Ocular Therapeutics Inc (NASDAQ: OCUL) is likely going to have a rough time in the market after-hours today and throughout the day tomorrow. That’s because a CRL was just released by the FDA announcing a rejections. At 4:35, OCUL was halted ahead of the news, trading at $7.55 per share. Shortly after the CRL was released, the stock resumed and fell dramatically. Currently (5:31), OCUL is trading at $5.26 per share after a loss of $2.34 per share or 30.79% thus far today.
As mentioned above, the FDA recently released a Complete Response Letter or CRL, announcing that it has rejected a recent New Drug Application filed by Ocular Therapeutics. Dextenza was a treatment that was designed to deliver a complete course of steroids to the eye following an ocular procedure.
Recently, OCUL asked the FDA for an extended review surrounding the treatment. However, they obviously did not get what they wanted. Just minutes ago, the FDA released a complete response letter, informing the company and its investors that they have made the decision to reject the treatment. In a statement, OCUL President, CEO and Chairman, Amar Sawhney, Ph.D, had the following to offer…
“We are evaluating the FDA’s response and plan to work closely with the agency in an effort to satisfy the requirements related to the NDA… Importantly, there were no clinical issues identified in the CRL pertaining to efficacy or safety related to the post-surgical pain indication. We believe that DEXTENZA can be approved once these open manufacturing items are resolved.”
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will be keeping a close eye on OCUL. In particular, we’re interested in how the company reacts to the rejection by the FDA. In particular, the company says that it does believe that it can get the treatment approved, but how long will this take and what steps will be taken to make this happen? Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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