Clearside Biomedical Inc (NASDAQ: CLSD) is having an overwhelmingly strong day in the market today, and for good reason. The company announced positive data from a Phase 3 clinical trial, leading to excitement among investors and sending the stock screaming for the top. Today, we’ll talk about the news, what we’re seeing from CLSD as a result, and what we’ll be watching for ahead.
CLSD Gains On Data Release
As mentioned above, Clearside Biomedical is having an incredibly strong start to the trading session this morning after announcing positive data. In a press release issued early this morning, the company provided positive topline results from a pivotal Phase 3 clinical trial. During the trial, suprachoroidal CLS-TA was used for patients suffering from macular edema associated with non-infectious uveitis.
The clinical trial included 160 patients and was randomized, controlled, and masked. In the release, CLSD said that out of the 160 patients enrolled, 96 were randomized to the treatment arm in which they would receive two 4.0mg doses of suprachoroidal CLS-TA 12 weeks apart. 64 of the patients were randomized to undergo sham procedures at the same rate. CLSD said that 155 patients, representing 97% of the patients enrolled, completed the full evaluation period of the trial.
Clearside announced that 47% of patients who received the treatment ever 12 weeks gained at least 15 letters in best corrected visual acuity, also known as BCVA, from baseline at week 24. Those who underwent the sham procedure only saw this in 16% of the cases, meeting the primary endpoint of the clinical trial. In a statement, Daniel H. White, CEO and President at CLSD, had the following to offer:
Having nearly 50% of the PEACHTREE trial patients treated with suprachoroidal CLS-TA gain 15 or more letters in vision is highly compelling. It represents a huge step forward in advancing suprachoroidal administration of CLS-TA towards becoming a powerful new approach in potentially treating blinding eye diseases… We currently expect to submit a new drug application for suprachoroidal CLS-TA in patients with macular edema associated with uveitis to the FDA in the fourth quarter of 2018, and we are also evaluating a number of options for submissions to regulatory agencies in additional territories outside of the United States.
What We’re Seeing From the Stock
One of the first lessons that we learn when we start to dabble in the market is that the news causes movement. In this particular case, the news was overwhelmingly positive. Due to the fact Clearside met its primary endpoint in the PEACHTREE trial, a New Drug Application is on the horizons. So, it’s no surprise to see that the stock is making a run for the top today. Currently (9:47), CLSD is trading at $11.29 per share after a gain of $3.47 per share (44.37%) thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on CLSD. In particular, we’re interested in following the story surrounding suprachoroidal CLS-TA, as the treatment seems to be yielding incredible results. Nonetheless, we’ll continue to follow the progress toward regulatory approval and bring the news to you as it breaks!
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