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EyePoint Appoints Michael Campbell as Chief Commercial Officer
Globenewswire· 2026-02-18 12:00
Core Viewpoint - EyePoint, Inc. has appointed Michael Campbell as Chief Commercial Officer to lead the commercial strategy and launch readiness for DURAVYU, an investigational treatment for retinal diseases currently in Phase 3 development [1][2] Company Overview - EyePoint, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for serious retinal diseases, with its lead product candidate DURAVYU expected to provide significant commercial potential [8][9] - The company is headquartered in Watertown, Massachusetts, and has a commercial manufacturing facility in Northbridge, Massachusetts [9] Leadership Appointment - Michael Campbell brings over 30 years of commercial leadership experience, having successfully launched several ophthalmology products, including Lucentis and Xiidra [1][3][4] - His previous roles include Chief Commercial Officer at Opthea and Senior Vice President at Viatris Eye Care, where he led the launch of Tyrvaya [3][4] Product Development - DURAVYU is currently in Phase 3 pivotal trials for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), with topline data expected in mid-2026 [8][10] - The product is designed as a sustained delivery treatment combining vorolanib, a selective tyrosine kinase inhibitor, and is positioned to potentially be the first sustained release TKI to market [2][8] Commercial Strategy - The company aims to leverage Campbell's expertise to position DURAVYU for a successful U.S. launch, emphasizing a patient-centric approach and robust clinical data [2][8] - DURAVYU is expected to address both VEGF-mediated vascular leakage and IL-6 mediated inflammatory drivers of DME, enhancing its potential market impact [10]
C4 Therapeutics (NasdaqGS:CCCC) 2026 Conference Transcript
2026-02-11 17:32
Summary of C4 Therapeutics Conference Call Company Overview - C4 Therapeutics is focused on targeted protein degradation (TPD) with a clinical pipeline that includes its lead program, cemsidomide, an IKZF1/3 degrader, which is in later-stage clinical development [6][8] - The company has a phase 2 study called the MOMENTUM trial, which is set to start this quarter, and a phase 1/b study in combination with elranatamab planned for the second quarter [6][8] - C4 has collaborations with Betta Pharmaceuticals for an EGFR degrader in China, and ongoing partnerships with Biogen, Roche, and Merck KGaA [7] Pipeline and Development Focus - Cemsidomide is a key focus, but the company is also excited about its discovery efforts and collaborations [8] - The company plans to evaluate data from the phase 1 study for the EGFR degrader to determine potential U.S. clinical development [8] - The emphasis on discovery collaborations is crucial for the company's strategy [8] Regulatory Environment and MRD Negativity - The FDA's new draft guidance on minimal residual disease (MRD) as a surrogate endpoint for myeloma is seen as beneficial for expediting drug development [10][11] - C4 Therapeutics believes that incorporating MRD negativity as an endpoint can help de-risk drug development and support accelerated approval [11][14] - The company plans to measure MRD negativity in its trials to strengthen the case for cemsidomide's approval [13][14] Competitive Landscape - Upcoming data from Bristol's iberdomide and mezigdomide trials will provide insights into the efficacy of highly potent degraders, which could benefit the field [16][17] - C4 Therapeutics does not view these trials as direct competition but anticipates they will provide benchmark data for planning pivotal trials [17] Clinical Trial Design and Expectations - The company aims for a 40% response rate in the MOMENTUM trial, with a minimum expected response rate of 20% to support accelerated approval [25][24] - The timeline for patient enrollment is set at 12 months, with early readouts expected within a year of closing the study [26][23] - Full regulatory endpoints will require longer follow-up, projected into 2028 [26] Financing and Future Plans - Recent financing has extended the company's runway to the end of 2028, allowing for the execution of planned studies [28] - Additional funding of over $200 million could facilitate a swift transition from phase 1/b to phase 3 planning [28] Combination Studies and Dosing Strategies - The company is designing studies for cemsidomide in combination with elranatamab, focusing on patients with 2 to 4 lines of prior therapy [30] - Dosing strategies are being carefully considered to manage overlapping toxicities and ensure patient safety [34][35] Communication and Updates - C4 Therapeutics commits to providing reasonable top-line updates as the trial progresses, with the first update expected after completing the first cohort [37][39] Conclusion - C4 Therapeutics is strategically positioned in the TPD space with a strong focus on cemsidomide and its potential for accelerated approval through innovative trial designs and regulatory strategies [6][8][10]
EyePoint to Present at the Guggenheim Emerging Outlook: Biotech Summit 2026
Globenewswire· 2026-02-05 12:00
Company Overview - EyePoint, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapeutics for serious retinal diseases [3][4] - 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][5] - EyePoint has a history of four approved drugs over three decades and has treated tens of thousands of eyes with its innovations [4] Product Development - DURAVYU™ is currently undergoing Phase 3 pivotal trials for wet age-related macular degeneration, with topline data expected in mid-2026 [3] - The first patient dosing in the pivotal Phase 3 clinical trials for diabetic macular edema is anticipated in the first quarter of 2026 [3] Corporate Events - 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 February 12, 2026 [1] - A webcast and archived replay of the fireside chat will be available on the company's website [2]
C4 Therapeutics (NasdaqGS:CCCC) FY Conference Transcript
2025-12-03 21:27
Summary of C4 Therapeutics FY Conference Call Company Overview - C4 Therapeutics is a targeted protein degradation company focused on developing breakthrough medicines for patients with high unmet medical needs [3][4] - The company has two active clinical programs: - Cemsidomide (IKZF1/3 degrader) with data recently presented at IMS in Toronto, expected to enter the next phase of development early next year [3][4] - CFT8919 (EGFR L858R degrader) currently in a phase one first-in-human study in collaboration with Betta Pharmaceuticals in China [3][4] Clinical Program Updates - **Cemsidomide**: - Phase 1 dose escalation study showed an overall objective response rate (ORR) of 36% across 72 patients, with higher doses (75 micrograms and 100 micrograms) achieving ORRs of 40% and 53% respectively [6][7] - Median duration of treatment was 9.3 months, with a safety profile indicating only 6% of patients had dose reductions due to safety reasons [7][8] - 100% of patients were triple-class exposed, with 75% having prior CAR T or T cell engager therapy, showing consistent response rates across these subgroups [8][14] - **Comparison with Mezigdomide**: - Cemsidomide's response rate (53%) is competitive with mezigdomide (55%), but with a significantly better safety profile, as mezigdomide had higher rates of discontinuations and dose reductions due to safety [13][14] Future Development Plans - The company plans to advance Cemsidomide to the next phase of studies, with a meeting scheduled with the FDA to align on dosing [16][18] - The expected ORR for the upcoming 4L+ study is around 40%, based on a background rate of 20% [20] Financial and Strategic Considerations - C4 Therapeutics has a cash runway through the end of 2028, which does not include potential milestone payments of up to $40 million from collaboration partners [32] - The company is focused on moving Cemsidomide to the next phase while also supporting the ongoing study with Betta Pharmaceuticals [31][32] Commercial Considerations - Pricing for Cemsidomide is still under consideration, with the goal to be competitive based on the value it brings to patients [21] - The expected duration of response in a last-line setting is anticipated to be over six months, with current data showing 9.3 months [23] Combination Therapy Insights - C4 Therapeutics is exploring the combination of Cemsidomide with bispecific T-cell engagers, with evidence suggesting potential synergistic effects [24][25] - The study design will introduce Cemsidomide only after patients reach the loaded dose of the BiTE, with careful monitoring of safety and tolerability [26][27] Key Takeaways - C4 Therapeutics is making significant progress in its clinical programs, particularly with Cemsidomide, which shows promising efficacy and safety profiles compared to competitors - The company is strategically positioned for future growth with a solid financial runway and ongoing collaborations, while also preparing for potential commercial opportunities in the near future
EyePoint to Report Third Quarter 2025 Financial Results on November 5, 2025
Globenewswire· 2025-10-29 11:00
Core Viewpoint - EyePoint Pharmaceuticals, Inc. is set to report its third quarter 2025 financial results and discuss recent corporate developments during a conference call on November 5, 2025 [1] Company Overview - EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for serious retinal diseases [3] - The company's lead product candidate, DURAVYU, is an investigational sustained delivery treatment for serious retinal diseases, combining vorolanib, a selective tyrosine kinase inhibitor, with next-generation bioerodible Durasert E technology [3] - DURAVYU is currently undergoing evaluation in two Phase 3 pivotal trials for wet age-related macular degeneration (wet AMD), with data expected in mid-2026, and the first patient dosing in trials for diabetic macular edema (DME) anticipated in Q1 2026 [3] Product Information - Vorolanib is exclusively licensed to EyePoint for the localized treatment of all ophthalmic diseases outside of specific regions in Asia [5] - DURAVYU has received conditional acceptance from the FDA as the proprietary name for EYP-1901 (vorolanib intravitreal insert) but is not yet authorized for sale in any country [6] 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 patients [4]
C4 Therapeutics Reports Second Quarter 2025 Financial Results and Recent Business Highlights
Globenewswire· 2025-08-07 11:00
Core Insights - C4 Therapeutics, Inc. reported that cemsidomide, an investigational drug for multiple myeloma, has shown an overall response rate (ORR) of 40% at the 75 µg dose level and 50% at the 100 µg dose level in Phase 1 trials [1][7] - The company is on track to initiate registrational development for cemsidomide in early 2026 following a productive Type C meeting with the FDA [1][3] - Financial results for Q2 2025 showed total revenue of $6.5 million, a decrease from $12.0 million in Q2 2024, primarily due to a milestone payment received in the previous year [9][10] Cemsidomide Development - C4 Therapeutics completed enrollment in ongoing Phase 1 trials for cemsidomide in multiple myeloma and non-Hodgkin's lymphoma, with data to be presented at the International Myeloma Society Annual Meeting in September 2025 [3][7] - The next phase of development will evaluate cemsidomide in combination with dexamethasone and a B-cell maturation antigen bispecific T-cell engager for multiple myeloma treatment [7] Financial Performance - R&D expenses for Q2 2025 were $26.2 million, up from $23.8 million in Q2 2024, mainly due to clinical trial costs for cemsidomide [10] - General and administrative expenses decreased to $8.8 million in Q2 2025 from $9.7 million in Q2 2024 [11] - The net loss for Q2 2025 was $26.0 million, compared to $17.7 million in Q2 2024, with a net loss per share of $0.37 [11][12] Cash Position - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $223.0 million, down from $267.3 million at the end of 2024 [12][20] - The current cash position is expected to fund operations through mid-2027 [12]
EyePoint to Present at the H.C. Wainwright 5th Annual Ophthalmology Virtual Conference
Globenewswire· 2025-08-06 11:30
Core Insights - EyePoint Pharmaceuticals, Inc. is focused on developing innovative therapeutics for serious retinal diseases, with a commitment to improving patient lives [3][4] - The company will participate in the H.C. Wainwright 5th Annual Ophthalmology Virtual Conference on August 13, 2025 [1] Company Overview - EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company with a lead product candidate, DURAVYU, which is a sustained delivery treatment for VEGF-mediated retinal diseases [3] - DURAVYU combines vorolanib, a selective tyrosine kinase inhibitor, with next-generation bioerodible Durasert E technology [3] - The company is currently evaluating DURAVYU in two Phase 3 pivotal trials for wet age-related macular degeneration (wet AMD), with topline data expected in 2026 [3] - DURAVYU has also completed a positive Phase 2 clinical trial in diabetic macular edema (DME), with Phase 3 planning underway [3] - Despite existing therapies, patients with wet AMD and DME continue to experience long-term vision loss, with wet AMD being the leading cause of vision loss in individuals aged 50 and older in the U.S. [3] Product and Development - Vorolanib is exclusively licensed to EyePoint for the localized treatment of all ophthalmic diseases outside of specific regions in Asia [5] - DURAVYU has been conditionally accepted by the FDA as the proprietary name for EYP-1901, although it has not yet received FDA approval [5]
EyePoint to Report Second Quarter 2025 Financial Results on August 6, 2025
Globenewswire· 2025-07-30 11:00
Company Overview - EyePoint Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for serious retinal diseases [3] - The company is headquartered in Watertown, Massachusetts, with a commercial manufacturing facility in Northbridge, Massachusetts [4] Product Development - EyePoint's lead product candidate, DURAVYU, is an investigational sustained delivery treatment for VEGF-mediated retinal diseases, combining vorolanib, a selective tyrosine kinase inhibitor, with next-generation bioerodible Durasert E technology [3] - DURAVYU is currently being evaluated in two Phase 3 pivotal trials for wet age-related macular degeneration (wet AMD), with topline data expected in 2026 [3] - The product has also completed a positive Phase 2 clinical trial in diabetic macular edema (DME), with Phase 3 pivotal planning underway [3] - Vorolanib is exclusively licensed to EyePoint for the localized treatment of all ophthalmic diseases outside of certain regions in Asia [5] Market Context - Wet AMD is the leading cause of vision loss among individuals aged 50 and older in the United States, indicating a significant unmet medical need [3] - Despite existing therapies, patients with wet AMD and DME continue to experience long-term vision loss [3] Corporate Communication - EyePoint Pharmaceuticals will host a conference call and live webcast on August 6, 2025, to report its second quarter 2025 financial results and highlight recent corporate developments [1]
EyePoint to Report First Quarter 2025 Financial Results on May 7, 2025
Globenewswire· 2025-04-30 11:00
Core Insights - EyePoint Pharmaceuticals, Inc. is set to host a conference call on May 7, 2025, to discuss its Q1 2025 financial results and recent corporate developments [1] - The company focuses on developing innovative therapeutics for serious retinal diseases, utilizing its proprietary Durasert E™ technology for sustained intraocular drug delivery [3][4] Company Overview - EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company headquartered in Watertown, Massachusetts, with a commercial-ready manufacturing facility in Northbridge, Massachusetts [4] - The lead product candidate, DURAVYU™, is an investigational treatment for VEGF-mediated retinal diseases, currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD) and has completed a Phase 2 trial for diabetic macular edema (DME) [3][5] Pipeline and Technology - The company's pipeline includes EYP-2301, a TIE-2 agonist, and razuprotafib, both formulated in Durasert E™ to potentially enhance outcomes in serious retinal diseases [4] - Durasert technology has been safely administered to thousands of patient eyes across four FDA-approved products for various disease indications [4] Licensing and Regulatory Status - Vorolanib, the active ingredient in DURAVYU™, is exclusively licensed to EyePoint by Equinox Sciences for the treatment of ophthalmic diseases outside of specific Asian markets [5] - DURAVYU™ has received conditional acceptance from the FDA as the proprietary name for EYP-1901, but it remains investigational and has not yet been approved by the FDA [5]
EyePoint to Report Fourth Quarter and Full-Year 2024 Financial Results on March 5, 2025
Globenewswire· 2025-02-26 12:00
Core Viewpoint - EyePoint Pharmaceuticals, Inc. is set to report its fourth quarter and full-year 2024 financial results on March 5, 2025, during a conference call and live webcast [1] Company Overview - EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for serious retinal diseases [3] - The company utilizes its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery [3] - EyePoint's lead product candidate, DURAVYU™, is an investigational treatment for VEGF-mediated retinal diseases, currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD) and has completed a Phase 2 trial for diabetic macular edema (DME) [3][5] Pipeline and Development - The pipeline includes EYP-2301, a TIE-2 agonist, and razuprotafib, both formulated in Durasert E™ to potentially enhance outcomes in serious retinal diseases [4] - DURAVYU™ has been conditionally accepted by the FDA as the proprietary name for EYP-1901, although it has not yet received FDA approval [5] - Positive Phase 2 results from the VERONA clinical trial in DME have led the company to plan meetings with regulatory agencies in Q2 2025 to discuss pivotal program plans [3]