SVB Securities launched coverage of ARS Pharmaceuticals (NASDAQ:SPRY) with an “outperform” rating and $14 price target. The stock closed at $7.12 on Dec. 12.
ARS is developing neffy, an intranasal epinephrine product in clinical development for patients with Type I allergic reactions, including food, medications and insect bites that could lead to life-threatening anaphylaxis.
Analyst Rosanna Ruiz, Ph.D., writes that neffy is the first intranasal epinephrine product to potentially launch in the US, and it “could disrupt the epinephrine market” as the first no-needle, easy-to-use, pain-free treatment for Type 1 allergic reactions that has achieved rapid PK/PD profiles, comparable to that of intramuscular epinephrine and EpiPen in clinical trials.
“We believe neffy could become a preferred option among patients and caregivers,” she added.
Dr. Ruiz said catalysts to watch in 2023 include:
- enrollment completion in the pediatric EPI-10 trial for 1 mg neffy by end of the first quarter;
- FDA approval decision for 2 mg neffy in individuals greater than30 kg by the mid-2023 PDUFA and potential U.S. launch in the second half;
- EMA approval decision for 2 mg neffy in individuals greater than 30 kg in the second half;
- sNDA filing for 1 mg neffy for children between 15-to-30 kg soon after 2 mg U.S. approval;
- post-approval filing with EMA for 1 mg neffy for children between 15-to-30 kg in 2023;
- and anticipated PMDA filing for neffy in Japan and NMPA filing for neffy in China by regional partners in 2023.