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Ocular Therapeutix™ Appoints David W. Robinson as Global Chief Commercial Officer
Globenewswire· 2026-01-21 12:00
Accomplished global commercial leader with deep expertise in retina drug launches Primary architect for the industry-defining launch of EYLEA® while at Regeneron Most recently served as Chief Marketing Officer, Global Ophthalmology at Merck BEDFORD, Mass., Jan. 21, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, today announced that David W. Robinson has agreed to join the Company as Global Chi ...
Ocular Therapeutix, Inc. (OCUL): A Bull Case Theory
Yahoo Finance· 2026-01-15 18:03
We came across a bullish thesis on Ocular Therapeutix, Inc. on TipRanks’ YouTube channel. In this article, we will summarize the bulls’ thesis on OCUL. Ocular Therapeutix, Inc.'s share was trading at $10.43 as of January 13th. nrd-aMmDIsdnUro-unsplash Ocular Therapeutics (OCUL), currently trading at $13.24, has gained 62% over the past year and 13% in the last three months, reflecting strong investor confidence in its innovative ocular therapies. The company develops and commercializes treatments for re ...
Strength Seen in Ocular Therapeutix (OCUL): Can Its 6.1% Jump Turn into More Strength?
ZACKS· 2026-01-15 15:31
Core Viewpoint - Ocular Therapeutix's stock experienced a significant increase of 6.1% to $11.07, driven by rising investor confidence in its product pipeline, particularly for Axpaxli, aimed at treating wet age-related macular degeneration [1][2]. Group 1: Stock Performance - The stock's recent gain contrasts with a 27.5% decline over the previous four weeks, indicating a potential turnaround in investor sentiment [1]. - The trading session saw a higher-than-average volume of shares exchanged, suggesting increased market interest [1]. Group 2: Product Pipeline Developments - Ocular Therapeutix plans to submit a new drug application for Axpaxli in Q1 2026, contingent on positive results from the ongoing phase III SOL-1 study [2]. - Axpaxli is also being investigated for other conditions, including diabetic retinopathy and diabetic macular edema, expanding its potential market [2]. Group 3: Financial Expectations - The company is projected to report a quarterly loss of $0.33 per share, reflecting a year-over-year decrease of 13.8% [3]. - Expected revenues for the upcoming quarter are $15.1 million, down 11.6% from the same period last year [3]. Group 4: Earnings Estimate Trends - The consensus EPS estimate for Ocular Therapeutix has remained unchanged over the last 30 days, indicating stability in earnings expectations [4]. - A lack of movement in earnings estimate revisions typically correlates with stock price trends, suggesting that future performance should be monitored closely [4]. Group 5: Industry Context - Ocular Therapeutix holds a Zacks Rank of 3 (Hold), indicating a neutral outlook within the Zacks Medical - Drugs industry [5]. - In comparison, another company in the same industry, Profound Medical, has seen a 9.1% decline in its stock price, highlighting varying performance within the sector [5][6].
Biotech outperformance expected to continue in 2026, Baird analysts say
Proactiveinvestors NA· 2026-01-09 16:46
About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...
BofA Bullish on Ocular Therapeutix (OCUL) as AXPAXLI Targets Superiority Label and Faster Regulatory Path in Wet AMD
Yahoo Finance· 2025-12-31 16:25
Ocular Therapeutix Inc. (NASDAQ:OCUL) is one of the low priced stocks to buy with high upside potential. On December 12, Bank of America raised the firm’s price target on Ocular Therapeutix to $21 from $18 and maintained a Buy rating on the shares. After hosting CEO Pravin Dugel to review upcoming corporate milestones, the firm highlighted the development strategy for AXPAXLI, supported by pivotal trials in both wet AMD and diabetic retinopathy. BofA remains optimistic about the drug’s unique competitive a ...
H.C. Wainwright Lifts Ocular Therapeutix, Inc. (OCUL) Price Target Following Intravitreal Implant FDA Submission
Yahoo Finance· 2025-12-11 12:44
Core Viewpoint - Ocular Therapeutix Inc. is highlighted as a promising biotech stock by Wall Street analysts, with a recent price target increase from $19 to $21 by H.C. Wainwright, reflecting confidence in the company's future prospects following a significant FDA submission [1][3]. Group 1: Company Developments - Ocular Therapeutix has submitted a new drug application for AXPAXLI, a 450 µg axitinib intravitreal implant, which is expected to enhance its market position [3]. - The FDA has indicated that only one pivotal clinical trial will be required for new drug approvals, which is a positive development for Ocular Therapeutix [3]. - The company is set to deliver topline results from its Phase 3 SOL-1 trial in the first quarter of the next year, utilizing the 505(b)(2) regulatory pathway to potentially expedite the review process for AXPAXLI [4]. Group 2: Leadership Insights - Pravin U. Dugel, Executive Chairman, President, and CEO of Ocular Therapeutix, expressed the company's commitment to innovation in retina treatments and indicated plans to submit the NDA for AXPAXLI for wet AMD shortly after the SOL-1 trial results, assuming they are positive [5]. Group 3: Product Focus - Ocular Therapeutix specializes in developing, manufacturing, and selling innovative eye treatments for serious eye diseases, employing proprietary hydrogel technology to deliver drugs directly to the eye, which enhances treatment efficacy for conditions such as wet AMD, glaucoma, and post-surgery pain/inflammation [5].
Ocular Therapeutix Stock Skyrockets On Faster FDA Path For Vision Drug
Benzinga· 2025-12-08 17:59
Core Viewpoint - Ocular Therapeutix Inc. plans to accelerate the submission timeline for a New Drug Application (NDA) for Axpaxli in treating wet age-related macular degeneration (wet AMD), potentially submitting it after year one data from the ongoing SOL-1 Phase 3 clinical trial, expected in the first quarter of 2026 [1][4]. Regulatory Context - The FDA has historically required two well-controlled clinical trials for ophthalmic products, but recent statements suggest a shift towards accepting a single registrational trial if adequately powered and controlled [3]. - The expedited submission could lead to a potential approval decision over a year earlier than previously expected, making Axpaxli the first long-acting TKI to market [2]. Clinical Program and Data Readouts - The company anticipates that additional data from SOL-1, SOL-R, and SOL-X will demonstrate Axpaxli's efficacy, safety, and durability, facilitating its adoption in clinical practice [5]. - Ocular Therapeutix will continue to engage with the FDA regarding the regulatory pathway for Axpaxli and provide updates as necessary [5]. Market Reaction - Following the announcement, Ocular Therapeutix shares increased by 29.57%, reaching $16.30, marking a new 52-week high [7]. - HC Wainwright has maintained a Buy rating on Ocular Therapeutix and raised the price forecast from $19 to $21 [6].
Paramount Skydance, Wave Life Sciences, Ocular Therapeutix, Carvana And Other Big Stocks Moving Higher On Monday - Arcellx (NASDAQ:ACLX), Arrowhead Pharma (NASDAQ:ARWR)
Benzinga· 2025-12-08 17:33
Group 1 - U.S. stocks experienced a decline, with the Dow Jones falling over 200 points on Monday [1] - Paramount Skydance Corporation launched an all-cash tender offer to acquire Warner Bros. Discovery, Inc. for $30 per share, valuing the company at $108.4 billion [1] - Paramount aims to create a scaled Hollywood leader by merging with Warner Bros. [1] Group 2 - Paramount Skydance shares increased by 9.8% to $14.68 on Monday [2] - Other notable stocks that gained include Wave Life Sciences Ltd., which rose 129.1% to $17.16 after positive interim Phase 1 data for its obesity drug [4] - Structure Therapeutics Inc. saw a gain of 100.5% to $69.30 following the announcement of topline data from its clinical program for obesity treatment [4] Group 3 - Fulcrum Therapeutics, Inc. shares rose 62.3% to $14.44 after reporting initial results from its Phase 1b trial for sickle cell disease [4] - Kymera Therapeutics, Inc. gained 51.2% to $100.75 after reporting successful trial results for its KT-621 drug [4] - Confluent, Inc. shares increased by 29.2% to $29.89 after IBM agreed to acquire the company for $31 per share [4]
Ocular Therapeutix™ Announces Plans to Accelerate NDA Submission Timeline for AXPAXLI™ in Wet AMD
Globenewswire· 2025-12-08 12:00
Core Insights - Ocular Therapeutix plans to submit a New Drug Application (NDA) for AXPAXLI for wet age-related macular degeneration (wet AMD) following positive year one data from the SOL-1 Phase 3 clinical trial, expected in Q1 2026 [1][2] - AXPAXLI could be the first tyrosine kinase inhibitor (TKI) approved for wet AMD, potentially offering best-in-class durability and a superiority label [1][2] - The company aims to utilize the 505(b)(2) regulatory pathway to expedite the review process for AXPAXLI [1][2] Company Overview - Ocular Therapeutix is an integrated biopharmaceutical company focused on redefining the retina experience, with AXPAXLI being a key investigational product for retinal diseases [10] - The company has developed AXPAXLI as a bioresorbable intravitreal hydrogel incorporating axitinib, which has anti-angiogenic properties [5][10] Clinical Trial Details - The SOL-1 trial is a registrational Phase 3 study designed to evaluate the safety and efficacy of AXPAXLI, involving over 100 clinical trial sites in the U.S. and Argentina, with 344 treatment-naïve subjects randomized [6][8] - The primary endpoint of the SOL-1 trial is the proportion of subjects maintaining visual acuity at Week 36, with evaluations for durability extending to Week 52 [8] Market Context - Wet AMD is a leading cause of blindness, affecting approximately 14.5 million individuals globally and 1.8 million in the U.S., with many patients requiring frequent injections [4][9] - Current anti-VEGF therapies often lead to treatment discontinuation rates of up to 40% within the first year, highlighting the need for therapies with longer dosing intervals [4][9] Potential Impact - AXPAXLI aims to extend dosing intervals to every 6 to 12 months, potentially improving treatment adherence and long-term visual outcomes without altering current treatment procedures [3][4] - If successful, AXPAXLI could significantly reduce treatment discontinuation and redefine the treatment landscape for wet AMD [3][4]
Healthcare Names Post Strong After-Hours Moves: KYMR, OCUL, POAI Among Top Gainers
RTTNews· 2025-12-08 04:09
Group 1: Market Movements - Several healthcare and biotech companies experienced notable gains in after-hours trading, driven by clinical updates, recent announcements, and technical rebounds [1] - Kymera Therapeutics Inc. (KYMR) saw a 9.58% increase to $73.00 after hours, following a modest 0.59% rise during the regular session [2] - Ocular Therapeutix Inc. (OCUL) advanced 11.29% to $14.00 after hours, with a 1.21% increase during the day [3] - Guardian Pharmacy Services Inc. (GRDN) shares rose 2.62% to $30.54 in after-hours trading, extending its earlier 1.50% gain [4] - Predictive Oncology Inc. (POAI) jumped 13.62% to $4.84 after hours, recovering from a 22% decline during the regular session [5] - Acumen Pharmaceuticals Inc. (ABOS) edged up 3.23% to $1.92 after hours, following a 6.06% drop during the day [6] - EUDA Health Holdings Ltd. (EUDA) rose 7.72% to $2.93 after hours, recovering from a 6.85% decline earlier [7] - Butterfly Network Inc. (BFLY) gained 4.90% to $3.21 after hours, after finishing the regular session flat [8] Group 2: Company-Specific Updates - Kymera Therapeutics is set to announce results from the BroADen Phase 1b clinical trial of KT-621 for atopic dermatitis on December 8, which has fueled after-hours momentum [2] - Ocular Therapeutix recently announced progress in its HELIOS-3 Phase 3 program for AXPAXLI in diabetic retinopathy, with the first patient randomized on November 24 [3] - Predictive Oncology regained compliance with Nasdaq's minimum stockholders' equity requirement, which has renewed investor confidence [5] - Acumen Pharmaceuticals presented new research at the CTAD conference, highlighting advancements in Alzheimer's treatment [6] - EUDA Health announced a securities purchase agreement for a convertible warrant valued at $100,000, providing financing flexibility for growth initiatives [7]