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Amicus Therapeutics…
Amicus Therapeutics announced that the U.S. Food and Drug Administration, FDA, has extended the review period by 90 days for the Biologics License Application, BLA, for cipaglucosidase alfa and the New Drug Application, NDA, for miglustat, the two components of AT-GAA. The revised PDUFA action dates for miglustat and cipaglucosidase alfa are August 29, 2022 and October 29, 2022, respectively. The Company continues to expect the FDA to approve the applications together. "We continue to work collaboratively with the FDA as it completes its review of the AT-GAA applications," said John Crowley, Chairman and Chief Executive Officer at Amicus Therapeutics. "We want to thank the FDA for its continued diligence during the review process. We remain deeply committed to bringing AT-GAA to as many people living with Pompe disease as quickly as possible and delivering on our promise to become the potential new standard of care."
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05/09/22 Amicus announces anticipated 2022 milestones 04/19/22 Amicus announces issuance of US patent for Galafold 03/16/22 Amicus announces long-term data from Phase 1/2 study of AT-GAA 02/24/22 Amicus sees FY22 Galafold revenue at least $350M-$365M 04/13/22 Goldman Sachs Amicus reinstated with a Neutral at Goldman Sachs 01/13/22 SVB Securities Amicus upgraded to Outperform at SVB Leerink after physician survey 01/13/22 SVB Securities Amicus upgraded to Outperform from Market Perform at SVB Leerink 01/10/22 Stifel Amicus weakness likely on preliminary Galafold sales, says Stifel 05/09/22 Amicus sees FY22 Galafold revenue $350M-$365M 05/09/22 Amicus reports Q1 EPS (30c), consensus (25c) 02/24/22 Amicus reports FY21 EPS (92c), consensus (78c) 01/10/22 Amicus sees Q4 Galafold revenue $84M, revenue consensus $84.77M 05/09/22 What You Missed On Wall Street On Monday 05/09/22 What You Missed On Wall Street This Morning 02/27/22 Week in SPAC News: Trump SPAC in spotlight as Truth Social makes users wait 01/13/22 Fly Intel: After-Hours Movers
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05/09/22 Hindenburg shorts Twitter on risk of deal getting repriced lower 05/08/22 Fly Intel: Top five weekend stock stories 05/06/22 Elon Musk says hasn't had communication with Trump 05/06/22 Vale confirms supply deal with Tesla for low-carbon nickel 02/22/22 Tegna rises 7.1% 02/22/22 TEGNA trading resumes 02/22/22 TEGNA trading halted, news pending 02/22/22 Tegna to be acquired by Standard General for $24.00 per share 05/05/22 Virgin Galactic expects to launch commercial service in Q1 of 2023 05/05/22 Virgin Galactic sees Q2 free cash flow of ($80M)-($90M) 02/22/22 Virgin Galactic sees Q1 free cash flow of ($85M) to ($75M) 02/18/22 Chamath Palihapitiya steps down from Virgin Galactic board $24.66 / -4.125 (-14.33%)
05/03/22 Rivian to receive $1.5B incentives package to build EV factory in Georgia 04/28/22 Rivian Automotive, Clearloop partner on renewable electricity 04/14/22 Rivian Automotive appoints Anisa Kamadoli Costa as chief sustainability officer 05/09/22 Lordstown Motors reports cash, equivalents of $203.5M at March 31 05/09/22 Lordstown Motors reaffirms Q3 target for start of Endurance production 02/28/22 Lordstown Motors down as losses mount, sees raising more funds 02/28/22 Lordstown Motors provides update on company's outlook 04/12/22 Party City rises 6.3% 11/29/21 Party City director buys 6K shares of common stock 05/09/22 Palantir falls -21.7% 05/09/22 Palantir falls -19.3% 04/15/22 Palantir announces expansion to partnership with CDC 04/01/22 Palantir announces new partnership with Carahsoft PCOM Points International 05/09/22 Points International trading resumes 05/09/22 Plusgrade to acquire Points for $385M in all cash transaction 05/09/22 Points International trading halted, news pending 03/03/22 Points International extends strategic collaboration with Marriott Bonvoy 03/18/22 PagSeguro Digital rises 14.8% 03/18/22 PagSeguro Digital rises 7.9% 01/04/22 PagSeguro Digital falls -12.0% 11/16/21 Cathie Wood's ARK Investment bought 226K shares of PagSeguro Digital on Tuesday 05/03/22 Match Group says Shar to step down as CEO, Bernard Kim to succeed 05/03/22 Match Group names Bernard Kim as CEO 04/04/22 Verizon's Visible, Match Group announce partnership on Singles Registry 03/25/22 Texas judge grants Match Group motion to dismiss $844M FTC claim 05/06/22 Raytheon, Lockheed Martin JV awarded $237.89M Army contract modification 05/06/22 Biden Administration announces launch of 'Additive Manufacturing Forward' plan 05/05/22 Lockheed Martin awarded $372.46M Navy contract modification 05/05/22 Aerojet Rocketdyne selected by Lockheed Martin to power DARPA OpFires missile 05/05/22 Summer Game Fest to be broadcast in IMAX theaters 04/26/22 Imax and AEON sign agreement for two new IMAX with Laser systems in Japan 04/19/22 IMAX appoints Natasha Fernandes as CFO $12.50 / -1.505 (-10.75%)
04/12/22 iHeartMedia D.C., Washington Commanders announce three-year audio partnership 03/30/22 Super League Gaming enters partnership with iHeartMedia 03/15/22 Digital Ally's TicketSmarter, iHeartMedia enter multi-year agreement 02/16/22 iHeartMedia partners with Sounder to launch safety tools 05/09/22 Amicus announces anticipated 2022 milestones 04/19/22 Amicus announces issuance of US patent for Galafold 03/16/22 Amicus announces long-term data from Phase 1/2 study of AT-GAA 02/24/22 Amicus sees FY22 Galafold revenue at least $350M-$365M 02/10/22 Exelon chairman Mayo Shattuck III retires 02/03/22 Constellation Energy joins Nasdaq-100 index 02/03/22 Constellation Energy to replace Gap in S&P 500 at open on 2/3 05/03/22 Samsung selected for deployment of 5G solutions across Dish network 05/02/22 Ceragon to provide 5G wireless transport solutions to Dish Wireless 02/04/22 Dish, Tegna reach new carriage agreement 01/18/22 Dish Wireless, WCI Technologies announce partnership 05/09/22 Imax announces $33M opening for 'Doctor Strange in the Multiverse of Madness' 05/05/22 Microsoft says 'Fortnite' to be available on Xbox Cloud Gaming 05/04/22 ESPN+ to broadcast its first exclusive NFL game on October 30 CBIO Catalyst Biosciences 03/15/22 Catalyst Biosciences regains full rights to CB 2782-PEG 02/17/22 Catalyst engages Perella Weinberg to assist in exploring strategic alternatives 01/25/22 Catalyst Biosciences receives RPDD for CB 4332 for treatment of CFID 11/12/21 Catalyst Biosciences announces expected milestones 05/04/22 KE Holdings announces proposed dual primary listing on SEHK 04/21/22 Li Auto, KE Holdings among new additions to SEC HFCAA provisional list 04/18/22 KE Holdings falls -13.7% 04/18/22 KE Holdings falls -7.4% 05/09/22 Blue Apron expects to return to positive y/y revenue growth in 2Q22 05/09/22 Blue Apron expects Q1 to be high water mark of quarterly spend this year 05/09/22 Blue Apron exited quarter with more normalized margin rate 05/09/22 Blue Apron has more customers now than at end of Q1 04/13/22 Applied Blockchain prices $40M initial public offering 05/03/22 Elon Musk says Apple Store like having 30% internet tax 05/02/22 Roku announces availability of Apple Music on its platform 05/02/22 EU charges Apple over NFC payment restrictions on iOS devices 04/28/22 Apple says COVID is 'difficult to predict' 05/09/22 Piper Sandler Heska should be bought ahead of next week's analyst day, says Piper Sandler 05/04/22 Piper Sandler Piper Sandler says buy Heska, report will differ from Idexx 03/17/22 Piper Sandler Heska price target lowered to $190 from $210 at Piper Sandler 03/02/22 Alliance Global Partners Heska price target lowered to $240 from $310 at Alliance Global Partners CBIO Catalyst Biosciences 03/31/22 Piper Sandler Piper says 'stick it out' with Catalyst Biosciences exploring options 11/12/21 JonesTrading Catalyst Biosciences downgraded to Hold from Buy at JonesTrading 11/12/21 Piper Sandler Catalyst Biosciences price target lowered to $4 from $16 at Piper Sandler 11/12/21 Raymond James Catalyst Biosciences downgraded to Market Perform from Outperform at Raymond James 04/20/22 JPMorgan Exelon upgraded to Overweight on pure-play transition at JPMorgan 04/20/22 JPMorgan Exelon upgraded to Overweight from Neutral at JPMorgan 03/11/22 Mizuho Exelon upgraded to Buy from Neutral at Mizuho 02/17/22 BMO Capital Exelon price target lowered to $47 from $63 at BMO Capital 05/05/22 Wells Fargo Wells Fargo downgrades Tegna to Equal Weight, ups price target to $24 05/04/22 Wells Fargo Tegna downgraded to Equal Weight from Overweight at Wells Fargo 04/13/22 Argus Tegna downgraded to Hold from Buy at Argus 09/22/21 Barrington Tegna downgraded to Market Perform from Outperform at Barrington 02/10/22 Canaccord Blue Apron price target lowered to $12 from $15 at Canaccord 03/01/22 R.F. Lafferty Lordstown Motors price target lowered to $4 from $7 at R.F. Lafferty 03/01/22 Deutsche Bank Lordstown Motors price target lowered to $3 from $7 at Deutsche Bank 01/04/22 Morgan Stanley Ferrari replacing GM as Morgan Stanley's new 'Top Pick' in U.S. autos 11/12/21 R.F. Lafferty R.F. Lafferty upgrades Lordstown to Hold on better odds for Endurance production 05/09/22 New Street PagSeguro Digital downgraded to Neutral from Buy at New Street 05/02/22 Susquehanna PagSeguro Digital price target lowered to $26 from $38 at Susquehanna 04/14/22 Piper Sandler PagSeguro initiated with Overweight, $22 target at Piper Sandler 04/13/22 Piper Sandler PagSeguro Digital initiated with an Overweight at Piper Sandler 04/18/22 UBS KE Holdings upgraded to Buy from Neutral at UBS 04/10/22 Goldman Sachs KE Holdings assumed with a Buy at Goldman Sachs 03/16/22 Morgan Stanley KE Holdings upgraded to Overweight at Morgan Stanley with turnaround seen coming 03/16/22 Morgan Stanley KE Holdings upgraded to Overweight from Equal Weight at Morgan Stanley 04/13/22 Goldman Sachs Amicus reinstated with a Neutral at Goldman Sachs 01/13/22 SVB Securities Amicus upgraded to Outperform at SVB Leerink after physician survey 01/13/22 SVB Securities Amicus upgraded to Outperform from Market Perform at SVB Leerink 01/10/22 Stifel Amicus weakness likely on preliminary Galafold sales, says Stifel 03/16/22 Piper Sandler Viatris price target lowered to $10 from $17 at Piper Sandler 03/10/22 Citi Viatris price target lowered to $11 from $16 at Citi 03/01/22 BMO Capital Viatris price target lowered to $19 from $23 at BMO Capital 03/01/22 Raymond James Viatris downgraded to Market Perform from Outperform at Raymond James 04/20/22 Argus Lockheed Martin price target raised to $500 from $415 at Argus 04/20/22 Wells Fargo Lockheed Martin price target raised to $496 from $486 at Wells Fargo 04/20/22 Susquehanna Lockheed Martin price target raised to $539 from $515 at Susquehanna 04/08/22 Canaccord Canaccord starts 'premier' small satellite maker Terran Orbital at Buy 05/04/22 Benchmark Cirrus Logic price target lowered to $95 from $100 at Benchmark 05/04/22 Benchmark Skyworks price target lowered to $155 from $190 at Benchmark 05/04/22 KeyBanc Cirrus Logic price target lowered to $105 from $120 at KeyBanc 05/03/22 Cowen Enovix order 'perhaps' from Apple or Google, says Cowen $811.85 / -55.25 (-6.37%)
04/27/22 Wedbush Twitter transaction 'was never ideal' for Tesla investors, says Wedbush 04/26/22 Wedbush 'Soap opera' now ends with Musk owning Twitter, says Wedbush 04/25/22 Gordon Haskett Twitter bid more attractive after market selloff, says Gordon Haskett 04/25/22 Wedbush Twitter bid unlikely to result in major sale of Musk's Tesla stock, says Wedbush 05/05/22 Argus Twitter downgraded to Hold at Argus after board approves Musk buyout 05/05/22 Argus Twitter downgraded to Hold from Buy at Argus 04/29/22 Evercore ISI Evercore 'impressed' by Snap's product innovation after partner summit 04/28/22 Piper Sandler Twitter price target raised to $51.50 from $46 at Piper Sandler 05/05/22 Oppenheimer Uber price target lowered to $40 from $45 at Oppenheimer 05/05/22 MKM Partners Uber price target lowered to $41 from $65 at MKM Partners 05/05/22 Needham Uber price target lowered to $50 from $68 at Needham 05/05/22 Wedbush Uber price target lowered to $38 from $48 at Wedbush $24.66 / -4.125 (-14.33%)
05/02/22 Piper Sandler Piper Sandler favors Rivian for exposure to commercial vans 05/02/22 Benchmark Ford price target lowered to $25 from $29 at Benchmark 04/26/22 Barclays Rivian Automotive price target lowered to $38 from $42 at Barclays 04/25/22 JPMorgan Ford price target lowered to $21 from $22 at JPMorgan 05/09/22 Lake Street Applied Blockchain initiated with a Buy at Lake Street 05/09/22 Northland Applied Blockchain initiated with an Outperform at Northland 05/09/22 B. Riley Applied Blockchain initiated with a Buy at B. Riley 05/09/22 Needham Applied Blockchain initiated with a Buy at Needham $12.50 / -1.505 (-10.75%)
05/09/22 JPMorgan iHeartMedia downgraded to Neutral from Overweight at JPMorgan 05/06/22 B. Riley iHeartMedia price target lowered to $36 from $40 at B. Riley 10/20/21 B. Riley iHeartMedia price target lowered to $39 from $42 at B. Riley 09/08/21 B. Riley iHeartMedia price target raised to $42 from $36 at B. Riley 05/09/22 Wells Fargo Wells Fargo upgrades Match Group to Overweight, lowers price target to $115 05/09/22 Wells Fargo Match Group upgraded to Overweight from Equal Weight at Wells Fargo 05/05/22 RBC Capital Match Group price target lowered to $115 from $150 at RBC Capital 05/05/22 Wedbush Match Group price target lowered to $98 from $130 at Wedbush 05/09/22 Truist Virgin Galactic downgraded to Hold from Buy at Truist 05/09/22 Truist Virgin Galactic downgraded to Hold from Buy at Truist 05/06/22 Canaccord Virgin Galactic downgraded to Hold at Canaccord after commercial launch delay 05/06/22 Canaccord Virgin Galactic downgraded to Hold from Buy at Canaccord 05/09/22 Raymond James Dish price target lowered to $42 from $49 at Raymond James 05/09/22 Benchmark Dish price target lowered to $37 from $50 at Benchmark 05/09/22 Deutsche Bank Dish price target lowered to $61 from $67 at Deutsche Bank 05/09/22 JPMorgan JPMorgan downgrades Dish with 'little path for investor excitement' 05/09/22 BofA Coca-Cola, Kraft Heinz added to 'US 1' list at BofA 04/26/22 Deutsche Bank Deutsche Bank sees Disney being unharmed from Florida vote 04/19/22 JPMorgan Disney price target lowered to $175 from $200 at JPMorgan 04/19/22 Rosenblatt Disney initiated with a Buy at Rosenblatt 05/02/22 Barrington Imax price target lowered to $20 from $25 at Barrington 03/01/22 Benchmark Benchmark sees limited financial impact to Imax from Russia 02/24/22 Benchmark Benchmark keeps a Buy rating on Imax, raises price target to $28 02/23/22 Benchmark Imax's Q4 saw cinema recovery business accelerate, says Benchmark PCOM Points International 05/09/22 Barrington Points International downgraded to Underperform from Outperform at Barrington 08/12/21 Northland Points International upgraded to Outperform from Market Perform at Northland 08/12/21 Northland Points International upgraded to Outperform from Market Perform at Northland 05/18/21 Barrington Points International price target raised to $22 from $18 at Barrington 04/22/22 Piper Sandler Palantir price target raised to $16 from $15 at Piper Sandler 04/19/22 RBC Capital Palantir upgraded to Sector Perform from Underperform at RBC Capital 04/11/22 Monness Crespi Palantir initiated with a Buy at Monness Crespi 03/09/22 Piper Sandler Palantir initiated with an Overweight at Piper Sandler 05/03/22 Piper Sandler Tyson Foods downgraded to Underweight from Neutral at Piper Sandler 03/14/22 BMO Capital Tyson Foods downgraded to Market Perform from Outperform at BMO Capital 02/14/22 Barclays Tyson Foods downgraded on limited potential upside at Barclays 02/14/22 Barclays Tyson Foods downgraded to Equal Weight from Overweight at Barclays 05/09/22 Viatris sees 2022 revenue $17B-$17.5B, consensus $17.24B 05/09/22 Viatris reports Q1 EPS 33c, consensus 83c 02/28/22 Viatris sees FY22 revenue $17B-$17.5B, consensus $17.6B 02/28/22 Viatris reports Q4 EPS (22c), consensus 83c 05/04/22 Uber reports Q1 EPS ($3.04), consensus (24c) 02/09/22 Uber reports Q4 EPS 44c, consensus (35c) 02/09/22 Uber reports Q4 revenue $5.78B, consensus $5.34 02/09/22 Notable companies reporting after market close 04/28/22 Twitter withdrawing previously provided outlook given pending acquisition 04/28/22 Twitter reports Q1 EPS 90c, consensus 3c 02/10/22 Twitter expects FY22 revenue growth in low to mid 20's range 02/10/22 Twitter sees Q1 revenue $1.17B-$1.27B, consensus $1.26B 05/09/22 Tyson Foods raises FY22 revenue view to $52B-$54B from $49B-$51B 05/09/22 Tyson Foods sees FY22 revenue $52B-$54B, consensus $51.79B 05/09/22 Tyson Foods reports Q2 adjusted EPS $2.29, consensus $1.91 02/07/22 Tyson Foods sees 2022 sales at upper end $49B-$51B, consensus $50.35B $811.85 / -55.25 (-6.37%)
04/20/22 Tesla reports Q1 EPS $3.22, consensus $2.26 04/20/22 Notable companies reporting after market close 01/26/22 Tesla reports Q4 non-GAAP EPS $2.54, consensus $2.26 01/26/22 Notable companies reporting after market close 05/09/22 Tegna reports Q1 EPS 59c, consensus 53c 02/28/22 Tegna reports Q4 EPS 57c, consensus 55c 05/05/22 Virgin Galactic reports Q1 EPS (36c), consensus (32c) 05/05/22 Notable companies reporting after market close 02/22/22 Virgin Galactic reports Q4 EPS (31c), consensus (34c) 02/22/22 Notable companies reporting after market close $24.66 / -4.125 (-14.33%)
04/28/22 Amazon reports Q1 EPS ($7.56) with Rivian expense, consensus $8.36 03/10/22 Rivian sees FY22 adjusted EBITDA ($4.75B) 03/10/22 Rivian reports Q4 EPS ($4.83) vs ($1.97) 03/10/22 Notable companies reporting after market close 05/09/22 Lordstown Motors reports Q1 EPS (46c), consensus (46c) 02/28/22 Lordstown Motors reports Q4 EPS (42c), consensus (73c) 11/11/21 Lordstown Motors reports Q3 EPS (54c), consensus (59c) 11/11/21 Notable companies reporting after market close 05/09/22 Party City cuts FY22 revenue view to $2.225B-$2.3B from $2.275B-$2.35B 05/09/22 Party City reports Q1 adjusted EPS (22c) vs (5c) last year 02/28/22 Party City sees 2022 revenue $2.275B-$2.35B, consensus $2.21B 02/28/22 Party City reports Q4 adjusted EPS 40c, consensus 40c 05/09/22 Palantir sees Q2 revenue base case $470M, consensus $483.84M 05/09/22 Palantir sees annual revenue growth 30% or greater through 2025 05/09/22 Palantir reports Q1 EPS 2c, consensus 4c 02/17/22 Palantir sees annual revenue growth of 30% or greater through 2025 PCOM Points International 03/09/22 Points International reports Q4 revenue $115.1M, consensus $106.52M 01/20/22 Points International sees 2021 revenue $370M, consensus $350.89M 01/20/22 Points International sees Q4 revenue $115M, consensus $95.99M 11/10/21 Points International reports Q3 EPS (8c), consensus 2c 03/22/22 PagSeguro Digital reports Q4 EPS R$1.28 vs. R$1.30 last year 11/12/21 PagSeguro Digital reports Q3 adjusted EPS R$1.26 vs. R$1.00 last year 05/03/22 Match Group sees Q2 revenue $800M-$810M, consensus $835.2M 05/03/22 Match Group reports Q1 EPS 60c, consensus 54c 05/03/22 Notable companies reporting after market close 02/01/22 Match Group sees FY22 revenue up 15%-20% y/y, consensus $3.62B 04/19/22 Lockheed Martin backs FY22 EPS view $26.70, consensus $26.80 04/19/22 Lockheed Martin reports Q1 EPS $6.44, consensus $6.21 04/18/22 Notable companies reporting before tomorrow's open 04/28/22 Imax reports Q1 adjusted EPS (2c), consensus (5c) 02/23/22 Imax reports Q4 adjusted EPS 31c, consensus 13c $12.50 / -1.505 (-10.75%)
05/05/22 iHeartMedia sees Q2 revenue up 10%-14% year-over-year 05/05/22 iHeartMedia reports Q1 revenue $843.5M, consensus $839.41M 02/23/22 iHeartMedia sees Q1 revenue up 17%-19%, consensus $828.19M 02/23/22 iHeartMedia reports Q4 revenue $1.06B, consensus $1.04B 05/09/22 Heska reports Q1 non-GAAP EPS 27c, consensus 0c 02/28/22 Heska reports Q4 non-GAAP EPS 35c, consensus (4c) 05/09/22 Amicus sees FY22 Galafold revenue $350M-$365M 05/09/22 Amicus reports Q1 EPS (30c), consensus (25c) 02/24/22 Amicus reports FY21 EPS (92c), consensus (78c) 01/10/22 Amicus sees Q4 Galafold revenue $84M, revenue consensus $84.77M 05/09/22 Exelon reaffirms 2022 adjusted EPS view $2.18-$2.32, consensus $2.26 05/09/22 Exelon reports Q1 adjusted EPS 64c, consensus 66c 02/25/22 Exelon backs FY22 adjusted EPS view $2.18-$2.32, consensus $2.24 02/25/22 Exelon reports FY21 adjusted EPS $2.82, consensus $2.81 05/06/22 Dish reports Q1 EPS 68c, consensus 75c 02/24/22 Dish reports Q4 EPS 87c, consensus 87c 02/09/22 Disney reports Q1 EPS ex-items $1.06, consensus 57c 11/10/21 Disney reports Q4 EPS ex-items 37c, consensus 49c 11/10/21 Notable companies reporting after market close CBIO Catalyst Biosciences 05/09/22 Catalyst Biosciences reports Q1 EPS (46c), consensus (44c) 03/31/22 Catalyst Biosciences reports Q4 EPS (65c), consensus (59c) 11/12/21 Catalyst Biosciences reports Q3 EPS (80c), consensus (66c) 03/09/22 KE Holdings sees Q1 revenue $1.8B-$2B, consensus $1.98B 03/09/22 KE Holdings reports Q4 adjusted earnings per ADS 1c, consensus (7c) 05/09/22 Blue Apron sees FY revenue growth in mid teens, one est. $532.3M 05/09/22 Blue Apron reports Q1 EPS ($1.19) vs. (88c) a year ago 02/10/22 Blue Apron reports Q4 EPS (93c), one estimate (67c) 12/07/21 HelloFresh sees 2022 adjusted EBITDA EUR 500M-EUR 580M 04/28/22 Apple says y/y Q3 revenue growth to be impacted by COVID 04/28/22 Apple reports Q2 EPS $1.52, consensus $1.43 04/28/22 Notable companies reporting after market close 02/27/22 Berkshire operating earnings surge, Buffett repurchases record $27B in stock
Earnings
Double-digit revenue…
Double-digit revenue growth between 15 and 20% at CER1 in 2022 is expected to be driven by continued underlying demand from both switch and naive patients, geographic expansion, the continued diagnosis of new Fabry patients and commercial execution across all major markets, including the U.S., EU, U.K., and Japan. Applying average April 2022 exchange rates, the negative currency impact on full-year 2022 Galafold reported sales would be approximately 6%. Non-GAAP operating expense guidance for the full-year 2022 is $470 million to $485 million. Cash, cash equivalents, and marketable securities totaled $411.2 million at March 31, 2022. Based on current operating models, the Company believes that the current and projected cash flows are sufficient to achieve self-sustainability.
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05/09/22 Amicus announces anticipated 2022 milestones 04/19/22 Amicus announces issuance of US patent for Galafold 03/16/22 Amicus announces long-term data from Phase 1/2 study of AT-GAA 02/24/22 Amicus sees FY22 Galafold revenue at least $350M-$365M 04/13/22 Goldman Sachs Amicus reinstated with a Neutral at Goldman Sachs 01/13/22 SVB Securities Amicus upgraded to Outperform at SVB Leerink after physician survey 01/13/22 SVB Securities Amicus upgraded to Outperform from Market Perform at SVB Leerink 01/10/22 Stifel Amicus weakness likely on preliminary Galafold sales, says Stifel 05/09/22 Amicus reports Q1 EPS (30c), consensus (25c) 02/24/22 Amicus reports FY21 EPS (92c), consensus (78c) 01/10/22 Amicus sees Q4 Galafold revenue $84M, revenue consensus $84.77M 01/10/22 Amicus sees FY21 Galafold revenue $350M-$365M, revenue consensus $396.55MM 02/27/22 Week in SPAC News: Trump SPAC in spotlight as Truth Social makes users wait 01/13/22 Fly Intel: After-Hours Movers 01/10/22 Wall Street in Fives - Must Read Lists for Monday 01/10/22 Wall Street in Fives - Must Read Lists at Midday
Hot Stocks
Galafold Oral Precision…
Galafold Oral Precision Medicine for Fabry Disease: Sustain double-digit revenue growth in 2022 of $350 million to $365 million at CER; Continue geographic expansion; and Registry and other Phase 4 studies ongoing. AT-GAA for Pompe Disease: U.S. Prescription Drug User Fee Act action date of May 29, 2022 for the NDA and July 29, 2022 for the BLA; EU Committee for Medicinal Products for Human Use opinion expected in late 2022; Continue to broaden early access plans in the U.K., Germany, France, Japan, and other countries; Ongoing supportive studies, including pediatric and extension studies
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04/19/22 Amicus announces issuance of US patent for Galafold 03/16/22 Amicus announces long-term data from Phase 1/2 study of AT-GAA 02/24/22 Amicus sees FY22 Galafold revenue at least $350M-$365M 02/24/22 Arya Sciences Acquisition, Amicus agree to terminate combination agreement 04/13/22 Goldman Sachs Amicus reinstated with a Neutral at Goldman Sachs 01/13/22 SVB Securities Amicus upgraded to Outperform at SVB Leerink after physician survey 01/13/22 SVB Securities Amicus upgraded to Outperform from Market Perform at SVB Leerink 01/10/22 Stifel Amicus weakness likely on preliminary Galafold sales, says Stifel 05/09/22 Amicus reports Q1 EPS (30c), consensus (25c) 02/24/22 Amicus reports FY21 EPS (92c), consensus (78c) 01/10/22 Amicus sees Q4 Galafold revenue $84M, revenue consensus $84.77M 01/10/22 Amicus sees FY21 Galafold revenue $350M-$365M, revenue consensus $396.55MM 02/27/22 Week in SPAC News: Trump SPAC in spotlight as Truth Social makes users wait 01/13/22 Fly Intel: After-Hours Movers 01/10/22 Wall Street in Fives - Must Read Lists for Monday 01/10/22 Wall Street in Fives - Must Read Lists at Midday
Earnings
Reports Q1 revenue…
Reports Q1 revenue $78.715M, consensus $77.13M. John Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics, Inc., stated, "Against a tumultuous market, we at Amicus have a deeply sharpened focus. We continue to ensure that Galafold gets to as many amenable people living with Fabry disease around the world, as seen by the significant first quarter performance of this precision medicine. We are committed to the regulatory approvals of AT-GAA for people living with Pompe disease, first in the United States and then in Europe and beyond. We are well on track with these anticipated approvals and the associated launch preparations, furthering our belief in the potential for this treatment regimen to become the new global standard of care in Pompe disease. And finally, we are laser focused on the financial strength of the business. This is anchored by the continued growth of Galafold and the anticipated approval of AT-GAA, each with strong exclusivity well into the late 2030s. Together this uniquely positions Amicus to deliver substantial value for shareholders and patients ahead."
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04/19/22 Amicus announces issuance of US patent for Galafold 03/16/22 Amicus announces long-term data from Phase 1/2 study of AT-GAA 02/24/22 Amicus sees FY22 Galafold revenue at least $350M-$365M 02/24/22 Arya Sciences Acquisition, Amicus agree to terminate combination agreement 04/13/22 Goldman Sachs Amicus reinstated with a Neutral at Goldman Sachs 01/13/22 SVB Securities Amicus upgraded to Outperform at SVB Leerink after physician survey 01/13/22 SVB Securities Amicus upgraded to Outperform from Market Perform at SVB Leerink 01/10/22 Stifel Amicus weakness likely on preliminary Galafold sales, says Stifel 02/24/22 Amicus reports FY21 EPS (92c), consensus (78c) 01/10/22 Amicus sees Q4 Galafold revenue $84M, revenue consensus $84.77M 01/10/22 Amicus sees FY21 Galafold revenue $350M-$365M, revenue consensus $396.55MM 01/10/22 Amicus sees FY21 Galafold revenue $306M, revenue consensus $308.46M 02/27/22 Week in SPAC News: Trump SPAC in spotlight as Truth Social makes users wait 01/13/22 Fly Intel: After-Hours Movers 01/10/22 Wall Street in Fives - Must Read Lists for Monday 01/10/22 Wall Street in Fives - Must Read Lists at Midday
Hot Stocks
Amicus Therapeutics…
Amicus Therapeutics announced that the United States Patent and Trademark Office, USPTO, has issued U.S. Patent No. 11,304,940, which is directed to a composition of matter covering migalastat, or Galafold. The new U.S. patent titled "Methods of Treating Fabry Patients Having Renal Impairments" is directed to a molecule comprising migalastat bound to an alpha-galactosidase A protein and expires in 2038. John Crowley, Chairman and Chief Executive Officer of Amicus stated, "We are very pleased that the USPTO has issued this patent around this unique oral pharmacological chaperone, which builds upon our existing intellectual property portfolio and provides patent protection for Galafold to 2038. The issuance of this very important patent embodies the many years of tremendous hard work, perseverance and ingenuity of the Amicus teams as well as the investment of hundreds of millions of dollars to create and deliver this novel precision medicine to people living with Fabry disease with amenable variants. This patent, in concert with our other 34 orange book listed patents and regulatory exclusivities for Galafold, provide Amicus with broad and long-term intellectual property rights well into the late-2030s."
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03/16/22 Amicus announces long-term data from Phase 1/2 study of AT-GAA 02/24/22 Amicus sees FY22 Galafold revenue at least $350M-$365M 02/24/22 Arya Sciences Acquisition, Amicus agree to terminate combination agreement 01/10/22 Amicus provides updates, anticipated milestones by program 04/13/22 Goldman Sachs Amicus reinstated with a Neutral at Goldman Sachs 01/13/22 SVB Securities Amicus upgraded to Outperform at SVB Leerink after physician survey 01/13/22 SVB Securities Amicus upgraded to Outperform from Market Perform at SVB Leerink 01/10/22 Stifel Amicus weakness likely on preliminary Galafold sales, says Stifel 02/24/22 Amicus reports FY21 EPS (92c), consensus (78c) 01/10/22 Amicus sees Q4 Galafold revenue $84M, revenue consensus $84.77M 01/10/22 Amicus sees FY21 Galafold revenue $350M-$365M, revenue consensus $396.55MM 01/10/22 Amicus sees FY21 Galafold revenue $306M, revenue consensus $308.46M 02/27/22 Week in SPAC News: Trump SPAC in spotlight as Truth Social makes users wait 01/13/22 Fly Intel: After-Hours Movers 01/10/22 Wall Street in Fives - Must Read Lists for Monday 01/10/22 Wall Street in Fives - Must Read Lists at Midday
Initiation
Goldman Sachs analyst…
Goldman Sachs analyst Salveen Richter reinstated coverage of Amicus Therapeutics with a Neutral rating and $11 price target. The analyst is positive on the approval outlook for AT-GAA in Pompe disease but says the company's "quieter R&D effort" via gene therapy programs that are now only entering the clinic in the next several years puts heightened focus on commercial execution.
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