Ocular Therapeutix Inc. (NASDAQ:OCUL) is one of the best biotech stocks to buy according to Wall Street analysts. On December 8, H.C. Wainwright reiterated a Buy rating on Ocular Therapeutix Inc. (NASDAQ:OCUL) and raised the price target to $21 from $19. H.C. Wainwright Lifts Ocular Therapeutix, Inc. (OCUL) Price Target Following Intravitreal Implant FDA Submission The research firm remains confident about the company’s outlook following the submission of a new drug application for AXPAXLI, its 450 µg ax ...

Ocular Therapeutix Inc. (NASDAQ:OCUL) stock surged on Monday after the company announced plans to accelerate the timeline for submitting a New Drug Application (NDA) for Axpaxli (OTX-TKI) in the treatment of wet age-related macular degeneration (wet AMD).The company intends to submit an NDA for Axpaxli following year one data, if positive, from its ongoing SOL-1 Phase 3 clinical trial, for which data are on track for the first quarter of 2026.William Blair noted, “Compared to prior expectations of filing af ...

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 intends to submit AXPAXLI New Drug Application (NDA) for wet AMD shortly after year one data from SOL-1, if positive SOL-1 topline data remain on track for 1Q 2026 Ocular plans to leverage the 505(b)(2) regulatory pathway for new drug approvals which has the potential to shorten the review timeline for AXPAXLI If approved, AXPAXLI could be the first TKI to be commercialized in wet AMD, with a potential superiority label and best-in-class durability BEDFORD, Mass., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Oc ...

Several healthcare and biotech names posted notable gains in Friday's after-hours trading session, with momentum driven by clinical updates, recent announcements, and technical rebounds.Kymera Therapeutics Inc. (KYMR) surged in extended trading, climbing to $73.00, a 9.58% rise from the close. Shares had ended the regular session at $66.62, up modestly by 0.59%. The company is preparing to announce results from the BroADen Phase 1b clinical trial of KT-621, its oral STAT6 degrader for moderate to severe at ...

Ocular Therapeutix (NasdaqGM:OCUL) FY Conference December 03, 2025 08:30 AM ET Company ParticipantsPravin Dugel - CEOConference Call ParticipantsNone - AnalystNoneOkay, let's kick things off. Welcome, everyone, to the Piper Sandler Healthcare Conference. I'd like to introduce our next company. We have Ocular Therapeutix and their CEO, Pravin Dugel. Welcome, Pravin. You know, I know the company really well, but maybe for the audience and for those on the webcast, if you could maybe just provide an overview o ...

Core Insights - The initiation of the HELIOS registrational program represents a significant advancement in the treatment of diabetic retinal disease, with AXPAXLI potentially addressing the needs of over 6 million NPDR patients in the U.S. who currently receive minimal therapy due to treatment burdens [2][3] - The HELIOS-2 and HELIOS-3 trials are designed to evaluate the efficacy of AXPAXLI in treating non-proliferative diabetic retinopathy (NPDR) and aim for a broad diabetic retinopathy label, including patients with non-center-involved diabetic macular edema (non-CI-DME) [2][3][12] - AXPAXLI is expected to provide durable efficacy with less frequent dosing, which could significantly improve patient adherence and outcomes compared to current treatment options that require frequent injections [2][3][12] Company Overview - Ocular Therapeutix, Inc. is an integrated biopharmaceutical company focused on redefining the retina experience through innovative treatments for retinal diseases, including AXPAXLI, which is currently in Phase 3 clinical trials for wet AMD and NPDR [14][15] - AXPAXLI is a bioresorbable intravitreal hydrogel that incorporates axitinib, a multi-target tyrosine kinase inhibitor with anti-angiogenic properties, aimed at treating various retinal diseases [4][5] HELIOS Program Details - The HELIOS program consists of two complementary superiority studies: HELIOS-2 and HELIOS-3, which will assess the safety and efficacy of AXPAXLI in approximately 432 and 930 subjects, respectively, with moderately severe to severe NPDR [6][9] - Both studies utilize a novel ordinal diabetic retinopathy severity score (DRSS) as the primary endpoint, focusing on changes in severity at Week 52 from baseline [8][11] - HELIOS-2 compares AXPAXLI dosed every 12 months to ranibizumab, while HELIOS-3 evaluates different dosing regimens of AXPAXLI against sham treatment [7][10] Industry Context - Diabetic retinopathy is a prevalent condition affecting over 103 million people globally, with a significant portion of NPDR patients remaining untreated due to the burdensome nature of existing therapies [12][13] - The HELIOS trials aim to address the unmet need for effective treatments with durable efficacy, potentially transforming care for diabetic retinal disease and improving patient outcomes [3][12]

Core Viewpoint - Ocular Therapeutix (OCUL) shares have increased by 6.7% recently, with a mean price target of $22.08 suggesting a potential upside of 82.5% from the current price of $12.1 [1] Price Targets - The average of 12 short-term price targets ranges from a low of $18.00 to a high of $31.00, with a standard deviation of $4.23, indicating variability among analysts [2] - The lowest estimate suggests a 48.8% increase, while the highest points to a 156.2% upside [2] Analyst Consensus - There is strong agreement among analysts regarding OCUL's ability to report better earnings than previously predicted, which supports the potential for stock upside [4] - The Zacks Consensus Estimate for the current year has risen by 2.5% over the past month, with five estimates increasing and no negative revisions [12] Zacks Rank - OCUL holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating a strong potential for upside [13] Earnings Estimate Revisions - Increasing optimism among analysts about OCUL's earnings prospects is reflected in the upward revisions of EPS estimates, which have a strong correlation with near-term stock price movements [11]

Summary of Ocular Therapeutix Conference Call Company Overview - **Company**: Ocular Therapeutix (NasdaqGM: OCUL) - **Focus**: Development of innovative therapies for retinal diseases, particularly through their lead program AXPAXLI Key Points and Arguments Clinical Trials and Drug Development - Ocular Therapeutix is currently conducting two pivotal Phase III clinical trials: SOL-1 (superiority study) and SOLAR (non-inferiority study) [3][10] - SOL-1 results are expected in Q1 2026, while SOLAR results are anticipated in the first half of 2027 [3][4] - AXPAXLI is a TKI (tyrosine kinase inhibitor) on an attunable hydrogel platform, showing promising results in studies conducted in Australia and the U.S. [5][6] - AXPAXLI is reported to be 100 times more potent and 50 times more selective than other TKIs [5] Unmet Needs in Retinal Diseases - There is a significant dropout rate of 40% in wet macular degeneration treatments, leading to blindness for many patients [6] - AXPAXLI aims to provide a sustainable treatment option, allowing for annual injections instead of monthly or bi-monthly visits [8] - For diabetic retinopathy, less than 1% of patients currently receive treatment, despite the high risk of complications [7][30] Confidence in Clinical Trial Design - The design of SOL-1 and SOLAR trials follows FDA guidelines, with a focus on de-risking patient populations [12][15] - SOL-1 has a rescue-free rate of 100% at six months and 80% at twelve months, indicating strong efficacy [11] - The superiority label is considered a significant advantage, as it differentiates AXPAXLI from other anti-VEGF treatments [16][18] Regulatory Pathway - Ocular Therapeutix plans to utilize a 505(b)(2) regulatory pathway for expedited approval, leveraging existing FDA-approved components of AXPAXLI [28][29] - The company expects to submit for approval immediately after successful SOLAR results [28] Market Opportunity - The target market for diabetic retinopathy is estimated to be 3.5 times larger than that for wet macular degeneration, with a substantial unmet need [30] - AXPAXLI is designed to address both diabetic retinopathy and diabetic macular edema, potentially leading to a broad label for treatment [32][38] Commercial Strategy - Ocular Therapeutix has an existing product, Dextenza, which provides a foundation for scaling up their commercial efforts in ophthalmology [39] - The company is well-capitalized and does not currently see a need for partnerships or licensing opportunities for the commercialization of AXPAXLI [40] Additional Important Information - The company has a strong intellectual property position, with extensions to 2044, enhancing the attractiveness of AXPAXLI [17] - The novel ordinal endpoint for diabetic retinopathy studies has been accepted by the FDA, increasing the likelihood of successful outcomes in future trials [34][35] This summary encapsulates the critical insights from the Ocular Therapeutix conference call, highlighting the company's strategic direction, clinical advancements, and market potential in the field of retinal diseases.

Company Participation in Investor Conferences - Ocular Therapeutix, Inc. will participate in several investor conferences in November and December 2025, including the Jefferies Global Healthcare Conference and the Piper Sandler 37th Annual Healthcare Conference [1][2] Leadership Presentation Details - Pravin U. Dugel, MD, Executive Chairman, President and CEO, will present at both conferences, with the Jefferies conference scheduled for November 18, 2025, and the Piper Sandler conference on December 3, 2025 [2] Product Pipeline and Clinical Trials - Ocular Therapeutix is focused on redefining the retina experience with its investigational product AXPAXLI™ (OTX-TKI), currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD) and planning to initiate a Phase 3 program for non-proliferative diabetic retinopathy (NPDR) imminently [3] - The company also leverages its proprietary ELUTYX™ technology in its commercial product DEXTENZA, an FDA-approved corticosteroid for treating ocular inflammation and pain, and in the investigational product OTX-TIC, which has completed a Phase 2 clinical trial for open-angle glaucoma or ocular hypertension [4]