Amicus Therapeutics, Inc.NASDAQ
A Look At Amicus Therapeutics
Amicus Fairly Rewarded For Substantial Progress
Stephen Simpson, CFA
Stephen Simpson, CFA
Tue, Nov. 29, 12:42 PM
Tue, Nov. 29, 11:00 AM
Tue, Nov. 29, 9:22 AM
Mon, Nov. 28, 5:36 PM
Mon, Nov. 28, 4:50 PM
- Amicus Therapeutics' (NASDAQ:FOLD) hopes for accelerated approval in the U.S. of migalastat for the treatment of Fabry disease have vaporized. In a statement released after the close, it says the FDA wants to see more data, specifically a 12-month cross-over study in treatment-naive Fabry patients who have amenable mutation and gastrointestinal (GI) symptoms.
- In addition, the FDA indicated that it does not consider kidney globotriaosylceramide (GL-3) a basis for accelerated approval. GL-3 builds up over time in Fabry patients due to the deficiency of an enzyme called alpha-galactosidase A. Excess GL-3 causes the blood vessels to narrow leading to decreased blood flow and undernourished tissues.
- The company is working with the agency to finalize the study protocol. Enrollment should commence in 2017 with top-line data expected in 2019. A New Drug Application (NDA) will probably not happen until 2020.
- An intermediate Expanded Access Program (EAP) will be set up to ensure short-term access to U.S. Fabry patients who are currently on enzyme replacement therapy and meet EAP guidelines. Clinical trial participants will continue receiving treatment.
- Shares are down 28% after hours on robust volume.
Mon, Nov. 7, 12:44 PM
Mon, Nov. 7, 7:35 AM
Sun, Nov. 6, 5:30 PM| Sun, Nov. 6, 5:30 PM | 5 Comments
Tue, Aug. 9, 10:43 AM| Tue, Aug. 9, 10:43 AM
Tue, Aug. 9, 7:34 AM
Tue, May 31, 9:15 AM
Fri, May 20, 7:32 AM
- Arrowhead Pharmaceuticals (NASDAQ:ARWR) initiated with Buy rating and $12 (140% upside) price target by Chardan Capital.
- Amicus Therapeutics (NASDAQ:FOLD) initiated with Buy rating and $10 (45% upside) price target by Bank of America.
- Quorum Health (NYSE:QHC) initiated with Equal Weight rating and $12 (2% upside) price target by Morgan Stanley.
- TESARO (NASDAQ:TSRO) initiated with Outperform rating and $56 (30% upside) price target by Credit Suisse.
- Prothena (NASDAQ:PRTA) initiated with Overweight rating and $60 (47% upside) price target by Barclays.
- Mazor Robotics (NASDAQ:MZOR) upgraded to Outperform from Market Perform by Wells Fargo. Price target raised to $15-17 (14% upside from midpoint) from $10-13.
- Eli Lilly (NYSE:LLY) upgraded to Strong Buy with a price target of $88.67 (19% upside) by the Vetr Community.
- Haemonetics (NYSE:HAE) upgraded to Neutral from Sell by Goldman Sachs. Price target raised to $29 (5% upside) from $25.
- Nanosphere (NASDAQ:NSPH) downgraded to Neutral from Buy by Rodman & Renshaw. Price target lowered to $1.35 (2% upside) from $2.00.
- Anacor Pharmaceuticals (NASDAQ:ANAC) downgraded to Neutral from Buy by Mizuho Securities. Price target set at $99.25 (0% upside).
- Globus Medical (NYSE:GMED) downgraded to Sell from Neutral by Goldman Sachs. Price target lowered to $21 (10% downside risk) from $26.
- EPIRUS Biopharmaceuticals (NASDAQ:EPRS) downgraded to Market Perform from Outperform by Leerink Swann. Price target lowered to $0.75 (27% upside).
Tue, May 3, 9:55 AM
- Amicus Therapeutics (FOLD -2.8%) Q1 results: Revenues: $0; R&D Expense: $23.4M (+45.3%); SG&A: $15.7M (+145.3%); Operating Loss: ($43M) (-78.4%); Net Loss: ($43.7M) (-79.8%); Loss Per Share: ($0.35) (-40.0%); Quick Assets: $165.9M (-22.5%).
- 2016 Guidance: Net Cash Spend: $135M - 155M.
Tue, May 3, 7:04 AM
- Amicus Therapeutics (NASDAQ:FOLD): Q1 EPS of -$0.35 misses by $0.01.
Tue, Apr. 12, 9:27 AM
- Amicus Therapeutics (NASDAQ:FOLD) is up 7% premarket on robust volume in apparent response to Chardan Capital's increase in its price target to $15 (92% upside) from $10 saying the company is an attractive buyout target.
- The company's lead product candidate, pharmacological chaperone migalastat, is poised for regulatory approval in the EU for the treatment of Fabry disease after a positive CHMP vote on April 1.
- Previously: European Ad Comm backs Amicus Therapeutics' migalastat for Fabry disease; shares up 10% (April 1)
Tue, Apr. 12, 9:12 AM