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Investors have yet to regain confidence in drug delivery company Acrux after the United States regulator said it would investigate links between its therapy and the risk of heart attacks.

The stock plunged to a 12-month low of $1.81 on February 5, from a high of $3.90 in April, after the Food and Drug Administration announced an investigation into testosterone replacement therapy (TRT). Acrux’s lead product is Axiron, a therapy to treat hypogonadism, a condition of low or no testosterone in men. At results two weeks later, neither a special dividend nor guidance that Acrux would hit 2014 sales targets proposed by distributor Eli Lilly were enough to win back investors.

The stock is now down 50 per cent for year, compared with a 5 per cent rise in the S&P/ASX200. The value of healthcare companies in the index have risen 18 per cent in the same time.

Canaccord analyst Matthijs Smith has a “buy” call on Acrux and a $2.50 price target, but said he would watch the stock “incredibly carefully”.

Dr Smith said a lot of TRT’s growth came from off-label use: “As a result if there are safety issues that are lurking in the background, many clinicians would be reluctant to prescribe it.”

Dr Smith said the FDA’s scrutiny affected the entire TRT industry. He is watching for any data relating to falls in prescription volume.

But RBS analyst Scott Power said the FDA study is “being overplayed” by the market.

“These sorts of concerns were probably always possible and it will take the FDA some time to decide if in fact there is a problem that needs some sort of blackbox warning,” he said, referring to the addition of label precautions. “I think that’s unlikely.”

Mr Power said any link between TRT and heart attack it could make it more difficult for new therapies to be approved, which would be positive for Acrux. He has an “add” call on the stock with a price target of $2.89.