Acrux Share Price Explodes Higher on FDA Approval (ASX:ACR)

When it comes to biotech stocks, the ultimate goal is always to get a drug to market.

A process that often takes years of hard work, lots of money, and a whole lot of patience for investors. A process that many biotechs often fail to ever reach.

Drug development is not easy, and making an effective drug is even harder.

That’s why, when it does happen, shareholders are often rewarded handsomely. And that’s exactly what has happened for Acrux Ltd [ASX:ACR] today. The ACR share price was up 36.36% at the time of writing to $0.22.

FDA approved and ready for the market

Acrux today shared the good news that their testosterone topic solution has been approved by the US Food & Drug Administration (FDA). Meaning that the drug is now good to go to market.

A decision that has taken roughly 17 months to finalise. Granted, COVID-19 may have played a part in dragging out the deliberation.

Nevertheless, with approval now granted, Acrux is ready to bring this testosterone product to market, and hopefully net some meaningful revenue. With the closest competitor raking in US$25 million worth of sales for the 12-month period to the end of September.

As Acrux CEO Michael Kotsanis comments:

FDA approval is a major milestone for Acrux and its generic strategy. It is a testament to the hard work and dedication of the product development and regulatory team. We are excited to partner with Dash Pharmaceuticals to bring this product to market in the current financial year.

What’s next for Acrux?

With development of this topical solution now all but finished, Acrux will be able to focus on other areas. And while that certainly doesn’t mean they will ignore the ongoing efforts of this drug; a lot of the upkeep will be largely handled by Dash — the distributor.

This will provide Acrux with the ability to free up resources for other endeavours. After all, they have plenty of other solutions in the pipeline.

At last count, they have 11 undisclosed products in various stages of development currently. Each of which could be the next major focus for the company.

Only time will tell where they prioritise their efforts next. For shareholders though, today is certainly a good day to own Acrux stock.

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Ryan Clarkson-Ledward,
For Money Morning

Ryan Clarkson-Ledward is an Editor at Money Morning.

Ryan holds degrees in both communication and international business. He helps bring Money Morning readers the latest market updates, both locally and abroad. Ryan tackles all the issues investors need to know about that the mainstream media neglects.

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