January 31, 2017
By Mark Terry, BioSpace.com Breaking News Staff
If January has been a little bit slow in terms of catalysts in biopharma, February is going to change that. Bret Jensen, writing for Seeking Alpha, discusses a number of PDUFA dates and key clinical trial data releases coming in the month of February.
Amgen ’s Parsabiv has a PDUFA date of February 9. The drug was approved in Europe in November 2016 for the treatment of secondary hyperparathyroidism in adults on hemodialysis. It is up for a decision by the U.S. Food and Drug Administration (FDA).
Amgen is currently trading for $155.74.
The company’s brodalumab for psoriasis is awaiting an FDA decision on February 16. If approved, Valeant Pharmaceuticals would likely launch in the second quarter. The market is projected to be $10 billion. Jensen writes, “The beaten down ‘pariah’ of the drug industry could use any good news at the moment.
Valeant is currently trading for $13.60.
Rancho Cucamonga, Calif.-based Amphastar has a February 19 PDUFA date for an intranasal version of naxolone for opioid overdose. Jensen writes, “I know little of the company but another SeekingAlpha contributor has a bearish view on the company right now. Also after getting burned by the recent FDA labeling decision on the intranasal version of ARYMO ER from Egalet , I would be somewhat leery of the stock and the upcoming FDA decision.”
On December 27, 2016, the FDA shot down the company’s New Drug Application for Primatene Mist, indicating that it couldn’t be approved in its present form.
Amphastar is currently trading for $15.49.
Lexicon Pharmaceuticals has a February 28 PDUFA date for Telotristat for carcinoid syndrome. Jensen writes, “Based on trial results, I view the approval as likely and recently highlighted why I like the maker of this compound, Lexicon Pharmaceuticals as an investment right now.”
Lexicon is currently trading for $13.93.
Amicus Therapeutics is expected to release additional data from its Phase I/II clinical trial for ATB200 in Pompe Disease at the 13th Annual WORLD Symposium February 13-17. It provided preliminary data in December that was positive. The company is also awaiting a decision in late March in Europe for Galafold for Fabry disease.
Jensen writes, “I think Amicus is undervalued just based on its approved compound Galafold for the treatment of Fabry Disease outside the United States.”
Amicus is currently trading for $5.33.
Axovant Sciences is expected to announce Phase II data from its trial of Nelotanserin for visual hallucinations associated with Lewy body dementia. In early December, Axovant announced positive data from a Phase IIb trial of intepirdine (RVT-101), combined with standard of care donepezil, in mild-to-moderate Alzheimer’s disease.
Jensen writes, “It is a busy year for the company’s pipeline development. The key catalyst will be for Phase III data for its compound Intepirdine aimed at Alzheimer’s Disease. This is due out in the third quarter and most likely to cause at least a 50 percent move in either direction when released depending on the results.”
Axovant is currently trading for $11.98.
