Shares of Ocular Therapeutix Inc.
(OCUL) - Get Report were down 30.8% to $5.26 in premarket trading on Wednesday, July 12, on the heels of the announcement that the Bedford, Mass.-based firm's Dextenza was not approved by the U.S. Food and Drug Administration. Ocular on Tuesday said it has received a complete response letter from the agency on its resubmission of a new drug application for Dextenza to treat ocular pain after ophthalmic surgery.
"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," said Ocular president, CEO and chairman Amar Sawhney in a statement. "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."
Meanwhile, shares of Alder BioPharmaceuticals Inc. (ALDR) - Get Report were down 12.7% to $10.65 after the Bothell, Wash.-based firm on Tuesday unveiled plans to sell 12.5 million shares in an underwriter public offering. Alder said it plans to give underwriters a 30-day option to buy up to 1.875 million additional shares.
The company said it plans to use net proceeds from the offering, along with other available funds, for the continued development of eptinezumab, for working capital and other general corporate purposes.
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