Back to top

Aclaris' Alopecia Candidate Gets Fast Track Designation

Read MoreHide Full Article

Aclaris Therapeutics, Inc. (ACRS - Free Report) shares increased 1.5% on Jul 9 after the company announced that its Janus kinase (“JAK”) inhibitor, ATI-502, has been granted a fast track designation by the FDA.

The company is looking to get the candidate approved for treatment of patients with alopecia areata (“AA”), including patchy alopecia areata and the more severe variants of the disease, alopecia totalis (“AT”) and alopecia universalis (“AU”). Alopecia areata, an autoimmune dermatologic condition, causes partial or complete loss of hair on the scalp and body.

The FDA grants a fast track designation to expedite a candidate’s development as well as its faster review to treat serious and unmet medical conditions. With this designation, a candidate is expected to be granted a priority review once it files a new drug application.

The candidate is currently being evaluated in a phase II study for the indication.

Shares of Aclaris have decreased 15.7% so far this year against the industry’s gain of 2.8%.


The company announced encouraging interim data late last month from the phase II study evaluating ATI-502 for the treatment of AT and AU. Data showed that ATI-502 positively impacted the gene expression signature implicated in alopecia areata. The candidate penetrates the skin and engages the target safely as well as has low systemic exposure.

A successful completion of the study will boost the prospect of the candidate as there is no approved drug for this indication in the United States.

Zacks Rank & Stocks to Consider

Aclaris currently carries a Zacks Rank #4 (Sell).

Better-ranked stocks in the same sector include AcelRx Pharmaceuticals, Inc. (ACRX - Free Report) , CollPlant Holdings Ltd. (CLGN - Free Report) and BioLineRx Ltd. (BLRX - Free Report) , all carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Estimates for AcelRx’s loss have narrowed 4.4% for 2018 and 15.3% for 2019 in the past 60 days. The stock has surged 77.8% year to date.

Estimates for CollPlant’s loss have narrowed 1.7% for 2018 and 1.4% for 2019 over the past 60 days.

Estimates for BioLineRx’s loss have narrowed 16.1% for 2018 and 15.2% for 2019 over the past 60 days.

The Hottest Tech Mega-Trend of All

Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.

See Zacks' 3 Best Stocks to Play This Trend >>

More from Zacks Analyst Blog

You May Like