TAK - next big FDA approval, under FDA Priority Review - Tuesday Nov 23
$Takeda Pharmaceutical(TAK.US$
If approved by the FDA, maribavir will be the first and only treatment indicated for adults in this patient population
The FDA has placed Takeda's New Drug Application for maribavir under Priority Review, and this vote of confidence from the AMDAC will be taken into account when the regulator makes its final decision. The NDA submission is based on the Phase III study. The AMDAC also collected insights and responses from advocates, patients, and healthcare providers in a public forum.
The U.S. Food and Drug Administration's Antimicrobial Drugs Advisory Committee (AMDAC) has unanimously voted on the use of Takeda Pharmaceutical Company's maribavir to treat different types of refractory cytomegalovirus (CMV) infection.
CMV is a beta herpes virus that commonly affects individuals who have compromised immune systems. Out of the approximately 200,000 adult transplants per year worldwide, CMV is one of the most common viral infections. It has an estimated incidence rate of between 16% and 56% in solid organ transplant recipients and 30% to 70% percent in hematopoietic stem cell transplant patients.
https://www.biospace.com/article/candidate-cmv-infection-therapy-maribavir-gets-nod-from-key-fda-advisory-committee/
https://www.businesswire.com/news/home/20211007006064/en/FDA-Advisory-Committee-Recommends-Use-of-Investigational-Drug-Maribavir-TAK-620-to-Treat-Post-Transplant-Recipients-with-Cytomegalovirus-CMV-Infection-and-Disease-Refractory-to-Treatment-With-or-Without-Resistance
In addition, there was a big insider buy
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) announced that its Board of Directors resolved today to engage in the acquisition of its own shares pursuant to the provision of its Articles of Incorporation in accordance with Article 459, paragraph 1 of the Companies Act of Japan, as detailed below.
“At our current share price, we see an opportunity to buy back our shares at a substantial discount to what we perceive is their underlying value,” said Costa Saroukos, director and Chief Financial Officer of Takeda. “We expect that this share buyback of up to 100B yen will not impact our deleveraging plans, and that we will remain firmly on track to deliver on our target for 2x (‘low twos’) net debt to Adjusted EBITDA by the end of FY23. We are also maintaining our existing dividend policy and updating our capital allocation policy to allow for share buybacks in the future when appropriate. This underscores our business’ strong cash generation ability, our confidence in our fundamental growth driven by the 14 global brands, and our belief that the R&D strategy with ~40 new molecular entities in the pipeline, will deliver for the long term.”
This buyback of shares will be funded by Takeda’s operating cash flow driven by growth in our 14 global brands and working capital improvements.
https://www.takeda.com/newsroom/newsreleases/2021/takeda-announces-acquisition-of-own-shares/
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If approved by the FDA, maribavir will be the first and only treatment indicated for adults in this patient population
The FDA has placed Takeda's New Drug Application for maribavir under Priority Review, and this vote of confidence from the AMDAC will be taken into account when the regulator makes its final decision. The NDA submission is based on the Phase III study. The AMDAC also collected insights and responses from advocates, patients, and healthcare providers in a public forum.
The U.S. Food and Drug Administration's Antimicrobial Drugs Advisory Committee (AMDAC) has unanimously voted on the use of Takeda Pharmaceutical Company's maribavir to treat different types of refractory cytomegalovirus (CMV) infection.
CMV is a beta herpes virus that commonly affects individuals who have compromised immune systems. Out of the approximately 200,000 adult transplants per year worldwide, CMV is one of the most common viral infections. It has an estimated incidence rate of between 16% and 56% in solid organ transplant recipients and 30% to 70% percent in hematopoietic stem cell transplant patients.
https://www.biospace.com/article/candidate-cmv-infection-therapy-maribavir-gets-nod-from-key-fda-advisory-committee/
https://www.businesswire.com/news/home/20211007006064/en/FDA-Advisory-Committee-Recommends-Use-of-Investigational-Drug-Maribavir-TAK-620-to-Treat-Post-Transplant-Recipients-with-Cytomegalovirus-CMV-Infection-and-Disease-Refractory-to-Treatment-With-or-Without-Resistance
In addition, there was a big insider buy
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) announced that its Board of Directors resolved today to engage in the acquisition of its own shares pursuant to the provision of its Articles of Incorporation in accordance with Article 459, paragraph 1 of the Companies Act of Japan, as detailed below.
“At our current share price, we see an opportunity to buy back our shares at a substantial discount to what we perceive is their underlying value,” said Costa Saroukos, director and Chief Financial Officer of Takeda. “We expect that this share buyback of up to 100B yen will not impact our deleveraging plans, and that we will remain firmly on track to deliver on our target for 2x (‘low twos’) net debt to Adjusted EBITDA by the end of FY23. We are also maintaining our existing dividend policy and updating our capital allocation policy to allow for share buybacks in the future when appropriate. This underscores our business’ strong cash generation ability, our confidence in our fundamental growth driven by the 14 global brands, and our belief that the R&D strategy with ~40 new molecular entities in the pipeline, will deliver for the long term.”
This buyback of shares will be funded by Takeda’s operating cash flow driven by growth in our 14 global brands and working capital improvements.
https://www.takeda.com/newsroom/newsreleases/2021/takeda-announces-acquisition-of-own-shares/
$Longeveron(LGVN.US$
$RenovoRx(RNXT.US$
$Novavax(NVAX.US$
$ChemoCentryx(CCXI.US$
$Pfizer(PFE.US$
$Futu Holdings Ltd(FUTU.US$
$Moderna(MRNA.US$
$BioNTech(BNTX.US$
$CorMedix(CRMD.US$
$Amgen(AMGN.US$
$Sanofi(SNY.US$
$Bristol-Myers Squibb(BMY.US$
$MERCK KGAA SPON ADR EACH REPR 0.2 ORD SHS(MKKGY.US$
$Johnson & Johnson(JNJ.US$
$AbbVie(ABBV.US$
$Novartis AG(NVS.US$
$ROCHE HOLDING AG(RHHBY.US$
$iSpecimen(ISPC.US$
$Petros Pharmaceuticals(PTPI.US$
$Aadi Biosciences(AADI.US$
$Pasithea Therapeutics(KTTA.US$
$Fennec Pharmaceuticals(FENC.US$
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小 鬼 : What time will I know the results today ^_^
上了贼船888 : May I ask what is the current situation
UnholyD :
Let's forget about this stock ~ it won't be a big deal ~
DavLoh :