In a July 1 research note, Roth Capital Partners analyst Zegbeh Jallah reported that the women's health biopharma Daré Bioscience Inc. (DARE:NASDAQ) filed a new drug application with the U.S. Food and Drug Administration (FDA) for its lead candidate DARE-BV1, for bacterial vaginosis.
Given the drug's fast track and qualified infectious disease designations, FDA review should be a priority, Jallah purported, with the agency issuing a decision on acceptance and a Prescription Drug User Fee Act (PDUFA) date in about August 2021. If the FDA subsequently approves the drug, that would happen around late 2021, with a commercial launch following in the first half of 2022.
Jallah reiterated that the bacterial vaginosis market is sizable, with about 21 million women in the U.S. alone experiencing this recurrent infection.
Phase 3 data for DARE-BV1, a single application vaginal gel of clindamycin, were positive, Jallah indicated. They showed statistically significant cure rates of 70% versus 36% for placebo (p<0.001) between days 21 and 30, with cures evident between days 7 and 14. DARE-BV1's demonstrated cure rate is better than the 30–68% cure rate with other FDA approved treatments such as metronidazole, and those require multiple applications.
"Thus, DARE-BV1 remains largely differentiated in its efficacy and convenience," Jallah wrote.
Daré intends to partner with another company to commercialize DARE-BV1 to the market, and discussions on that front are taking place, Jallah noted. Three prospective partners are Pfizer, which already has a clindamycin product; Organon, which wants to expand its bacterial vaginosis program; and Bayer, which already partners with Daré for Ovaprene.
Roth has a Buy rating on Daré Bioscience and an $11 price target. The stock is trading at about $1.93 per share.[NLINSERT]
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Disclosures from ROTH Capital Partners, Dare Bioscience Inc., Company Note, July 1, 2021
Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.
ROTH makes a market in shares of Daré Bioscience, Inc. and as such, buys and sells from customers on a principal basis.
Shares of Daré Bioscience, Inc. may be subject to the Securities and Exchange Commission's Penny Stock Rules, which may set forth sales practice requirements for certain low-priced securities.
ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months.