These 2 ASX biotech stocks are hoping to get FDA approval this week

Nick Sundich Nick Sundich, September 25, 2023

It is set to be a big week for 2 ASX biotech stocks, which are awaiting news from the FDA.


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2 ASX biotech stocks are awaiting news from the FDA

Botanix Pharmaceuticals (ASX: BOT) has a gel that it is trying to get FDA approved for the treatment of primary axillary hyperhidrosis (excessive sweating). It has just entered a trading halt pending an answer from the FDA, expected on or before Wednesday. This would mark 12 months since it made this submission to the FDA, a step taken after successful Phase 3 clinical trials.

Botanix estimates that it has a market of over 7m people in the US alone, which FDA approval would unlock.


Cyclopharm is awaiting a decision too

Fellow ASX biotech stock Cyclopharm (ASX:CYC) has not entered a trading halt, but is also expecting a yes or no answer from the FDA about its bioagent Technegas this week, considering the 6-month deadline it is expecting an answer will draw to a close this week.

We are confident that the company has done all it can and investors are too – judging by the company’s rally in recent weeks. But it will all hinge on the regulator’s decision.


Disclosure: Stocks Down Under staff and directors own Cyclopharm shares


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