Daré Bioscience Rallies On FDA Designation For Bacterial Vaginosis Drug

Shares of the thinly-traded, nano-cap penny stock Daré Bioscience Inc DARE were trading higher Monday. 

What Happened

Daré, which focuses on women's health, said Monday that its BV1 — a thermosetting hydrogel containing clindamycin phosphate 2% — has been given the Qualified Infectious Disease Product, or QIDP, designation by the FDA for the treatment of bacterial vaginosis in women.

BVI is a viscous liquid which goes through solution-to-gel transition using the body temperature as a trigger, which facilitates easy direction of the product to the site of infection.

"Receiving QIDP designation for DARE-BV1 for the treatment of BV is validation that BV is a serious infection for which current treatment options are inadequate," Daré CEO Sabrina Martucci Johnson said in a statement. 

Why It's Important

The clinical cure rates for currently approved products in bacterial vaginosis are about 37-39%, and the condition affects over 21 million among women ages 14-49, according to Daré.

The proof-of-concept study of BV1 showed an 86% clinical cure rate in the evaluable subjects at the test-of-cure visit after a single administration.

The QIDP designation is meant to incentivize development of antibacterial and antifungal drug products that treat serious or life-threatening infections. 

The designation confers: 

  • a five-year exclusivity extension, added to any exclusivity for which a QIDP qualifies upon FDA approval
  • The QIDP designation also makes the product candidate eligible for Fast Track designation and Priority Review

What's Next

Daré said it plans to start a late-stage study of BVI in about 250 women in the fourth quarter of 2019.

The company said it believes the Phase 3 study, if successful, would be sufficient for approval of BV1 to treat bacterial vaginosis.

Daré shares were rising 2.67% to 77 cents at the time of publication Monday. 

Related Links:

The Week Ahead In Biotech: Vanda Awaits FDA Decision, BioVie Plans IPO

Attention Biotech Investors: Mark Your Calendar For These August PDUFA Dates

Posted In: BiotechNewsFDATrading IdeasBV1
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

Loading...