On September 10, Amicus Therapeutics (FOLD) announced the regulatory and clinical progress of its AT-GAA development program for Pompe disease. The company has met with the FDA to discuss the regulatory trajectory for AT-GAA, and the FDA has provided final written minutes of the meeting.
Amicus Therapeutics has implemented the suggestions of the FDA and the European Medicines Agency for the study. It plans to start the pivotal trial for AT-GAA in the second half of 2018.
In the second quarter, Amicus Therapeutics reported net income and EPS of -$61.8 million and -$0.33, respectively, compared to -$48.1 million and -$0.34, respectively, in Q2 2017.
In the first half of the year, Amicus Therapeutics reported net income and EPS of -$111.8 million and -$0.61, respectively, compared to -$103.1 million and -$0.72, respectively, in the first half of 2017.
On September 11, Amicus Therapeutics stock closed at $11.79, which is ~49% below its 52-week high of $17.62 on June 20, 2018. On September 10, it hit its 52-week low of $11.92.
Of the seven analysts tracking Amicus Therapeutics (FOLD) in September, three of them have recommended a “strong buy,” while two have recommended a “buy.” Two have recommended a “hold.”
On September 10, it had a consensus 12-month target price of $20, which represents ~69.64% return on investment over the next 12 months.
All four of the analysts tracking Progenics Pharmaceuticals (PGNX) in September have recommended a “buy” for the stock. All of the seven analysts tracking Array BioPharma (ARRY) have recommended a “buy.”
On September 11, Progenics Pharmaceuticals and Array BioPharma had consensus 12-month target prices of $15 and $23.57, respectively, which represents ~102.16% and ~68% returns on investment, respectively, over the next 12 months.