HomeMarket NewsARS Pharma hits 52-week low as William Blair downgrades on FDA snub

ARS Pharma hits 52-week low as William Blair downgrades on FDA snub

Actionable Trade Ideas

always free

bad day at wall street

Photo by franckreporter on Getty Images

ARS Pharmaceuticals, listed on NASDAQ as SPRY, experienced a significant drop as its value decreased by more than half on Wednesday, leading to a new 52-week low. The biotech company’s epinephrine nasal spray failed to gain approval from the FDA, triggering a downgrade by neffy and William Blair.

According to William Blair analyst Tim Lugo, the FDA’s request for additional data to support approval introduces both execution and clinical risks. Lugo questions whether the agency truly intends to approve the therapy, as the requirements already surpass those of existing epinephrine products like EpiPen. As a result, Lugo downgraded SPRY from Outperform to Market Perform.

Despite facing clinical and regulatory uncertainties, ARS Pharma (SPRY) intends to submit a formal dispute resolution request to challenge the decision and resubmit a new drug application (NDA) in the first half of 2024. With an estimated $195 million in cash, cash equivalents, and short-term investments upon neffy’s potential launch in the second half of 2024, Lugo believes SPRY possesses sufficient capital to withstand the delay.

Swing Trading Ideas and Market Commentary

Need some new swing ideas? Get free weekly swing ideas and market commentary from Jonathan Bernstein here: Swing Trading.

Explore More

Weekly In-Depth Market Analysis and Actionable Trade Ideas

Get institutional-level analysis and trade ideas to take your trading to the next level, sign up for free and become apart of the community.