BioPharm Updates: Mylan N.V. (NASDAQ, TASE: MYL)
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Posted On: 10/05/2017 7:54:55 AM
BioPharm Updates:
Mylan N.V. (NASDAQ, TASE: MYL) announced that the FDA has approved its Abbreviated New Drug Applications (ANDAs) for its generic version of Teva's Copaxone, indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS). Shares of Mylan surged to close up 16% to $37.80 while competitors Teva (NYSE:TEVA) Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA) closed down 16% and 15% respectively.
Motif Bio plc (NASDAQ:MTFB) announced that it met the primary endpoint of non-inferiority in its Phase 3 REVIVE-2 trial evaluating iclaprim compared to the current standard of care, vancomycin, in patients with acute bacterial skin and skin structure infections (ABSSSI). The data showed a clinical cure rate of 78% compared with 77.7% in patients taking vancomycin. Motif expects to file a New Drug Application (NDA) during 1Q 2018.
Amicus Therapeutics (Nasdaq:FOLD) shares closed up 9% to $16.24 following the announcement of further positive results from its Phase 1/2 trial of ATB200/AT2221 in patients with Pompe disease. Amicus expects to provide a regulatory update 1H 2018. Key data as noted by the company:
Six-minute walk test (6MWT) distance, a primary measure of motor function in Pompe disease patients, improved in both ERT-naive and ERT-switch patients and was durable to month 9. ERT-naive patients showed mean increases of 42 meters at month 6 (n=5) and 75 meters at month 9 (n=2). ERT-switch patients showed mean increases of 35 meters at month 6 (n=9) and 37 meters at month 9 (n=
. Other motor function tests showed mean improvements consistent with 6MWT distance.
Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB) reported data from its open-label extension trial of edasalonexent for the treatment of Duchenne muscular dystrophy (DMD). The company noted that these data provide clinically meaningful evidence that edasalonexent substantially slowed the progression of Duchenne muscular dystrophy (DMD). The extension part of the trial follows data released January 2017, which did not meet the primary endpoint. Shares initially spiked on today's news, before retracing gains to close up 7% to $3.03. Catabasis plans to initiate a Phase 3 trial in 1H 2018 with top-line data due in 2020.
Other major price movers (stocks priced > $1.00, volume > 50k):
Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume INCLUDING sub-$1 stocks.
ADVANCERS:
MannKind Corporation (NASDAQ:MNKD): $3.54; +26%.
CytomX Therapeutics Inc (NASDAQ:CTMX): $23.09; +22%.
Arca Biopharma Inc (NASDAQ:ABIO): $1.55; +19%.
aTyr Pharma Inc (NASDAQ:LIFE): $5.65; +19%.
Benitec Biopharma Ltd (NASDAQ:BNTC): $2.99; +17%.
DECLINERS:
Celsion Corporation (NASDAQ:CLSN): $3.80; -37%.
Strongbridge Biopharma (NASDAQ:SBBP): $6.10; -19%.
Invivo Therapeutics Holdings Corp (NASDAQ:NVIV): $1.60; -11%.
Ocera Therapeutics Inc (NASDAQ:OCRX): $1.00; -10%.
ContraFect Corp (NASDAQ:CFRX): $1.14; -9%
Pipeline updates below:
DRUG STAGE CATALYST
TICKER: ACAD
Pimavanserin - Harmony
Alzheimer’s disease psychosis
PHASE 3 Phase 3 trial initiation announced October 4, 2017.
TICKER: ACAD
Pimavanserin - SERENE
Alzheimer’s disease agitation
PHASE 2 Announced October 4, 2017 that trial will be discontinued.
TICKER: ATNM
Actimab-A
Acute Myeloid Leukemia (AML)
PHASE 2 Phase 2 to initiated September 2016. Interim analysis due by end of 2017 with top-line data due 1H 2018.
TICKER: BLUE
Lenti-D - Starbeam
Childhood cerebral adrenoleukodystrophy (CCALD)
PHASE 2/3 Phase 2/3 trial initiated October 2013. Interim top-line data released June 26, 2017. Further data released October 4, 2017 - 88% free of free of major functional disabilities.
TICKER: CAPR
CAP-1002 HOPE-Duchenne
Duchenne Muscular Dystrophy (DMD)
PHASE 1/2 Phase 1/2 data presented October, 2017 - Phase 2 HOPE-2 trial to be initiated 1Q 2018.
TICKER: CATB
Edasalonexent (CAT-1004)
Duchenne muscular dystrophy (DMD)
PHASE 2 Phase 1/2 top-line data released January 31 - primary endpoint not met. Data from open-label presented October 4, 2017 deemed sufficient to proceed to Phase 3 development - to commence 1H 2018 with data due 2020.
TICKER: FOLD
ATB200
Pompe Disease
PHASE 1/2 Phase 1/2 additional data released February 15, 2017. Further data released May 15, 2017 and October 4, 2017 - update expected 1H 2018 regarding regulatory path forward.
TICKER: MYL
Glatiramer Acetate Injection - Generic for Copaxone
Multiple sclerosis (MS)
APPROVED Approval announced October 4, 2017.
TICKER: MTFB
Iclaprim - REVIVE-2
Acute bacterial skin and skin structure infections (ABSSSI)
PHASE 3 Phase 3 data released October 4, 2017 - primary endpoint met. NDA filing due 1Q 2018.
Mylan N.V. (NASDAQ, TASE: MYL) announced that the FDA has approved its Abbreviated New Drug Applications (ANDAs) for its generic version of Teva's Copaxone, indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS). Shares of Mylan surged to close up 16% to $37.80 while competitors Teva (NYSE:TEVA) Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA) closed down 16% and 15% respectively.
Motif Bio plc (NASDAQ:MTFB) announced that it met the primary endpoint of non-inferiority in its Phase 3 REVIVE-2 trial evaluating iclaprim compared to the current standard of care, vancomycin, in patients with acute bacterial skin and skin structure infections (ABSSSI). The data showed a clinical cure rate of 78% compared with 77.7% in patients taking vancomycin. Motif expects to file a New Drug Application (NDA) during 1Q 2018.
Amicus Therapeutics (Nasdaq:FOLD) shares closed up 9% to $16.24 following the announcement of further positive results from its Phase 1/2 trial of ATB200/AT2221 in patients with Pompe disease. Amicus expects to provide a regulatory update 1H 2018. Key data as noted by the company:
Six-minute walk test (6MWT) distance, a primary measure of motor function in Pompe disease patients, improved in both ERT-naive and ERT-switch patients and was durable to month 9. ERT-naive patients showed mean increases of 42 meters at month 6 (n=5) and 75 meters at month 9 (n=2). ERT-switch patients showed mean increases of 35 meters at month 6 (n=9) and 37 meters at month 9 (n=
. Other motor function tests showed mean improvements consistent with 6MWT distance. Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB) reported data from its open-label extension trial of edasalonexent for the treatment of Duchenne muscular dystrophy (DMD). The company noted that these data provide clinically meaningful evidence that edasalonexent substantially slowed the progression of Duchenne muscular dystrophy (DMD). The extension part of the trial follows data released January 2017, which did not meet the primary endpoint. Shares initially spiked on today's news, before retracing gains to close up 7% to $3.03. Catabasis plans to initiate a Phase 3 trial in 1H 2018 with top-line data due in 2020.
Other major price movers (stocks priced > $1.00, volume > 50k):
Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume INCLUDING sub-$1 stocks.
ADVANCERS:
MannKind Corporation (NASDAQ:MNKD): $3.54; +26%.
CytomX Therapeutics Inc (NASDAQ:CTMX): $23.09; +22%.
Arca Biopharma Inc (NASDAQ:ABIO): $1.55; +19%.
aTyr Pharma Inc (NASDAQ:LIFE): $5.65; +19%.
Benitec Biopharma Ltd (NASDAQ:BNTC): $2.99; +17%.
DECLINERS:
Celsion Corporation (NASDAQ:CLSN): $3.80; -37%.
Strongbridge Biopharma (NASDAQ:SBBP): $6.10; -19%.
Invivo Therapeutics Holdings Corp (NASDAQ:NVIV): $1.60; -11%.
Ocera Therapeutics Inc (NASDAQ:OCRX): $1.00; -10%.
ContraFect Corp (NASDAQ:CFRX): $1.14; -9%
Pipeline updates below:
DRUG STAGE CATALYST
TICKER: ACAD
Pimavanserin - Harmony
Alzheimer’s disease psychosis
PHASE 3 Phase 3 trial initiation announced October 4, 2017.
TICKER: ACAD
Pimavanserin - SERENE
Alzheimer’s disease agitation
PHASE 2 Announced October 4, 2017 that trial will be discontinued.
TICKER: ATNM
Actimab-A
Acute Myeloid Leukemia (AML)
PHASE 2 Phase 2 to initiated September 2016. Interim analysis due by end of 2017 with top-line data due 1H 2018.
TICKER: BLUE
Lenti-D - Starbeam
Childhood cerebral adrenoleukodystrophy (CCALD)
PHASE 2/3 Phase 2/3 trial initiated October 2013. Interim top-line data released June 26, 2017. Further data released October 4, 2017 - 88% free of free of major functional disabilities.
TICKER: CAPR
CAP-1002 HOPE-Duchenne
Duchenne Muscular Dystrophy (DMD)
PHASE 1/2 Phase 1/2 data presented October, 2017 - Phase 2 HOPE-2 trial to be initiated 1Q 2018.
TICKER: CATB
Edasalonexent (CAT-1004)
Duchenne muscular dystrophy (DMD)
PHASE 2 Phase 1/2 top-line data released January 31 - primary endpoint not met. Data from open-label presented October 4, 2017 deemed sufficient to proceed to Phase 3 development - to commence 1H 2018 with data due 2020.
TICKER: FOLD
ATB200
Pompe Disease
PHASE 1/2 Phase 1/2 additional data released February 15, 2017. Further data released May 15, 2017 and October 4, 2017 - update expected 1H 2018 regarding regulatory path forward.
TICKER: MYL
Glatiramer Acetate Injection - Generic for Copaxone
Multiple sclerosis (MS)
APPROVED Approval announced October 4, 2017.
TICKER: MTFB
Iclaprim - REVIVE-2
Acute bacterial skin and skin structure infections (ABSSSI)
PHASE 3 Phase 3 data released October 4, 2017 - primary endpoint met. NDA filing due 1Q 2018.
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