BIOTECH ALERT: New Therapy Could Send This Stock Flying
The FDA has a big job.
Food, medicines, medical devices… the regulator oversees more than $2.4 trillion in spending.
That’s about 20 cents of every dollar Americans spend.
What the FDA does has a huge impact on the creation of new pharmaceuticals. Biotech companies can spend hundreds of millions in discovering and developing new drugs.
But at the end of the day, they must be able to demonstrate efficacy and safety to the FDA’s satisfaction.
New Leadership Brings Big Changes
In more traditional fields of drug development, such as small molecules, the FDA has many decades of experience. The regulator knows what it needs to know in order to make a decision. Pharma companies also have relative clarity in what they need to look for and demonstrate in order to bring products to market.
But the pharmaceutical market is in an accelerated rate of change. No longer do we solely use small-molecule drugs produced using chemical processes. We also have a class of drugs known as biologics — complex organic molecules that rely on biological processes for their manufacture.
And things are getting even more complicated for the FDA. A suite of new therapies are emerging that aren’t really like drugs at all. Some of them work by rewriting our DNA. Others use human cells to replace, repair or heal.
The FDA, under Commissioner Scott Gottlieb, is moving toward developing a better set of standards for these emerging gene and cell-based therapies. Among these are documents that will lay out acceptable endpoints for the FDA to bring accelerated approval to gene therapies.
These are, by now, greatly needed. According to Gottlieb, the “FDA has more than 500 active investigational new drug applications involving gene therapy products. We’ve received more than 100 such applications last year alone.”
All of this is great for gene therapy companies in general, but it’s particularly good for the company I want to show you today.
Bluebird Flies High Off New Trial Data
Bluebird Bio (NASDAQ: BLUE), in a partnership with Celgene, are in the midst of bringing a new breakthrough cancer treatment to market.
The treatment, code named bb21221, is a new form of CAR-T therapy that genetically alters a patient’s white blood cells to treat patients stricken with late stage multiple myeloma.
According to Forbes, the treatment has shown “impressive results” in earlier stage clinical trials.
Monday, Bluebird released Phase 1 FDA trial data. According to Market Watch, the trial focused on stage 3 or relapsed/refractory multiple myeloma.
The American Cancer Society notes that for patients with stage 3 myeloma (late stage) the median time of survival is 43 months.
Bluebird’s recent trial data “showed cancer patients survived for a median of roughly 12 months after receiving the treatment before their conditions worsened,” as reported by Schaeffer’s.
For patients with little time left, the prospect of living another year is priceless.
And as a Forbes report states:
“Among 22 patients who had the highest dose of the therapy—that’s more than 150 million cells—21, or 95.5%, had a response, meaning that the amount of cancer in their blood shrank; 11, or 50%, had a complete response, meaning that the cancer became undetectable; and 8 had a very good partial response, meaning that signs of cancer in their blood almost vanished.”
Investor reaction to the news was muted. The stock only saw a small pop closing Monday up 3%. But for our purposes, the data shows Bluebird could have a major run coming soon.
The stock is trading well off its high of $231.95 earlier in March.
There’s plenty of room for this stock to grow.
Meaning there could be plenty of profits for you to take as Bluebird moves its treatment into Phase 2 and Phase 3 FDA trials.
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Chief Technology Expert, Technology Profits Daily