Takeda's TAK-861 hits all Phase 3 endpoints; NDA filing FY25

Q: What did Takeda (TAK) announce in its July 2025 Form 6-K?

Takeda reported that both Phase 3 trials of oveporexton (TAK-861) met all endpoints in narcolepsy type 1 with strong statistical significance.

Q: How effective was TAK-861 in the Phase 3 studies?

TAK-861 showed statistically significant (p < 0.001) improvements in wakefulness, daytime sleepiness, cataplexy and quality-of-life measures across all doses.

Q: Were there any safety concerns for TAK-861?

No serious treatment-related adverse events occurred; the most common events were insomnia and urinary urgency/frequency.

Q: When will Takeda file for regulatory approval of TAK-861?

The company plans to submit a New Drug Application to the FDA and other authorities during fiscal year 2025.

Q: Will the Phase 3 results affect Takeda鈥檚 FY 2026 financial guidance?

Takeda stated that the study outcomes have no significant impact on its consolidated forecast for the fiscal year ending March 31, 2026.

[6-K] Takeda Pharmaceutical Company Limited American Current Report (Foreign Issuer)

Filing Impact

(Low)

Filing Sentiment

(Neutral)

Form Type

6-K

Rhea-AI Filing Summary

Takeda Pharmaceutical (NYSE:TAK) filed a Form 6-K disclosing top-line results from two pivotal Phase 3 studies鈥擣irstLight (n=168) and RadiantLight (n=105)鈥攐f oveporexton (TAK-861), an oral, first-in-class orexin-2 receptor agonist for narcolepsy type 1 (NT1).

Clinical efficacy: All primary and secondary endpoints were met at every dose level with highly significant p-values (<0.001). Improvements were observed in objective wakefulness (MWT), subjective sleepiness (ESS), weekly cataplexy rate, attention, quality of life and daily functioning, with outcomes reported as reaching near-normal ranges.

Safety: The drug was generally well-tolerated; no serious treatment-related adverse events occurred. The most common events were insomnia and urinary urgency/frequency. >95 % of completers entered the long-term extension, supporting tolerability.

Next steps & financial impact: Takeda intends to submit an NDA to the FDA and other regulators in FY 2025 and is preparing for launch. Management states the data have no significant impact on FY 2026 consolidated forecasts, indicating limited near-term revenue effect.

Strategic relevance: The results validate orexin biology in late-stage trials for the first time and strengthen Takeda鈥檚 multi-asset orexin franchise, which the CEO highlights as a driver of long-term growth.

Takeda Pharmaceutical (NYSE:TAK)電� 霊� 臧滌潣欷戩稊鞝� 3靸� 鞛勳儊鞁滍棙鈥擣irstLight (n=168)鞕€ RadiantLight (n=105)鈥旍潣欤检殧瓴瓣臣毳� 瓿店皽頃橂姅 Form 6-K毳� 鞝滌稖頄堨姷雼堧嫟. 鞚� 鞐瓣惮霌れ潃旮半┐歃� 1順�(NT1)鞚� 鞙勴暅瓴疥惮鞖� 1靹鸽寑鞓る爥鞁�-2 靾橃毄觳� 鞛戩毄鞝滌澑 鞓る矤韽爥靷绊姼(罢础碍-861)鞐� 甏€頃� 瓴冹瀰雼堧嫟.

鞛勳儊須姤: 氇摖 1彀� 氚� 2彀� 韽夑皜氤€靾橃棎靹� 氇摖鞖╇焿甑办棎靹� 毵れ毎鞙犾潣頃� p臧�(<0.001)鞙茧 氇╉憸毳� 雼劚頄堨姷雼堧嫟. 臧濌磤鞝� 臧侅劚霃�(MWT), 欤缄磤鞝� 臁鸽(ESS), 欤缄皠旃错儉頂岆爥鞁� 氚滌儩毳�, 欤检潣霠�, 靷鹅潣歆� 氚� 鞚检儊旮半姤鞐愳劀臧滌劆鞚� 甏€彀半悩鞐堨溂氅�, 瓴瓣臣電� 瓯办潣鞝曥儊氩旍渼鞐� 霃勲嫭頃� 瓴冹溂搿� 氤搓碃霅橃棃鞀惦媹雼�.

鞎堨爠靹�: 鞎诫鞚€ 鞝勲皹鞝侅溂搿� 鞛� 瓴帉臁岇溂氅�; 旃橂 甏€霠� 欷戨寑頃� 鞚挫儊氚橃潙鞚€ 氚滌儩頃橃 鞎婌晿鞀惦媹雼�. 臧€鞛� 頋旐暅攵€鞛戩毄鞚€ 攵堧┐歃濌臣鞖旍爤氚�/牍堧嚚鞓€鞀惦媹雼�. 鞕勲鞛� 欷� 95% 鞚挫儊鞚� 鞛リ赴鞐办灔鞐瓣惮鞐� 彀胳棳頃橃棳雮挫暯靹膘潉霋冯皼旃暕雼堧嫟.

頄ロ泟瓿勴殟氚� 鞛 鞓來枼: Takeda電� 2025 須岅硠鞐半弰鞐� FDA 氚� 旮绊儉攴滌牅旮瓣磤鞐� NDA毳� 鞝滌稖頃� 瓿勴殟鞚措┌ 於滌嫓欷€牍� 欷戩瀰雼堧嫟. 瓴届榿歆勳潃鞚� 雿办澊韯瓣皜 2026 須岅硠鞐半弰韱淀暕鞓堨浮鞐� 欷戨寑頃� 鞓來枼鞚� 氙胳箻歆€ 鞎婋姅雼�瓿� 氚濏榾雼赴靾橃澋鞐� 鞝滍暅鞝侅澑鞓來枼鞚� 鞁滌偓頃╇媹雼�.

鞝勲灥鞝� 欷戩殧靹�: 鞚措矆瓴瓣臣電� 頉勱赴鞛勳儊鞁滍棙鞐愳劀鞓る爥鞁� 靸濍頃欖潉觳橃潓鞙茧 瓴€歃濏枅鞙茧┌, CEO臧€ 鞛リ赴靹膘灔霃欕牓鞙茧 臧曥“頃橂姅 Takeda鞚� 雼れ瀽靷� 鞓る爥鞁� 靷梾鞚� 臧曧檾頃╇媹雼�.

Positive

Both Phase 3 studies met all primary and secondary endpoints with p < 0.001, confirming robust efficacy.
No serious treatment-related adverse events reported; safety consistent with earlier trials.
NDA and global filings planned for FY 2025, accelerating potential market entry for a first-in-class therapy.

Negative

Common adverse events included insomnia and urinary urgency/frequency, which may affect tolerability for some patients.
Management expects no significant impact on FY 2026 forecast, indicating limited short-term financial benefit.
Regulatory approvals still pending; commercialization contingent on successful filings and review.

Insights

TL;DR: TAK-861 clears Phase 3 with p<0.001, de-risking NDA in FY25.

The dual global studies firmly establish clinical proof-of-concept for an orexin-2 agonist, a mechanism never before validated at Phase 3. Statistically robust efficacy across wakefulness and cataplexy endpoints, aligned with a benign safety profile and high LTE rollover, significantly cut development risk. Breakthrough Therapy status may expedite review, making approval in 2026 plausible. While management guides to no FY26 P&L impact, future peak-sales potential in a high-unmet-need niche is meaningful. Overall, the disclosure is materially positive for pipeline value and positions Takeda as class pioneer.

TL;DR: Strong data boost long-term optionality; near-term cash flow unchanged.

The clean efficacy/safety read-out meaningfully raises the probability of success for TAK-861 and enhances Takeda鈥檚 neuroscience narrative. However, regulatory filings are slated for FY2025, and management explicitly reiterates no impact on current FY2026 guidance, tempering immediate valuation effects. Commercial upside depends on market education and payer uptake, but competitive positioning is favorable given first-in-class status. For diversified portfolios, today鈥檚 news shifts risk-reward positively without altering short-term earnings expectations.

07/14/2025 - 06:05 AM

FORM 6-K

U.S. SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16 of

the Securities Exchange Act of 1934

For the month of July 2025

Commission File Number: 001-38757

TAKEDA PHARMACEUTICAL COMPANY LIMITED

(Translation of registrant’s name into English)

1-1, Nihonbashi-Honcho 2-Chome

Chuo-ku, Tokyo 103-8668

Japan

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

Form 20-F ☒ Form 40-F ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐

Information furnished on this form:

EXHIBIT



Exhibit Number

1						Takeda Announces Positive Results from Two Pivotal Phase 3 Studies of Oveporexton (TAK-861) in Narcolepsy Type 1

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.



	TAKEDA PHARMACEUTICAL COMPANY LIMITED

Date: July 14, 2025	By:	/s/ Norimasa Takeda
		Norimasa Takeda Chief Accounting Officer and Corporate Controller

Takeda Announces Positive Results from Two Pivotal Phase 3 Studies of Oveporexton (TAK-861) in Narcolepsy Type 1

–Both Phase 3 Studies Met all Primary and Secondary Endpoints Demonstrating Statistically Significant Improvements Across Symptoms at All Doses, Building Upon Phase 2b Results

– Oveporexton was Generally Well-Tolerated in Phase 3 Safety Profile

–Takeda is Rapidly Advancing Regulatory Submissions and Launch Preparedness with the Aim to Bring Oveporexton to People Living with Narcolepsy Type 1 as Quickly as Possible

–These Results Mark a Major Advancement Toward Transforming the Standard of Care by Addressing the Underlying Cause of Narcolepsy Type 1

OSAKA, Japan and CAMBRIDGE, Massachusetts, July 14, 2025 – Takeda (TSE:4502/NYSE:TAK) today announced that all primary and secondary endpoints were met in two Phase 3 randomized, double-blind, placebo-controlled studies of oveporexton (TAK-861), a potential first-in-class investigational oral orexin receptor 2 (OX2R)-selective agonist, in narcolepsy type 1 (NT1). NT1 is caused by the loss of orexin-producing neurons in the brain. Orexin agonists are designed to address this underlying orexin deficiency. For the first time, this mechanism of action has been validated in Phase 3 studies demonstrating significant improvement across a broad range of symptoms. These results reinforce the potential of oveporexton to transform the standard of care.

“We are thrilled to reach this pivotal milestone for the oveporexton program. Oveporexton is a testament to Takeda’s strength in discovering and developing a potential new class of medicines for difficult to treat diseases such as narcolepsy type 1,” said Christophe Weber, president and chief executive officer at Takeda. "Our leadership in orexin biology and building a multi-asset orexin franchise with transformative potential will position Takeda for long-term future growth.”

The FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002) studies were two large, global Phase 3 studies conducted in 19 countries. Both studies achieved statistically significant improvement compared to placebo with p-values of <0.001 for all primary and secondary endpoints across all doses at week 12. The primary and secondary endpoints measuring objective and patient reported improvements in wakefulness, excessive daytime sleepiness, cataplexy, ability to maintain attention, overall quality of life and daily life functions demonstrate statistically significant and clinically meaningful improvements achieving near normal ranges across the broad range of symptoms investigated.

Oveporexton was generally well-tolerated with a safety profile from the Phase 3 studies overall consistent with oveporexton studies to date including the Phase 2b study. No serious treatment-related adverse events were reported. The most common adverse events were insomnia, urinary urgency and frequency. More than 95 percent of the participants who completed the studies enrolled in the ongoing long-term extension (LTE) study.

“We are grateful to the patients who took part in these clinical studies and to their families, the investigators and clinical staff. The studies were accelerated at an unprecedented pace with the aim to bring this potential treatment to people living with narcolepsy type 1 as quickly as possible,” said Andy Plump, M.D., Ph.D., president of R&D at Takeda. “The comprehensive assessments from our Phase 3 studies build on the transformative results we saw with our Phase 2b study with most participants reaching normative ranges and reporting clinically meaningful improvement across a broad range of symptoms at the end of the 12-week treatment period. The positive results also reinforce the continued momentum for our late-stage pipeline, which we believe will deliver value to the patients we serve around the world.”

Takeda intends to present the results at upcoming medical congresses and plans to submit a New Drug Application with the United States Food and Drug Administration and additional global regulatory authorities in fiscal year 2025.

Results from the Phase 3 studies have no significant impact on the full year consolidated forecast for the fiscal year ending March 31, 2026.

About Narcolepsy Type 1 (NT1) and Orexin Science

NT1 is a chronic, rare neurological disease that results in a range of debilitating symptoms including excessive daytime sleepiness (EDS), cataplexy, disrupted nighttime sleep, sleep paralysis and hallucinations upon falling asleep or waking. Additionally, individuals living with NT1 often report cognitive symptoms, including difficulty thinking clearly, remembering, concentrating and paying attention. NT1 is caused by loss of the orexin-producing neurons in the brain, which regulate wakefulness and sleep, and is also believed to be essential to other functions such as attention through activation of orexin receptors. Currently, the standard of care is limited to symptomatic therapies that may only partially address some of the symptoms people face.

About Oveporexton (TAK-861)

Oveporexton (TAK-861) is an investigational orexin receptor 2 (OX2R)-selective agonist, which selectively stimulates the OX2R to restore signaling and address the underlying orexin deficiency that causes narcolepsy type 1 (NT1). By activating OX2Rs, oveporexton is designed to promote wakefulness and reduce abnormal rapid eye movement (REM)-sleep like phenomena, including cataplexy, to address the broad spectrum of daytime and nighttime symptoms.

About the FirstLight and RadiantLight Phase 3 Studies

FirstLight (TAK-861-3001; NCT06470828) and RadiantLight (TAK-861-3002; NCT06505031) are global, multicenter, placebo-controlled studies to evaluate the efficacy, safety and tolerability of oveporexton compared to placebo in patients with narcolepsy type 1 (NT1) over 12 weeks. The studies were conducted in 19 countries with enrollment completed within six months. The FirstLight study enrolled 168 participants randomized to one of three dosing arms (high dose, low dose and placebo). The RadiantLight study enrolled 105 participants randomized to two dosing arms (high dose and placebo). The primary endpoint in both studies was improvement in excessive daytime sleepiness (EDS) as measured by the Maintenance of Wakefulness Test (MWT), a standard measure of wakefulness. Key secondary endpoints included improvement in EDS as measured by the Epworth Sleepiness Scale (ESS) and in the Weekly Cataplexy Rate (WCR), a measure evaluating cataplexy. The studies also evaluated the effect of oveporexton on participants' ability to maintain attention, participants’ overall quality of life, the spectrum of narcolepsy symptoms and daily life functions, as well as the safety and tolerability of oveporexton.

About Takeda’s Orexin Agonists for Sleep-Wake Disorders

Takeda is leading the field of orexin science with a multi-asset franchise. Orexin is a key regulator of sleep and wake patterns and contributes to other essential functions including attention, mood, metabolism and respiration. Oveporexton (TAK-861) is the lead investigational orexin receptor 2 (OX2R) agonist asset in Takeda’s orexin franchise and received Breakthrough Therapy designation for the treatment of excessive daytime sleepiness in narcolepsy type 1 (NT1) from the U.S. Food and Drug Administration and the Center for Drug Evaluation of China’s National Medical Products Administration. The company is also investigating other orexin agonists in populations with orexin levels in the normal range, including TAK-360, an oral OX2R agonist initially being investigated for the treatment of narcolepsy type 2 (NT2), idiopathic hypersomnia (IH), and other potential indications where orexin signaling is implicated.

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

Media Contacts:

Japanese Media

Yuko Yoneyama

yuko.yoneyama@takeda.com

U.S. and International Media

Rachel Wallace

rachel.wallace2@takeda.com

Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question-and-answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects”, “forecasts”, “outlook” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

Medical Information

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Source:

FAQ

What did Takeda (TAK) announce in its July 2025 Form 6-K?

Takeda reported that both Phase 3 trials of oveporexton (TAK-861) met all endpoints in narcolepsy type 1 with strong statistical significance.

How effective was TAK-861 in the Phase 3 studies?

TAK-861 showed statistically significant (p < 0.001) improvements in wakefulness, daytime sleepiness, cataplexy and quality-of-life measures across all doses.

Were there any safety concerns for TAK-861?

No serious treatment-related adverse events occurred; the most common events were insomnia and urinary urgency/frequency.

When will Takeda file for regulatory approval of TAK-861?

The company plans to submit a New Drug Application to the FDA and other authorities during fiscal year 2025.

Will the Phase 3 results affect Takeda鈥檚 FY 2026 financial guidance?

Takeda stated that the study outcomes have no significant impact on its consolidated forecast for the fiscal year ending March 31, 2026.

AG真人官方

[6-K] Takeda Pharmaceutical Company Limited American Current Report (Foreign Issuer)

Insights

FAQ

What did Takeda (TAK) announce in its July 2025 Form 6-K?

How effective was TAK-861 in the Phase 3 studies?

Were there any safety concerns for TAK-861?

When will Takeda file for regulatory approval of TAK-861?

Will the Phase 3 results affect Takeda鈥檚 FY 2026 financial guidance?

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[6-K] Takeda Pharmaceutical Company Limited American Current Report (Foreign Issuer)

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FAQ

What did Takeda (TAK) announce in its July 2025 Form 6-K?

How effective was TAK-861 in the Phase 3 studies?

Were there any safety concerns for TAK-861?

When will Takeda file for regulatory approval of TAK-861?

Will the Phase 3 results affect Takeda鈥檚 FY 2026 financial guidance?

NYSE:TAK

TAK Rankings

TAK Latest News

TAK Latest SEC Filings

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