BioPhar Update:
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BioPharmCatalyst wishes to apologize to readers who were not able to access the website during Monday's trading session due a website outage. The exact cause is still being investigated.
Arena ARNA shares surge after hours following Phase 2 PAH data; Ocular OCUL submits amendment to DEXTENZA NDA
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) shares have surged in the after-hours session, currently trading up 41% to $25.85 following the release of Phase 2 data of ralinepag for the treatment of pulmonary arterial hypertension (PAH). Ralinepag demonstrated a 29.8% improvement in pulmonary vascular resistance (PVR), the primary endpoint, compared to placebo (0.03). The trial did not meet a secondary endpoint of improvement in 6-minute walk distance (6MWD).
Ocular Therapeutix, Inc. (NASDAQ:OCUL) announced that it has submitted details of a manufacturing equipment change as an amendment to the New Drug Application (NDA) resubmission for DEXTENZA for the treatment of ocular pain following ophthalmic surgery. The company is requesting the FDA to consider the submission a major amendment and extend the current PDUFA date of July 19, 2017 by three months. Otherwise, it will be required to file a new NDA. Shares closed the normal trading session down 9% before gaining 12% to $7.24 following the news in the after-hours session.
Inotek Pharmaceuticals Corp (NASDAQ:ITEK) shares closed down 45% to $0.95. The slide in its share price follows news after-hours Friday of the failure of its Phase 2 trial of trabodenoson and latanoprost for the treatment of glaucoma.
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:
KemPharm Inc (NASDAQ:KMPH): $3.75; +14%.
AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO): $3.15; +13%.
Abeona Therapeutics Inc (NASDAQ:ABEO): $9.20; +10%.
Apricus Biosciences Inc (NASDAQ:APRI): $1.19; +9%.
Dova Pharmaceuticals Inc (NASDAQ
OVA): $27.47; +9%.
DECLINERS:
ImmunoCellular Therapeutics Ltd (NYSEMKT:IMUC): $1.20; -24%.
Infinity Pharmaceuticals Inc. (NASDAQ:INFI): $1.30; -14%.
Cara Therapeutics Inc (NASDAQ:CARA): $12.21; -10%.
Egalet Corp (NASDAQ:EGLT): $1.41; -10%.
Dynavax Technologies Corporation (NASDAQVAX): $9.00; -8%.
Pipeline updates below:
DRUG STAGE CATALYST
TICKER: ALNY
Fitusiran
Hemophilia A and B
PHASE 2 Phase 2 Open-label Extension Study data released July 10, 2017 at ISTH.
TICKER: ARNA
Ralinepag
Pulmonary Arterial Hypertension
PHASE 2 Phase 2 data released July 10, 2017. Primary endpoint met. Secondary missed.
TICKER: BLRX
BL-8040 in combination with TECENTRIQ (atezolizumab)
Pancreatic cancer
PHASE 1/2 Phase 1b/2 trial initiation announced July 10, 2017.
TICKER: BMY
Sprycel (dasatinib)
Philadelphia Chromosome-Positive Chronic Phase Chronic Myeloid Leukemia
PDUFA PRIORITY REVIEW PDUFA date under priority review for sNDA of November 9, 2017.
TICKER: CNCE
CTP-543
Alopecia areata
PHASE 2A Phase 2 clinical hold placed May 17, 2017 lifted July 10, 2017. Trial completion due 2H 2018.
TICKER: EXEL
CABOMETYX (cabozantinib) with Opdivo and Yervoy - CheckMate 9ER
First-line renal cell carcinoma
PHASE 3 Phase 3 trial initiation announced July 10, 2017.
TICKER: GBT
GBT440 HOPE-KIDS 1
Sickle cell disease - children age 6-17.
PHASE 1/2 Phase 2a initiated June 2016. Preliminary data released at European Hematology Association (EHA) - June 23, 2017. Noted July 10, 2017 that trial has been expanded to include a new single-dose cohort in children age 6 to 11 with data due by the end of 2017.
TICKER: LLY
Abemaciclib - MONARCH 1 and 2
Second-line hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer and HR+, HER2- breast cancer
PDUFA PRIORITY REVIEW Phase 3 data released March 20, 2017 - PFS primary endpoint met. Noted July 10, 2017 PDUFA under priority review. No exact data released. Assume 6-month review rendering a PDUFA date on or around January 10, 2018.
TICKER: OCUL
DEXTENZA
Ocular inflammation and pain following cataract surgery
PDUFA CRL July 25 2016 - due to manufacturing deficiencies. NDA resubmitted, PDUFA date July 19, 2017. However, an amendment was submitted July 10, 2017 and if accepted by the FDA a 3-month extension to October 19, 2017 would result. PDUFA date of July 19, 2017 will remain in the BioPharmCatalyst calendar until confirmation from the company/FDA.
TICKER: ONCE
SPK-9001
Hemophilia B
PHASE 1/2 Phase 1/2 updated data released July 10, 2017. 99% fall in infusion rate.
TICKER: QURE
AMT-060
hemophilia B
PHASE 1/2 Phase 1/2 long term updated data presented July 10, 2017. Pivotal trial to be initiated in 2018.
TICKER: RETA
Bardoxolone methyl - CARDINAL
Chronic Kidney Disease Caused by Alport Syndrome
PHASE 2/3 Phase 2/3 trial initiation announced February 23, 2017. Data from Phase 2 part of trial due by the end of 2017.
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BioPharmCatalyst wishes to apologize to readers who were not able to access the website during Monday's trading session due a website outage. The exact cause is still being investigated.
Arena ARNA shares surge after hours following Phase 2 PAH data; Ocular OCUL submits amendment to DEXTENZA NDA
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) shares have surged in the after-hours session, currently trading up 41% to $25.85 following the release of Phase 2 data of ralinepag for the treatment of pulmonary arterial hypertension (PAH). Ralinepag demonstrated a 29.8% improvement in pulmonary vascular resistance (PVR), the primary endpoint, compared to placebo (0.03). The trial did not meet a secondary endpoint of improvement in 6-minute walk distance (6MWD).
Ocular Therapeutix, Inc. (NASDAQ:OCUL) announced that it has submitted details of a manufacturing equipment change as an amendment to the New Drug Application (NDA) resubmission for DEXTENZA for the treatment of ocular pain following ophthalmic surgery. The company is requesting the FDA to consider the submission a major amendment and extend the current PDUFA date of July 19, 2017 by three months. Otherwise, it will be required to file a new NDA. Shares closed the normal trading session down 9% before gaining 12% to $7.24 following the news in the after-hours session.
Inotek Pharmaceuticals Corp (NASDAQ:ITEK) shares closed down 45% to $0.95. The slide in its share price follows news after-hours Friday of the failure of its Phase 2 trial of trabodenoson and latanoprost for the treatment of glaucoma.
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:
KemPharm Inc (NASDAQ:KMPH): $3.75; +14%.
AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO): $3.15; +13%.
Abeona Therapeutics Inc (NASDAQ:ABEO): $9.20; +10%.
Apricus Biosciences Inc (NASDAQ:APRI): $1.19; +9%.
Dova Pharmaceuticals Inc (NASDAQ
OVA): $27.47; +9%. DECLINERS:
ImmunoCellular Therapeutics Ltd (NYSEMKT:IMUC): $1.20; -24%.
Infinity Pharmaceuticals Inc. (NASDAQ:INFI): $1.30; -14%.
Cara Therapeutics Inc (NASDAQ:CARA): $12.21; -10%.
Egalet Corp (NASDAQ:EGLT): $1.41; -10%.
Dynavax Technologies Corporation (NASDAQ
VAX): $9.00; -8%. Pipeline updates below:
DRUG STAGE CATALYST
TICKER: ALNY
Fitusiran
Hemophilia A and B
PHASE 2 Phase 2 Open-label Extension Study data released July 10, 2017 at ISTH.
TICKER: ARNA
Ralinepag
Pulmonary Arterial Hypertension
PHASE 2 Phase 2 data released July 10, 2017. Primary endpoint met. Secondary missed.
TICKER: BLRX
BL-8040 in combination with TECENTRIQ (atezolizumab)
Pancreatic cancer
PHASE 1/2 Phase 1b/2 trial initiation announced July 10, 2017.
TICKER: BMY
Sprycel (dasatinib)
Philadelphia Chromosome-Positive Chronic Phase Chronic Myeloid Leukemia
PDUFA PRIORITY REVIEW PDUFA date under priority review for sNDA of November 9, 2017.
TICKER: CNCE
CTP-543
Alopecia areata
PHASE 2A Phase 2 clinical hold placed May 17, 2017 lifted July 10, 2017. Trial completion due 2H 2018.
TICKER: EXEL
CABOMETYX (cabozantinib) with Opdivo and Yervoy - CheckMate 9ER
First-line renal cell carcinoma
PHASE 3 Phase 3 trial initiation announced July 10, 2017.
TICKER: GBT
GBT440 HOPE-KIDS 1
Sickle cell disease - children age 6-17.
PHASE 1/2 Phase 2a initiated June 2016. Preliminary data released at European Hematology Association (EHA) - June 23, 2017. Noted July 10, 2017 that trial has been expanded to include a new single-dose cohort in children age 6 to 11 with data due by the end of 2017.
TICKER: LLY
Abemaciclib - MONARCH 1 and 2
Second-line hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer and HR+, HER2- breast cancer
PDUFA PRIORITY REVIEW Phase 3 data released March 20, 2017 - PFS primary endpoint met. Noted July 10, 2017 PDUFA under priority review. No exact data released. Assume 6-month review rendering a PDUFA date on or around January 10, 2018.
TICKER: OCUL
DEXTENZA
Ocular inflammation and pain following cataract surgery
PDUFA CRL July 25 2016 - due to manufacturing deficiencies. NDA resubmitted, PDUFA date July 19, 2017. However, an amendment was submitted July 10, 2017 and if accepted by the FDA a 3-month extension to October 19, 2017 would result. PDUFA date of July 19, 2017 will remain in the BioPharmCatalyst calendar until confirmation from the company/FDA.
TICKER: ONCE
SPK-9001
Hemophilia B
PHASE 1/2 Phase 1/2 updated data released July 10, 2017. 99% fall in infusion rate.
TICKER: QURE
AMT-060
hemophilia B
PHASE 1/2 Phase 1/2 long term updated data presented July 10, 2017. Pivotal trial to be initiated in 2018.
TICKER: RETA
Bardoxolone methyl - CARDINAL
Chronic Kidney Disease Caused by Alport Syndrome
PHASE 2/3 Phase 2/3 trial initiation announced February 23, 2017. Data from Phase 2 part of trial due by the end of 2017.
'Everything works out in the end,,,If it hasn't worked out,,it's not the end'
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