Welcome to our dedicated page for Ocular Therapeut news (Ticker: OCUL), a resource for investors and traders seeking the latest updates and insights on Ocular Therapeut stock.
Ocular Therapeutix, Inc. (NASDAQ: OCUL) generates frequent news as an ophthalmology-focused biopharmaceutical company advancing late-stage retinal programs and a commercial eye-care product. Its press releases highlight progress across the AXPAXLI (OTX-TKI) clinical programs in wet age-related macular degeneration (wet AMD) and non-proliferative diabetic retinopathy (NPDR), as well as updates related to DEXTENZA, financings, and corporate events.
News coverage for OCUL commonly includes clinical milestones such as target randomization in the SOL-R Phase 3 wet AMD trial, completion of randomization in SOL-1, and the initiation or advancement of the HELIOS Phase 3 registrational program in NPDR. The company also issues announcements about regulatory strategy, including Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration for SOL-1 and HELIOS-2 and plans to leverage the 505(b)(2) pathway for AXPAXLI in wet AMD.
Investors following OCUL news will see regular business and capital markets updates, such as underwritten equity offerings, cash runway disclosures, and inducement equity grants under Nasdaq Listing Rule 5635(c)(4). The company also reports quarterly financial results and business highlights, describing clinical execution, trial timelines, and planned extension studies like SOL-X for long-term evaluation of AXPAXLI in wet AMD.
In addition, Ocular Therapeutix announces participation in scientific and investor conferences, where it presents data from earlier-stage trials (for example, HELIOS Phase 1 results in NPDR) and discusses its strategy to "redefine the retina experience." For a consolidated view of these developments, the OCUL news page on Stock Titan brings together clinical, regulatory, financial, and corporate communications so readers can track how trial outcomes, regulatory interactions, and financing activities may shape the company’s ophthalmic pipeline and commercial portfolio over time.
Ocular Therapeutix (NASDAQ: OCUL), a biopharmaceutical company focused on developing therapies for retinal diseases and eye conditions, has announced inducement awards for its newly appointed Director of IT Cybersecurity, Russell Isaacs. The awards, granted under Ocular's 2019 Inducement Stock Incentive Plan, include:
1. Non-statutory stock options: 14,000 shares at market price, vesting over four years
2. Restricted stock unit awards: 4,666 shares, vesting over three years
These equity awards are designed to incentivize Mr. Isaacs' employment with Ocular and are subject to his continued service with the company. The grants comply with Nasdaq Listing Rule 5635(c)(4) and were effective as of September 9, 2024.
Ocular Therapeutix (NASDAQ: OCUL) announces multiple presentations at four major retina meetings in Portugal and Spain this September. The presentations focus on their innovative therapies for retinal diseases, particularly the axitinib hydrogel implant (OTX-TKI) for treating neovascular age-related macular degeneration (AMD) and diabetic retinopathy.
Key presentations include:
- 52-week results of OTX-TKI in AMD patients at The Retina Society meeting
- One-year results of OTX-TKI in diabetic retinopathy from the HELIOS Phase 1 trial
- Panel discussions on novel drug delivery approaches for posterior segment diseases
- 48-week safety and efficacy results from the HELIOS trial for non-proliferative diabetic retinopathy
These presentations highlight Ocular's transformation into a retina-focused company and its efforts to change the future paradigm for managing retinal vascular diseases.
Ocular Therapeutix (NASDAQ: OCUL), a biopharmaceutical company focused on improving vision through innovative therapies, has announced its participation in two upcoming investor conferences in September 2024. The company will be present at:
1. The Baird 2024 Global Healthcare Conference on Tuesday, September 10, with a fireside chat scheduled for 12:50 PM ET in New York, NY.
2. The H.C. Wainwright 26th Annual Global Investment Conference on Wednesday, September 11, featuring a fireside chat at 8:30 AM ET, also in New York, NY.
Investors can access a live webcast of the H.C. Wainwright fireside chat through the Investors section of Ocular Therapeutix's website at investors.ocutx.com.
Ocular Therapeutix (NASDAQ: OCUL), a biopharmaceutical company focused on improving vision through innovative therapies, has announced the granting of inducement awards to four newly hired employees. These awards, made under Ocular's 2019 Inducement Stock Incentive Plan, include:
1. Non-statutory stock options to purchase up to 132,400 shares of Ocular's common stock, with a ten-year term and a four-year vesting schedule.
2. Restricted stock unit awards representing the right to receive 44,133 shares of Ocular's common stock, with a three-year vesting schedule.
The grants, effective August 5, 2024, are designed to incentivize new employees and comply with Nasdaq Listing Rule 5635(c)(4).
Ocular Therapeutix (NASDAQ: OCUL) reported Q2 2024 results and provided updates on its AXPAXLI™ wet AMD program. Key highlights include:
1. FDA confirmed SOL-R repeat dosing study is acceptable as a registrational trial
2. SOL-1 enrollment accelerating; SOL-R actively enrolling patients
3. Cash balance of $459.7M as of June 30, 2024, expected to fund operations into 2028
4. Q2 2024 total net revenue: $16.4M, up 8.3% YoY
5. Full-year 2024 DEXTENZA revenue guidance: $62.0M - $67.0M
6. Q2 2024 net loss: $(43.8M) or $(0.26) per share
The company remains focused on becoming a leader in retinal disease treatment, with promising progress in its AXPAXLI clinical trials for wet AMD and NPDR.
Ocular Therapeutix (NASDAQ: OCUL) has received FDA confirmation that its Phase 3 SOL-R clinical trial is suitable as a registrational study for AXPAXLI™ (axitinib intravitreal implant) in treating wet age-related macular degeneration (wet AMD). The FDA agreed that using one superiority study (SOL-1) and one non-inferiority study (SOL-R) is acceptable for a potential New Drug Application. SOL-R evaluates repeat dosing of AXPAXLI every six months compared to standard aflibercept treatment. This development clarifies the regulatory path for AXPAXLI in wet AMD, potentially offering a new treatment paradigm with long-term visual improvements through durable VEGF suppression.
Ocular Therapeutix (NASDAQ:OCUL), a biopharmaceutical company focused on developing innovative therapies for retinal diseases and other eye conditions, has announced its plans to host a conference call and webcast on August 7, 2024, at 8:00 AM ET. The event will cover recent business progress and financial results for the second quarter ended June 30, 2024.
Participants can join the call using the following details:
- U.S. Dial-In: 1 (800) 343-4136
- International Dial-in: 1 (203) 518-9843
- Conference ID: OCULAR
Ocular Therapeutix (NASDAQ: OCUL) has initiated patient enrollment in the Phase 3 SOL-R clinical trial for AXPAXLI™, evaluating its efficacy in treating wet age-related macular degeneration (wet AMD). This global study involves 825 patients and aims to demonstrate non-inferiority of AXPAXLI dosed every six months compared to 2 mg aflibercept dosed every eight weeks. The trial includes a third arm with 8 mg aflibercept dosed every six months for masking purposes.
SOL-R complements the ongoing SOL-1 trial, focusing on repeat dosing to reflect real-world treatment scenarios. It will initially enroll patients ineligible for SOL-1, later expanding to include treatment-naïve patients or those recently diagnosed with wet AMD. The study design incorporates multiple aflibercept loading doses and evaluates patients to limit retinal fluid fluctuations, potentially increasing the likelihood of success.
Ocular Therapeutix (NASDAQ:OCUL), a biopharmaceutical company focused on developing therapies for eye diseases, has announced inducement awards for its new Senior Vice President and Chief of Staff, Chad Clatterbaugh. The awards, granted under Ocular's 2019 Inducement Stock Incentive Plan, include:
1. A non-statutory stock option to purchase 110,000 shares of Ocular's common stock, vesting over four years.
2. A restricted stock unit award for 36,666 shares, vesting over three years.
These awards are designed to incentivize Mr. Clatterbaugh's employment and are subject to his continued service with Ocular. The grants comply with Nasdaq Listing Rule 5635(c)(4) and were effective as of July 12, 2024.
Ocular Therapeutix announced the acceptance of a late-breaking abstract related to their Phase 1 HELIOS study for presentation at the 42nd ASRS Annual Scientific Meeting. The study evaluates AXPAXLI, an axitinib intravitreal implant, for non-proliferative diabetic retinopathy (NPDR). The presentation, titled 'Interim Safety and Efficacy Results From the Phase 1 HELIOS Trial of Sustained-release Axitinib Implant (OTX-TKI) for NPDR', is scheduled for July 18, 2024, during the Diabetic Retinopathy Symposium 2 at 10:47 – 10:51 AM CEST. Dr. Dilsher S. Dhoot will present the interim findings emphasizing the potential of AXPAXLI in treating NPDR.
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