Paradigm Biopharmaceuticals Ltd (ASX:PAR) has been granted a trading halt by ASX as it finalises its review of a response from the Food & Drug Administration (FDA) and an update to the market.
In its request to the ASX for the halt, the company said that its regulatory consultants were reviewing the FDA response.
The halt will remain in place until the start of regular trading on Tuesday, August 3, or until an announcement is released to the market, whichever occurs earliest.
Shares last traded at $2.22 and the company’s market cap is approximately $504.4 million.
Brazil trial approval
Last month the company received a key regulatory approval from Brazilian National Health Surveillance Agency ANVISA for its Phase 2 clinical trial evaluating the safety and tolerability of injectable (SC) pentosan polysulfate sodium (iPPS) versus placebo in subjects with Mucopolysaccharidosis type VI (MPS VI).
The company has also received ethics approval from the National Research Ethics Commission (Comissão Nacional de Ética em Pesquisa - CONEP) for the trial.
A successful trial outcome will support partnering discussions for a registrational study to support the use of PPS, in conjunction with enzyme replacement therapy (ERT), in this orphan disease population.