August Is Key For Amgen, Inc. (AMGN) And Bristol-Myers Squibb Co (BMY) As FDA Action Looms
The current month assumes importance for Amgen, Inc. (NASDAQ:AMGN), as well as, Bristol-Myers Squibb Co (NYSE:BMY). That is primarily because the Food and Drug Administration will decide on these two companies biologics license application (BLA) and supplemental biologics license application (sBLA). These firms stocks could be watched since any favorable decision will push their stock prices higher. There is also the risk of unfavorable news affecting the stocks. There are also three more firms waiting for the FDA’s ruling in August.
There are at least two BLAs filed by Amgen, Inc. (NASDAQ:AMGN) in respect of Evolocumab and Repatha. The FDA is meeting on August 27 to take a call on the treatment of these two drugs for high cholesterol. Evolocumab is meant to treat the bad cholesterol from the blood. The overall cholesterol market is estimated to be $31 billion in 2022 with a growth expected to be around 2% a year.
Cholesterol is nothing but a waxy material, which is produced by the liver naturally. It not only protects the nerves but also produces hormones besides making cell tissues. This was disclosed by the American Academy of Family Physicians. Of course, too much of cholesterol could be a bad one. That is the reason it is important to manage the cholesterol levels to keep it at manageable levels. Amgen, Inc. (NASDAQ:AMGN)’s drugs are only trying to address the issue.
Another big company, Bristol-Myers Squibb Co (NYSE:BMY) has filed sBLA with the FDA in the United States. The regulator has accepted the filing, as well as, the review of sBLA for Opdivo. The drug is for the previously untreated patients of metastatic or unresectable melanoma. In April, the regulator has given the approval for Priority Review of the application. Accordingly, the FDA is taking up the review on August 27.
The company disclosed earlier that Opdivo is a PD-1 (programmed death-a) resistant checkpoint inhibitor, which received FDA approval for monotherapy in two cancer signals. In March, the FDA gave its approval for pdivo for treating patients with metastatic squamous non-small cell lung cancer or NSCLC. That is applicable either with progression on or after platinum-based chemotherapy. Interestingly, other countries have approved the drug.
Other Pharma Events
At least three more companies, Alkermes Plc (NASDAQ:ALKS), Seattle Genetics, Inc. (NASDAQ:SGEN), and Raptor Pharmaceuticals Corp. (NASDAQ:RPTP) are also expecting FDA’s response to their different requests. For instance, the regulator is meeting on August 14 to take Raptor Pharmaceutical’s application for label expansion of Procysbi to add nephropathic cystinosis in patients aged between two and six years. This has been approved by other nations.
Similarly, Seattle Genetics, Inc. (NASDAQ:SGEN)’s sBLA is coming up before the FDA on August 18 for its Adcetris. The drug is for the treatment of Hodgkin lymphoma. Other countries have given their approval. Alkermes Plc (NASDAQ:ALKS) submitted NDA for aripiprazole Lauroxil for treating schizophrenia. The FDA is meeting on August 22 to take the NDA.
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