BioPharm Update: View this email in your browse
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Posted On: 08/07/2017 9:36:33 PM
BioPharm Update:
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FibroGen (FGEN( and MyoKardia (MYOK) shares soar on positive news: Zynerba (ZYNE) and Gemphire (GEMP) plunge on poor data
FibroGen, Inc. (NASDAQ:FGEN) shares have soared after-hours, currently trading up 61% to $33.40. The company announced that top-line data from its Phase 2 trial of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF) met the primary efficacy endpoint of change of forced vital capacity percent predicted.
MyoKardia, Inc. (Nasdaq:MYOK) shares surged to close up 83% following positive top-line data from the first patient cohort of its Phase 2 PIONEER-HCM study of mavacamten in symptomatic, obstructive hypertrophic cardiomyopathy (oHCM) patients. The first cohort met the primary as well as key secondary endpoints. It expects to initiate its next trial, EXPLORER-HCM, potentially a pivotal study, by the end of this year. The company also noted that data from its second, low-dose patient cohort in PIONEER-HCM has completed enrollment with top-line data due 1Q 2018.
Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE) slumped to close down 56% to $6.67 following the release of top-line results from its Phase 2 STAR 1 trial evaluating ZYN002 in adult epilepsy patients with focal seizures. Both primary and secondary endpoints were not met with no statistically significant differences between ZYN002 and placebo.
Gemphire Therapeutics Inc. (NASDAQ:GEMP) announced top-line data from its Phase 2b ROYAL-1 trial of oral gemcabene. The trial met its primary endpoint, however, its mean percent change in LDL cholesterol of -17.2% vs -5.5% for placebo was lower than expectations, sending shares plunging to close down 47% to $9.93.
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:
Aradigm Corporation (NASDAQ:ARDM): $1.42; +26%.
Marinus Pharmaceuticals Inc (NASDAQ:MRNS): $2.39; +13%.
Dynavax Technologies Corporation (NASDAQ
VAX): $2.39; +13%.
Invivo Therapeutics Holdings Corp (NASDAQ:NVIV): $2.00; +11%.
Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR): $2.04; +11%.
DECLINERS:
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX): $4.42; -13%.
Celsion Corporation (NASDAQ:CLSN): $1.36; -12%
Teva Pharmaceutical Industries (NYSE:TEVA): $18.59; -10%.
Galectin Therapeutics Inc (NASDAQ:GALT): $1.90: -10%.
Cara Therapeutics Inc (NASDAQ:CARA): $14.93; -9%.
Pipeline updates below:
DRUG STAGE CATALYST
TICKER: AXON
Nelotanserin
DLB patients experiencing REM Behavior Disorder (RBD)
PHASE 2 Phase 2 data due 1Q 2018.
TICKER: AXON
Nelotanserin
Visual hallucinations in subjects with Lewy body dementia
PHASE 2 Phase 2 preliminary data released February 13, 2017. Primary endpoint hit, secondary endpoints missed. Top-line data due 4Q 2017.
TICKER: AXON
Intepirdine - MINDSET
Alzheimer's disease
PHASE 3 Phase 3 data are due late September 2017.
TICKER: AXON
Intepirdine - HEADWAY-DLB
Dementia with Lewy bodies (DLB)
PHASE 2B Phase 2b data due 4Q 2017
TICKER: BLPH
INOpulse delivery device
Pulmonary Hypertension associated with COPD (PH-COPD)
PHASE 2 Phase 2 initiated 3Q 2016. Noted August 7, 2017 that data are due "shortly". BPC estimate end of August as latest likely date.
TICKER: BLPH
INOpulse delivery device
Pulmonary Arterial Hypertension (PAH)
PHASE 3 Phase 3 commenced enrollment June 2016. Interim analysis and top-line data due 2018.
TICKER: CALA
CB-839 + AFINITOR (everolimus)
Clear cell renal cell carcinoma
PHASE 2 Phase 2 initiation announced August 7, 2017.
TICKER: CLSD
Suprachoroidal CLS-TA - PEACHTREE
Macular edema associated with non-infectious uveitis
PHASE 3 Phase 3 completion of enrollment noted August 7, 2017 with preliminary data due 1Q 2018.
TICKER: FGEN
Pamrevlumab (FG-3019)
Idiopathic pulmonary fibrosis
PHASE 2 Phase 2 data released August 7, 2017 - primary endpoint met.
TICKER: GEMP
Gemcabene - ROYAL-1
Heterozygous Familial Hypercholesterolemia (HeFH)
PHASE 2B Phase 2b data released August 7, 2017 - primary endpoint met but lower than expectations.
TICKER: MYOK
MYK-461 - PIONEER-HCM
Hypertrophic cardiomyopathy (HCM)
PHASE 2 Phase 2 top-line data released August 7, 2017 - primary endpoint met. Data from low dose cohort due 1Q 2018.
TICKER: RETA
Bardoxolone methyl - CARDINAL
Chronic Kidney Disease Caused by Alport Syndrome
PHASE 3 Phase 2/3 trial initiation announced February 23, 2017. Data from Phase 2 part of trial released July 24, 2017. Phase 3 commencement of enrollment announced August 7, 2017.
TICKER: SBBP
COR-003 (levoketoconazole) - SONICS
Endogenous Cushing’s syndrome
PHASE 3 Phase 3 completion of enrollment announced June 27, 2017 with top-line data due 2Q 2018.
TICKER: SBBP
COR-003 (levoketoconazole) - LOGICS
Endogenous Cushing’s syndrome
PHASE 3 Phase 3 enrollment from second trial to begin 3Q 2017 with top-line data expected in 3Q 2018.
TICKER: ZYNE
ZYN002 - STAR 1
Adult Epilepsy Patients with Refractory Focal Seizures
PHASE 2 Phase 2 data released August 7, 2017 - endpoints not met.
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FibroGen (FGEN( and MyoKardia (MYOK) shares soar on positive news: Zynerba (ZYNE) and Gemphire (GEMP) plunge on poor data
FibroGen, Inc. (NASDAQ:FGEN) shares have soared after-hours, currently trading up 61% to $33.40. The company announced that top-line data from its Phase 2 trial of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF) met the primary efficacy endpoint of change of forced vital capacity percent predicted.
MyoKardia, Inc. (Nasdaq:MYOK) shares surged to close up 83% following positive top-line data from the first patient cohort of its Phase 2 PIONEER-HCM study of mavacamten in symptomatic, obstructive hypertrophic cardiomyopathy (oHCM) patients. The first cohort met the primary as well as key secondary endpoints. It expects to initiate its next trial, EXPLORER-HCM, potentially a pivotal study, by the end of this year. The company also noted that data from its second, low-dose patient cohort in PIONEER-HCM has completed enrollment with top-line data due 1Q 2018.
Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE) slumped to close down 56% to $6.67 following the release of top-line results from its Phase 2 STAR 1 trial evaluating ZYN002 in adult epilepsy patients with focal seizures. Both primary and secondary endpoints were not met with no statistically significant differences between ZYN002 and placebo.
Gemphire Therapeutics Inc. (NASDAQ:GEMP) announced top-line data from its Phase 2b ROYAL-1 trial of oral gemcabene. The trial met its primary endpoint, however, its mean percent change in LDL cholesterol of -17.2% vs -5.5% for placebo was lower than expectations, sending shares plunging to close down 47% to $9.93.
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:
Aradigm Corporation (NASDAQ:ARDM): $1.42; +26%.
Marinus Pharmaceuticals Inc (NASDAQ:MRNS): $2.39; +13%.
Dynavax Technologies Corporation (NASDAQ
VAX): $2.39; +13%. Invivo Therapeutics Holdings Corp (NASDAQ:NVIV): $2.00; +11%.
Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR): $2.04; +11%.
DECLINERS:
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX): $4.42; -13%.
Celsion Corporation (NASDAQ:CLSN): $1.36; -12%
Teva Pharmaceutical Industries (NYSE:TEVA): $18.59; -10%.
Galectin Therapeutics Inc (NASDAQ:GALT): $1.90: -10%.
Cara Therapeutics Inc (NASDAQ:CARA): $14.93; -9%.
Pipeline updates below:
DRUG STAGE CATALYST
TICKER: AXON
Nelotanserin
DLB patients experiencing REM Behavior Disorder (RBD)
PHASE 2 Phase 2 data due 1Q 2018.
TICKER: AXON
Nelotanserin
Visual hallucinations in subjects with Lewy body dementia
PHASE 2 Phase 2 preliminary data released February 13, 2017. Primary endpoint hit, secondary endpoints missed. Top-line data due 4Q 2017.
TICKER: AXON
Intepirdine - MINDSET
Alzheimer's disease
PHASE 3 Phase 3 data are due late September 2017.
TICKER: AXON
Intepirdine - HEADWAY-DLB
Dementia with Lewy bodies (DLB)
PHASE 2B Phase 2b data due 4Q 2017
TICKER: BLPH
INOpulse delivery device
Pulmonary Hypertension associated with COPD (PH-COPD)
PHASE 2 Phase 2 initiated 3Q 2016. Noted August 7, 2017 that data are due "shortly". BPC estimate end of August as latest likely date.
TICKER: BLPH
INOpulse delivery device
Pulmonary Arterial Hypertension (PAH)
PHASE 3 Phase 3 commenced enrollment June 2016. Interim analysis and top-line data due 2018.
TICKER: CALA
CB-839 + AFINITOR (everolimus)
Clear cell renal cell carcinoma
PHASE 2 Phase 2 initiation announced August 7, 2017.
TICKER: CLSD
Suprachoroidal CLS-TA - PEACHTREE
Macular edema associated with non-infectious uveitis
PHASE 3 Phase 3 completion of enrollment noted August 7, 2017 with preliminary data due 1Q 2018.
TICKER: FGEN
Pamrevlumab (FG-3019)
Idiopathic pulmonary fibrosis
PHASE 2 Phase 2 data released August 7, 2017 - primary endpoint met.
TICKER: GEMP
Gemcabene - ROYAL-1
Heterozygous Familial Hypercholesterolemia (HeFH)
PHASE 2B Phase 2b data released August 7, 2017 - primary endpoint met but lower than expectations.
TICKER: MYOK
MYK-461 - PIONEER-HCM
Hypertrophic cardiomyopathy (HCM)
PHASE 2 Phase 2 top-line data released August 7, 2017 - primary endpoint met. Data from low dose cohort due 1Q 2018.
TICKER: RETA
Bardoxolone methyl - CARDINAL
Chronic Kidney Disease Caused by Alport Syndrome
PHASE 3 Phase 2/3 trial initiation announced February 23, 2017. Data from Phase 2 part of trial released July 24, 2017. Phase 3 commencement of enrollment announced August 7, 2017.
TICKER: SBBP
COR-003 (levoketoconazole) - SONICS
Endogenous Cushing’s syndrome
PHASE 3 Phase 3 completion of enrollment announced June 27, 2017 with top-line data due 2Q 2018.
TICKER: SBBP
COR-003 (levoketoconazole) - LOGICS
Endogenous Cushing’s syndrome
PHASE 3 Phase 3 enrollment from second trial to begin 3Q 2017 with top-line data expected in 3Q 2018.
TICKER: ZYNE
ZYN002 - STAR 1
Adult Epilepsy Patients with Refractory Focal Seizures
PHASE 2 Phase 2 data released August 7, 2017 - endpoints not met.
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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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