Paullee
3 years ago
Zacks Equity Research
Mon, December 20, 2021, 11:02 AM
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GBT
+2.32%
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Global Blood Therapeutics, Inc. GBT announced that the FDA has granted accelerated approval to its supplemental new drug application (βsNDAβ) for Oxbryta (voxelotor) to treat sickle cell disease (βSCDβ) in children aged four to less than 12 years.
The regulatory body also approved the new drug application (βNDAβ) for Oxbryta tablets for oral suspension β a new dispersible, once-daily tablet dosage for patients aged four to less than 12 years, as well as for older patients who have difficulty swallowing whole tablets.
Oxbryta is currently approved by the FDA as an oral, once-daily treatment for SCD in patients aged 12 years or above.
The FDA nod for the sNDA was based on data from the phase IIa HOPE-KIDS 1 study, which evaluated Oxbryta in the given patient population. Data from the same showed that weight-based treatment with the dispersible tablet formulation of Oxbryta led to rapid and sustained improvements in hemoglobin. Concurrent reduction of hemolysis or red blood cell destruction was also demonstrated in the study.
Shares of Global Blood have plunged 29.5% so far this year compared with industryβs decrease of 19%.
Timetravelerdos
5 years ago
5 Best Mid-Cap Biotech Acquisition Targets
2019 Q4 has been a great quarter for biotech investors and more M&A deals are expected in 2020.
With the FDA approval of Oxbryta, GBT is the perfect acquisition candidate for treating sickle cell disease.
Global Blood Therapeutics (GBT) - $9B
With a market cap of $4.9B, Global Blood Therapeutics is engaged in the innovation and commercialization of drugs to serve the needs of sickle cell disease (NYSE:SCD). SCD is an inherited blood disorder caused by a genetic mutation in the beta-chain of hemoglobin, leading to the formation of abnormal hemoglobin known as sickle hemoglobin. GBT went up 60% over 3 weeks since the company confirmed FDA approval of Oxbryta (voxelotor), company's main drug to treat sickle cell disease in adults and children 12 years of age and older.
Oxbryta, an oral therapy taken once daily, is the first approved treatment that directly inhibits sickle hemoglobin polymerization, the root cause of SCD.
FDA Approves Oxbrytaβ’ (Voxelotor), the First Medicine Specifically Targeting the Root Cause of Sickle Cell Disease
Following suit, the European Medicines Agency (NYSEMKT:EMA) has also included voxelotor in its Priority Medicines (PRIME) program, while the European Commission (NYSE:EC) has designated voxelotor as an orphan medicinal product for the treatment of patients with SCD. Based on GBT's EHA corporate update in June, Oxbryta is addressing the needs of over 100,000 SCD patients in U.S. and 60,000 patients in Europe. The annual cost of SCD care is $200,000 per patient. An approved drug means R&D risks are largely absent and GBT is attractive to large Biopharma companies which seek to expand their drug pipelines without development risks.
Additionally, GBT started HOPE-KIDS2 which is to confirm there is a decreased risk of stroke for children 2 to 15 years old with Oxbryta. GBT also announced a collaboration with Syros Pharmaceuticals (SYRS) to discover, develop and commercialize novel therapies for sickle cell disease and beta thalassemia. On Dec 18, GBT secured $150M non-dilutive term loan to enhance its cash position for further development and commercialization, which clears any near-term dilution risks and places company in a great spot to negotiate a good deal with potential acquirers.
https://seekingalpha.com/article/4314536-5-best-mid-cap-biotech-acquisition-targets
Timetravelerdos
5 years ago
Global Blood Therapeutics: Oxbryta Is Aimed For Success
Excellent article.
One of the most exciting times for bioscience investors is during a positive regulatory binary, i.e. a drug approval. As I forecasted, Global Blood Therapeutics (GBT) gained FDA approval for its lead medicine, Oxbryta. Being the first of its kind, Oxbryta has a very strong chance of dominating an untamed market.
From a trading viewpoint, the stock usually but not always rallies after an approval. However, there are situations where the stock trades either sideways or lower. Regardless of the immediate or short-term event, a fundamentally strong company nearly always appreciates in the long haul. Either that or it'll get bought out to reward investors with a huge premium. In this article, I'll feature a fundamental update on GBT and provide my expectations for this intriguing growth equity.
In all, I maintain my buy recommendation on GBT with the four out of five stars rating. Riding the historic Oxbryta approval, GBT now has the best new medicine for SCD. Not only that Oxbryta has an excellent efficacy and safety profile, but it also is the only of its kind. As such, physicians are motivated to prescribe the drug when they know about it. That is to say when the marketing kicks in.
Now the SCD market is quite large, standing at approximately $3B without a dominant drug. As you see, Oxbryta is making its entry into this niche as a gamed "Apex predator." To be realistic, there are still crucial factors that can deter successful commercialization. While you don't have to agree with me, you should weigh the negatives and positives to gauge the long-term prospect of GBT.
Last but not least, two surprise catalysts can occur going forward. One is that GBT suddenly announced a marketing partner. Another possibility is a buyout. Either one would be a surprise present for the holiday.
Here is the entire article:
https://seekingalpha.com/article/4310396-global-blood-therapeutics-oxbryta-is-aimed-for-success
librarianlover
9 years ago
Worth 20? Not really sure, if thats it just a plain IPO with no news they think they can get 20 with not much revenue or earnings yet, seems greedy... will watch for movement beginning of day if I see a spike I in 5 minutes I will of course try but not sure about it.
The way biotech is running lately, I think anything could run 100%, its just valuation, 16 can certainly run to 32 but can 20 run to 40?
Maybe the play is wait and see, if it drops to 15 then thats cheap, grab the dip and then retail catches up to it might run to 25, that would be sweet.
By the way thank you for the message board protagonist12!