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Eyenovia Inc - EYEN STOCK NEWS

Welcome to our dedicated news page for Eyenovia (Ticker: EYEN), a resource for investors and traders seeking the latest updates and insights on Eyenovia.

Our selection of high-quality news articles is accompanied by an expert summary from Rhea-AI, detailing the impact and sentiment surrounding the news at the time of release, providing a deeper understanding of how each news could potentially affect Eyenovia's stock performance. The page also features a concise end-of-day stock performance summary, highlighting the actual market reaction to each news event. The list of tags makes it easy to classify and navigate through different types of news, whether you're interested in earnings reports, stock offerings, stock splits, clinical trials, fda approvals, dividends or buybacks.

Designed with both novice traders and seasoned investors in mind, our page aims to simplify the complex world of stock market news. By combining real-time updates, Rhea-AI's analytical insights, and historical stock performance data, we provide a holistic view of Eyenovia's position in the market.

News
Eyenovia Announces Updated Strategy and Corporate Priorities to Focus on Shareholder Value Generation and Immediate Commercial Opportunities
Rhea-AI Summary
Eyenovia, Inc. (NASDAQ: EYEN) announces plans to accelerate the development of MicroPine for pediatric progressive myopia, with an interim analysis scheduled for 4Q 2024 and a potential NDA submission to the FDA in 2025. The company is also exploring strategic alternatives to enhance shareholder value, including asset sales, mergers, or other strategic actions. Eyenovia aims to capitalize on the significant market opportunity of pediatric progressive myopia, estimated at $1.8 billion, by leveraging its late-stage MicroPine asset. The company is committed to advancing its commercialization efforts for Mydcombi and preparing for the launch of clobetasol propionate ophthalmic suspension 0.05%. Eyenovia is focused on maximizing value generation while reducing operating expenses and evaluating various strategic options.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-17.99%
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News
Eyenovia to Feature its Suite of Commercial Products and the Optejet Dispenser at Upcoming National Eyecare Meetings
Rhea-AI Summary
Eyenovia, Inc. (NASDAQ: EYEN) will showcase its commercial products, including Mydcombi™, Avenova®, and Clobetasol Propionate Ophthalmic Suspension 0.05%, at upcoming medical meetings. The company aims to raise awareness of its products and discuss commercial terms, positioning itself as a leading partner in the ophthalmic field. Eyenovia plans to drive sales growth in 2025 through synergistic product offerings and innovative technology.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-6.6%
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none
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News
Eyenovia Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update
Rhea-AI Summary
Eyenovia, Inc. announces FDA approval of clobetasol propionate ophthalmic suspension 0.05% for post-operative pain and inflammation following ocular surgery. The company reacquired rights to MicroPine for pediatric myopia in the U.S. and Canada. Eyenovia advances commercial operations with Mydcombi™ launch, FDA approval of manufacturing facility, and copromotion agreement.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-23.2%
Tags
earnings
News
NovaBay Pharmaceuticals and Eyenovia to Co-Promote Prescription Ophthalmic Products to U.S. Eyecare Professionals
Rhea-AI Summary
NovaBay Pharmaceuticals, Inc. and Eyenovia, Inc. have signed a co-promotion agreement to commercialize prescription ophthalmic products in the U.S. NovaBay will market Eyenovia's Clobetasol propionate ophthalmic suspension 0.05%, while Eyenovia will market NovaBay's Avenova Antimicrobial Lid & Lash Solution. Clobetasol received FDA approval for post-surgical pain and inflammation treatment, with high success rates. This collaboration aims to leverage both companies' networks for product commercialization and growth.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
3.03%
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none
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News
Eyenovia to Report Fourth Quarter 2023 Results and Provide Business Update on Monday, March 18th
Rhea-AI Summary
Eyenovia, Inc. (EYEN) will release Q4 2023 financial results on March 18, 2024, followed by an investor conference call and webcast. Participants can join the call to review financial and operating results. The event will be accessible via phone and webcast, with a one-year archive available on Eyenovia's website.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
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conferences earnings
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News
Eyenovia Congratulates Formosa Pharmaceuticals on FDA Approval of Clobetasol Propionate Ophthalmic Suspension 0.05% for the Treatment of Post-operative Inflammation and Pain Following Ocular Surgery
Rhea-AI Summary
Eyenovia celebrates Formosa Pharmaceuticals' FDA approval of clobetasol propionate ophthalmic suspension 0.05% for post-operative inflammation and pain. Eyenovia plans a U.S. launch in the $1.3 billion market with Mydcombi™ sales force. The product offers high efficacy, safety, and convenience with a twice-daily dosing regimen.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-22.81%
Tags
fda approval
News
Formosa Pharmaceuticals and AimMax Therapeutics Receive FDA Approval for Clobetasol Propionate Ophthalmic Suspension 0.05%, for the Treatment of Post-Operative Inflammation and Pain Following Ocular Surgery
Rhea-AI Summary
Formosa Pharmaceuticals and AimMax Therapeutics receive FDA approval for clobetasol propionate ophthalmic suspension 0.05%, a novel steroid for post-operative ocular surgery. The product shows superior results in Phase 3 trials, targeting a $1.3 billion market.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-22.81%
Tags
fda approval
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News
Eyenovia Announces FDA Approval of Redwood City as Commercial Manufacturing Facility
Rhea-AI Summary
Eyenovia, Inc. announces FDA approval for its Redwood City facility in California to manufacture Mydcombi, a unique ophthalmic product. The facility will support the production of the first fixed combination of tropicamide and phenylephrine using Optejet™ technology.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-5.76%
Tags
fda approval
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News
Eyenovia Re-Acquires Development and Commercialization Rights to MicroPine in the U.S. and Canada
Rhea-AI Summary
Eyenovia, Inc. re-acquires the rights to MicroPine in the U.S. and Canada, an investigational ophthalmic spray for pediatric progressive myopia. This acquisition expands Eyenovia's phase III pipeline and commercial opportunities, complementing its commercial-stage asset, Mydcombi, and pre-PDUFA candidate, APP13007. The market for pediatric progressive myopia is estimated to be nearly $2 billion annually in the U.S. The re-acquisition aims to expedite commercialization of advanced products using the Optejet device, providing a significant asset value increase compared to the original license agreement. The company plans to accelerate the ongoing CHAPERONE phase III trial and engage with FDA to explore options to expedite development and registration of MicroPine. Eyenovia will pay Bausch + Lomb Ireland Limited an upfront payment consisting of $2 million in cash and $3 million in shares of common stock, as well as a low single-digit royalty on Eyenovia’s net sales of MicroPine in the United States and Canada.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-7.51%
Tags
acquisition
News
Eyenovia Reports Third Quarter 2023 Financial Results and Provides Business Update
Rhea-AI Summary
Eyenovia, Inc. (NASDAQ: EYEN) Acquires U.S. Commercial Rights to APP13007 from Formosa Pharmaceuticals and Announces FDA Approval of Coastline International as Contract Manufacturer for Mydcombi Cartridge Subassemblies. The company also reported its financial and operating results for the third quarter of 2023. The acquisition of APP13007, currently under FDA review, aims to complement Eyenovia's commercially approved mydriasis product, Mydcombi, potentially generating additional near-term revenue. The company also appointed Mr. Michael Geltzeiler as an independent director and Chair of the Audit Committee. FDA approval of Coastline International as a contract manufacturer for Mydcombi cartridge subassemblies enables a national launch in early 2024. Eyenovia is also advancing its Gen-2 Optejet device and continues to validate its manufacturing facilities in preparation for future commercial use.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
5.04%
Tags
earnings
Stock EYEN logo
Eyenovia Inc

Nasdaq:EYEN

EYEN Rankings

#5022 Ranked by Market Cap
#4670 Ranked by Stock Gains
N/A Ranked by Dividends

EYEN Stock Data

25.11M
36.54M
16.2%
22.44%
11.02%
Medicinal and Botanical Manufacturing
Manufacturing
Link
United States
New York

About EYEN

eyenovia, inc. (nasdaq: eyen) is a specialty biopharmaceutical company building a portfolio of next generation topical eye treatments based on its proprietary delivery and formulation platform for microdosing. eyenovia’s pipeline is currently focused on the late-stage development of microdosed medications for myopia progression, presbyopia, mydriasis and other eye diseases.