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Emergent BioSolutions (NYSE:EBS) shares have surged 21% premarket after the company announced Thursday that the US Food and Drug Administration’s (FDA) Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee unanimously voted in favor of the benefit-risk profile of NARCAN Nasal Spray.
The committees voted, with a total of 19 votes, that the nasal spray supports its use as a non-prescription opioid overdose reversal agent, although the FDA is not bound by the vote and only considers the committees’ advice.
Emergent had previously presented an overview of its over-the-counter development program, the medical need, Human Factors study data, and seven years of post-marketing safety data.
If the FDA approves NARCAN, a prescription medicine used for the emergency treatment of a known or suspected opioid overdose emergency, it would be the first 4 mg naloxone nasal spray available OTC in the US.
Reacting to the announcement, Cowen analysts, who have a Market Perform rating and $25 price target on the stock, said the vote in favor was “largely expected,” and they anticipate the approval of OTC Narcan by the March 29, 2023, PDUFA date.
“However, we believe that generic dilution remains the key risk for Narcan and we anticipate significant revenue decline over the next several years,” the analysts added.
