4 - EYENOVIA, INC. (0001682639) (Issuer)
3 - EYENOVIA, INC. (0001682639) (Issuer)
4 - EYENOVIA, INC. (0001682639) (Issuer)
Submission status for EYENOVIA INC.'s drug MYDCOMBI (ORIG-1) with active ingredient TROPICAMIDE AND PHENYLEPHRINE HYDROCHLORIDE has changed to 'Approval' on 05/05/2023. Application Category: NDA, Application Number: 215352, Application Classification: Type 5 - New Formulation or New Manufacturer
HC Wainwright & Co. analyst Matthew Caufield reiterates Eyenovia (NASDAQ:EYEN) with a Buy and maintains $12 price target.
NEW YORK, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic technology company, today announced that the Company has commenced manufacturing of registration batches of its FDA-approved mydriasis product, Mydcombi, a key step in the approval process for its state-of-the-art Gen-2 Optejet dispensing platform. Mydcombi will undergo 12-month stability testing and other functional testing in the Gen-2 Optejet device that is consistent with feedback from the Type-C meeting on Eyenovia's device qualification plan that the Company received from the FDA in July. "We were very pleased to have received feedback from the FDA that was very consistent with our Gen-2 qualifi
NEW YORK, Sept. 27, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN) ("Eyenovia" or the "Company"), an ophthalmic technology company with two FDA-approved products and a late-stage asset in development for the treatment of pediatric progressive myopia, today announced it has entered into a securities purchase agreement with a healthcare focused institutional investor for the purchase and sale of 8,695,653 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to an aggregate of 8,695,653 shares of common stock in a registered direct offering at a combined offering price of $0.46 per share and accompanying warrant. The warrants have an exer
NEW YORK, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic technology company, today announced the U.S. launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05% ("Clobetasol"), approved by the FDA for the treatment of post-operative inflammation and pain following ocular surgery. "The commercial launch of Clobetasol represents a significant milestone for our company, and as the first new ophthalmic steroid to be approved in more than 15 years, a meaningful advancement in the field of ocular surgery," stated Michael Rowe, Chief Executive Officer of Eyenovia. "With its efficacy and safety profile, convenient twice-a-day dosing reg
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NEW YORK, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), a commercial-stage ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, today announced the appointment of experienced finance and accounting executive Andrew Jones as Chief Financial Officer. Mr. Jones brings to the Eyenovia team more than 30 years of diverse finance and accounting leadership experience spanning therapeutics and medical technology/devices, most recently serving as Chief Financial Officer of NovaBay Pharmaceuticals, Inc., a publicly traded, commercial stage ophthalmic company. Eyenovia's current CFO, John Gandolfo, is retiring and will remain with
NEW YORK, July 27, 2022 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic pharmaceutical technology company developing a pipeline of late-stage microdose array print (MAP™) therapeutics, today announced the appointment of current Chief Operating Officer Michael Rowe as the Company's new Chief Executive Officer, effective August 1, 2022. Mr. Rowe's appointment follows the company's nationwide search and interviews with multiple candidates. Mr. Rowe has also been appointed to Eyenovia's Board of Directors, increasing the Board to nine seats following recent appointments of Drs. Strahlman and Palanki as new independent directors, announced in July. Eyenovia's current Chief Exec
NEW YORK, July 18, 2022 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic pharmaceutical technology company developing a pipeline of late-stage microdose array print (MAP™) therapeutics, today provided an update on its expanded manufacturing capabilities and also announced the appointment of Bren Kern as Senior Vice President of Manufacturing and Operations. Redwood City, CA Facility The Company today announced that its new manufacturing facility in Redwood City, CA is operational. The facility, which is located in close proximity to Silicon Valley-based vendors and customers, will primarily focus on Optejet® manufacturing finishing operations, including drug loading, label
Following FDA consultation, announced plans for validation of the Gen-2 Optejet® device and 2025 regulatory submission with Mydcombi™ as lead product Advanced Phase 3 CHAPERONE study of MicroPine as a treatment of pediatric progressive myopia with preparations for analysis in Q4 Commenced sales activities with focus on Mydcombi in 260+ offices and preparations for launch of clobetasol propionate ophthalmic suspension 0.05%, the first new ophthalmic steroid to enter the market in 15 years Announced development collaborations with Formosa, Senju and SGN to leverage the Optejet for the $5 billion global dry eye disease market Company to host conference call and webcast today, August 12th, a
NEW YORK, Aug. 08, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, today announced that the Company will release financial results for the second quarter ended June 30, 2024 on Monday, August 12th, 2024, after the markets close. Following the release, Eyenovia management will host a conference call and webcast at 4:30 p.m. ET to review the financial and operating results. Participants should dial 1-877-407-9039 (domestic) or 1-201-689-8470 (international) and reference Conference ID# 13747356. To access the Call me™ feature, which avoids having to wait for an operat
Remains on track towards accelerating development of its late-stage product candidate in the multi-billion-dollar pediatric progressive myopia market, MicroPine Preparing for a 3Q 2024 launch of the first new ophthalmic steroid in 15 years, clobetasol propionate ophthalmic suspension 0.05%, for the treatment of inflammation and pain following ocular surgery Company to host conference call and webcast today, May 15th, at 4:30 pm ET NEW YORK, May 15, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), a commercial-stage ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, today announced its financial and operating results for the fi
HC Wainwright & Co. reiterated coverage of Eyenovia with a rating of Buy and set a new price target of $8.00 from $6.00 previously
Northland Capital initiated coverage of Eyenovia with a rating of Outperform and set a new price target of $10.00
Northland Securities initiated coverage of Eyenovia with a rating of Outperform