Antisense (ASX:ANP) share price accelerates 5% on FDA news

What did the biotechnology company announce?

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The Antisense Therapeutics Limited (ASX: ANP) share price is rising on the back of positive investor sentiment on Thursday. This comes after the company provided an update on its application for ATL1102 with the United States Food and Drug Administration (FDA).

At the time of writing, the biotechnology company’s shares are up 5.56% to 19 cents.

What did Antisense announce?

Investors are driving up the Antisense share price today following news about an extended study of ATL1102.

According to its release, Antisense has submitted the protocol synopsis for a 9-month chronic monkey toxicology study to the FDA. This is expected to support the clinical dosing of patients with ATL1102 beyond 6 months for Duchenne Muscular Dystrophy (DMD).

As such, the company is hoping to receive feedback from the FDA on the protocol in the first quarter of 2022.

In June, the FDA provided clarification on the company’s Type C guidance meeting regarding the chronic monkey study and design of a Phase IIb/III trial.

The study will run for 52 weeks in the United States and will assess muscle strength among participants.

However, Antisense is considering taking the European Phase IIb/III data to the FDA to support a future marketing application.

Antisense hopes the information will be enough to get ATL1102 approved without further trials.

In addition, the FDA has previously granted a Rare Paediatric Disease Designation to ATL1102 for the treatment of DMD. Should its European trial be successful, Antisense could receive a rare pediatric disease priority review voucher from the FDA.

This is provided the company receives the green light for ATL1102 before 30 September 2026. If granted, it could sell the priority review voucher and use it as a source of non-dilutive capital. The value of these vouchers ranges from US$80 million to US$150 million.

About ATL1102 and the Antisense share price

Founded in 2000, Antisense develops and commercialises antisense pharmaceuticals for patients suffering from rare diseases.

Antisense is developing ATL1102, an antisense inhibitor of the CD49d receptor, for DMD patients.

Antisense recently reported promising Phase II trial results showing a significantly reduced number of brain lesions in patients with relapsing-remitting multiple sclerosis (RRMS).

Over the past 12 months, the Antisense share price has almost doubled, up 90%.

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