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Aldeyra Therapeutics has promising year ahead with clinical trials underway

Published: 18:08 20 Mar 2015 GMT

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Shares of Aldeyra Therapeutics (NASDAQ:ALDX) rose on Friday after the company's price target was lifted by analysts at H.C. Wainwright, who cited a pivotal year for clinical studies in 2015.

The biotech company, which released its 2014 results earlier this week and held a conference call on Thursday, is planning to conduct two clinical studies with its lead drug candidate NS2 in 2015. NS2 was specifically developed to trap and allow for the disposal of free aldehydes. 

The first study will be a phase 2 double blind, placebo-controlled trial for Sjogren-Larsson Syndrome (SLS), and the company began enrolling patients on March 17, with results anticipated in the second half of this year. SLS is a condition that is inherited from gene mutations and is characterized by dry, scaly skin, neurological and eye problems.

The second trial will be a phase 2 study of NS2 for treating non-infectious anterior uveitis, with the U.S. FDA accepting the company's amended protocol for the study. Aldeyra is planning to start the trial shortly, pending approval by institutional review boards.

H.C. Wainwright said enrollment for this study is expected to begin in the first half of the year, with preliminary results potentially available by year-end.

HCW analyst Swayampakula Ramakanth pointed out that management is also considering new products and indications for NS2, including autoimmune diseases and local inflammation.

"For example, at the 2015 Annual Meeting of the Association for Research in Vision and Ophthalmology, the company presented efficacy evidence using NS2 to treat ocular fibrosis in a preclinical model of photorefractive keratectomy," Ramakanth wrote in a research note released Friday.

"We believe management is also considering developing additional drug candidates, such as other aldehyde traps and treatments for rare diseases."

The HCW analyst also highlighted the company's strong cash position after completing two private placement financings in January worth some $9.8 million. With pro forma cash of almost $18 million, H.C. Wainwright believes Aldeyra could fund operations through 2016.

The company reported no revenues for 2014, in line with estimates, and a net loss of $9.6 million, slightly lower than HCW's forecast of $9.8 million.

The equities research firm said it has adjusted its financial model to reflect the 2014 results and 2015 guidance, including decreased projected G&A expenses. For 2015, HCW expects no revenues and a net loss of $10.5 million.

H.C. Wainwright continues to rate Aldeyra as a buy, and increased its 12-month price target to $14.00 per share, up from $13.00 previously. Shares rose more than 3 percent Friday, to US$10.92 in New York, stretching year-to-date gains to over 51 percent.

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