Ocular to present detailed SOL-1 data at the 49th Macula Society Annual Meeting on Friday, February 27, 2026, starting at 1:00 PM PT (4:00 PM ET) Company to host an investor webcast on Monday, March 2, 2026, at 7:30 AM ET to discuss the Macula Society presentations BEDFORD, Mass., Feb. 23, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, today announced that the Company will present detailed re ...

The biotech space this week witnessed significant key milestones, including FDA approvals, NDA path-setting meetings, rejections, licensing agreements, and oncology drug acquisitions. The clinical trial arena achieved positive results in therapeutic areas such as idiopathic nephrotic syndrome, age-related macular degeneration, ulcerative colitis, plaque psoriasis, obesity, autoimmune and inflammatory diseases.Let us unpack the key developments and milestones of this week. FDA Approvals & Rejections NRx Pha ...

Ocular Therapeutix Inc. (NASDAQ:OCUL) shares are down during Tuesday's premarket session following a significant announcement regarding their Axpaxli treatment for wet age-related macular degeneration (AMD). The stock is trading lower as data did not meet investor expectations. STAT News reported that Axpaxli's durability advantage over the active control was smaller than investors had anticipated, potentially raising questions about its commercial outlook in wet age-related macular degeneration, a market ...

Core Viewpoint - Johnson Fistel, PLLP is investigating potential claims on behalf of investors of Ocular Therapeutix, Inc. regarding possible recovery of investor losses under federal securities laws following a significant stock price decline after trial results announcement [1][4]. Group 1: Investigation Details - The investigation focuses on Ocular's executive officers and their compliance with federal securities laws [1][4]. - Ocular announced topline results from its SOL-1 Phase 3 trial on February 17, 2026, revealing that 74% of patients maintained vision at nine months, 66% at twelve months, and approximately 69% were rescue-free at 52 weeks [3]. - Following the announcement, Ocular's stock price declined approximately 27% [3]. Group 2: Law Firm Background - Johnson Fistel, PLLP is a nationally recognized shareholder-rights law firm with multiple offices across the United States, representing both individual and institutional investors [5]. - The firm has been ranked among the Top 10 Plaintiff Law Firms by ISS Securities Class Action Services in 2024, having recovered approximately $90.725 million for clients in cases where it served as lead or co-lead counsel [6].

Core Insights - The conference call was held to discuss the positive topline results from the SOL-1 Phase III clinical trial of AXPAXLI (OTX-TKI) for wet AMD [2][3]. Group 1: Company Overview - Ocular Therapeutix is presenting topline data from its Phase III clinical trial, indicating a significant advancement in its product pipeline [2]. - The call features remarks from key executives and clinical researchers involved in the SOL program, highlighting the collaborative effort in the trial [3]. Group 2: Clinical Trial Details - The SOL-1 trial results are positioned as a pivotal moment for Ocular Therapeutix, potentially impacting the treatment landscape for wet AMD [2]. - The involvement of prominent figures in the ophthalmology field, such as Dr. Arshad Khanani and Dr. Darius Moshfeghi, underscores the credibility and importance of the trial results [3].

Core Insights - The article discusses Ocular Therapeutix and its advancements in diabetic retinopathy and wet AMD treatments, highlighting the company's ongoing research and development efforts [2]. Company Overview - Ocular Therapeutix is focused on developing innovative therapies for eye diseases, particularly diabetic retinopathy and wet age-related macular degeneration (AMD) [2]. Investment Analysis - The author emphasizes the importance of deep-dive analysis in the biotech sector, providing insights into various pharmaceutical companies and their potential for long-term value [2]. - The Biotech Analysis Central service offers a model portfolio of over 10 small and mid-cap stocks, along with extensive analysis and news reports to assist healthcare investors [2].

This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers a deep-dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but those who sign up for the yearly plan will be able to take advantage of a 33.50% dis ...

Market Overview - The US stock market experienced a decline, with the Dow Jones Industrial Average falling 114.78 points to 49,386.15, the S&P 500 dropping 16.85 points to 6,819.32, and the Nasdaq Composite declining 78.52 points to 22,468.15 [1][26] - This decline marks continued weakness, with the Dow and S&P 500 down in four of the past five weeks [1][26] Investor Sentiment - Concerns about artificial intelligence disrupting major industries, falling oil prices following Iran-US nuclear talks, and uncertainty regarding Federal Reserve rate cuts have negatively impacted investor sentiment [2][26] - The earnings season is nearing its end, with significant corporate reports from Walmart, Constellation Energy, Medtronic, and Palo Alto Networks being closely monitored [2][26] AI and Industry Impact - Investors are increasingly questioning how artificial intelligence will reshape various industries, including wealth management, transportation, logistics, and energy [5][26] - The uncertainty surrounding AI has led to profit-taking across technology and growth stocks, contributing to a 0.35% decline in the Nasdaq and a 0.25% loss in the S&P 500 [8][26] Earnings Reports - Constellation Energy's results are being watched for insights into how AI-driven data center demand is affecting electricity consumption [9][26] - Walmart's upcoming quarterly earnings report is critical as it is the company's first update since reaching a trillion-dollar market cap, with investors focusing on consumer spending trends [11][26] Commodity Market - Commodity markets are experiencing heavy selling pressure, with WTI crude oil down 1.05% to $62.23 and Brent crude declining 0.74% to $66.11 [16][27] - The decline in oil prices may ease inflation concerns but also signals potential demand worries [27] Cryptocurrency Market - The cryptocurrency market is also facing declines, with Bitcoin falling 2.19% to $67,326 and the Nasdaq Crypto Index losing 1.91% to 3,255.42, reflecting a broad-based weakness across digital assets [21][27] Economic Indicators - Upcoming economic data, including the Personal Consumption Expenditures (PCE) inflation index and fourth-quarter GDP, could significantly influence market movements [3][22] - A new analysis from Bank of America highlights a "K-shaped economy," where corporate profits are rising while labor income is falling, indicating potential long-term pressures on consumer spending [24][26]

Summary of Ocular Therapeutix SOL-1 Top Line Data Conference Call Company Overview - **Company**: Ocular Therapeutix (NasdaqGM: OCUL) - **Product**: AXPAXLI (OTX-TKI) - **Indication**: Wet Age-related Macular Degeneration (AMD) Key Points from the Conference Call Clinical Trial Results - **SOL-1 Phase 3 Trial**: Positive top-line results announced for AXPAXLI, demonstrating significant efficacy in treating wet AMD [2][4] - **Vision Maintenance**: 74.1% of subjects maintained vision through week 36, with 65.9% maintaining vision through week 52 [5][19] - **Central Subfield Thickness (CSFT)**: 55.9% maintained CSFT within 30 microns of baseline at week 36, and 44.1% at week 52 [5][40] - **Statistical Superiority**: AXPAXLI demonstrated superiority over aflibercept (Eylea) with an 18.3% difference in vision maintenance at week 36 (74.1% vs. 55.8%) and a p-value of 0.0006 [8][11] Mechanism of Action - **Novel Mechanism**: AXPAXLI is the first investigational product in wet AMD with a novel mechanism of action to show superiority to an approved anti-VEGF agent in over 20 years [6][40] Safety Profile - **Well-Tolerated**: AXPAXLI showed a reassuring safety profile with no observed treatment-related ocular or systemic serious adverse events [11][41] - **Durability and Safety**: The combination of durability and safety is expected to facilitate real-world adoption [11][30] Implications for Treatment Paradigm - **Reduced Treatment Burden**: AXPAXLI aims to break the cycle of treatment burden and long-term vision loss, offering a therapy that patients can stay on [7][19] - **Potential for Fixed Dosing**: The ongoing SOLR trial is designed to evaluate fixed six-month dosing, which may yield even better results in a more stable patient population [12][24] Market Positioning - **Immediate Adoption**: If approved, AXPAXLI is expected to be rapidly adopted by retinal specialists due to its safety, durability, and seamless integration into existing workflows [13][30] - **Regulatory Pathway**: Plans to submit an NDA through the accelerated 505(b)(2) pathway, aiming to become the first TKI in the retinal market with a superiority label [39][41] Future Outlook - **Upcoming Presentations**: Detailed results will be shared at the 49th Macular Society Annual Meeting [15][42] - **Long-term Strategy**: A robust patent estate extending into 2044 supports long-term differentiation and sustained value creation [42] Additional Insights - **Rescue-Free Rates**: 80.6% of AXPAXLI-treated subjects were rescue-free at week 24, indicating strong clinical relevance [23][41] - **Clinical Relevance of Data**: The data from SOL-1 provides a clear and clinically intuitive read-through to the ongoing SOLR trial, reinforcing confidence in AXPAXLI's potential [41][42] This summary encapsulates the critical findings and implications from the Ocular Therapeutix conference call regarding AXPAXLI's performance in the SOL-1 trial, highlighting its potential to transform the treatment landscape for wet AMD.

At 7:05 a.m. ET on Tuesday, premarket trading is seeing notable activity in several stocks, with early price movements signaling potential opportunities before the opening bell.For active traders, premarket trading offers a head start in spotting potential breakouts, reversals, or sharp price swings. These early moves often indicate where momentum may carry into the regular session, making premarket analysis a key part of the trading day.In the Green - Premarket GainersThe following stocks are trading high ...