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Athenex (ATNX) Skin Treatment Klisyri Gets Approval in Europe

Athenex, Inc. ATNX announced that its Spanish biopharmaceutical partner, Almirall, received approval for first-in-class microtubule inhibitor, Klisyri (tirbanibulin), for the topical treatment of actinic keratosis (“AK”) on the face or scalp.

The approval was expected as the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had recommended the drug’s approval in May.

Please note that Klisyri was approved by the FDA for a similar indication in December last year.

The European 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 five 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.

So far this year, shares of Athenex have lost 65.1% compared with the industry’s decrease of 3.1%.

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Athenex manufactures Klisyri and the same is commercialized by its Spanish biopharmaceutical company, Almirall. The company’s partner launched the drug in the United States following its approval and it will also handle the launch of the drug in Europe.

Per the agreement between Athenex and Almirall, Athenex is eligible to receive up to $45 million in milestone payments following launch and expansion of Klisyri into additional indications. The company will also receive sales-based milestone payments as well as royalties on sales of the drug from Almirall.

Regulatory applications seeking approval for Klisyri in Switzerland and Great Britain have been submitted by Almirall.

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.

Apart from Klisyri, Athenex is also developing oral paclitaxel plus encequidar for treating metastatic breast cancer. The company’s new drug application (NDA) seeking approval for the combination regimen was granted priority review in September last year. However, the FDA issued a complete response letter for the NDA in March citing safety issues and uncertainty over objective response rate. The regulatory body recommended the company to conduct a new study to support approval of the breast cancer regimen.

The company completed a type A meeting with the FDA earlier this month where it submitted additional data, including overall survival. The FDA was supportive of the development of oral paclitaxel plus encequidar for treating metastatic breast cancer during the meeting. The company plans to collect more data before designing the new study. It plans to present the study design to the FDA in the fourth quarter of 2021.

Zacks Rank & Stocks to Consider

Athenex currently has a Zacks Rank #4 (Sell).

Some better-ranked stocks from the biotech sector include Codexis CDXS, Bicycle Therapeutics BCYC and Arcutis Biotherapeutics ARQT, all carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Codexis’ loss per share estimates have narrowed from 55 cents to 50 cents for 2021 and from 54 cents to 50 cents for 2022 in the past 30 days. The company delivered an earnings surprise of 44.34%, on average, in the last four quarters.

Bicycle Therapeutics’ loss per share estimates have improved from $3.18 to $2.79 for 2021 and from $3.63 to $3.29 for 2022 in the past 30 days. The stock has risen 92.2% so far this year.

Arcutis’ loss per share estimates have narrowed from $4.76 to $4.41 for 2021 and from $5.16 to $4.67 in the past 30 days. The company delivered an earnings surprise of 2.46%, on average, in the last four quarters. The stock has surged 102.1% so far this year.

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