After Amicus Therapeutics, Inc. (NASDAQ:FOLD) met with the FDA and received written minutes, the biotech firm revealed yesterday that with the present data alone, it cannot file the NDA for its pipeline drug Galafold, a first line therapy for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (alpha-galactosidase A deficiency) and who have an amenable missense mutation. FOLD indicates it will now require a new trial with data anticipated by 2019.
In reaction to the news, investors are running for the hills, with shares falling 24% in pre-market trading.
However, though Cowen analyst Ritu Baral is pushing back her U.S. approval estimate to 2020, she still believes in the success of the firm’s new GI Phase 3 trial, particularly when considering past Phase 3 statistically significant relevant GI secondary endpoint data. Therefore, the analyst reiterates an Outperform rating on shares of FOLD while reducing the price target from $15 to $12, which represents a 90% increase from current levels.
Baral explains, “We think the trial has a good chance of success given the ‘011 FACETS migalastat trial showed a significant 40-50% decrease in GSRS-diarrhea (p= 0.03 vs PBO) at 6 mo and effects persisted in the 18 and 24 month extension period. The GSRS abdominal pain at 6 months did not show a difference, so differences between the GSRS and new scale used for the trial will be important.”
Moving forward, “FOLD may not need another formal FDA meeting, so we expect finalization of the clinical protocol and primary endpoint in early 1H17. We expect FOLD to initiate enrollment in 2017. FOLD estimates there is a 500-1000 patient pool (naive amenable non-EU with GI symptom) from which to enroll the study. We expect reasonably quick enrollment and data in 2019,” Baral surmises.
According to TipRanks, which measures analysts’ and bloggers’ success rate based on how their calls perform, four-star analyst Ritu Baral is ranked #852 out of 4,239 analysts. Baral has a 37% success rate and yields 3.6% in her yearly returns. When suggesting FOLD, Baral garners 2.5% in average profits on the stock.
TipRanks analytics exhibit FOLD as a Buy. Based on two analysts polled by TipRanks in the last 3 months, both rate a Buy on FOLD. The 12-month average price target stands at $16.00, marking a 92% upside from where the shares last closed.