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EyePoint to Present at the Guggenheim Emerging Outlook: Biotech Summit 2026
Globenewswire· 2026-02-05 12:00
WATERTOWN, Mass., Feb. 05, 2026 (GLOBE NEWSWIRE) -- EyePoint, Inc. (Nasdaq: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced that George O. Elston, Executive Vice President and Chief Financial Officer of EyePoint, will participate in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit 2026 on Thursday, February 12, 2026 at 11:00 am ET. A webcast and subsequent archived replay of ...
EyePoint, Inc. (EYPT) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript
Seeking Alpha· 2026-01-13 19:26
Company Overview - EyePoint is a leader in sustained-release drug delivery for retinal diseases [3] - The company's lead product, DURAVYU, is currently in Phase III trials for wet age-related macular degeneration [3] - Both Phase III trials for DURAVYU are fully enrolled, with top-line data expected midyear [3] Product Development - DURAVYU is also in Phase III trials for diabetic macular edema (DME), with the first patients expected to be dosed this quarter [3] - The proprietary delivery system, Durasert, has been utilized in four FDA-approved products, demonstrating a strong safety and efficacy record [3] Leadership and Experience - EyePoint has a veteran leadership team with over three decades of experience in clinical drug development and successful commercialization [3]
EyePoint Pharmaceuticals (NasdaqGM:EYPT) FY Conference Transcript
2026-01-13 16:32
EyePoint Pharmaceuticals Conference Call Summary Company Overview - **Company**: EyePoint Pharmaceuticals (NasdaqGM:EYPT) - **Industry**: Biotechnology, specifically focused on sustained-release drug delivery for retinal diseases Key Points and Arguments Product Development - **Lead Product**: Duraview, currently in phase III trials for wet age-related macular degeneration (AMD) and diabetic macular edema (DME) [2][4] - **Trial Status**: Both phase III trials for wet AMD are fully enrolled, with top-line data expected mid-year 2026 [2][12] - **Durasert Technology**: Proprietary delivery system with a strong safety and efficacy record, used in four FDA-approved products [3][6] - **Financial Position**: Approximately $300 million in cash, providing a runway well past data readouts into the end of 2027 [4][55] Market Potential - **Market Size**: The retinal disease market is significant, with recent products like Vabysmo generating nearly $4.5 billion in revenue [4][31] - **Unmet Needs**: Key unmet needs in VEGF-mediated diseases include longevity of treatment and new mechanisms of action [5][6] - **Competitive Landscape**: EyePoint aims to be first to market with a sustained-release option, competing against established products like Eylea and Vabysmo [12][44] Clinical Trial Insights - **Efficacy**: Duraview showed statistically non-inferior results compared to Eylea in previous trials, with a significant reduction in treatment burden (75%-90%) [17][41] - **Safety Profile**: No reported ocular systemic serious adverse events (SAEs) in completed trials, with ongoing monitoring showing similar safety [11][12] - **DME Trials**: Two phase III trials (COMO and CAPRI) are underway, leveraging safety data from wet AMD trials [24][52] Product Advantages - **Multi-Mechanism of Action (MOA)**: Duraview blocks both VEGF and IL-6, addressing inflammation and vascular leakage [5][6][9] - **Durability**: Sustained release for at least six months, with potential for longer intervals between doses [10][18] - **Convenience**: Can be stored at room temperature, unlike competitors that require refrigeration [9] Commercial Strategy - **Market Adoption**: Education of physicians on the dual mechanism of action and integration into existing treatment regimens is crucial for adoption [49] - **Regulatory Pathway**: Trials designed in alignment with FDA and EMA, aiming for a non-inferiority regulatory pathway [13][14] Future Outlook - **Data Readouts**: Top-line data for wet AMD trials expected in mid-2026, with DME trials following [14][29] - **Cash Management**: Sufficient cash reserves to support ongoing trials and commercial buildout [55][56] Additional Important Information - **Facility**: EyePoint has a commercial manufacturing facility in Northbridge, Massachusetts, built to FDA and EMA standards, capable of producing hundreds of thousands of inserts annually [22][56] - **Physician Feedback**: Positive feedback from physicians regarding Duraview's unique profile and potential to reduce treatment burden [32][47] - **Competitive Trials**: Ongoing studies in the TKI space are expected to show positive results, reinforcing the efficacy of TKIs in retinal diseases [50] This summary encapsulates the critical insights from the conference call, highlighting EyePoint Pharmaceuticals' strategic positioning, product development, and market potential in the retinal disease sector.
EyePoint Pharmaceuticals (NasdaqGM:EYPT) FY Earnings Call Presentation
2026-01-13 15:30
J.P. Morgan Healthcare Conference Presentation January 13, 2026 Jay S. Duker, M.D. President and CEO © 2026 EyePoint. All Rights Reserved. Legal Disclaimers Various statements made in this presentation are forward-looking, within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect, plan or believe may occur in t ...
EyePoint Pharmaceuticals (NasdaqGM:EYPT) Earnings Call Presentation
2026-01-12 12:00
Investor Presentation January 2026 © 2026 EyePoint. All Rights Reserved. Legal Disclaimers Various statements made in this presentation are forward-looking, within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect, plan or believe may occur in the future, are forward-looking statements, including but not limit ...
EyePoint Pharmaceuticals(EYPT) - 2025 Q4 - Annual Results
2026-01-07 12:05
Product Development - EyePoint's lead product candidate, DURAVYU™, is currently in Phase 3 trials for wet AMD and DME, with topline data expected in mid-2026[2] - Over 900 patients have been enrolled in the Phase 3 LUGANO and LUCIA trials within 7 months, making it one of the fastest enrolling wet AMD pivotal programs[4] - The Phase 3 wet AMD program has a primary endpoint of noninferiority in best corrected visual acuity (BCVA) at weeks 52 and 56, compared to aflibercept[6] - First patient dosing in the Phase 3 DME trials (COMO and CAPRI) is expected in Q1 2026, with each trial enrolling approximately 240 patients[6] - The independent Data Safety Monitoring Committee recommended the continuation of the Phase 3 program with no protocol modifications[6] Treatment Efficacy - DURAVYU demonstrated an 88% reduction in treatment burden six months after treatment, with over 80% of patients being supplement-free or requiring only one supplemental anti-VEGF injection[10] - DURAVYU's multi-mechanism of action includes a greater than 50% reduction in IL-6 activity, which is significant for treating wet AMD and DME[6] - DURAVYU is positioned as the only sustained release TKI in development for DME, addressing a significant need for new therapeutic options[3] Financial Overview - The company completed a public offering with gross proceeds of $172.5 million in October 2025, with approximately $300 million in cash and investments as of December 31, 2025[6] - EyePoint is preparing for an expeditious NDA filing and FDA review to deliver DURAVYU to patients as soon as possible[3]
EyePoint Reports Corporate Update and Anticipated Pivotal Milestones for 2026
Globenewswire· 2026-01-07 12:00
Core Insights - EyePoint, Inc. is advancing its lead product candidate, DURAVYU, through pivotal Phase 3 trials for wet age-related macular degeneration (AMD) and diabetic macular edema (DME), with significant milestones expected in 2026 [1][2] Company Updates - DURAVYU is positioned as a unique sustained-release treatment for retinal diseases, with pivotal trials for wet AMD on track for data readout starting mid-2026 and first patient dosing for DME expected in Q1 2026 [1][2] - The company reported a successful year in 2025, focusing on scientific rigor and a patient-centric approach, aiming for expedited NDA filing and FDA review for DURAVYU [2][4] - EyePoint completed enrollment of over 900 patients in the Phase 3 trials for wet AMD, making it one of the fastest enrolling programs in this space [4] Product Details - DURAVYU (vorolanib intravitreal insert) is designed for sustained drug delivery, releasing therapeutic doses for at least six months via a simple in-office injection [8][9] - Vorolanib, a tyrosine kinase inhibitor, has shown no ocular safety signals in previous trials and targets both VEGF-mediated vascular permeability and IL-6 mediated inflammation [9][10] - The Phase 3 trials for wet AMD (LUGANO and LUCIA) are designed to demonstrate noninferiority compared to aflibercept, with primary endpoints focused on visual acuity changes [4][11] Financial Position - EyePoint raised $172.5 million in a public offering in October 2025, with approximately $300 million in cash and investments as of December 31, 2025, providing a cash runway into Q4 2027 [11][12] Upcoming Events - The company will present at the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026, highlighting its advancements and future plans [1][11]
EyePoint (EYPT) Is Up 9.01% in One Week: What You Should Know
ZACKS· 2025-12-22 18:01
Core Viewpoint - Momentum investing focuses on following a stock's recent price trends, aiming to buy high and sell higher, with the expectation that established trends will continue [1] Company Overview: EyePoint (EYPT) - EyePoint currently holds a Momentum Style Score of A, indicating strong momentum characteristics [2] - The company has a Zacks Rank of 2 (Buy), suggesting it is positioned for potential outperformance in the market [3] Performance Metrics - Over the past week, EYPT shares increased by 9.01%, while the Zacks Medical - Biomedical and Genetics industry declined by 1.33% [5] - In a longer timeframe, EYPT's shares rose by 27.41% over the past month, significantly outperforming the industry's 0.8% [5] - For the last three months, EYPT shares have increased by 25.4%, and over the past year, they have surged by 145.49%, compared to the S&P 500's gains of 2.85% and 17.84%, respectively [6] Trading Volume - EYPT's average 20-day trading volume is 1,226,230 shares, which serves as a bullish indicator when combined with rising stock prices [7] Earnings Outlook - In the past two months, three earnings estimates for EYPT have been revised upwards, while none have been lowered, leading to an increase in the consensus estimate from -$3.06 to -$3.00 [9] - For the next fiscal year, three estimates have also moved upwards with no downward revisions [9] Conclusion - Given the strong performance metrics and positive earnings outlook, EYPT is positioned as a solid momentum pick with a Momentum Score of A and a Zacks Rank of 2 (Buy) [11]
3 Biotech Stocks Wall Street Analysts Are Bullish on for 2026
ZACKS· 2025-12-22 14:11
Industry Overview - The biotech sector has shown a strong recovery in 2025, with the Nasdaq Biotechnology Index rising by 33.1% year to date after bottoming out in April 2025 due to potential steep tariffs impacting the pharma and biotech sectors [1][2] - Key drivers of this rally include new drug approvals, a positive pipeline, regulatory updates, and a surge in mergers and acquisitions (M&A) activity, with the FDA approving over 42 drugs so far this year [2][3] M&A Activity - The year has seen a significant increase in M&A activity, driven by the changing landscape and focus on AI-driven drug discovery, as large pharmaceutical and biotech companies seek to expand and diversify their product portfolios amid rising generic competition [3] Regulatory Agreements - The Trump administration has signed agreements with major pharma and biotech companies, including Gilead Sciences, Amgen, Merck, and Novartis, aimed at lowering prescription drug prices for chronic conditions [4] - These companies are expected to collectively invest at least $150 billion in domestic production in the near term, indicating a commitment to innovation in medical treatments [5] Company Highlights EyePoint, Inc. (EYPT) - EYPT focuses on developing innovative therapeutics for serious retinal diseases, with its lead candidate, Duravyu, being evaluated in late-stage studies for wet age-related macular degeneration [7][11] - EYPT's shares have surged by 140.5% in 2025, with a current average target price of $34.18 representing an upside of 100.35% [12] ANI Pharmaceuticals (ANIP) - ANIP is a diversified biopharmaceutical company with a strong focus on rare diseases, particularly through its ACTH-based injection, Cortrophin Gel, which saw sales jump by 70% year over year to $236 million in the first nine months of 2025 [13][14] - The stock has gained 52.9% over the year, with a current average target price of $109.25 representing an upside of 31.9% [16] Tango Therapeutics (TNGX) - Tango Therapeutics is focused on precision oncology, developing treatments based on synthetic lethality for specific tumors, with promising pipeline candidates including PRMT5 inhibitors for various cancers [17][19] - TNGX shares have increased by 163.8% in the past year, with a current average target price of $13.22 representing an upside of 56.26% [21]
EyePoint to Present at the 44th Annual J.P. Morgan Healthcare Conference
Globenewswire· 2025-12-17 12:00
Core Insights - EyePoint, Inc. is focused on developing innovative therapeutics for serious retinal diseases and will present at the J.P. Morgan Healthcare Conference on January 13, 2026 [1] Company Overview - EyePoint, Inc. is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients with serious retinal diseases [3] - The company's lead product candidate, DURAVYU, is an investigational sustained delivery treatment combining vorolanib, a selective tyrosine kinase inhibitor, with next-generation bioerodible Durasert E technology [3] - DURAVYU is currently in Phase 3 pivotal trials for wet age-related macular degeneration, with topline data expected in mid-2026, and first patient dosing in diabetic macular edema trials anticipated in Q1 2026 [3] Product and Development - Vorolanib is exclusively licensed to EyePoint for the localized treatment of ophthalmic diseases outside of specific regions in Asia [5] - DURAVYU has been conditionally accepted by the FDA as the proprietary name for EYP-1901, but it remains an investigational product and has not yet received FDA approval [5] Commitment to Community - The company aims to partner with the retina community to enhance patient lives while creating long-term value, having developed four approved drugs over three decades and treated tens of thousands of eyes [4]