Ocular Therapeutix (NSDQ:OCUL) said today that the FDA rejected its resubmission of a new drug application for Dextenza. This is the second time that Ocular has received the FDA’s dreaded complete response letter for Dextenza. In July last year, the FDA denied approval for Ocular’s hydrogel plug after it discovered ‘deficiencies in manufacturing process and controls’ in a pre-new […]
Ocular Therapeutix
Ocular seeks to extend regulatory timeline for Dextenza due to manufacturing concerns
Ocular Therapeutix (NSDQ:OCUL) said today that it submitted details of a manufacturing equipment change as an amendment to the new drug application resubmission for Dextenza, the company’s dexamethasone insert that is currently under review by the FDA. The FDA is slated to make a decision about the product’s regulatory approval by July 19. But the company recently […]
Ocular Therapeutix faces more manufacturing problems as FDA decision deadline looms
Shares in Ocular Therapeutix (NSDQ:OCUL) fell last week after the company revealed that it received another letter from the FDA about issues spotted by the regulatory agency during a pre-approval inspection of a manufacturing plant. This isn’t the first time that the company has dealt with manufacturing issues. In July last year, the FDA denied approval for Ocular’s hydrogel […]
Ocular Therapeutix founder & CEO Sawhney to step down | Personnel Moves – June 23, 2017
The president & CEO of Ocular Therapeutix (NSDQ:OCUL), Amarpreet Sawhney, is slated to step down from the company that he helped start in 2006. He will serve as the board’s executive chairman for 1 year, unless he decides to leave earlier. The company wrote in a regulatory filing that “his service will be automatically renewed for […]
Braeburn names former Teva exec as new president, CEO | Personnel Moves – June 14, 2017
Braeburn Pharmaceuticals said last week that it named Michael Derkacz as president and CEO of the buprenorphine implant-maker. Most recently, Derkacz worked as senior VP and head of global central nervous system and pain therapeutic areas for Teva Pharmaceuticals (NYSE:TEVA). Behshad Sheldon, who helped to found Braeburn in 2012, is slated to step down from Braeburn […]
Ocular’s Dextenza meets primary endpoints in Phase III trial
Shares in Ocular Therapeutix (NSDQ:OCUL) rose more than 5% today after the company said its Dextenza post-surgical ocular pain relief implant met primary endpoints in the company’s most recent Phase III trial. The hydrogel plug, inserted into a patient’s tear duct, is designed to deliver a sustained dose of dexamethasone over 4 weeks following ophthalmic surgery. […]
Ocular Therapeutix shares fall on Q1 miss
Shares in Ocular Therapeutix (NSDQ:OCUL) fell today after the ophthalmologic device developer posted 1st quarter earnings that missed expectations on Wall Street. The Bedford, Mass.-based company posted losses of $16 million, or 58¢ per share, on sales of $475,000 for the 3 months ended March 31, seeing losses grow 47.8% while sales grew 14.2% compared with […]
Sanofi promotes Sibold to exec VP of Sanofi Genzyme | Personnel Moves – April 13, 2017
Sanofi (NYSE:SNY) said at the start of April that it promoted Bill Sibold to exec VP of Sanofi Genzyme, effective July 1, 2017. Sibold succeeds Dr. David Meeker, who is slated to leave the company at the end of June. Sibold is the head of Sanofi Genzyme’s global multiple sclerosis, oncology and immunology organization. He […]
Ocular touts patient experience data for Dextenza implant
Ocular Therapeutix (NSDQ:OCUL) touted data today from a patient experience study of its Dextenza post-surgical pain relief implant. The study was published in Patient Preference and Adherence. The Bedford, Mass.-based company’s hydrogel plug, inserted into a patient’s tear duct, is designed to deliver a sustained dose of dexamethasone over 4 weeks following ophthalmic surgery. After the […]
Ocular misses estimates for Q4 earnings, but beats on rev
Shares in Ocular Therapeutix (NSDQ:OCUL) fell today after the biopharmaceutical company missed earnings expectations, but beat sales estimates on Wall Street with its 4th quarter results. The Bedford, Mass.-based company posted losses of -$-12.8 million, or -52¢ per share, on sales of $0.5 million for the 3 months ended Dec. 31, for bottom-line loss of -20.5% on […]
