BIOPHARM CATALYST: Update on dates Bristol
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Posted On: 07/06/2017 7:39:57 AM
BIOPHARM CATALYST: Update on dates
Bristol-Myers BMY meets melanoma endpoint; Merck MRK clinical hold issued on KEYTRUDA multiple myeloma trials
Bristol-Myers Squibb Company (NYSE:BMY) announced that its Phase 3 trial (CheckMate -238) of Opdivo in patients with late stage melanoma who are at high risk of recurrence following surgery, met its primary endpoint following an interim analysis, demonstrating superior recurrence-free survival (RFS) compared to Yervoy. These data will be submitted for presentation at an upcoming medical conference.
Merck (NYSE:MRK) announced that the FDA has placed a clinical hold on KEYNOTE-183, KEYNOTE-185 and KEYNOTE-023, three combination studies of KEYTRUDA, in trials for multiple myeloma. This decision follows a review of data that indicate that the risks of KEYTRUDA plus pomalidomide or lenalidomide outweigh any potential benefit for patients with multiple myeloma. This clinical hold does not apply to other studies with KEYTRUDA. Shares are currently trading down 1% to $64.16 in the after-hours session.
Array BioPharma (Nasdaq: ARRY) announced the submission of two New Drug Applications (NDAs) to the FDA for the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once daily (COMBO450) for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The submissions are supported by data from the pivotal Phase 3 COLUMBUS study.
Neurocrine Biosciences, Inc. (NASDAQ:NBIX) noted in a SEC filing that it has submitted a supplemental New Drug Application (sNDA) with the FDA for the approval of 80 mg capsules of INGREZZA for the treatment of tardive dyskinesia. INGREZZA is currently approved for its 40 mg capsule. The PDUFA date is October 14, 2017.
Egalet Corporation (Nasdaq: EGLT) announced that it intends to offer and sell shares of its common stock and warrants to purchase shares of common stock in an underwritten public offering. Shares are down 17% to $2.10 in the after hours session.
Major price movers (stocks priced > $1.00, volume > 100k):
ADVANCERS:
Cerulean Pharma Inc (NASDAQ:CERU): $1.13; +144%.
ImmunoCellular Therapeutics Ltd (NYSEMKT:IMUC): $1.70; +89%.
Celsion Corporation (NASDAQ:CLSN): $2.42; +20%.
Calithera Biosciences Inc (NASDAQ:CALA): $17.60; +12%.
Verastem Inc (NASDAQ:VSTM): $2.43; +11%.
DECLINERS:
Moleculin Biotech Inc (NASDAQ:MBRX): $1.62; -15%.
Opexa Therapeutics Inc (NASDAQ:OPXA): $1.00; -15%.
Cerus Corporation (NASDAQ:CERS): $2.32; -8%.
Immune Design Corp (NASDAQ:IMDZ): $9.20; -7%.
MannKind Corporation (NASDAQ:MNKD): $1.24; -7%.
Pipeline updates below:
DRUG STAGE CATALYST
TICKER: EARS
AM-111 HEALOS
Acute inner ear hearing loss
PHASE 3 Phase 3 HEALOS completion of enrollment announced July 5, 2017. Data due fall of 2017.
TICKER: ARRY
Binimetinib - COLUMBUS
BRAF mutant melanoma cancer
NDA FILING Phase 3 data released September 26, 2016 met primary endpoint. Data from Part 2 portion of trial due released May 9, 2017. NDA filing announced July 5, 2017.
TICKER: AIMT
AR101 ARTEMIS
Peanut Allergy
PHASE 3 Phase 3 enrollment has commenced - noted July 5, 2017.
TICKER: GLPG
Filgotinib
Non-infectious uveitis
PHASE 2 Phase 2 trial initiation announced July 5, 2017.
TICKER: NBIX
INGREZZA
Tardive dyskinesia
PDUFA PDUFA date for sNDA 80 mg capsules October 14, 2017.
TICKER: MRK
KEYTRUDA - KEYNOTE-183
Multiple myeloma
PHASE 2 Phase 3 clinical hold announced July 6, 2017.
TICKER: MRK
KEYTRUDA - KEYNOTE-185
Multiple myeloma
PHASE 2 Phase 3 clinical hold announced July 6, 2017.
Bristol-Myers BMY meets melanoma endpoint; Merck MRK clinical hold issued on KEYTRUDA multiple myeloma trials
Bristol-Myers Squibb Company (NYSE:BMY) announced that its Phase 3 trial (CheckMate -238) of Opdivo in patients with late stage melanoma who are at high risk of recurrence following surgery, met its primary endpoint following an interim analysis, demonstrating superior recurrence-free survival (RFS) compared to Yervoy. These data will be submitted for presentation at an upcoming medical conference.
Merck (NYSE:MRK) announced that the FDA has placed a clinical hold on KEYNOTE-183, KEYNOTE-185 and KEYNOTE-023, three combination studies of KEYTRUDA, in trials for multiple myeloma. This decision follows a review of data that indicate that the risks of KEYTRUDA plus pomalidomide or lenalidomide outweigh any potential benefit for patients with multiple myeloma. This clinical hold does not apply to other studies with KEYTRUDA. Shares are currently trading down 1% to $64.16 in the after-hours session.
Array BioPharma (Nasdaq: ARRY) announced the submission of two New Drug Applications (NDAs) to the FDA for the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once daily (COMBO450) for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The submissions are supported by data from the pivotal Phase 3 COLUMBUS study.
Neurocrine Biosciences, Inc. (NASDAQ:NBIX) noted in a SEC filing that it has submitted a supplemental New Drug Application (sNDA) with the FDA for the approval of 80 mg capsules of INGREZZA for the treatment of tardive dyskinesia. INGREZZA is currently approved for its 40 mg capsule. The PDUFA date is October 14, 2017.
Egalet Corporation (Nasdaq: EGLT) announced that it intends to offer and sell shares of its common stock and warrants to purchase shares of common stock in an underwritten public offering. Shares are down 17% to $2.10 in the after hours session.
Major price movers (stocks priced > $1.00, volume > 100k):
ADVANCERS:
Cerulean Pharma Inc (NASDAQ:CERU): $1.13; +144%.
ImmunoCellular Therapeutics Ltd (NYSEMKT:IMUC): $1.70; +89%.
Celsion Corporation (NASDAQ:CLSN): $2.42; +20%.
Calithera Biosciences Inc (NASDAQ:CALA): $17.60; +12%.
Verastem Inc (NASDAQ:VSTM): $2.43; +11%.
DECLINERS:
Moleculin Biotech Inc (NASDAQ:MBRX): $1.62; -15%.
Opexa Therapeutics Inc (NASDAQ:OPXA): $1.00; -15%.
Cerus Corporation (NASDAQ:CERS): $2.32; -8%.
Immune Design Corp (NASDAQ:IMDZ): $9.20; -7%.
MannKind Corporation (NASDAQ:MNKD): $1.24; -7%.
Pipeline updates below:
DRUG STAGE CATALYST
TICKER: EARS
AM-111 HEALOS
Acute inner ear hearing loss
PHASE 3 Phase 3 HEALOS completion of enrollment announced July 5, 2017. Data due fall of 2017.
TICKER: ARRY
Binimetinib - COLUMBUS
BRAF mutant melanoma cancer
NDA FILING Phase 3 data released September 26, 2016 met primary endpoint. Data from Part 2 portion of trial due released May 9, 2017. NDA filing announced July 5, 2017.
TICKER: AIMT
AR101 ARTEMIS
Peanut Allergy
PHASE 3 Phase 3 enrollment has commenced - noted July 5, 2017.
TICKER: GLPG
Filgotinib
Non-infectious uveitis
PHASE 2 Phase 2 trial initiation announced July 5, 2017.
TICKER: NBIX
INGREZZA
Tardive dyskinesia
PDUFA PDUFA date for sNDA 80 mg capsules October 14, 2017.
TICKER: MRK
KEYTRUDA - KEYNOTE-183
Multiple myeloma
PHASE 2 Phase 3 clinical hold announced July 6, 2017.
TICKER: MRK
KEYTRUDA - KEYNOTE-185
Multiple myeloma
PHASE 2 Phase 3 clinical hold announced July 6, 2017.
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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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