Australia's Botanix Pharmaceuticals tumbles on anticipated delay in FDA nod for gel

Botanix Pharmaceuticals

26/09/2023 02:10

** Shares of Botanix Pharmaceuticals  BOT.AX  fall as much
as 36.1% to A$0.115, their lowest level since June 30
    ** Stock last down 27.8%, sees worst day since March 25,
2020 if current losses hold
    ** Dermatology co receives Complete Response Letter from the
U.S. Food and Drug Administration (FDA) in relation to its New
Drug Application (NDA) submission for Sofpironium Bromide gel
    ** Gel is for the treatment of excessive sweating
    ** Co to meet with FDA and undertake relatively minor
activities required to address product use instructions 
    ** Co to resubmit NDA by early 1Q CY2024, with a target
approval of mid-CY2024
    ** Co says based on the letter and interactions with FDA, no
new review issues anticipated as part of resubmission review
    ** More than 12.5 mln shares change hands, 3.3x the 30-day
average volume of 3.8 mln shares
    ** Stock had more than tripled in value this year, as of
last close

 (Reporting by Shivangi Lahiri in Bengaluru)
 ((Shivangi.Lahiri@thomsonreuters.com;))