We’ve had a relatively quiet close to the end of the week in the biotechnology space this week but this doesn’t mean that we haven’t seen any degree of movement in the markets. During the session on Thursday, we got some news from Antares Pharma, Inc. (NASDAQ:ATRS) relating to its lead development program and the company has seen an uptick in volume on the back of the release.
We also learned that biotechnology and healthcare behemoth Amgen, Inc. (NASDAQ:AMGN) is set to provide funding for a Harvard professors’ startup with, initially, the goal being to direct this funding into the development of a drug targeting ALS – a disease that’s very much in the spotlight right now on the back of the recent death of world-renowned sufferer of ALS, Stephen Hawking.
Here is what’s important.
So, first up, Antares.
This week, Antares reported that the FDA has accepted its New Drug Application (NDA) for a drug called XYOSTED (testosterone enanthate subcutaneous injection).
This is noteworthy because the development derives from a resubmission of this NDA, which the company initially submitted last year and for which it subsequently received a complete response letter (CRL) from the agency with various concerns rooted in both safety and efficacy cited as the roots of the response.
However, on the back of the latest news, and in line with the fact that the FDA in the US has reconsidered the application as a class 2 response, the program now looks to be very much back on track.
For anybody new to this drug, it’s one that the company is trying to get approved for the treatment of testosterone deficiency (hypogonadism) which, as its name pretty much sums up, is a condition rooted in a lack of testosterone in males (primarily) and that can cause a whole variety of different issues including reduced sexual desire, hot flushes and sweating, lethargy and fatigue, depression and, in some cases, breast development.
The current standard of care treatment in this space is testosterone HRT as a sort of but, as is often the case with HRT, it has its drawbacks. XYOSTED is a subcutaneous delivery, self-injection asset that aims to overcome these drawbacks and, in doing so, to provide these patients with a simple and effective way to go about treating their condition.
So what’s next?
Well, now the application has been accepted, there is a PDUFA in place meaning the FDA will return its ruling on XYOSTED by the date in question, which is slated as September 29, 2018.
Markets have responded positively to the development, as might be expected, and the company is trading for a few percentage points of premium to the price at which it opened the session on Thursday morning in the US.
Chances are we will see a continuation of this strength as we head into the close of the week and, further, moving forward into PDUFA territory.
Moving on, Amgen.
As mentioned, this one is rooted in the company’s investment in a startup that is working on the development of a treatment for ALS. For anybody not familiar with ALS, it’s a condition that’s also known as motor neurone disease (MND) and Lou Gehrig’s disease, and is a specific disease which causes the death of neurons controlling voluntary muscles. Some also use the term motor neuron disease for a group of conditions of which ALS is the most common.
There is no current cure for the condition and treatment options are extremely limited and, with the exception of the above mentioned Stephen Hawking, sufferers generally have dramatically shortened lives as compared to healthy peers.
We don’t really have too much information as to the specifics of the deal, but we do know that Amgen joined forces with MP Healthcare Venture Management and Alexandria Venture Investments to put the latest tranche of funding into the company, called QurAlis.
The target is to develop a stem cell-based treatment for these patients in line with a couple of other assets that the same company has put through tentative early-stage studies over the last couple of years.
This is a long-term program but it’s one that, if it reaches a successful conclusion, could be a real winner for both Amgen and the patient population it’s targeting.
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