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Athenex's NDA for Breast Cancer Drug Gets Priority Review

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Athenex, Inc. (ATNX - Free Report) announced that the FDA has accepted the new drug application (NDA) for its pipeline candidate oral paclitaxel and encequidar (Oral Paclitaxel). The company is seeking an approval for the candidate to treat patients with metastatic breast cancer.

With the FDA granting a priority review to the NDA, a decision from the regulatory body is expected on Feb 28, 2021. The regulatory agency authorities also reaffirmed the company that it is not currently planning to hold an advisory committee meeting to discuss the NDA application.

The FDA generally grants a priority review to the drugs that have the potential to treat a serious condition and if approved, will substantially improve safety or effectiveness.

On gaining an approval, Athenex plans to establish Oral Paclitaxel as the chemotherapy of choice for patients receiving the same for metastatic breast cancer. Athenex currently deepens its focus on the launch program of Oral Paclitaxel upon potential approval.

Shares of Athenex were up 9.1% following the above news on Tuesday. However, the stock has declined 17.9% so far this year against the industry’s increase of 2.7%.


The NDA was based on data from a pivotal phase III study, which evaluated the safety and efficacy of Oral Paclitaxel monotherapy compared to intravenous (IV) paclitaxel monotherapy for the above-mentioned indication.

Notably, Oral Paclitaxel (formerly known as Oraxol) is an oral formulation of paclitaxel, a very effective and commonly used anti-cancer chemotherapy combined with HM30181A (a novel gastrointestinal tract specific P-glycoprotein pump inhibitor).

In August 2019, Athenex announced positive top-line data from the phase III study, which showed that Oral Paclitaxel met the primary efficacy endpoint with statistically significant improvement in the overall response rate along with lower neuropathy over IV paclitaxel in metastatic breast cancer.

Athenex is also evaluating Oral Paclitaxel as a monotherapy in a phase II study for treating elderly patients with unresectable cutaneous angiosarcoma, an aggressive and rare form of cancer for which no FDA-approved treatment is currently available. It is also being evaluated in combination studies for several other cancer indications.

Zacks Rank & Stocks to Consider

Athenex currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Emergent BioSolutions Inc. (EBS - Free Report) , Horizon Therapeutics Public Limited Company (HZNP - Free Report) and QIAGEN N.V. (QGEN - Free Report) , all sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Emergent’s earnings estimates have moved 83.2% and 62.6% north for 2020 and 2021, respectively, over the past 60 days. The stock has skyrocketed 105.4% year to date.

Horizon’s earnings estimates have been revised 60.6% and 56.5% upward for 2020 and 2021 each over the past 60 days. The stock has rallied 108.5% year to date.

QIAGEN’s earnings estimates have moved 23.8% and 35.2% north for 2020 and 2021, respectively, over the past 60 days. The stock has soared 50.1% year to date.

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