Ocular Plans to Submit NDA for AXPAXLI in Wet AMD Following Positive SOL-1 Data
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 08 2025
0mins
Should l Buy OCUL?
Source: Newsfilter
- NDA Submission Plan: Ocular intends to submit a New Drug Application for AXPAXLI for wet AMD in Q1 2026, contingent on positive year-end data from the SOL-1 trial, which could position it as the first TKI approved in this indication with a potential best-in-class durability label.
- Clinical Trial Design: The SOL-1 trial is the only ongoing Phase 3 study conducted under a Special Protocol Assessment with the FDA, utilizing a superiority design that ensures robust statistical power, which is expected to strongly support AXPAXLI's NDA submission.
- Regulatory Pathway Optimization: Ocular plans to leverage the 505(b)(2) regulatory pathway to accelerate the review timeline for AXPAXLI, a strategy that could enable rapid market entry in the competitive wet AMD treatment landscape.
- Market Demand Response: Wet AMD affects approximately 14.5 million individuals globally, and AXPAXLI aims to significantly improve patient adherence and long-term visual outcomes by extending dosing intervals to every 6 to 12 months, addressing the urgent need for more durable therapies in the market.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy OCUL?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on OCUL
Wall Street analysts forecast OCUL stock price to rise
8 Analyst Rating
8 Buy
0 Hold
0 Sell
Strong Buy
Current: 9.060
Low
20.00
Averages
23.43
High
31.00
Current: 9.060
Low
20.00
Averages
23.43
High
31.00
About OCUL
Ocular Therapeutix, Inc. is a fully-integrated biopharmaceutical company. AXPAXLI, the Company's investigational product candidate for retinal disease, is an axitinib intravitreal hydrogel based on its ELUTYX bioresorbable hydrogel-based formulation technology. Its pipeline also leverages the ELUTYX technology in its commercial product DEXTENZA, a corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery in adults and pediatric patients, and ocular itching associated with allergic conjunctivitis in adults and pediatric patients aged two years or older, and in its investigational product candidate PAXTRAVA, which is a travoprost intracameral hydrogel for the treatment of open-angle glaucoma or ocular hypertension. The ELUTYX technology provides delivery solutions for durable therapies for wet age-related macular degeneration (wet AMD), NPDR, DME, proliferative diabetic retinopathy, retinal vein occlusion, and other diseases and conditions of the eye.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Ocular Therapeutix Reports Q4 Earnings with Revenue Decline
- Earnings Report: Ocular Therapeutix reported a Q4 GAAP EPS of -$0.29, indicating ongoing challenges in profitability and reflecting persistent financial pressures on the company.
- Revenue Decline: The company’s revenue for Q4 was $13.25 million, a 22.4% year-over-year decrease, suggesting weak product sales and market demand, which could impact future liquidity and investor confidence.
- Market Reaction: Despite the poor earnings report, Ocular Therapeutix's stock surged on reports of a potential buyout bid from Sanofi, indicating market optimism about a possible acquisition that could alter the company's strategic direction.
- Rating Downgrade: Analysts have downgraded their ratings on Ocular Therapeutix, reflecting concerns about the company's future performance, particularly given the uncertainty surrounding the outcome of a single clinical trial, which may influence investor decisions.
See More
Sanofi Prepares to Raise Bid for Ocular Therapeutix to $16 per Share
- Bid Increase: Sanofi is preparing to raise its acquisition bid for Ocular Therapeutix to $16 per share after the initial offer was rejected, indicating strong interest that could further enhance Ocular's market valuation.
- Stock Surge: Ocular Therapeutix shares surged approximately 21% in premarket trading, rising from $10.50 to $11.20, reflecting positive market sentiment regarding the acquisition news and investor optimism about the company's future.
- Market Potential: Ocular's tyrosine kinase inhibitor Axpaxli is in late-stage development for wet age-related macular degeneration (AMD), with topline data from the SOL-1 study expected in Q1 2026, potentially providing Sanofi with an entry into this lucrative market.
- Mixed Technical Indicators: Currently, Ocular's stock is trading 1.7% above its 20-day simple moving average but 0.7% below its 50-day moving average, indicating mixed short-term technical signals, although shares have increased approximately 48.34% over the past year, suggesting cautious optimism among investors.
See More
Boston Scientific Acquires Penumbra at $374 per Share
- Acquisition Deal: Boston Scientific has agreed to acquire Penumbra at $374 per share, valuing the transaction at approximately $14.5 billion, indicating strong interest in the medical device market and expected to enhance Boston Scientific's product portfolio and market share.
- Shareholder Options: Penumbra shareholders can choose between cash or Boston Scientific stock, with an overall proration of about 73% cash and 27% equity, which may attract more investor participation and enhance shareholder satisfaction.
- Strong Performance: Penumbra's preliminary fourth-quarter results exceeded expectations, with shares rising 12.1% to $351.25 on Thursday, reflecting market confidence in its future growth potential and likely boosting investor sentiment further.
- Market Reaction: The acquisition news significantly boosted Penumbra's stock price, demonstrating a positive market response to M&A activities in the healthcare sector, which may also trigger similar acquisition activities among other related companies, further energizing the market.
See More
Sanofi Prepares Enhanced Takeover Bid for Ocular Therapeutix, Shares Surge 21%
- Enhanced Bid: Sanofi is preparing an improved takeover offer for Ocular Therapeutix after the latter rejected a previous bid of $16 per share, indicating strong acquisition interest.
- Positive Market Reaction: Ocular's shares surged approximately 21% in premarket trading, reflecting investor optimism regarding Sanofi's acquisition intentions, with a market capitalization of about $2.2 billion.
- R&D Progress: Ocular's tyrosine kinase inhibitor Axpaxli is in late-stage development for wet age-related macular degeneration, with topline data expected in Q1 2026 and H1 2027, potentially adding strategic value to the acquisition.
- Changing Market Dynamics: Amid the impending loss of market exclusivity for its blockbuster asthma drug Dupixent, Sanofi has accelerated its M&A activities, demonstrating its commitment to expansion in the biopharmaceutical sector.
See More
Ocular Therapeutics (OCUL) Shares Surge 23% on Positive Late-Stage Pipeline Developments
- Clinical Trial Progress: Ocular Therapeutics' AXPAXLI shows promising results in wet age-related macular degeneration (AMD) and non-proliferative diabetic retinopathy (NPDR), with topline data expected in Q1 2026 and H1 2027, indicating potential long-term benefits of the therapy.
- Strong Financial Position: As of September 30, 2025, Ocular reported a cash balance of $344.8 million and raised approximately $445 million from its October 2025 equity offering, which is expected to fund its clinical development through 2028.
- Drug Development Strategy: The sustained-release characteristics of AXPAXLI and the development of OTX-TIC aim to reduce treatment burden and improve outcomes, reflecting Ocular's strategic focus on addressing unmet needs in the ophthalmology sector.
- Strong Stock Performance: OCUL's stock has fluctuated between $5.78 and $16.44 over the past year, closing yesterday at $11.07 with a 6.14% increase, and further rising to $13.64 in pre-market trading, marking a 23.22% gain.
See More
Ocular Therapeutix Rejects Sanofi's Bid, Stock Surges 13%
- Acquisition Proposal: Ocular Therapeutix rejected Sanofi's initial takeover bid of $16 per share in September, which represented a significant premium over its then-trading price of approximately $10.50, indicating Sanofi's interest in expanding its ophthalmology footprint.
- Market Reaction: Following the acquisition news, Ocular Therapeutix's stock surged 13% in premarket trading, reflecting investor optimism regarding the potential acquisition, while OCUL shares have gained about 34% over the past year.
- Strategic Implications: If the acquisition goes through, it would bolster Sanofi's market position in ophthalmology, particularly in age-related macular degeneration treatments, and could support the development of combination therapies by integrating Ocular's existing drugs with Sanofi's portfolio.
- Acquisition Trend: Sanofi has ramped up its acquisition strategy recently, acquiring Dynavax for $2.2 billion and Blueprint Medicines for $9.1 billion, aiming to enhance its vaccine and rare disease treatment offerings.
See More
Ocular Therapeutix Reports Q4 Earnings with Revenue Decline
- Earnings Report: Ocular Therapeutix reported a Q4 GAAP EPS of -$0.29, indicating ongoing challenges in profitability and reflecting persistent financial pressures on the company.
- Revenue Decline: The company’s revenue for Q4 was $13.25 million, a 22.4% year-over-year decrease, suggesting weak product sales and market demand, which could impact future liquidity and investor confidence.
- Market Reaction: Despite the poor earnings report, Ocular Therapeutix's stock surged on reports of a potential buyout bid from Sanofi, indicating market optimism about a possible acquisition that could alter the company's strategic direction.
- Rating Downgrade: Analysts have downgraded their ratings on Ocular Therapeutix, reflecting concerns about the company's future performance, particularly given the uncertainty surrounding the outcome of a single clinical trial, which may influence investor decisions.
See More
Sanofi Prepares to Raise Bid for Ocular Therapeutix to $16 per Share
- Bid Increase: Sanofi is preparing to raise its acquisition bid for Ocular Therapeutix to $16 per share after the initial offer was rejected, indicating strong interest that could further enhance Ocular's market valuation.
- Stock Surge: Ocular Therapeutix shares surged approximately 21% in premarket trading, rising from $10.50 to $11.20, reflecting positive market sentiment regarding the acquisition news and investor optimism about the company's future.
- Market Potential: Ocular's tyrosine kinase inhibitor Axpaxli is in late-stage development for wet age-related macular degeneration (AMD), with topline data from the SOL-1 study expected in Q1 2026, potentially providing Sanofi with an entry into this lucrative market.
- Mixed Technical Indicators: Currently, Ocular's stock is trading 1.7% above its 20-day simple moving average but 0.7% below its 50-day moving average, indicating mixed short-term technical signals, although shares have increased approximately 48.34% over the past year, suggesting cautious optimism among investors.
See More
Boston Scientific Acquires Penumbra at $374 per Share
- Acquisition Deal: Boston Scientific has agreed to acquire Penumbra at $374 per share, valuing the transaction at approximately $14.5 billion, indicating strong interest in the medical device market and expected to enhance Boston Scientific's product portfolio and market share.
- Shareholder Options: Penumbra shareholders can choose between cash or Boston Scientific stock, with an overall proration of about 73% cash and 27% equity, which may attract more investor participation and enhance shareholder satisfaction.
- Strong Performance: Penumbra's preliminary fourth-quarter results exceeded expectations, with shares rising 12.1% to $351.25 on Thursday, reflecting market confidence in its future growth potential and likely boosting investor sentiment further.
- Market Reaction: The acquisition news significantly boosted Penumbra's stock price, demonstrating a positive market response to M&A activities in the healthcare sector, which may also trigger similar acquisition activities among other related companies, further energizing the market.
See More
Sanofi Prepares Enhanced Takeover Bid for Ocular Therapeutix, Shares Surge 21%
- Enhanced Bid: Sanofi is preparing an improved takeover offer for Ocular Therapeutix after the latter rejected a previous bid of $16 per share, indicating strong acquisition interest.
- Positive Market Reaction: Ocular's shares surged approximately 21% in premarket trading, reflecting investor optimism regarding Sanofi's acquisition intentions, with a market capitalization of about $2.2 billion.
- R&D Progress: Ocular's tyrosine kinase inhibitor Axpaxli is in late-stage development for wet age-related macular degeneration, with topline data expected in Q1 2026 and H1 2027, potentially adding strategic value to the acquisition.
- Changing Market Dynamics: Amid the impending loss of market exclusivity for its blockbuster asthma drug Dupixent, Sanofi has accelerated its M&A activities, demonstrating its commitment to expansion in the biopharmaceutical sector.
See More
Ocular Therapeutics (OCUL) Shares Surge 23% on Positive Late-Stage Pipeline Developments
- Clinical Trial Progress: Ocular Therapeutics' AXPAXLI shows promising results in wet age-related macular degeneration (AMD) and non-proliferative diabetic retinopathy (NPDR), with topline data expected in Q1 2026 and H1 2027, indicating potential long-term benefits of the therapy.
- Strong Financial Position: As of September 30, 2025, Ocular reported a cash balance of $344.8 million and raised approximately $445 million from its October 2025 equity offering, which is expected to fund its clinical development through 2028.
- Drug Development Strategy: The sustained-release characteristics of AXPAXLI and the development of OTX-TIC aim to reduce treatment burden and improve outcomes, reflecting Ocular's strategic focus on addressing unmet needs in the ophthalmology sector.
- Strong Stock Performance: OCUL's stock has fluctuated between $5.78 and $16.44 over the past year, closing yesterday at $11.07 with a 6.14% increase, and further rising to $13.64 in pre-market trading, marking a 23.22% gain.
See More
Ocular Therapeutix Rejects Sanofi's Bid, Stock Surges 13%
- Acquisition Proposal: Ocular Therapeutix rejected Sanofi's initial takeover bid of $16 per share in September, which represented a significant premium over its then-trading price of approximately $10.50, indicating Sanofi's interest in expanding its ophthalmology footprint.
- Market Reaction: Following the acquisition news, Ocular Therapeutix's stock surged 13% in premarket trading, reflecting investor optimism regarding the potential acquisition, while OCUL shares have gained about 34% over the past year.
- Strategic Implications: If the acquisition goes through, it would bolster Sanofi's market position in ophthalmology, particularly in age-related macular degeneration treatments, and could support the development of combination therapies by integrating Ocular's existing drugs with Sanofi's portfolio.
- Acquisition Trend: Sanofi has ramped up its acquisition strategy recently, acquiring Dynavax for $2.2 billion and Blueprint Medicines for $9.1 billion, aiming to enhance its vaccine and rare disease treatment offerings.
See More
