Teva and Medincell's NDA for Long-Acting Olanzapine Accepted by FDA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 hour ago
0mins
Should l Buy TEVA?
Source: seekingalpha
- NDA Acceptance: Teva and Medincell announced that the FDA has accepted their New Drug Application for the long-acting antipsychotic olanzapine, TEV-'749, which aims to provide a more convenient treatment option for schizophrenia patients.
- Clinical Trial Validation: The NDA is supported by data from the Phase 3 SOLARIS trial, demonstrating that patients receiving TEV-'749 do not require post-administration monitoring, significantly reducing treatment burdens while aligning with the safety profile of existing olanzapine formulations.
- Addressing Market Needs: Teva's Chief Medical Officer Eric Hughes emphasized that the lack of viable long-acting olanzapine formulations has limited treatment options for patients, and the introduction of TEV-'749 will fill this care gap and enhance patient quality of life.
- Regulatory Collaboration Outlook: Teva looks forward to collaborating with the FDA on the review of TEV-'749, which, if approved, will offer a once-monthly subcutaneous injection, simplifying the current three-hour monitoring requirement and improving treatment convenience.
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Analyst Views on TEVA
Wall Street analysts forecast TEVA stock price to rise
11 Analyst Rating
10 Buy
1 Hold
0 Sell
Strong Buy
Current: 34.330
Low
29.00
Averages
35.71
High
40.00
Current: 34.330
Low
29.00
Averages
35.71
High
40.00
About TEVA
Teva Pharmaceutical Industries Ltd is a Israeli-based pharmaceutical company. The Company operates through three segments: North America, Europe and International Markets. Each business segment manages entire product portfolio in its region, including generics, specialty and over-the-counter (OTC) products. In addition to these three segments, The Company has other activities, primarily the sale of active pharmaceutical ingredients (API) to third parties, certain contract manufacturing services and an out-licensing platform offering a portfolio of products to other pharmaceutical companies through its affiliate Medis.
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.
TEVA's New Drug Application Accepted by FDA for Schizophrenia Treatment
- New Drug Approval: Teva Pharmaceutical's U.S. affiliate announced that the FDA has accepted its New Drug Application for TEV-'749, an extended-release injectable for treating schizophrenia in adults, marking a significant advancement in the mental health sector.
- Clinical Trial Data Support: The application is based on late-stage trial data showing that TEV-'749, administered as a once-monthly subcutaneous injection, has an efficacy and safety profile consistent with existing olanzapine formulations and eliminates the need for post-injection monitoring, reducing treatment burden for patients.
- Market Reaction: Despite the positive news of FDA acceptance, TEVA's shares traded 1% lower at the time of writing, reflecting market caution regarding the new drug's commercial prospects, which may impact investor confidence.
- Strategic Implications: The successful development of TEV-'749 not only helps TEVA solidify its position in the competitive psychiatric drug market but also has the potential to generate new revenue streams, driving future growth.
See More
Teva and Medincell's NDA for Long-Acting Olanzapine Accepted by FDA
- NDA Acceptance: Teva and Medincell announced that the FDA has accepted their New Drug Application for the long-acting antipsychotic olanzapine, TEV-'749, which aims to provide a more convenient treatment option for schizophrenia patients.
- Clinical Trial Validation: The NDA is supported by data from the Phase 3 SOLARIS trial, demonstrating that patients receiving TEV-'749 do not require post-administration monitoring, significantly reducing treatment burdens while aligning with the safety profile of existing olanzapine formulations.
- Addressing Market Needs: Teva's Chief Medical Officer Eric Hughes emphasized that the lack of viable long-acting olanzapine formulations has limited treatment options for patients, and the introduction of TEV-'749 will fill this care gap and enhance patient quality of life.
- Regulatory Collaboration Outlook: Teva looks forward to collaborating with the FDA on the review of TEV-'749, which, if approved, will offer a once-monthly subcutaneous injection, simplifying the current three-hour monitoring requirement and improving treatment convenience.
See More
Teva and Medincell's NDA for Olanzapine Accepted by FDA
- NDA Acceptance: Teva Pharmaceuticals and Medincell announced that the FDA has accepted their New Drug Application for TEV-'749, an extended-release injectable for schizophrenia, addressing the lack of long-acting olanzapine formulations without REMS requirements in the market.
- Clinical Trial Findings: The Phase 3 SOLARIS trial demonstrated that TEV-'749, administered as a once-monthly subcutaneous injection, maintained efficacy and safety profiles consistent with existing olanzapine formulations, importantly showing no need for post-injection monitoring, which could streamline patient treatment.
- Market Opportunity: As a long-acting injectable of the second-generation atypical antipsychotic olanzapine, TEV-'749 represents a potential new treatment option for schizophrenia patients, with significant market potential given the absence of similar products currently available.
- Stock Price Reaction: Despite the NDA acceptance, TEVA's stock closed down 0.32% at $34.22 and further declined to $33.90 in after-hours trading, indicating market caution regarding the drug's future approval prospects.
See More
Teva's Long-Acting Injectable for Schizophrenia Receives FDA Acceptance
- FDA Application Acceptance: Teva and Medincell announced that the FDA has accepted the New Drug Application for TEV-'749, a long-acting injectable aimed at providing more effective treatment options for adults with schizophrenia, addressing the significant gap in viable long-acting olanzapine formulations.
- Clinical Trial Results: In the Phase 3 SOLARIS trial, TEV-'749 demonstrated an efficacy and safety profile consistent with existing olanzapine formulations as a once-monthly subcutaneous injection, eliminating the need for FDA-mandated post-injection monitoring, which significantly enhances patient treatment adherence.
- Meeting Market Demand: The introduction of TEV-'749 is expected to improve long-term stability for schizophrenia patients, addressing adherence challenges faced by those relying on oral olanzapine, thereby potentially reducing healthcare costs associated with relapses.
- Strategic Development Focus: Teva is committed to strengthening its scientific leadership in complex neurological conditions through the development of TEV-'749, advancing its Pivot to Growth strategy, and enhancing the competitiveness of its long-acting injectable product line.
See More
Corcept Loses Patent Appeal for Korlym, Shares Plunge
- Patent Litigation Outcome: The U.S. Court of Appeals upheld the New Jersey district court's ruling that Corcept failed to prove patent infringement, resulting in significant legal challenges that could impact the company's competitive position in the market.
- Stock Price Reaction: Following the ruling, Corcept's (CORT) shares plummeted by 15%, reflecting investor concerns about the company's future, especially as its Korlym product faces generic competition.
- Market Dynamics: While Corcept's stock declined, Teva Pharmaceuticals (TEVA) saw a slight increase in its share price, indicating a positive market reaction to Teva's victory in the patent dispute, which may enhance its market share.
- Investor Sentiment Shift: On Stocktwits, retail sentiment around CORT stock shifted from 'bearish' to 'bullish' over the past 24 hours, with message volume increasing from 'extremely low' to 'high', indicating investor expectations for a potential rebound.
See More
Corcept Therapeutics Faces Significant Pressure as Shares Approach Lows
- Legal Ruling Impact: The appeals court upheld a ruling against Corcept, concluding that Teva's generic Korlym label would not lead doctors to follow patented dosing methods, weakening Corcept's patent protection and potentially exposing its flagship product to earlier competition, thereby increasing market uncertainty.
- Stock Price Decline: Corcept's shares are currently trading 24.4% below the 20-day simple moving average and 52.9% below the 100-day simple moving average, indicating a significant bearish trend, with a 57.55% decline over the past 12 months, positioning the stock closer to its 52-week lows, reflecting ongoing market weakness.
- Upcoming Earnings Report: Corcept is set to report earnings on February 24, with an estimated EPS of 31 cents (up from 26 cents) and revenue expected to reach $254.72 million (up from $181.89 million), indicating potential growth in revenue despite current challenges.
- Analyst Rating Changes: Despite facing challenges, Corcept's stock retains a Buy rating with an average price target of $100, with Canaccord Genuity and HC Wainwright & Co. raising their targets on January 23, reflecting analysts' confidence in the company's future performance.
See More
TEVA's New Drug Application Accepted by FDA for Schizophrenia Treatment
- New Drug Approval: Teva Pharmaceutical's U.S. affiliate announced that the FDA has accepted its New Drug Application for TEV-'749, an extended-release injectable for treating schizophrenia in adults, marking a significant advancement in the mental health sector.
- Clinical Trial Data Support: The application is based on late-stage trial data showing that TEV-'749, administered as a once-monthly subcutaneous injection, has an efficacy and safety profile consistent with existing olanzapine formulations and eliminates the need for post-injection monitoring, reducing treatment burden for patients.
- Market Reaction: Despite the positive news of FDA acceptance, TEVA's shares traded 1% lower at the time of writing, reflecting market caution regarding the new drug's commercial prospects, which may impact investor confidence.
- Strategic Implications: The successful development of TEV-'749 not only helps TEVA solidify its position in the competitive psychiatric drug market but also has the potential to generate new revenue streams, driving future growth.
See More
Teva and Medincell's NDA for Long-Acting Olanzapine Accepted by FDA
- NDA Acceptance: Teva and Medincell announced that the FDA has accepted their New Drug Application for the long-acting antipsychotic olanzapine, TEV-'749, which aims to provide a more convenient treatment option for schizophrenia patients.
- Clinical Trial Validation: The NDA is supported by data from the Phase 3 SOLARIS trial, demonstrating that patients receiving TEV-'749 do not require post-administration monitoring, significantly reducing treatment burdens while aligning with the safety profile of existing olanzapine formulations.
- Addressing Market Needs: Teva's Chief Medical Officer Eric Hughes emphasized that the lack of viable long-acting olanzapine formulations has limited treatment options for patients, and the introduction of TEV-'749 will fill this care gap and enhance patient quality of life.
- Regulatory Collaboration Outlook: Teva looks forward to collaborating with the FDA on the review of TEV-'749, which, if approved, will offer a once-monthly subcutaneous injection, simplifying the current three-hour monitoring requirement and improving treatment convenience.
See More
Teva and Medincell's NDA for Olanzapine Accepted by FDA
- NDA Acceptance: Teva Pharmaceuticals and Medincell announced that the FDA has accepted their New Drug Application for TEV-'749, an extended-release injectable for schizophrenia, addressing the lack of long-acting olanzapine formulations without REMS requirements in the market.
- Clinical Trial Findings: The Phase 3 SOLARIS trial demonstrated that TEV-'749, administered as a once-monthly subcutaneous injection, maintained efficacy and safety profiles consistent with existing olanzapine formulations, importantly showing no need for post-injection monitoring, which could streamline patient treatment.
- Market Opportunity: As a long-acting injectable of the second-generation atypical antipsychotic olanzapine, TEV-'749 represents a potential new treatment option for schizophrenia patients, with significant market potential given the absence of similar products currently available.
- Stock Price Reaction: Despite the NDA acceptance, TEVA's stock closed down 0.32% at $34.22 and further declined to $33.90 in after-hours trading, indicating market caution regarding the drug's future approval prospects.
See More
Teva's Long-Acting Injectable for Schizophrenia Receives FDA Acceptance
- FDA Application Acceptance: Teva and Medincell announced that the FDA has accepted the New Drug Application for TEV-'749, a long-acting injectable aimed at providing more effective treatment options for adults with schizophrenia, addressing the significant gap in viable long-acting olanzapine formulations.
- Clinical Trial Results: In the Phase 3 SOLARIS trial, TEV-'749 demonstrated an efficacy and safety profile consistent with existing olanzapine formulations as a once-monthly subcutaneous injection, eliminating the need for FDA-mandated post-injection monitoring, which significantly enhances patient treatment adherence.
- Meeting Market Demand: The introduction of TEV-'749 is expected to improve long-term stability for schizophrenia patients, addressing adherence challenges faced by those relying on oral olanzapine, thereby potentially reducing healthcare costs associated with relapses.
- Strategic Development Focus: Teva is committed to strengthening its scientific leadership in complex neurological conditions through the development of TEV-'749, advancing its Pivot to Growth strategy, and enhancing the competitiveness of its long-acting injectable product line.
See More
Corcept Loses Patent Appeal for Korlym, Shares Plunge
- Patent Litigation Outcome: The U.S. Court of Appeals upheld the New Jersey district court's ruling that Corcept failed to prove patent infringement, resulting in significant legal challenges that could impact the company's competitive position in the market.
- Stock Price Reaction: Following the ruling, Corcept's (CORT) shares plummeted by 15%, reflecting investor concerns about the company's future, especially as its Korlym product faces generic competition.
- Market Dynamics: While Corcept's stock declined, Teva Pharmaceuticals (TEVA) saw a slight increase in its share price, indicating a positive market reaction to Teva's victory in the patent dispute, which may enhance its market share.
- Investor Sentiment Shift: On Stocktwits, retail sentiment around CORT stock shifted from 'bearish' to 'bullish' over the past 24 hours, with message volume increasing from 'extremely low' to 'high', indicating investor expectations for a potential rebound.
See More
Corcept Therapeutics Faces Significant Pressure as Shares Approach Lows
- Legal Ruling Impact: The appeals court upheld a ruling against Corcept, concluding that Teva's generic Korlym label would not lead doctors to follow patented dosing methods, weakening Corcept's patent protection and potentially exposing its flagship product to earlier competition, thereby increasing market uncertainty.
- Stock Price Decline: Corcept's shares are currently trading 24.4% below the 20-day simple moving average and 52.9% below the 100-day simple moving average, indicating a significant bearish trend, with a 57.55% decline over the past 12 months, positioning the stock closer to its 52-week lows, reflecting ongoing market weakness.
- Upcoming Earnings Report: Corcept is set to report earnings on February 24, with an estimated EPS of 31 cents (up from 26 cents) and revenue expected to reach $254.72 million (up from $181.89 million), indicating potential growth in revenue despite current challenges.
- Analyst Rating Changes: Despite facing challenges, Corcept's stock retains a Buy rating with an average price target of $100, with Canaccord Genuity and HC Wainwright & Co. raising their targets on January 23, reflecting analysts' confidence in the company's future performance.
See More
