BioPharm Updates: Good read and I missed picking up FLEX.
Neuralstem, Inc. (Nasdaq:CUR) shares slumped to close down 50% TO $2.81 following its announcement that its Phase 2 trial of NSI-189 for the treatment of major depressive disorder (MDD) did not meet its primary efficacy endpoint of a statistically significant reduction in depression symptoms on the Montgomery-Asberg Depression Rating Scale (MADRS).
Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH) announced positive top-line results from IGNITE4, its Phase 3 clinical trial evaluating the efficacy and safety of twice-daily intravenous (IV) eravacycline compared to meropenem for the treatment of patients with complicated intra-abdominal infections (cIAI). The trial met its primary efficacy endpoint and the company plans to file an NDA in 1Q 2018. Shares are trading up 25% to $8.60 in the after-hours session.
Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) issued a statement that it has not yet received correspondence from the FDA regarding its New Drug Application for RYANODEX for the treatment of exertional heat stroke. The PDUFA date, which is now overdue, was Sunday, July 23, 2017.
Eli Lilly and Company ( NYSE : LLY) and Incyte Corporation (NASDAQ: INCY) announced today that their resubmission of the NDA for baricitinib, for the treatment of moderate-to-severe rheumatoid arthritis (RA), will be delayed for at least 18 months. The companies received a Complete Response Letter (CRL) in April 2017.
Flex Pharma, Inc. (NASDAQ: FLKS) shares closed up 11% to $4.33 following its announcement that the FDA has granted Fast Track designation for the development of FLX-787, for the treatment of severe muscle cramps in patients with ALS. Fast Track designation is intended to accelerate the clinical development and review of drugs to treat serious conditions that address an unmet medical need.
Pacira Pharmaceuticals, Inc. (NASDAQ
CRX) shares closed down 12% to $42.65. The company announced data from two Phase 3 trials of EXPAREL as a single-dose nerve block for prolonged regional analgesia. The first trial which evaluated EXPAREL in patients undergoing one of two upper extremity surgeries (total shoulder arthroplasty or rotator cuff repair), met the primary endpoint. However, the second trial for patients undergoing a lower extremity surgical procedure (total knee arthroplasty, or TKA), did not meet the primary endpoint. The company noted a significant deviation from protocol identified at a single center as the reason for the trial failure.
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:
Marinus Pharmaceuticals Inc (NASDAQ:MRNS): $1.98; +9%.
Moleculin Biotech Inc (NASDAQ:MBRX): $2.01; +7%.
Myokardia Inc (NASDAQ:MYOK): $15.30; +8%.
Syros Pharmaceuticals Inc (NASDAQ:SYRS): $22.14; +8%.
Idera Pharmaceuticals Inc (NASDAQ:IDRA): $2.06; +7%.
DECLINERS:
Novavax, Inc. (NASDAQ:NVAX): $1.10; -27%.
Achaogen Inc (NASDAQ:AKAO): $19.90; -9%.
AnaptysBio Inc (NASDAQ:ANAB): $27.90; -9%.
Ionis Pharmaceuticals Inc (NASDAQ:IONS): $54.71; -8%.
Kadmon Holdings Inc (NYSE:KDMN): $2.72; -7%.
Pipeline updates below:
DRUG STAGE CATALYST
TICKER: DERM
Cimzia
Moderate-to-severe plaque psoriasis
SNDA FILING Phase 3 data from first trial released October 2016 - endpoints met. Second trial data released December 8, 2016 - endpoints met. Data from third and final trial met primary endpoint - January 19, 2017. sBLA filing announced July 24, 2017.
TICKER: EGRX
Ryanodex
Exertional heat stroke (EHS)
PDUFA PRIORITY REVIEW PDUFA date under priority review July 23, 2017. Company indicated July 25, 2017 that it has not received correspondence regarding the decision.
TICKER: FLKS
FLX-787
Charcot-Marie-Tooth (CMT)
PHASE 2 Phase 2 trial to commence 3Q 2017.
TICKER: FLKS
FLX-787 - US trial
Amyotrophic lateral sclerosis (ALS)
PHASE 2 Phase 2 trial to commence 3Q 2017.
TICKER: INCY
Baricitinib
Rheumatoid arthritis
CRL Announced January 19 2016 that NDA Filing had been submitted. Three month delay announced January 13, 2017. CRL received April 14, 2017. Noted July 25, 2017 that resubmission will be delayed beyond 2018.
TICKER: LLY
Baricitinib
Rheumatoid arthritis
CRL Announced January 19 2016 that NDA Filing had been submitted. Three month delay announced January 13, 2017. CRL received April 14, 2017. Noted July 25, 2017 that resubmission will be delayed beyond 2018.
TICKER: RDHL
RIZAPORT (RHB-103)
Migraine
NDA FILING Planned NDA resubmission due October 2017.
TICKER: RTRX
RE-024
Pantothenate kinase-associated neurodegeneration (PKAN)
PHASE 3 Phase 3 dosing has commenced - noted July 25, 2017.
TICKER: TTPH
Eravacycline (TP-434) - IGNITE4
cIAI (complicated intra-abdominal infections)
PHASE 3
Neuralstem, Inc. (Nasdaq:CUR) shares slumped to close down 50% TO $2.81 following its announcement that its Phase 2 trial of NSI-189 for the treatment of major depressive disorder (MDD) did not meet its primary efficacy endpoint of a statistically significant reduction in depression symptoms on the Montgomery-Asberg Depression Rating Scale (MADRS).
Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH) announced positive top-line results from IGNITE4, its Phase 3 clinical trial evaluating the efficacy and safety of twice-daily intravenous (IV) eravacycline compared to meropenem for the treatment of patients with complicated intra-abdominal infections (cIAI). The trial met its primary efficacy endpoint and the company plans to file an NDA in 1Q 2018. Shares are trading up 25% to $8.60 in the after-hours session.
Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) issued a statement that it has not yet received correspondence from the FDA regarding its New Drug Application for RYANODEX for the treatment of exertional heat stroke. The PDUFA date, which is now overdue, was Sunday, July 23, 2017.
Eli Lilly and Company ( NYSE : LLY) and Incyte Corporation (NASDAQ: INCY) announced today that their resubmission of the NDA for baricitinib, for the treatment of moderate-to-severe rheumatoid arthritis (RA), will be delayed for at least 18 months. The companies received a Complete Response Letter (CRL) in April 2017.
Flex Pharma, Inc. (NASDAQ: FLKS) shares closed up 11% to $4.33 following its announcement that the FDA has granted Fast Track designation for the development of FLX-787, for the treatment of severe muscle cramps in patients with ALS. Fast Track designation is intended to accelerate the clinical development and review of drugs to treat serious conditions that address an unmet medical need.
Pacira Pharmaceuticals, Inc. (NASDAQ
CRX) shares closed down 12% to $42.65. The company announced data from two Phase 3 trials of EXPAREL as a single-dose nerve block for prolonged regional analgesia. The first trial which evaluated EXPAREL in patients undergoing one of two upper extremity surgeries (total shoulder arthroplasty or rotator cuff repair), met the primary endpoint. However, the second trial for patients undergoing a lower extremity surgical procedure (total knee arthroplasty, or TKA), did not meet the primary endpoint. The company noted a significant deviation from protocol identified at a single center as the reason for the trial failure. 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:
Marinus Pharmaceuticals Inc (NASDAQ:MRNS): $1.98; +9%.
Moleculin Biotech Inc (NASDAQ:MBRX): $2.01; +7%.
Myokardia Inc (NASDAQ:MYOK): $15.30; +8%.
Syros Pharmaceuticals Inc (NASDAQ:SYRS): $22.14; +8%.
Idera Pharmaceuticals Inc (NASDAQ:IDRA): $2.06; +7%.
DECLINERS:
Novavax, Inc. (NASDAQ:NVAX): $1.10; -27%.
Achaogen Inc (NASDAQ:AKAO): $19.90; -9%.
AnaptysBio Inc (NASDAQ:ANAB): $27.90; -9%.
Ionis Pharmaceuticals Inc (NASDAQ:IONS): $54.71; -8%.
Kadmon Holdings Inc (NYSE:KDMN): $2.72; -7%.
Pipeline updates below:
DRUG STAGE CATALYST
TICKER: DERM
Cimzia
Moderate-to-severe plaque psoriasis
SNDA FILING Phase 3 data from first trial released October 2016 - endpoints met. Second trial data released December 8, 2016 - endpoints met. Data from third and final trial met primary endpoint - January 19, 2017. sBLA filing announced July 24, 2017.
TICKER: EGRX
Ryanodex
Exertional heat stroke (EHS)
PDUFA PRIORITY REVIEW PDUFA date under priority review July 23, 2017. Company indicated July 25, 2017 that it has not received correspondence regarding the decision.
TICKER: FLKS
FLX-787
Charcot-Marie-Tooth (CMT)
PHASE 2 Phase 2 trial to commence 3Q 2017.
TICKER: FLKS
FLX-787 - US trial
Amyotrophic lateral sclerosis (ALS)
PHASE 2 Phase 2 trial to commence 3Q 2017.
TICKER: INCY
Baricitinib
Rheumatoid arthritis
CRL Announced January 19 2016 that NDA Filing had been submitted. Three month delay announced January 13, 2017. CRL received April 14, 2017. Noted July 25, 2017 that resubmission will be delayed beyond 2018.
TICKER: LLY
Baricitinib
Rheumatoid arthritis
CRL Announced January 19 2016 that NDA Filing had been submitted. Three month delay announced January 13, 2017. CRL received April 14, 2017. Noted July 25, 2017 that resubmission will be delayed beyond 2018.
TICKER: RDHL
RIZAPORT (RHB-103)
Migraine
NDA FILING Planned NDA resubmission due October 2017.
TICKER: RTRX
RE-024
Pantothenate kinase-associated neurodegeneration (PKAN)
PHASE 3 Phase 3 dosing has commenced - noted July 25, 2017.
TICKER: TTPH
Eravacycline (TP-434) - IGNITE4
cIAI (complicated intra-abdominal infections)
PHASE 3
'Everything works out in the end,,,If it hasn't worked out,,it's not the end'
https://twitter.com/twitter/statuses/957208055766241280
https://twitter.com/twitter/statuses/957208055766241280
