This ASX healthcare share is surging 17% on a new FDA ruling


An ASX healthcare share is racing into the green today following an update from the US Food and Drug Administration (FDA). The Noxopharm Ltd (ASX: NOX) share price has rocketed 17.19% today and is currently at 38 cents.

In earlier trade, the Noxopharm shares exploded 21% to 40 cents.

Let’s take a look at what the company announced.

The Noxopharm share price is soaring after the biotechnology company received Orphan Drug Designation (ODD) by the FDA for Veyonda.

Veyonda is the company’s lead oncology drug candidate for the treatment of soft tissue sarcoma, an aggressive cancer.

The granting of ODD provides Noxopharm with seven years of market exclusivity for the drug and a waiver of new drug application fees. In 2021, the cost for a new drug application was about $2.9 million.

The FDA will also assist with regulatory guidance during the drug development process. Noxopharm said out of 360 ODD’s approved last year, only four went to Australian companies.

Noxopharm is currently conducting a CEP-2 trial using Veyonda in the treatment of patients with soft tissue sarcoma in the United States.

Commenting on the news fuelling the Noxopharm share price today, CEO Dr Gisela Mautner said:

It is pleasing that the Noxopharm application for Orphan Drug Designation was approved so quickly.

The 7-year period of market exclusivity is commercially extremely valuable, as it means that the FDA will not approve a subsequent drug for the same use within this timeframe.

With the FDA orphan drug designation now secured for Veyonda, the Noxopharm team is excited to move our preclinical assets along the drug development process, while continuing to deliver on our clinical program plan.

Thirty patients are being enrolled in the clinical trials to investigate the use of the drug. The City of Hope Cancer Center in Los Angeles has started treatment already.

The Noxopharm share price has dropped 43% in the last year, while it has fallen 4% year to date. For perspective, the S&P/ASX 200 Index (ASX: XJO) has returned more than 9% over the past year.

In the past month, this ASX healthcare share has dropped 1.3% although it has climbed by almost 9% over the past week.

The company has a market capitalisation of about $108 million.

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