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Ocular Therapeutix, Inc. (OCUL)- $1 off HIGH!!
NasdaqGM - NasdaqGM Real Time Price. Currency in USD
11.14+1.39 (+14.28%)
As of 12:54PM EDT.
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Ocular Therapeutix announces FDA approval of Dextenza sNDA 12:31 OCUL Ocular Therapeutix announced the U.S. FDA has approved its Supplemental New Drug Application to broaden the DEXTENZA label to add an additional indication for the treatment of ocular itching associated with allergic conjunctivitis. With the approval, DEXTENZA is the first, FDA-approved, physician-administered intracanalicular insert capable of delivering a preservative-free drug for the treatment of ocular itching associated with allergic conjunctivitis with a single administration for up to 30 days, Ocular said in a statement. DEXTENZA originally received FDA approval in November 2018 for the treatment of ocular pain following ophthalmic surgery, followed by an expansion of the label to also include the treatment of ocular inflammation following ophthalmic surgery in June 2019, it added. The efficacy of DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis was based on three randomized, multicenter, double-masked, parallel group, vehicle-controlled studies in subjects with a positive history of ocular allergies and positive skin test reaction to perennial and seasonal allergens. In all three trials, DEXTENZA demonstrated lower mean ocular itching scores compared with the vehicle group at all time points throughout the study duration of up to 30 days.
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Ocular Therapeutix reports in-market unit sales of DEXTENZA billable inserts 09/13 OCUL Ocular Therapeutix reported in-market unit sales of DEXTENZA billable inserts of 6,924 and 9,321 in July and August, respectively, as part of the company's corporate presentation at the H.C. Wainwright 23rd Annual Global Investment Conference. August units represent the second highest month of in-market unit sales of DEXTENZA billable inserts to date.
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Ocular Therapeutix CEO buys 5K shares of common stock 08/24 OCUL In a regulatory filing, Ocular Therapeutix disclosed that its CEO Antony Mattessich bought 5K shares of common stock on August 20th in a total transaction size of $49.5K, boosting his stake by about 5%. Shares of Ocular Therapeutix are up 1.9% in pre-market trading at $10.60.
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Ocular Therapeutix upgraded to Buy from Neutral at H.C. Wainwright 08/10 OCUL H.C. Wainwright analyst Yi Chen upgraded Ocular Therapeutix to Buy from Neutral with a $17 price target after the company reported "strong" Dextenza sales growth in Q2 and management said it expects to see strong growth through the remainder of the year due to continued physician interest in the drug as well as more normalized cataract procedure volumes. Dextenza could obtain FDA approval of its supplemental New Drug Application for the treatment of ocular itching associated with allergic conjunctivitis on the PDUFA date of October 18, driving further market adoption, noted Chen.
Ocular Therapeutix reports preliminary Q2 product revenue of $11.7M 07/22 OCUL The Company is reporting preliminary second quarter 2021 total net product revenue of approximately $11.7 million, representing a greater than 600% year-over-year increase versus the second quarter 2020 and an approximately 60% sequential increase over the first quarter of 2021. President and CEO. "What gives us the greatest satisfaction however is knowing that more and more patients are enjoying a better experience following their ophthalmic surgeries."
Insider was $10.40 it looks like VAN THIS IS A BUY!