Axsome Acquires Exclusive Global Rights to Takeda's TAK-063
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Apr 01 2026
0mins
Should l Buy AXSM?
Axsome Therapeutics (AXSM) announced that it has entered into an asset purchase agreement to obtain exclusive global rights to TAK-063, an oral, potent, and selective phosphodiesterase 10A inhibitor from Takeda (TAK). Axsome intends to develop the selective inhibitor for the treatment of schizophrenia and Tourette syndrome, and plans to begin Phase 3 trial-enabling activities for the schizophrenia indication in 2026. Balipodect has completed a 164-patient proof-of-concept Phase 2 trial in schizophrenia. The selective PDE10A inhibitor has demonstrated a favorable safety and tolerability profile in clinical studies in over 360 individuals to date. Under the terms of the agreement, Axsome obtained worldwide commercial, development, and manufacturing rights to balipodect. Takeda received an upfront payment and is eligible to receive additional payments related to development, regulatory, and commercial milestones for the first two indications, as well as royalties related to potential global net sales.
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Analyst Views on AXSM
Wall Street analysts forecast AXSM stock price to rise
15 Analyst Rating
14 Buy
1 Hold
0 Sell
Strong Buy
Current: 188.690
Low
153.00
Averages
209.54
High
260.00
Current: 188.690
Low
153.00
Averages
209.54
High
260.00
About AXSM
Axsome Therapeutics, Inc. is a fully integrated biopharmaceutical company. The Company focused on developing medicines for people impacted by central nervous system (CNS) conditions. Its commercial products include AUVELITY, SUNOSI, and SYMBRAVO. It is also advancing pipeline of novel product candidates in early- to late-stage development addressing a broad range of serious neurological and psychiatric conditions. Its product pipelines include AXS-05, AXS-12, and AXS-14. Its lead product candidate, AXS-05 (dextromethorphan-bupropion), is developed for the treatment of Alzheimer’s disease (AD) agitation and smoking cessation. Its AXS-12 (reboxetine) is a novel, oral, potent, highly selective investigational norepinephrine reuptake inhibitor (NRI) and cortical dopamine modulator being developed for the treatment of narcolepsy. Its AXS-14 (esreboxetine) is a novel, oral, potent, highly selective investigational NRI being developed for the management of fibromyalgia.
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.
Axsome Acquires Global Rights to TAK-063 from Takeda
- Asset Purchase Agreement: Axsome Therapeutics has signed an asset purchase agreement with Takeda Pharmaceutical to acquire exclusive global rights to TAK-063 (balipodect), further expanding its leading CNS portfolio and demonstrating strategic positioning in neuropsychiatric treatment.
- Clinical Trial Plans: Axsome intends to initiate Phase 3 trial-enabling activities for schizophrenia in 2026, indicating strong confidence in the development of balipodect and aiming to improve treatment outcomes for patients through this novel mechanism.
- Clinical Trial Results: Balipodect has shown positive results in a 164-patient proof-of-concept Phase 2 trial for schizophrenia and has demonstrated a favorable safety and tolerability profile in clinical studies involving over 360 individuals, enhancing its market potential.
- Financial Arrangement: Under the agreement, Axsome obtains worldwide commercial, development, and manufacturing rights to balipodect, while Takeda receives an upfront payment and is eligible for additional payments related to development, regulatory, and commercial milestones, as well as royalties on potential global net sales, ensuring mutual benefit.
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Summit Therapeutics Faces FDA Approval Risk for Ivonescimab
- FDA Approval Crucial: Summit Therapeutics has filed for FDA approval of ivonescimab, which is already approved in China; however, the drug has not shown statistically significant overall survival in Western countries, and a rejection could lead to a significant drop in stock price.
- Intensifying Market Competition: Axsome Therapeutics and Madrigal Pharmaceuticals have market caps of $8.1 billion and $10.2 billion respectively, with both companies poised to potentially surpass Summit by 2026, highlighting the fierce competition in the biotech sector.
- Axsome's Growth Momentum: Axsome Therapeutics reported a 65.5% revenue increase in 2025, reaching $638.5 million, and is awaiting FDA approval for its Alzheimer's drug AXS-05, which could significantly expand its market reach.
- Madrigal's Sales Surge: Madrigal Pharmaceuticals achieved $958.4 million in sales from its Rezdiffra drug in 2025, a 432% increase from 2024, indicating strong growth potential in the metabolic dysfunction space, with expectations for continued excellent financial performance.
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Superstring Capital Acquires Position in Axsome Therapeutics
- New Investment Disclosure: Superstring Capital Management disclosed a new position in Axsome Therapeutics, acquiring 37,433 shares worth $6.84 million in Q4 2025, indicating strong confidence in the company's prospects.
- Asset Allocation Shift: This acquisition represents nearly 4% of Superstring's 13F assets, highlighting Axsome's increasing significance in the portfolio and potentially influencing future investment strategies.
- Strong Company Performance: Axsome Therapeutics boasts a market capitalization of $8.1 billion, with a 27% stock price increase over the past year, significantly outperforming the S&P 500's 19% gain, showcasing its competitive edge in the biopharmaceutical sector.
- Diverse Product Pipeline: Axsome's portfolio includes commercial therapies for depression, migraine, and sleep disorders, which are expected to drive revenue growth, reduce financing risks, and enhance investment appeal.
See More
Investigation into Atkore and Others by Johnson Fistel
- Shareholder Investigation: Johnson Fistel, PLLP is investigating whether executives at Atkore Inc. and others breached their fiduciary duties, allowing shareholders who held shares continuously since specific dates to seek corporate governance reforms.
- Antitrust Allegations: Atkore is accused in a lawsuit of colluding with other PVC pipe manufacturers to engage in price-fixing, which artificially inflated prices and led to a significant decline in pricing once exposed, severely impacting the company's operations.
- Lack of Transparency at Axsome: Axsome Therapeutics faces allegations of failing to disclose critical chemistry and manufacturing issues during the preparation of its New Drug Application, potentially jeopardizing its market prospects and investor confidence.
- CTO's Financial Misrepresentation: CTO Realty Growth is accused of misleading investors about the sustainability of its dividends and using deceptive practices to inflate its financial performance, undermining investor trust in the company's future prospects.
See More
Axsome and Madrigal's Market Potential
- Axsome's Growth Potential: Axsome Therapeutics' stock has more than doubled over the past five years, primarily due to clinical and commercial progress with its leading candidate Auvelity, which is expected to significantly improve financial performance through new approvals and label expansions over the next five years.
- Significant Revenue Increase: In 2025, Axsome's revenue surged by 66% to $638.5 million, and although the net loss per share was $3.68, it showed improvement compared to the $5.99 loss per share reported in 2024, indicating potential for profitability.
- Madrigal's Market Breakthrough: Madrigal Pharmaceuticals received FDA approval for Rezdiffra in 2024, the first drug indicated for metabolic dysfunction-associated steatohepatitis, generating $958.4 million in revenue last year solely from this product, highlighting strong market demand.
- Unmet Medical Needs: Madrigal has treated approximately 36,250 patients, targeting 315,000, indicating a significant unmet need in the metabolic dysfunction-associated steatohepatitis space, which is likely to drive continued financial growth.
See More
Axsome Therapeutics CEO Sells Shares Amid Expiring Options
- Insider Share Sale: Axsome Therapeutics CEO Herriot Tabuteau exercised and sold 32,410 common shares on February 2, 2026, totaling $6 million, reducing his direct holdings by 81.76% to just 7,229 shares, which may indicate a waning confidence in the company's future prospects.
- Transaction Context: The sale was prompted by the exercise of options nearing expiration, with all shares sold immediately in the open market, indicating that Tabuteau did not engage in any new direct or indirect share grants or purchases, reflecting a cautious stance towards the market.
- Company Financials: With a market capitalization of $8.37 billion and a 66% year-over-year growth in net product revenue for 2025, Axsome Therapeutics demonstrates strong performance in the CNS drug market, despite a net income loss of $183.2 million, attracting growth-oriented investors.
- FDA Review Progress: The FDA has granted Priority Review for AXS-05 targeting Alzheimer's disease agitation, with a decision expected by April 30, 2026, marking a pivotal moment that could significantly impact the company's future revenue and profitability outlook.
See More
Axsome Acquires Global Rights to TAK-063 from Takeda
- Asset Purchase Agreement: Axsome Therapeutics has signed an asset purchase agreement with Takeda Pharmaceutical to acquire exclusive global rights to TAK-063 (balipodect), further expanding its leading CNS portfolio and demonstrating strategic positioning in neuropsychiatric treatment.
- Clinical Trial Plans: Axsome intends to initiate Phase 3 trial-enabling activities for schizophrenia in 2026, indicating strong confidence in the development of balipodect and aiming to improve treatment outcomes for patients through this novel mechanism.
- Clinical Trial Results: Balipodect has shown positive results in a 164-patient proof-of-concept Phase 2 trial for schizophrenia and has demonstrated a favorable safety and tolerability profile in clinical studies involving over 360 individuals, enhancing its market potential.
- Financial Arrangement: Under the agreement, Axsome obtains worldwide commercial, development, and manufacturing rights to balipodect, while Takeda receives an upfront payment and is eligible for additional payments related to development, regulatory, and commercial milestones, as well as royalties on potential global net sales, ensuring mutual benefit.
See More
Summit Therapeutics Faces FDA Approval Risk for Ivonescimab
- FDA Approval Crucial: Summit Therapeutics has filed for FDA approval of ivonescimab, which is already approved in China; however, the drug has not shown statistically significant overall survival in Western countries, and a rejection could lead to a significant drop in stock price.
- Intensifying Market Competition: Axsome Therapeutics and Madrigal Pharmaceuticals have market caps of $8.1 billion and $10.2 billion respectively, with both companies poised to potentially surpass Summit by 2026, highlighting the fierce competition in the biotech sector.
- Axsome's Growth Momentum: Axsome Therapeutics reported a 65.5% revenue increase in 2025, reaching $638.5 million, and is awaiting FDA approval for its Alzheimer's drug AXS-05, which could significantly expand its market reach.
- Madrigal's Sales Surge: Madrigal Pharmaceuticals achieved $958.4 million in sales from its Rezdiffra drug in 2025, a 432% increase from 2024, indicating strong growth potential in the metabolic dysfunction space, with expectations for continued excellent financial performance.
See More
Superstring Capital Acquires Position in Axsome Therapeutics
- New Investment Disclosure: Superstring Capital Management disclosed a new position in Axsome Therapeutics, acquiring 37,433 shares worth $6.84 million in Q4 2025, indicating strong confidence in the company's prospects.
- Asset Allocation Shift: This acquisition represents nearly 4% of Superstring's 13F assets, highlighting Axsome's increasing significance in the portfolio and potentially influencing future investment strategies.
- Strong Company Performance: Axsome Therapeutics boasts a market capitalization of $8.1 billion, with a 27% stock price increase over the past year, significantly outperforming the S&P 500's 19% gain, showcasing its competitive edge in the biopharmaceutical sector.
- Diverse Product Pipeline: Axsome's portfolio includes commercial therapies for depression, migraine, and sleep disorders, which are expected to drive revenue growth, reduce financing risks, and enhance investment appeal.
See More
Investigation into Atkore and Others by Johnson Fistel
- Shareholder Investigation: Johnson Fistel, PLLP is investigating whether executives at Atkore Inc. and others breached their fiduciary duties, allowing shareholders who held shares continuously since specific dates to seek corporate governance reforms.
- Antitrust Allegations: Atkore is accused in a lawsuit of colluding with other PVC pipe manufacturers to engage in price-fixing, which artificially inflated prices and led to a significant decline in pricing once exposed, severely impacting the company's operations.
- Lack of Transparency at Axsome: Axsome Therapeutics faces allegations of failing to disclose critical chemistry and manufacturing issues during the preparation of its New Drug Application, potentially jeopardizing its market prospects and investor confidence.
- CTO's Financial Misrepresentation: CTO Realty Growth is accused of misleading investors about the sustainability of its dividends and using deceptive practices to inflate its financial performance, undermining investor trust in the company's future prospects.
See More
Axsome and Madrigal's Market Potential
- Axsome's Growth Potential: Axsome Therapeutics' stock has more than doubled over the past five years, primarily due to clinical and commercial progress with its leading candidate Auvelity, which is expected to significantly improve financial performance through new approvals and label expansions over the next five years.
- Significant Revenue Increase: In 2025, Axsome's revenue surged by 66% to $638.5 million, and although the net loss per share was $3.68, it showed improvement compared to the $5.99 loss per share reported in 2024, indicating potential for profitability.
- Madrigal's Market Breakthrough: Madrigal Pharmaceuticals received FDA approval for Rezdiffra in 2024, the first drug indicated for metabolic dysfunction-associated steatohepatitis, generating $958.4 million in revenue last year solely from this product, highlighting strong market demand.
- Unmet Medical Needs: Madrigal has treated approximately 36,250 patients, targeting 315,000, indicating a significant unmet need in the metabolic dysfunction-associated steatohepatitis space, which is likely to drive continued financial growth.
See More
Axsome Therapeutics CEO Sells Shares Amid Expiring Options
- Insider Share Sale: Axsome Therapeutics CEO Herriot Tabuteau exercised and sold 32,410 common shares on February 2, 2026, totaling $6 million, reducing his direct holdings by 81.76% to just 7,229 shares, which may indicate a waning confidence in the company's future prospects.
- Transaction Context: The sale was prompted by the exercise of options nearing expiration, with all shares sold immediately in the open market, indicating that Tabuteau did not engage in any new direct or indirect share grants or purchases, reflecting a cautious stance towards the market.
- Company Financials: With a market capitalization of $8.37 billion and a 66% year-over-year growth in net product revenue for 2025, Axsome Therapeutics demonstrates strong performance in the CNS drug market, despite a net income loss of $183.2 million, attracting growth-oriented investors.
- FDA Review Progress: The FDA has granted Priority Review for AXS-05 targeting Alzheimer's disease agitation, with a decision expected by April 30, 2026, marking a pivotal moment that could significantly impact the company's future revenue and profitability outlook.
See More
