Acrux’s stock jumped after the US FDA approved its acne gel. Picture Getty
Health & Biotech
Acrux (ASX:ACR) jumped by as high as 27% this morning after announcing the US Food and Drug Administration’s (FDA) approval of its generic version of Aczone Gel, 7.5% (Dapsone Gel, 7.5%).
This approval marks Acrux’s fifth successful ANDA (Abbreviated New Drug Application) for a topical treatment, adding to its growing portfolio.
The generic Dapsone Gel, 7.5% is designed for treating acne vulgaris in patients aged nine and older. According to data, the market for this product in the US exceeds US$37.4 million annually.
With this FDA nod, Acrux can now manufacture and market this new generic option in the US, expanding its reach in the competitive acne treatment market.
“We are excited to receive FDA approval for another ANDA product which has been developed in house by the Acrux R&D team,” says Acrux CEO, Michael Kotsanis.
“The Dapsone Gel, 7.5% product is a complex product as defined by the FDA, and the Acrux development included bioequivalence data demonstrated through in vitro techniques.
“This approval again demonstrates the capability of the Acrux team to execute the company’s strategy to develop our pipeline of topical products.”
In April, Acrux’s stock price jumped by 70% after launching the 5% version –the generic of Dapsone Gel, 5% – in the US.
Dapsone Gel, 5% is also a prescription medicine used topically to treat acne vulgaris. According to data from IQVIA, annual market sales for Dapsone Gel, 5% products exceed US$15 million.
Read more about that here: Acrux jumps 70pc after launching its acne gel in the US
Island Pharmaceuticals (ASX:ILA) said it has officially begun screening patients for its ISLA-101 Phase 2 PROTECT clinical study, following recent Institutional Review Board (IRB) approval from the US Army.
This approval allows Island to start enrolling participants for this important trial aimed at treating dengue fever.
The PROTECT study will be conducted in two parts: a Phase 2a arm focused on prevention, and a Phase 2b arm targeting treatment.
The first part of the trial, involving a preventative approach, is set to start dosing in late September, with results expected by the end of 2024. The therapeutic portion will begin in January 2025.
Island’s CEO, Dr David Foster, said the IRB approval from the US Army was the final step needed to move forward.
“We are now working closely with SUNY Upstate New York to rapidly progress the screening and enrolling of our subjects for the Phase 2a prophylactic arm of the trial.
“We look forward to providing further updates once we begin dosing subjects in the coming weeks.”
Health & Biotech
Health & Biotech
Health & Biotech
