BioPharm Update: Some here have invested in some of these and some of you may see an opportunity for profit.
AcelRx ACRX Zalviso Phase 3 data due Tuesday; InVivo NVIV halts INSPIRE trial
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) announced that it will hold a conference call on Tuesday, August 1 at 8:30 am EST to discuss top-line results from its Phase 3 IAP312 trial of Zalviso for the treatment of moderate-to-severe acute pain. Shares closed up 7% to $3.90.
InVivo Therapeutics Holdings Corp. (NVIV) shares slid to close down 27% to $1.80. The company announced the temporary halt in its Inspire trial of its Neuro Spinal Scaffold implant due to the death of the most recent patient to enroll into the trial. While the third death in the trial has been deemed to be unrelated to the implant the company has decided to halt the trial until it determines whether or not a change in enrollment criteria is required. As a result of the temporary enrollment halt, the company anticipates completing enrollment 1H 2018 and submitting a Humanitarian Device Exemption (HDE) application 2H 2018.
Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) shares closed down 13% to $117.93. The company announced 2Q earnings together with data from its two Phase 3 trials of obeticholic acid (OCA) in patients with nonalcoholic steatohepatitis (NASH) with fibrosis or cirrhosis (CONTROL trial) and Primary Sclerosing Cholangitis (AESOP trial). The CONTROL trial met its primary endpoint. However, some concerns were raised from investors in respect to a patient death. As the company noted;
During the ongoing LTSE phase, there has been one patient death due to acute renal and liver failure. While Intercept determined it could not be ruled out that this was possibly related to treatment, the principal investigator and the independent Data Safety Monitoring Committee determined the death was unlikely related to OCA.
Dynavax Technologies Corporation (NASDAQ
VAX) shares closed up 71% to $15.85 following Friday’s positive news where an FDA Advisory Committee panel voted, 12-1, that the safety data for HEPLISAV-B support approval for the immunization against Hepatitis B infection in adults 18 years of age and older.
Recro Pharma, Inc. (Nasdaq:REPH) announced it has submitted a New Drug Application (NDA) to the FDA for intravenous (IV) meloxicam for patients with moderate to severe, acute postoperative pain.
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:
Moleculin Biotech Inc (NASDAQ:MBRX): $2.99; +24%.
Strongbridge Biopharma plc (NASDAQ:SBBP): $7.95; +17%.
Novan Inc (NASDAQ:NOVN): $5.98; +13%.
Novavax, Inc. (NASDAQ:NVAX): $1.04; +8%.
Bioline RX Ltd (NASDAQ:BLRX): $1.07; +8%.
DECLINERS:
ImmunoGen, Inc. (NASDAQ:IMGN): $5.94; -15%.
Clovis Oncology Inc (NASDAQ:CLVS): $84.81; -13%.
Arca Biopharma Inc (NASDAQ:ABIO: $1.85; -12%.
Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE): $14.10; -11%.
IntelliPharmaCeutics Intl Inc (NASDAQ:IPCI): $1.27; -10%.
Pipeline updates below:
DRUG STAGE CATALYST
TICKER: ACRX
Zalviso
Post-operative pain following open abdominal surgery and hip or knee replacement surgery
PHASE 3 CRL Jul 26 2014. Additional clinical trial required. Phase 3 trial initiated September 2016. Data to be released August 1, 2017.
TICKER: AMGN
Prolia (denosumab)
Glucocorticoid-induced osteoporosis (GIOP)
SNDA FILING sBLA filing announced July 31, 2017.
TICKER: AMGN
ABP 980
Herceptin biosimilar
BLA FILING BLA filing announced July 31, 2017.
TICKER: CLVS
Opdivo and Rubraca
Castration-resistant prostate cancer (mCRPC)
PHASE 2 Phase 2 trial planned for 2017.
TICKER: CLVS
Opdivo and Rubraca
Triple-negative breast cancers
PHASE 3 Phase 3 trial planned for 2017.
TICKER: CLVS
Opdivo and Rubraca
Ovarian Cancer - First-line maintenance treatment
PHASE 3 Phase 3 trial planned for 2017.
TICKER: DFFN
Trans sodium crocetinate (TSC)
Glioblastoma (GBM)
PHASE 3 Phase 3 to be initiated by the end of 2017.
TICKER: GLMD
Aramchol - ARREST
Non-Alcoholic Steatohepatitis (NASH)
PHASE 2B Phase 2b enrollment complettion announced January 9, 2017. Data due 2Q 2018.
TICKER: ICPT
Obeticholic acid (OCA) AESOP
Primary Sclerosing Cholangitis (PSC)
PHASE 2 Phase 2 data released July 31, 2017 - primary endpoint met.
TICKER: ICPT
Obeticholic acid (OCA) - CONTROL
NASH patients taking statins
PHASE 2 Phase 2 primary endpoint met - July 31, 2017. One patient death noted but DSMB noted unlikely to be related to OCA (company unsure).
TICKER: NVIV
Neuro-Spinal Scaffold
Complete Thoracic AIS A Spinal Cord Injury
PHASE 3 Noted July 31, 2017 that enrollment has been temporarily halted as it discusses potential changes to patient enrollment criteria due to patient deaths - enrollment now due to be completed 1H 2018 with Humanitarian Device Exemption (HDE) application due 2H 2018.
TICKER: RDHL
RHB-104 MAP US
Crohn’s disease
PHASE 3 Phase 3 DSMB safety analysis released December 13, 2016 - trial to continue as planned. Further analysis July 31, 2017 recommended trial continue as planned.
TICKER: REPH
Intravenous (IV) meloxicam
Acute pain following bunionectomy surgery
NDA FILING Phase 3 data from second trial released November 28, 2016. Primary endpoint met. Safety study to be completed May 9, 2017 - NDA filing announced July 31, 2017.
TICKER: SBPH
SB 9200
Hepatitis B (HBV)
PHASE 2A Phase 2a initial data released May 23, 2017. Second cohort enrolling with top-line results due 4Q 2017.
TICKER: ZIOP
Ad-RTS-hIL-12 + veledimex
AcelRx ACRX Zalviso Phase 3 data due Tuesday; InVivo NVIV halts INSPIRE trial
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) announced that it will hold a conference call on Tuesday, August 1 at 8:30 am EST to discuss top-line results from its Phase 3 IAP312 trial of Zalviso for the treatment of moderate-to-severe acute pain. Shares closed up 7% to $3.90.
InVivo Therapeutics Holdings Corp. (NVIV) shares slid to close down 27% to $1.80. The company announced the temporary halt in its Inspire trial of its Neuro Spinal Scaffold implant due to the death of the most recent patient to enroll into the trial. While the third death in the trial has been deemed to be unrelated to the implant the company has decided to halt the trial until it determines whether or not a change in enrollment criteria is required. As a result of the temporary enrollment halt, the company anticipates completing enrollment 1H 2018 and submitting a Humanitarian Device Exemption (HDE) application 2H 2018.
Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) shares closed down 13% to $117.93. The company announced 2Q earnings together with data from its two Phase 3 trials of obeticholic acid (OCA) in patients with nonalcoholic steatohepatitis (NASH) with fibrosis or cirrhosis (CONTROL trial) and Primary Sclerosing Cholangitis (AESOP trial). The CONTROL trial met its primary endpoint. However, some concerns were raised from investors in respect to a patient death. As the company noted;
During the ongoing LTSE phase, there has been one patient death due to acute renal and liver failure. While Intercept determined it could not be ruled out that this was possibly related to treatment, the principal investigator and the independent Data Safety Monitoring Committee determined the death was unlikely related to OCA.
Dynavax Technologies Corporation (NASDAQ
VAX) shares closed up 71% to $15.85 following Friday’s positive news where an FDA Advisory Committee panel voted, 12-1, that the safety data for HEPLISAV-B support approval for the immunization against Hepatitis B infection in adults 18 years of age and older. Recro Pharma, Inc. (Nasdaq:REPH) announced it has submitted a New Drug Application (NDA) to the FDA for intravenous (IV) meloxicam for patients with moderate to severe, acute postoperative pain.
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:
Moleculin Biotech Inc (NASDAQ:MBRX): $2.99; +24%.
Strongbridge Biopharma plc (NASDAQ:SBBP): $7.95; +17%.
Novan Inc (NASDAQ:NOVN): $5.98; +13%.
Novavax, Inc. (NASDAQ:NVAX): $1.04; +8%.
Bioline RX Ltd (NASDAQ:BLRX): $1.07; +8%.
DECLINERS:
ImmunoGen, Inc. (NASDAQ:IMGN): $5.94; -15%.
Clovis Oncology Inc (NASDAQ:CLVS): $84.81; -13%.
Arca Biopharma Inc (NASDAQ:ABIO: $1.85; -12%.
Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE): $14.10; -11%.
IntelliPharmaCeutics Intl Inc (NASDAQ:IPCI): $1.27; -10%.
Pipeline updates below:
DRUG STAGE CATALYST
TICKER: ACRX
Zalviso
Post-operative pain following open abdominal surgery and hip or knee replacement surgery
PHASE 3 CRL Jul 26 2014. Additional clinical trial required. Phase 3 trial initiated September 2016. Data to be released August 1, 2017.
TICKER: AMGN
Prolia (denosumab)
Glucocorticoid-induced osteoporosis (GIOP)
SNDA FILING sBLA filing announced July 31, 2017.
TICKER: AMGN
ABP 980
Herceptin biosimilar
BLA FILING BLA filing announced July 31, 2017.
TICKER: CLVS
Opdivo and Rubraca
Castration-resistant prostate cancer (mCRPC)
PHASE 2 Phase 2 trial planned for 2017.
TICKER: CLVS
Opdivo and Rubraca
Triple-negative breast cancers
PHASE 3 Phase 3 trial planned for 2017.
TICKER: CLVS
Opdivo and Rubraca
Ovarian Cancer - First-line maintenance treatment
PHASE 3 Phase 3 trial planned for 2017.
TICKER: DFFN
Trans sodium crocetinate (TSC)
Glioblastoma (GBM)
PHASE 3 Phase 3 to be initiated by the end of 2017.
TICKER: GLMD
Aramchol - ARREST
Non-Alcoholic Steatohepatitis (NASH)
PHASE 2B Phase 2b enrollment complettion announced January 9, 2017. Data due 2Q 2018.
TICKER: ICPT
Obeticholic acid (OCA) AESOP
Primary Sclerosing Cholangitis (PSC)
PHASE 2 Phase 2 data released July 31, 2017 - primary endpoint met.
TICKER: ICPT
Obeticholic acid (OCA) - CONTROL
NASH patients taking statins
PHASE 2 Phase 2 primary endpoint met - July 31, 2017. One patient death noted but DSMB noted unlikely to be related to OCA (company unsure).
TICKER: NVIV
Neuro-Spinal Scaffold
Complete Thoracic AIS A Spinal Cord Injury
PHASE 3 Noted July 31, 2017 that enrollment has been temporarily halted as it discusses potential changes to patient enrollment criteria due to patient deaths - enrollment now due to be completed 1H 2018 with Humanitarian Device Exemption (HDE) application due 2H 2018.
TICKER: RDHL
RHB-104 MAP US
Crohn’s disease
PHASE 3 Phase 3 DSMB safety analysis released December 13, 2016 - trial to continue as planned. Further analysis July 31, 2017 recommended trial continue as planned.
TICKER: REPH
Intravenous (IV) meloxicam
Acute pain following bunionectomy surgery
NDA FILING Phase 3 data from second trial released November 28, 2016. Primary endpoint met. Safety study to be completed May 9, 2017 - NDA filing announced July 31, 2017.
TICKER: SBPH
SB 9200
Hepatitis B (HBV)
PHASE 2A Phase 2a initial data released May 23, 2017. Second cohort enrolling with top-line results due 4Q 2017.
TICKER: ZIOP
Ad-RTS-hIL-12 + veledimex
'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
