Log in
E-mail
Password
Show password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
New member
Sign up for FREE
New customer
Discover our services
Settings
Settings
Dynamic quotes 
OFFON

TAKEDA PHARMACEUTICAL COMPANY LIMITED

(4502)
  Report
SummaryChartsNewsRatingsCalendarCompanyFinancialsConsensusRevisions 
SummaryMost relevantAll NewsAnalyst Reco.Other languagesPress ReleasesOfficial PublicationsSector newsMarketScreener Strategies

Takeda Pharmaceutical : U.S. Food and Drug Administration Grants Breakthrough Therapy Designation to Takeda's Investigational Compound TAK-994, an Oral Orexin Agonist in Clinical Development for Narcolepsy Type 1

07/29/2021 | 10:37am EDT

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ('Takeda') today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to TAK-994,1 its Phase 2 investigational oral orexin agonist, which is designed to selectively target orexin 2 receptors.

TAK-994 is currently being studied for the treatment of excessive daytime sleepiness (EDS) in patients with narcolepsy type 1 (NT1),2 a chronic neurological disorder that alters the sleep-wake cycle.3 EDS is a hallmark symptom of NT1 and is characterized by a person's inability to stay awake and alert throughout the day, and falling asleep unintentionally or at inappropriate times on a daily basis.3,4

The FDA's Breakthrough Therapy designation process is designed to expedite the development and review of a drug that is intended to treat a serious condition, for which preliminary clinical evidence exists indicating it may demonstrate a substantial improvement over available therapies on at least one clinically significant endpoint.5

The TAK-994 BTD was based, in part, on early phase and preliminary clinical data that indicates Takeda's investigational oral orexin agonist may demonstrate substantially improved objective and subjective measurements of daytime wakefulness in NT1 patients.1 Currently, TAK-994 is being studied in an ongoing Phase 2 (TAK-994-1501) study.2 Data from the completed Phase 2 study will be presented at a future scientific conference after the study's conclusion.

'Individuals with narcolepsy type 1 suffer from excessive daytime sleepiness, which might mean routinely falling asleep at work or in school. If approved, investigational TAK-994 has the potential to transform the way we currently treat NT1 by addressing the underlying orexin deficiency central to the disease,' said Sarah Sheikh, Head, Neuroscience Therapeutic Area Unit at Takeda. 'Orexin plays a critical role in regulating a person's sleep wake cycle, and supports the body's natural wake promoting pathways in the brain.'

Investigational TAK-994, which was discovered at Takeda's laboratories in Shonan, Japan, part of the open innovation center at the Shonan Health Innovation Park, is the lead candidate in Takeda's pioneering multi-asset orexin-focused franchise. This designation marks a key milestone in Takeda's accelerated development efforts to bring this important potential therapy to patients with NT1.

Takeda's Commitment to Neuroscience

Takeda Neuroscience is driven by the unmet need of patients with neurologic and psychiatric diseases. Our mission is to bring innovative and potentially disease-modifying medicines to these individuals. Our dedication extends beyond our marketed products and research efforts. We are committed to raising awareness for these conditions, building strategic partnerships with both industry and advocacy, educating patients and physicians, and broadening access to therapies.

About Takeda Pharmaceutical Company Limited

Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions.

Media Contact:

Abhi Basu

Tel: +1 (813) 943-4425

Email: abhi.basu@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' 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; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; 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, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda's operations and the timing of any such divestment(s) 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/ 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.

(C) 2021 Electronic News Publishing, source ENP Newswire

All news about TAKEDA PHARMACEUTICAL COMPANY LIMITED
04:03aTakeda Pharmaceutical Commences Construction on Zero-Emissions Building in Singapore fo..
MT
03:22aTAKEDA PHARMACEUTICAL : WFP and Takeda deepen partnership in West Africa to strengthen hea..
AQ
09/22TAKEDA PHARMACEUTICAL : Breaks Ground on its First Zero Energy Building in Singapore
PU
09/22TAKEDA PHARMACEUTICAL : WFP and Takeda deepen partnership in West Africa to strengthen hea..
AQ
09/22TAKEDA PHARMACEUTICAL : Selects Four New Partners for Annual Global Corporate Social Respo..
BU
09/21MIRUM PHARMACEUTICALS : Partners With Takeda Over Developing, Commercializing Liver Diseas..
MT
09/21TAKEDA PHARMACEUTICAL : Mirum Pharmaceuticals and Takeda Enter into Exclusive Licensing Ag..
BU
09/21Mirum Pharmaceuticals, Inc and Takeda Pharmaceutical Company Limited Enter into Exclusi..
CI
09/21Mirum Inks Japan License for Maralixibat With Takeda
DJ
09/16TAKEDA PHARMACEUTICAL : Continues to Advance Growth Strategy with Sale Of Non-Core Assets ..
PU
More news
Analyst Recommendations on TAKEDA PHARMACEUTICAL COMPANY LIMITED
More recommendations
Financials
Sales 2022 3 387 B 30 672 M 30 672 M
Net income 2022 253 B 2 295 M 2 295 M
Net Debt 2022 3 472 B 31 450 M 31 450 M
P/E ratio 2022 23,4x
Yield 2022 4,81%
Capitalization 5 881 B 53 383 M 53 267 M
EV / Sales 2022 2,76x
EV / Sales 2023 2,63x
Nbr of Employees 47 099
Free-Float 99,3%
Chart TAKEDA PHARMACEUTICAL COMPANY LIMITED
Duration : Period :
Takeda Pharmaceutical Company Limited Technical Analysis Chart | 4502 | JP3463000004 | MarketScreener
Technical analysis trends TAKEDA PHARMACEUTICAL COMPANY LIMITED
Short TermMid-TermLong Term
TrendsNeutralBearishNeutral
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus OUTPERFORM
Number of Analysts 15
Last Close Price 3 740,00 JPY
Average target price 4 844,67 JPY
Spread / Average Target 29,5%
EPS Revisions
Managers and Directors
Christophe Weber President, CEO & Representative Director
Constantine Saroukos Chief Financial Officer & Director
Andrew S. Plump Director, Research & Development President
Michael E. Mendelsohn Chief Medical & Scientific Officer
Norimasa Takeda Chief Accounting Officer & Corporate Controller
Sector and Competitors
1st jan.Capi. (M$)
TAKEDA PHARMACEUTICAL COMPANY LIMITED-0.40%53 671
JOHNSON & JOHNSON4.16%431 543
ROCHE HOLDING AG10.05%322 644
PFIZER, INC.19.32%246 414
NOVO NORDISK A/S50.62%232 291
ELI LILLY AND COMPANY35.22%206 972