinephrine threshold in its recent Phase 2 study, with a median T100 of 1.69 minutes versus 3.47 minutes for EpiPen.

In pre-market hours, NSRX was trading at $3.40, down 0.14 percent on the NYSE American.

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Nasus Pharma's IND Application For NS002 Gets FDA Clearance

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