We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Why is Ocular Therapeutics (OCUL) Surging 36% Today?
Read MoreHide Full Article
Ocular Therapeutics (OCUL - Free Report) is up 34.8% in afternoon trading after announcing that the FDA’s concerns regarding the company’s New Drug Application (NDA) appear to have been addressed.
Based in Bedford, MA, OCUL is a biopharmaceutical company that focuses on the development and commercialization of eye-care products. It has developed DEXTENZA, a treatment meant to be administered for ocular pain following eye-related surgery.
The FDA issued a Complete Response Letter (CRL) to the company’s NDA, citing concerns about deficiencies in OCUL’s manufacturing processes that were observed during an inspection. However there were no concerns stated relating to the safety of the drug.
According to OCUL’s official statement, “one outstanding item remains pertaining to manufacturing process and controls.” The FDA had issued ten inspectional observations in the form, meaning nine have since been settled.
The one concern left pertains to the proposed methodology for testing an inert gas used in the manufacturing process. The FDA requested that OCUL creates a final report when they have moved to technology that is capable of automatically testing the gas, which is anticipated during Q3 2016.
“We are working closely with the FDA to address the one remaining item and are planning for a resubmission to our NDA as soon as possible,” said Amar Sawhney, President, CEO, and Chairman. “We remain committed to bringing DEXTENZA to market as rapidly as possible.”
Analysts have not revised estimates for OCUL in the last 60 days. Current quarter estimates stand at a loss of $0.49 per share, with fiscal year estimates at -$1.78 in earnings per share. Even with today’s rise, OCUL is still trading near its 52 Week Low of $4.04. Stock value has dropped 55.5% year-to-date.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
Zacks' 7 Best Strong Buy Stocks (New Research Report)
Valued at $99, click below to receive our just-released report predicting the 7 stocks that will soar highest in the coming month.
Image: Bigstock
Why is Ocular Therapeutics (OCUL) Surging 36% Today?
Ocular Therapeutics (OCUL - Free Report) is up 34.8% in afternoon trading after announcing that the FDA’s concerns regarding the company’s New Drug Application (NDA) appear to have been addressed.
Based in Bedford, MA, OCUL is a biopharmaceutical company that focuses on the development and commercialization of eye-care products. It has developed DEXTENZA, a treatment meant to be administered for ocular pain following eye-related surgery.
The FDA issued a Complete Response Letter (CRL) to the company’s NDA, citing concerns about deficiencies in OCUL’s manufacturing processes that were observed during an inspection. However there were no concerns stated relating to the safety of the drug.
According to OCUL’s official statement, “one outstanding item remains pertaining to manufacturing process and controls.” The FDA had issued ten inspectional observations in the form, meaning nine have since been settled.
The one concern left pertains to the proposed methodology for testing an inert gas used in the manufacturing process. The FDA requested that OCUL creates a final report when they have moved to technology that is capable of automatically testing the gas, which is anticipated during Q3 2016.
“We are working closely with the FDA to address the one remaining item and are planning for a resubmission to our NDA as soon as possible,” said Amar Sawhney, President, CEO, and Chairman. “We remain committed to bringing DEXTENZA to market as rapidly as possible.”
Analysts have not revised estimates for OCUL in the last 60 days. Current quarter estimates stand at a loss of $0.49 per share, with fiscal year estimates at -$1.78 in earnings per share. Even with today’s rise, OCUL is still trading near its 52 Week Low of $4.04. Stock value has dropped 55.5% year-to-date.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>