Evofem Biosciences, Inc. (NASDAQ: EVFM) has been awarded Qualified Infectious Disease Product (QIDP) Designation for EVO100 by the U.S. Food and Drug Administration. EVFM stock gained 2.8% on Wednesday but lost 2.3% at the time of writing.
EVO100, or Phexxi, is designed to prevent urogenital chlamydia infection in women, a potential new indication in late-stage clinical development.
With this designation, FDA seeks to motivate development of new drugs for the treatment of life-threatening infections. Moreover, the drug awarded with QIDP qualifies for an additional five years of marketing exclusivity, following FDA approval for that indication.
“The unmet need for STI prevention for millions of women is significant when you consider that there are no FDA-approved products available to prevent infection with either chlamydia or gonorrhea,” said Saundra Pelletier, the CEO of Evofem Biosciences.
Evofem also informed that top-line data from Phexxi’s Phase 3 trial are expected in the third quarter of 2022. Also, positive results will likely support submission to the FDA for these potential new indications in the first quarter of 2023.
The company is expected to report a loss of $0.23 for the fourth quarter of 2021. Evofem stock earnings history has been volatile over the past few quarters. It is expected to report earnings on March 4, 2022.
Overall, the analysts are cautiously optimistic about the stock with a Moderate Buy consensus rating based on 2 Buys and 1 Sell.
TipRanks’ Stock Investors tool shows that investors currently have a Very Negative stance on Evofem, as 11.1% of investors on TipRanks decreased their exposure to EVFM stock over the past 30 days.
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