BioPharm Update: At least I have one of those men
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Posted On: 07/22/2017 7:49:27 AM
BioPharm Update: At least I have one of those mentioned this week!
GlaxoSmithKline plc (ADR) (NYSE:GSK) announced that the FDA has approved a new subcutaneous formulation of Benlysta for the treatment of Systemic Lupus Erythematosus (SLE). The approval marks the first subcutaneous self-injection treatment option for patients with SLE. Benlysta was approved for the intravenous (IV) formulation in 2011 when it was under the realm of Human Genome Sciences (NASDAQ:HGSI).
Brainstorm Cell Therapeutics Inc (NASDAQ:BCLI) shares closed up 9% to $4.94 following its announcement that it has been awarded a $16m grant from the California Institute for Regenerative Medicine (CIRM) to support the pivotal Phase 3 study of NurOwn, for the treatment of amyotrophic lateral sclerosis (ALS).
Advanced Accelerator Applications S.A. (NASDAQ:AAAP) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the marketing authorization of lutetium (Lutathera) for the treatment of unresectable or metastatic, progressive, well differentiated, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.
Nektar Therapeutics (NASDAQ: NKTR) announced that CHMP issued a negative opinion for the marketing authorization application for ONZEALD in the European Union. Nektar intends to appeal the CHMP opinion and immediately seek a re-examination of the opinion by the CHMP.
Shares of Pernix Therapeutics Holdings Inc (NASDAQ
TX) slumped to close down 24% to $3.43. The company announced preliminary 2Q revenue of $33-35m compared with $36.7m for the same period in 2016, potentially a decrease of 10%.
Other Major price movers (stocks priced > $1.00, volume > 100k):
Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume INCLUDING sub-$1 stocks.
ADVANCERS:
Dicerna Pharmaceuticals Inc (NASDAQ
RNA): $4.13; +16%.
Cyclacel Pharmaceuticals Inc (NASDAQ:CYCC): $1.91; +12%.
AzurRx BioPharma Inc (NASDAQ:AZRX): $3.80; +10%.
Cellectar Biosciences Inc (NASDAQ:CLRB): $1.63; +10%.
Neuroderm Ltd (NASDAQ:NDRM): $33.20; +7%.
DECLINERS:
Anavex Life Sciences Corp.(NASDAQ:AVXL): $4.21; -14%.
Dare Bioscience Inc (NASDAQARE): $5.26; -12%.
Peregrine Pharmaceuticals (NASDAQPHM): $4.60; -12%.
Catabasis Pharmaceuticals Inc (NASDAQ:CATB): $1.15; -8%.
Alimera Sciences Inc (NASDAQ:ALIM): $1.45; -8%.
GlaxoSmithKline plc (ADR) (NYSE:GSK) announced that the FDA has approved a new subcutaneous formulation of Benlysta for the treatment of Systemic Lupus Erythematosus (SLE). The approval marks the first subcutaneous self-injection treatment option for patients with SLE. Benlysta was approved for the intravenous (IV) formulation in 2011 when it was under the realm of Human Genome Sciences (NASDAQ:HGSI).
Brainstorm Cell Therapeutics Inc (NASDAQ:BCLI) shares closed up 9% to $4.94 following its announcement that it has been awarded a $16m grant from the California Institute for Regenerative Medicine (CIRM) to support the pivotal Phase 3 study of NurOwn, for the treatment of amyotrophic lateral sclerosis (ALS).
Advanced Accelerator Applications S.A. (NASDAQ:AAAP) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the marketing authorization of lutetium (Lutathera) for the treatment of unresectable or metastatic, progressive, well differentiated, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.
Nektar Therapeutics (NASDAQ: NKTR) announced that CHMP issued a negative opinion for the marketing authorization application for ONZEALD in the European Union. Nektar intends to appeal the CHMP opinion and immediately seek a re-examination of the opinion by the CHMP.
Shares of Pernix Therapeutics Holdings Inc (NASDAQ
TX) slumped to close down 24% to $3.43. The company announced preliminary 2Q revenue of $33-35m compared with $36.7m for the same period in 2016, potentially a decrease of 10%. Other Major price movers (stocks priced > $1.00, volume > 100k):
Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume INCLUDING sub-$1 stocks.
ADVANCERS:
Dicerna Pharmaceuticals Inc (NASDAQ
RNA): $4.13; +16%. Cyclacel Pharmaceuticals Inc (NASDAQ:CYCC): $1.91; +12%.
AzurRx BioPharma Inc (NASDAQ:AZRX): $3.80; +10%.
Cellectar Biosciences Inc (NASDAQ:CLRB): $1.63; +10%.
Neuroderm Ltd (NASDAQ:NDRM): $33.20; +7%.
DECLINERS:
Anavex Life Sciences Corp.(NASDAQ:AVXL): $4.21; -14%.
Dare Bioscience Inc (NASDAQ
ARE): $5.26; -12%. Peregrine Pharmaceuticals (NASDAQ
PHM): $4.60; -12%. Catabasis Pharmaceuticals Inc (NASDAQ:CATB): $1.15; -8%.
Alimera Sciences Inc (NASDAQ:ALIM): $1.45; -8%.
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'Everything works out in the end,,,If it hasn't worked out,,it's not the end'
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