Evofem Biosciences re-files for FDA approval of Amphora

26 November 2019

US biotech firm Evofem Biosciences (Nasdaq: EVFM) has announced the resubmission of its New Drug Application to the US Food and Drug Administration for its lead candidate Amphora (L-lactic acid, citric acid and potassium bitartrate) for the prevention of pregnancy.

Market reaction was mixed; the firm’s shares gained 2% pre-market, but were down 1.13% at $6.15 by mid-morning, having dropped as low as $5.87.

Amphora is an investigational Multipurpose Vaginal pH Regulator (MVP-R) designed to regulate vaginal pH in the normal, 3.5 - 4.5 range. This maintains an acidic vaginal environment which is inhospitable to sperm and also to various bacterial pathogens.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK