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 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 H1/22.
Also of note, Daré has fivebagger potential. The stock is trading at about $1.89 per share, and ROTH's price target on it is $11 per share.
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 like Metronidazole, and those require multiple applications.
"Thus, DARE-BV1 remains largely differentiated in its efficacy and convenience," Jallah wrote.
As for commercializing DARE-BV1 to the market, Daré intends to partner with another company to achieve that it, 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.
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