Athenex, Inc. (NASDAQ:ATNX) along with Taiwan’s PharmaEssentia Corp announced positive preliminary data from a phase I study on its pipeline candidate, KX2-391 (tirbanibulin) ointment. Positive early clinical signals were observed in a small cohort of patients with psoriasis, having undergone treatment with the ointment in a phase I study.
The World Health Organization has suggested tirbanibulin as the International Nonproprietary Name (INN) for KX2-391.
Shares of Athenex were up almost 10.5% following this news on Friday. In fact, the stock has surged 32.1% so far this year outperforming the industry’s increase of 1.8%.
In the study, six patients were examined with a mild to moderate psoriasis. All the subjects in the cohort, treated with KX2-391 1% ointment — once daily for 5 days — experienced some kind of an improvement. While one of them had a complete resolution of skin scaling, another, experienced better psoriatic plaque thickness. Overall, KX2-391 was well-tolerated with no serious adverse events reported.
Both companies are working to evaluate the optimal treatment regimen for psoriasis with KX2-391.
KX2-391 ointment is currently being developed in late-stage studies for treating actinic keratosis (AK) — a crusty, scaly growth caused by damage from exposure to ultraviolet radiation. Earlier this year, Athenex presented positive top-line safety and efficacy data from the two phase III studies on KX2-391 for addressing AK at the annual meeting of American Academy of Dermatology. The product was well tolerated by the enrolled patient population.
We would like to remind investors that PharmaEssentia in-licensed rights to KX2-391 from Athenex for treating psoriasis and non-malignant skin conditions (excluding actinic keratosis) in Mainland China, Taiwan, Hong Kong, Macau, Singapore and Malaysia along with the rights for treating AK across Taiwan.
In a separate press release, Athenex announced that its active pharmaceutical ingredient (API) plant in Chongqing, China has been voluntarily suspended with respect to all production activities. The company expects to have a resolution by the end of third-quarter 2019, subject to inspection and evaluation by the Department of Emergency Management of Chongqing.
Zacks Rank & Stocks to Consider
Athenex currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Acorda Therapeutics, Inc. (NASDAQ:ACOR) , Repligen Corp. (NASDAQ:RGEN) and Merus N.V. (NASDAQ:MRUS) , all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Acorda’s loss per share estimates have been narrowed 6.5% for 2019 and 6.9% for 2020 over the past 60 days.
Repligen’s earnings estimates have been revised 12% upward for 2019 and 12% for 2020 over the past 60 days. The stock has surged 42.9% year to date.
Merus’ loss per share estimates have been narrowed 22.2% for 2019 and 17.2% for 2020 over the past 60 days.
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