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Athenex (ATNX) Gets FDA Approval for Skin Treatment Klisyri

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Zacks Equity Research
·3 min read
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Athenex, Inc. ATNX announced that the FDA has approved its first-in-class microtubule inhibitor, Klisyri (tirbanibulin), for the topical treatment of actinic keratosis (“AK”) on the face or scalp. The drug is now the first proprietary product by Athenex to be approved by the regulatory body for the given indication.

Please note that Klisyri was approved by the FDA before the scheduled target action date of Dec 30, 2020.

The FDA approval was based on data from two pivotal, multicenter, vehicle-controlled phase III studies, which evaluated the safety and efficacy of Klisyri ointment 1%, once daily for 5 consecutive days in adult patients with AK. Data from the studies showed that treatment with Klisyri led to complete clearance of AK lesions in a significantly higher number of patients versus the vehicle arm at day 57 of treatment.

Athenex will manufacture Klisyri and the same will be launched in the United States by Spanish biopharmaceutical company Almirall, S.A. in the first quarter of 2021. Athenex is partnering with Almirall to market Klisyri in the United States as well as in Europe including Russia.

Despite the positive news, shares of Athenex were down 6% news on Tuesday. In fact, so far this year, the stock has lost 24.4% against the industry’s increase of 8.6%.

price chart for ATNX
price chart for ATNX


Per the company, AK is a pre-cancerous skin lesion that is caused by damage from exposure to ultraviolet radiation. If not treated at the right time, 10-15% of AK lesions will progress into skin cancer.

We note that Athenex awaits the FDA approval of another of its pipeline candidates – oral paclitaxel and encequidar (Oral Paclitaxel). In September 2020, the FDA accepted the new drug application for Oral Paclitaxel to treat patients with metastatic breast cancer. With the FDA granting a priority review, a decision from the regulatory body is expected on Feb 28, 2021.

Zacks Rank & Stocks to Consider

Athenex currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Repligen Corporation RGEN, Aptose Biosciences, Inc. APTO and Cara Therapeutics, Inc. CARA, all carrying  a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Repligen’s earnings estimates have moved 12.5% and 16.9% north for 2020 and 2021, respectively, over the past 60 days. The stock has rallied 100.6% year to date.

Aptose Biosciences’ loss per share estimate has narrowed 10.4% for 2020 and 4.7% for 2021 over the past 60 days.

Cara Therapeutics’ loss per share estimate has narrowed 14.2% for 2020 and 22.5% for 2021 over the past 60 days.

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