Ocular Therapeutix Releases Axpaxli Trial Data, Stock Drops 22%
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 day ago
0mins
Should l Buy OCUL?
Source: seekingalpha
- Clinical Trial Results: Ocular Therapeutix's SOL-1 Phase 3 trial showed that approximately 74% of patients on Axpaxli maintained vision at Week 36, compared to about 56% for aflibercept, indicating a significant therapeutic advantage for Axpaxli in treating wet age-related macular degeneration.
- Safety Assessment: The company reported that the intravitreal implant of Axpaxli was generally well tolerated, with no serious ocular or systemic adverse events related to the drug, which lays a solid foundation for its future market introduction.
- Regulatory Submission Plans: Ocular Therapeutix intends to submit a New Drug Application to the FDA for Axpaxli pending regulatory feedback, and if approved, it will be the first TKI available in the U.S. for wet AMD, representing substantial market potential.
- Market Reaction: Despite the encouraging trial results, Ocular Therapeutix's stock fell approximately 22% in premarket trading, reflecting market caution regarding the drug's future commercialization prospects.
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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: 6.990
Low
20.00
Averages
23.43
High
31.00
Current: 6.990
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 STOCK PLUMMETS 23.5% FOLLOWING RELEASE OF LATE-STAGE EYE DISEASE TRIAL RESULTS
- Stock Price Decline: Ocular Therapeutix shares fell by 23.5% following recent reports related to a late-stage trial for an eye disease treatment.
- Trial Data Impact: The decline in stock price is attributed to concerns raised by the trial data, which may affect investor confidence and future prospects for the company.
See More
Ocular Therapeutix Set to Release Axpaxli Phase 3 Trial Results
- Trial Results Announcement: Ocular Therapeutix is set to announce topline results from its Phase 3 trial of Axpaxli for wet AMD treatment on Tuesday, with the market closely monitoring this event, which is expected to positively impact the company's stock price.
- Significant Stock Surge: Ahead of the clinical data release, Ocular Therapeutix shares surged nearly 40% in Monday trading, reflecting strong investor optimism about Axpaxli, potentially pushing the company's valuation close to $2.2 billion.
- Acquisition Potential Renewed: As interest in Axpaxli intensifies, Sanofi is revisiting a potential acquisition of Ocular, having previously declined a $16 per share offer when the stock was trading around $10.5, indicating a market reassessment of the company's value.
- Increased Analyst Support: Analysts have shown growing optimism for Axpaxli, with Bank of America and TD Cowen maintaining 'Buy' ratings and projecting peak sales potential of $1 billion in wet AMD, reflecting confidence in the drug's long-term growth prospects.
See More
U.S. Stocks Mostly Lower, Nasdaq Drops Over 50 Points
- Market Performance: U.S. stocks traded mostly lower on Tuesday, with the Nasdaq Composite falling over 50 points, and the S&P 500 dropping 0.13% to 6,827.16, indicating a cautious investor sentiment amid market weakness.
- Company Highlights: Medtronic PLC (NYSE:MDT) reported an adjusted EPS of $1.36 for Q3, exceeding market expectations of $1.33, with quarterly sales of $9.017 billion surpassing the $8.905 billion forecast, showcasing the company's strong earnings capability.
- Sector Dynamics: Financial shares gained 0.9%, while materials stocks fell by 2%, reflecting a divergence in market performance as investors may be seeking more defensive investment opportunities amidst volatility.
- Economic Indicators: According to ADP Research, U.S. private employers added an average of 10,250 jobs per week during the four weeks ending January 31, up from 7,750 in the previous period, indicating an improving labor market trend.
See More
Ocular Therapeutix Shares Drop Following Axpaxli Trial Data Disappointment
- Clinical Trial Results: Ocular Therapeutix reported that 74.1% of patients maintained vision at Week 36 in the SOL-1 Phase 3 trial for Axpaxli, compared to 65.9% in the Eylea group, with a risk difference of 17.5% (p=0.0006); however, the durability advantage fell short of expectations, potentially impacting its commercial outlook.
- Next Steps: The company intends to submit a New Drug Application (NDA) based on the SOL-1 data, and if approved, Axpaxli could become the first tyrosine kinase inhibitor (TKI) commercialized for wet AMD, potentially being the only therapy with a superiority label, which holds significant strategic implications.
- Market Reaction: Ocular Therapeutix shares fell 26.46% in premarket trading, currently priced at $6.62, reflecting market disappointment over the Axpaxli data, despite a 23.33% increase over the past 12 months, indicating a generally positive long-term trend.
- Analyst Ratings: The stock maintains a Buy rating with an average price target of $21.00, with Chardan Capital and Needham keeping their targets unchanged, while HC Wainwright raised its target to $21.00, reflecting analysts' optimistic outlook for the future.
See More
Ocular Therapeutix Releases Axpaxli Trial Data, Stock Drops 22%
- Clinical Trial Results: Ocular Therapeutix's SOL-1 Phase 3 trial showed that approximately 74% of patients on Axpaxli maintained vision at Week 36, compared to about 56% for aflibercept, indicating a significant therapeutic advantage for Axpaxli in treating wet age-related macular degeneration.
- Safety Assessment: The company reported that the intravitreal implant of Axpaxli was generally well tolerated, with no serious ocular or systemic adverse events related to the drug, which lays a solid foundation for its future market introduction.
- Regulatory Submission Plans: Ocular Therapeutix intends to submit a New Drug Application to the FDA for Axpaxli pending regulatory feedback, and if approved, it will be the first TKI available in the U.S. for wet AMD, representing substantial market potential.
- Market Reaction: Despite the encouraging trial results, Ocular Therapeutix's stock fell approximately 22% in premarket trading, reflecting market caution regarding the drug's future commercialization prospects.
See More
U.S. Stock Futures Fluctuate Amid Government Shutdown Impact
- Market Fluctuations: U.S. stock futures showed volatility on Tuesday following a mixed close on Friday, with the S&P 500 down 1.4%, the Dow slipping 1.2%, and the Nasdaq declining 2.1% last week, reflecting cautious investor sentiment amid uncertainty.
- Government Shutdown Impact: The failure of Congressional Democrats and the Trump administration to reach a funding deal through September has triggered a partial government shutdown, which could exacerbate market instability and undermine investor confidence.
- Bond Yields: The 10-year Treasury bond yield stands at 4.02%, while the two-year bond yield is at 3.39%, indicating market expectations for future interest rate policies, with the CME Group's FedWatch tool showing a 90.2% likelihood of rates remaining unchanged in March.
- Stock Performance: Ocular Therapeutix's stock surged 33.56% ahead of its clinical trial data release for dry eye disease, while ZIM Integrated Shipping Services rose 34.46% following its acquisition agreement with Hapag-Lloyd, highlighting positive market reactions in specific sectors.
See More
OCULAR THERAPEUTIX STOCK PLUMMETS 23.5% FOLLOWING RELEASE OF LATE-STAGE EYE DISEASE TRIAL RESULTS
- Stock Price Decline: Ocular Therapeutix shares fell by 23.5% following recent reports related to a late-stage trial for an eye disease treatment.
- Trial Data Impact: The decline in stock price is attributed to concerns raised by the trial data, which may affect investor confidence and future prospects for the company.
See More
Ocular Therapeutix Set to Release Axpaxli Phase 3 Trial Results
- Trial Results Announcement: Ocular Therapeutix is set to announce topline results from its Phase 3 trial of Axpaxli for wet AMD treatment on Tuesday, with the market closely monitoring this event, which is expected to positively impact the company's stock price.
- Significant Stock Surge: Ahead of the clinical data release, Ocular Therapeutix shares surged nearly 40% in Monday trading, reflecting strong investor optimism about Axpaxli, potentially pushing the company's valuation close to $2.2 billion.
- Acquisition Potential Renewed: As interest in Axpaxli intensifies, Sanofi is revisiting a potential acquisition of Ocular, having previously declined a $16 per share offer when the stock was trading around $10.5, indicating a market reassessment of the company's value.
- Increased Analyst Support: Analysts have shown growing optimism for Axpaxli, with Bank of America and TD Cowen maintaining 'Buy' ratings and projecting peak sales potential of $1 billion in wet AMD, reflecting confidence in the drug's long-term growth prospects.
See More
U.S. Stocks Mostly Lower, Nasdaq Drops Over 50 Points
- Market Performance: U.S. stocks traded mostly lower on Tuesday, with the Nasdaq Composite falling over 50 points, and the S&P 500 dropping 0.13% to 6,827.16, indicating a cautious investor sentiment amid market weakness.
- Company Highlights: Medtronic PLC (NYSE:MDT) reported an adjusted EPS of $1.36 for Q3, exceeding market expectations of $1.33, with quarterly sales of $9.017 billion surpassing the $8.905 billion forecast, showcasing the company's strong earnings capability.
- Sector Dynamics: Financial shares gained 0.9%, while materials stocks fell by 2%, reflecting a divergence in market performance as investors may be seeking more defensive investment opportunities amidst volatility.
- Economic Indicators: According to ADP Research, U.S. private employers added an average of 10,250 jobs per week during the four weeks ending January 31, up from 7,750 in the previous period, indicating an improving labor market trend.
See More
Ocular Therapeutix Shares Drop Following Axpaxli Trial Data Disappointment
- Clinical Trial Results: Ocular Therapeutix reported that 74.1% of patients maintained vision at Week 36 in the SOL-1 Phase 3 trial for Axpaxli, compared to 65.9% in the Eylea group, with a risk difference of 17.5% (p=0.0006); however, the durability advantage fell short of expectations, potentially impacting its commercial outlook.
- Next Steps: The company intends to submit a New Drug Application (NDA) based on the SOL-1 data, and if approved, Axpaxli could become the first tyrosine kinase inhibitor (TKI) commercialized for wet AMD, potentially being the only therapy with a superiority label, which holds significant strategic implications.
- Market Reaction: Ocular Therapeutix shares fell 26.46% in premarket trading, currently priced at $6.62, reflecting market disappointment over the Axpaxli data, despite a 23.33% increase over the past 12 months, indicating a generally positive long-term trend.
- Analyst Ratings: The stock maintains a Buy rating with an average price target of $21.00, with Chardan Capital and Needham keeping their targets unchanged, while HC Wainwright raised its target to $21.00, reflecting analysts' optimistic outlook for the future.
See More
Ocular Therapeutix Releases Axpaxli Trial Data, Stock Drops 22%
- Clinical Trial Results: Ocular Therapeutix's SOL-1 Phase 3 trial showed that approximately 74% of patients on Axpaxli maintained vision at Week 36, compared to about 56% for aflibercept, indicating a significant therapeutic advantage for Axpaxli in treating wet age-related macular degeneration.
- Safety Assessment: The company reported that the intravitreal implant of Axpaxli was generally well tolerated, with no serious ocular or systemic adverse events related to the drug, which lays a solid foundation for its future market introduction.
- Regulatory Submission Plans: Ocular Therapeutix intends to submit a New Drug Application to the FDA for Axpaxli pending regulatory feedback, and if approved, it will be the first TKI available in the U.S. for wet AMD, representing substantial market potential.
- Market Reaction: Despite the encouraging trial results, Ocular Therapeutix's stock fell approximately 22% in premarket trading, reflecting market caution regarding the drug's future commercialization prospects.
See More
U.S. Stock Futures Fluctuate Amid Government Shutdown Impact
- Market Fluctuations: U.S. stock futures showed volatility on Tuesday following a mixed close on Friday, with the S&P 500 down 1.4%, the Dow slipping 1.2%, and the Nasdaq declining 2.1% last week, reflecting cautious investor sentiment amid uncertainty.
- Government Shutdown Impact: The failure of Congressional Democrats and the Trump administration to reach a funding deal through September has triggered a partial government shutdown, which could exacerbate market instability and undermine investor confidence.
- Bond Yields: The 10-year Treasury bond yield stands at 4.02%, while the two-year bond yield is at 3.39%, indicating market expectations for future interest rate policies, with the CME Group's FedWatch tool showing a 90.2% likelihood of rates remaining unchanged in March.
- Stock Performance: Ocular Therapeutix's stock surged 33.56% ahead of its clinical trial data release for dry eye disease, while ZIM Integrated Shipping Services rose 34.46% following its acquisition agreement with Hapag-Lloyd, highlighting positive market reactions in specific sectors.
See More
