Clearside Biomedical Inc (CLSD): CLS-TA Has a High Likelihood of Approval, Says Top Analyst
It was a very rewarding trading day for investors in Clearside Biomedical Inc (NASDAQ:CLSD) with shares up over 30%, making the stock Wall Street’s bull of the day. Why the excitement? The biopharmaceutical company announced positive topline results from its pivotal Phase 3 clinical trial of suprachoroidal CLS-TA in patients with macular edema associated with non-infectious uveitis.
Cowen’s top analyst Boris Peaker commented, “Following the positive data for CLS-TA, we expect an NDA submission by YE18 through the 505(b)(2) pathway, as only one Phase III trial was deemed necessary to support filing. We see a high probability of approval given the efficacy and tolerability demonstrated in the PEACHTREE trial. Though not required prior to filing, the company is collecting an additional 6 months of follow-up from a subset of patients to examine the durability of CLSTA’s clinical benefit and the incidence of cataract formation.”
“We see a high likelihood of approval in uveitis and good positioning for commercial launch […] In addition to uveitis, CLS-TA is being studied in RVO (~$400M US peak sales potential) and DME (~1.1MM patients) . We believe PEACHTREE validates the SCS injection strategy and see a high liklihood of success in ongoing trials. Topline Phase II data in TYBEE (DME) are expected in 2Q18 and Phase III SAPPHIRE data (RVO) are expected in early 2019,” the analyst added.
As such, Peaker reiterates an Outperform rating on Clearside Biomedical shares, while no price target was provided.
According to TipRanks.com, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Boris Peaker has a yearly average return of 17.5% and a 47% success rate. Peaker has a 4.7% average return when recommending CLSD, and is ranked #240 out of 4760 analysts.
Overall, all the 6 analysts polled in the past 12 months rate Clearside Biomedical stock a Buy. With a return potential of 92%, the stock’s consensus target price stands at $20.40.