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
4 - EYENOVIA, INC. (0001682639) (Issuer)
3 - EYENOVIA, INC. (0001682639) (Issuer)
4 - EYENOVIA, INC. (0001682639) (Issuer)
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
8-K - EYENOVIA, INC. (0001682639) (Filer)
8-K - EYENOVIA, INC. (0001682639) (Filer)
8-K - EYENOVIA, INC. (0001682639) (Filer)
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
4 - EYENOVIA, INC. (0001682639) (Issuer)
4 - EYENOVIA, INC. (0001682639) (Issuer)
4 - EYENOVIA, INC. (0001682639) (Issuer)
HC Wainwright & Co. analyst Matthew Caufield reiterates Eyenovia (NASDAQ:EYEN) with a Buy and maintains $12 price target.
SC 13D/A - EYENOVIA, INC. (0001682639) (Subject)
SC 13G - EYENOVIA, INC. (0001682639) (Subject)
SC 13D/A - EYENOVIA, INC. (0001682639) (Subject)
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
TAIPEI, Sept. 9, 2024 /PRNewswire/ -- Formosa Pharmaceuticals, Inc. (hereinafter referred to as "Formosa Pharma," 6838.TW) announced the successful first shipment to the United States of its new ophthalmic drug, Clobetasol Propionate Ophthalmic Suspension, 0.05% (APP13007), manufactured by Bora Pharmaceuticals Ophthalmic (hereinafter referred to as "Bora," 6472.TW). Formosa Pharma's U.S. partner, Eyenovia, Inc. (NASDAQ:EYEN), has initiated the pre-launch activities for APP13007 and is expected to begin commercialization in late September. APP13007, developed through Formosa Ph
NEW YORK, Sept. 05, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), a commercial-stage ophthalmic company with two FDA-approved products and a late-stage asset in development for the treatment of pediatric progressive myopia, today announced that its strategic partner, Taiwan-based Formosa Pharmaceuticals (TWO:6838), was granted a Taiwan Export License for clobetasol propionate ophthalmic suspension 0.05% ("clobetasol propionate") to allow for shipment of commercial product to the U.S. Clobetasol is a powerful steroid approved for reducing inflammation and pain following the approximately seven million ocular surgeries performed annually in the U.S. In August 2023, Eyenovia secur
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