SureFire Medical has named pharma veteran Mary Szela as its president, CEO and board member, succeeding founder James Chomas, who has served as the company’s chief executive and president since 2009. Chomas will assume the role of chief technology officer and oncology strategy officer, focusing his efforts on the the company’s oncology drug-delivery tech. Get the […]
oculartherapeutix
Ocular Therapeutix plans $32.5m public offering to fund NDA resubmission for Dextenza
Updated to include the offering’s pricing information. Ocular Therapeutix (NSDQ:OCUL) said today that it plans to launch an underwritten public offering of 6.5 million shares of common stock at $5.00 apiece to help fund the resubmission of its new drug application for Dextenza, an ocular post-surgical pain-relief implant that was rejected by the FDA last year. The Bedford, Mass.-based […]
SEC subpoenas Ocular Therapeutix over pain relief implant
Ocular Therapeutix (NSDQ:OCUL) revealed last week that it received a subpoena from the Securities and Exchange Commission dated Dec. 15, requesting information about the company’s post-surgical pain relief implant, Dextenza, which was rejected by the FDA earlier this year. The Bedford, Mass.-based company did not specify what the SEC was asking for, but noted that the request covers […]
Ocular shares fall on mixed Q3 results
Shares in Ocular Therapeutix (NSDQ:OCUL) fell yesterday after the company beat sales expectations but missed earnings estimates on Wall Street with its third quarter results. The Bedford, Mass.-based company posted a net loss of -$15.6 million on sales of $520,ooo for the 3 months ended Sept. 30, for bottom-line loss of -62% on sales growth of 8.3% […]
Ocular’s new CEO to ‘aggressively’ seek partnerships
Since the start of June, Ocular Therapeutix‘s (NSDQ:OCUL) stock price has fallen more than -45%. The company’s founder and chief executive, Amar Swahney, has stepped down, assuming the role of executive chairman, and the FDA has rejected Ocular’s resubmitted new drug application for its hydrogel plug, Dextenza. Amidst regulatory troubles, Ocular tapped former Mundipharma exec Antony Mattessich to serve […]
Ocular Therapeutix slashes workforce following FDA rejection
Ocular Therapeutix (NSDQ:OCUL) revealed yesterday that it plans to cut 26 jobs across the Bedford, Mass.-based company – about 19% of its workforce. The effort to reorganize comes just weeks after the FDA rejected Ocular’s resubmitted new drug application for its hydrogel plug, Dextenza. Get the full story at our sister site, Drug Delivery Business News.
FDA rejects Ocular’s Dextenza for a second time
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 drug […]
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 plug, Dextenza, […]
Ocular Therapeutix founder & CEO Sawhney to step down | Personnel Moves – April 13, 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 […]