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

Food and Drug Administration Approves Takeda’s EXKIVITY™ (Mobocertinib) for the Treatment of Adult Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cance

09/15/2021 | 04:40pm EDT

Takeda Pharmaceutical Company Limited announced that the U.S. Food and Drug Administration (FDA) has approved EXKIVITY (mobocertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. EXKIVITY, which was granted priority review and received Breakthrough Therapy Designation, Fast Track Designation and Orphan Drug Designation from the FDA, is the first and only approved oral therapy specifically designed to target EGFR Exon20 insertion mutations. This indication is approved under Accelerated Approval based on overall response rate (ORR) and DoR. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The FDA simultaneously approved Thermo Fisher Scientific’s Oncomine Dx Target Test as an NGS companion diagnostic for EXKIVITY to identify NSCLC patients with EGFR Exon20 insertions. NGS testing is critical for these patients, as it can enable more accurate diagnoses compared to polymerase chain reaction (PCR) testing, which detects less than 50% of EGFR Exon20 insertions. The FDA approval is based on results from the platinum-pretreated population in the Phase 1/2 trial of EXKIVITY, which consisted of 114 patients with EGFR Exon20 insertion+ NSCLC who received prior platinum-based therapy and were treated at the 160 mg dose. Results were presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting from the Phase 1/2 trial and demonstrated a confirmed ORR of 28% per independent review committee (IRC) (35% per investigator) as well as a median DoR of 17.5 months per IRC, a median overall survival (OS) of 24 months and a median progression-free survival (PFS) of 7.3 months per IRC. The most common adverse reactions (>20%) were diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, and musculoskeletal pain. The EXKIVITY Prescribing Information includes a boxed warning for QTc prolongation and Torsades de Pointes, and warnings and precautions for interstitial lung disease/pneumonitis, cardiac toxicity, and diarrhea.


© S&P Capital IQ 2021
All news about TAKEDA PHARMACEUTICAL COMPANY LIMITED
10:28aNOVAVAX : Dismisses Media Report on COVID-19 Vaccine Quality, Production Delays; Shares Do..
MT
10:23aNOVAVAX : Refutes Media Report on its COVID-19 Vaccine Quality, Production Delays
MT
10/18WAVE LIFE SCIENCES : Takeda Pharmaceutical Partially Amend Central Nervous System Collabor..
MT
10/18CALITHERA BIOSCIENCES : Buys Two Clinical-Stage Assets from Takeda to Boost Oncology Pipel..
MT
10/18Calithera Expands Oncology Pipeline with Acquisition of Two Clinical-Stage Assets from ..
CI
10/18Calithera Agrees to Acquire 2 Clinical-Stage Assets from Takeda Pharma
DJ
10/14TAKEDA PHARMACEUTICAL : Working With Immusoft to Develop B-Cell Therapies for Rare Neurome..
MT
10/13TR1 : Notification of Major Shareholding
DJ
10/13TAKEDA PHARMACEUTICAL : BioLife Plasma Services Announces Expansion of Plasma Donation Cen..
BU
10/13Immusoft and Takeda Pharmaceutical Company Limited Collaborate to Discover and Develop ..
CI
More news
Analyst Recommendations on TAKEDA PHARMACEUTICAL COMPANY LIMITED
More recommendations
Financials
Sales 2022 3 391 B 29 648 M 29 648 M
Net income 2022 248 B 2 168 M 2 168 M
Net Debt 2022 3 258 B 28 484 M 28 484 M
P/E ratio 2022 20,8x
Yield 2022 5,55%
Capitalization 5 104 B 44 688 M 44 633 M
EV / Sales 2022 2,47x
EV / Sales 2023 2,33x
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
TrendsBearishBearishBearish
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus OUTPERFORM
Number of Analysts 14
Last Close Price 3 246,00 JPY
Average target price 4 487,14 JPY
Spread / Average Target 38,2%
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-13.56%43 985
JOHNSON & JOHNSON4.12%431 385
ROCHE HOLDING AG15.84%337 562
NOVO NORDISK A/S57.04%239 813
PFIZER, INC.12.25%235 986
ELI LILLY AND COMPANY43.51%219 674