U.S. Food and Drug Administration (FDA) rulings and the results from clinical trials have proven time and again that they can make or break companies. The biotech and pharmaceutical companies that subject themselves to this lengthy process are taking on a fair amount of risk of failure, but if a drug is approved or passes a clinical trial, there can be massive upside.
24/7 Wall St. has collected several big FDA decisions and mid- to late-stage trials that should be coming up in November and December, as well as added some color with the trading range and price target. Also check out October’s FDA decisions and trial results.
November and December signify the end of the year and a time when many biotech and pharmaceutical companies expect to produce results or receive approvals — this time of the year perhaps more than any other time.
As a side note about the Prescription Drug User Fee Act (PDUFA): a Priority Review designation is granted to medicines that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.
Medicines Co. (NASDAQ: MDCO) has two Phase 2 studies expected to come out by November 15. First the company is conducting and presenting an interim analysis of its Orion-1 Phase 2 trial of single or multiple subcutaneous injections of PCSK9si in patients with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents (diabetes and familial hypercholesterolemia). Additionally, the company anticipates that top-line data from Day 180 follow-up for up to 200 patients will be presented at the Late-Breaking Clinical Trial Session and Day 180 follow-up in all 501 patients will be completed, analyzed and top-line results disclosed before the end of 2016.
As for the second Phase 2 study, the company expects to present to post results from its Milano-Pilot study for MDCO-216, which is a complex of dimeric recombinant apolipoprotein A-1 Milano (ApoA-1 Milano) and a phospholipid and is currently under development to improve cardiovascular outcomes by reducing plaque burden in patients with atherosclerotic disease. This also will take place at the Late-Breaking Clinical Trial Session at the AHA Scientific Sessions on November 15.
Shares of Medicines most recently closed at $38.51, with a consensus analyst price target of $50.80 and a 52-week trading range of $27.50 to $38.90.
At the end of August, Rigel Pharmaceuticals Inc. (NASDAQ: RIGL) announced that fostamatinib, its oral spleen tyrosine kinase inhibitor, met the primary endpoint in the first of two double-blind studies in the FIT Phase 3 clinical program for the treatment of adult chronic/persistent immune thrombocytopenia. The results from the second FIT Phase 3 study are expected in October/November 2016. November 30 is listed as the last possible date based on guidance.
Shares of Rigel last closed at $4.01. The consensus price target is $8.25, and the 52-week range is $1.88 to $4.38.