BioPharm Update:
Celgene CELG and Agios AGIO receive early FDA approval for IDHIFA
Celgene Corporation (NASDAQ:CELG) and Agios Pharmaceuticals, Inc.(NASDAQ:AGIO) announced that the FDA has approved IDHIFA (enasidenib)) for the treatment of adult patients with relapsed or refractory AML (R/R AML) with an isocitrate dehydrogenase-2 (IDH2) mutation. IDHIFA is the first and only FDA-approved therapy for patients with R/R AML and an IDH2 mutation, which represents between 8 and 19 percent of AML patients. Approval was granted under priority review one month earlier than the PDUFA date. Agios shares closed up 4.8% to $58.65.
Bristol-Myers Squibb Company (NYSE:BMY) announced the FDA has approved Opdivo for intravenous use for the treatment of adult and pediatric patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC).
Geron Corporation (NASDAQ:GERN) shares slipped to close down 15% to $2.24. The company provided an update Monday on its imetelstat clinical development program for the treatment of lower risk myelodysplastic syndromes (MDS) and relapsed or refractory myelofibrosis (MF). The company noted that its IMerge trial (MDS) will be “expanded to enroll additional patients in a refined MDS population to confirm the clinical benefit and safety observed from current results.” In other words, the patient base will be narrowed, which caused some concern among investors. No decision has yet to be made on whether or not its IMbark (MF) trial will be given the green light to commence further trials, with an internal review due 1Q 2018.
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:
22nd Century Group Inc (NYSEMKT:XXII): $1.92; +10%.
Celldex Therapeutics, Inc. (NASDAQ:CLDX): $2.46; +7%.
Neos Therapeutics Inc (NASDAQ:NEOS): $6.90; +7%.
Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE): $15.06; +7%.
Minerva Neurosciences Inc (NASDAQ:NERV): $7.10; +7%.
DECLINERS:
Geron Corporation (NASDAQ:GERN): $2.24; -15%.
Curis, Inc. (NASDAQ:CRIS): $1.67; -14%.
AEterna Zentaris Inc. (USA) (NASDAQ:AEZS): $1.72; -14%.
AcelRx Pharmaceuticals Inc (NASDAQ:ACRX): $3.40; -13%.
Neurotrope Inc (NASDAQ:NTRP): $4.21; -9%.
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 released August 1, 2017 with NDA to be refiled by the end of 2017.
TICKER: AGIO
IDHIFA (enasidenib) - AG-221
Advanced hematologic malignancies with an IDH2 mutation
APPROVED Approval announced August 1, 2017.
TICKER: BMY
CM-142 – Opdivo
(dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer (CRC)
APPROVED Approval announced August 1, 2017.
TICKER: CELG
IDHIFA (enasidenib) - AG-221
Relapsed/Refractory IDH2 mutant-positive Acute Myeloid Leukemia -
APPROVED Approval announced August 1, 2017.
TICKER: CTIC
Pacritinib - PAC203
Myelofibrosis
PHASE 3 PERSIST-2 data released August 2016. One of two primary endpoints met. Additional trial commenced enrollment - noted August 1, 2017.
TICKER: EDGE
EG-1962
Improving patient outcomes following an aneurysmal subarachnoid hemorrhage (aSAH)
PHASE 3 Phase 3 ongoing. Futility analysis late 2017. Interim top-line data due 1Q 2018. Full top-line data due late 2018.
TICKER: EYEG
EGP-437
Ocular inflammation and pain post cataract surgery
PHASE 2B Phase 1/2 top-line data released July 2016. Further data released December 5, 2016. Phase 2b commencement of enrollment announced August 1, 2017.
TICKER: FLKS
FLX-787 - COMMEND US trial
Amyotrophic lateral sclerosis (ALS)
PHASE 2 Phase 2 start noted August 1, 2017. Data due mid-2018.
TICKER: MDGL
MGL-3196
Non-alcoholic steatohepatitis (NASH)
PHASE 2 Phase 2 completion of enrollment announced August 1, 2017. Top-line data due end of 2017.
TICKER: MRNS
Ganaxolone
CDKL5 disorder
PHASE 2 Phase 2 preliminary CDKL5 cohort data released January 23, 2017. Top-line data due 3Q 2017.
TICKER: MRNS
Ganaxolone
Postpartum depression
PHASE 2 Phase 2 data due in 2H 2017.
TICKER: SPPI
SPI-2012 (ROLONTIS)
Chemotherapy-Induced Neutropenia
PHASE 3 Phase 3 completion of enrollment announced August 1, 2017 with top-line data due 1Q 2018.
TICKER: TGTX
TG-1101 - ULTIMATE I and ULTIMATE II
Multiple Sclerosis
PHASE 3 Phase 3 to be initiated 3Q 2017 under SPA.
TICKER: XLRN
ACE-083
Charcot-Marie-Tooth disease (CMT)
PHASE 2 Phase 2 commencement of dosing announced August 1, 2017.
TICKER: ZYNE
ZYN002
Fragile X syndrome
PHASE 2 Phase 2 trial initiation announced January 3, 2017. Data are due September 2017.
TICKER: ZYNE
ZYN002 - STOP
Osteoarthritis
PHASE 2 Phase 2 initiated September 2016. Data are due August 2017 (following epilepsy data).
TICKER: ZYNE
ZYN002 - STAR 1
Adult Epilepsy Patients with Refractory Focal Seizures
PHASE 2 Phase 2 dosing commenced August 2016. Data are due likely early August, 2017 - estimate August 15 as last possible date.
Celgene CELG and Agios AGIO receive early FDA approval for IDHIFA
Celgene Corporation (NASDAQ:CELG) and Agios Pharmaceuticals, Inc.(NASDAQ:AGIO) announced that the FDA has approved IDHIFA (enasidenib)) for the treatment of adult patients with relapsed or refractory AML (R/R AML) with an isocitrate dehydrogenase-2 (IDH2) mutation. IDHIFA is the first and only FDA-approved therapy for patients with R/R AML and an IDH2 mutation, which represents between 8 and 19 percent of AML patients. Approval was granted under priority review one month earlier than the PDUFA date. Agios shares closed up 4.8% to $58.65.
Bristol-Myers Squibb Company (NYSE:BMY) announced the FDA has approved Opdivo for intravenous use for the treatment of adult and pediatric patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC).
Geron Corporation (NASDAQ:GERN) shares slipped to close down 15% to $2.24. The company provided an update Monday on its imetelstat clinical development program for the treatment of lower risk myelodysplastic syndromes (MDS) and relapsed or refractory myelofibrosis (MF). The company noted that its IMerge trial (MDS) will be “expanded to enroll additional patients in a refined MDS population to confirm the clinical benefit and safety observed from current results.” In other words, the patient base will be narrowed, which caused some concern among investors. No decision has yet to be made on whether or not its IMbark (MF) trial will be given the green light to commence further trials, with an internal review due 1Q 2018.
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:
22nd Century Group Inc (NYSEMKT:XXII): $1.92; +10%.
Celldex Therapeutics, Inc. (NASDAQ:CLDX): $2.46; +7%.
Neos Therapeutics Inc (NASDAQ:NEOS): $6.90; +7%.
Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE): $15.06; +7%.
Minerva Neurosciences Inc (NASDAQ:NERV): $7.10; +7%.
DECLINERS:
Geron Corporation (NASDAQ:GERN): $2.24; -15%.
Curis, Inc. (NASDAQ:CRIS): $1.67; -14%.
AEterna Zentaris Inc. (USA) (NASDAQ:AEZS): $1.72; -14%.
AcelRx Pharmaceuticals Inc (NASDAQ:ACRX): $3.40; -13%.
Neurotrope Inc (NASDAQ:NTRP): $4.21; -9%.
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 released August 1, 2017 with NDA to be refiled by the end of 2017.
TICKER: AGIO
IDHIFA (enasidenib) - AG-221
Advanced hematologic malignancies with an IDH2 mutation
APPROVED Approval announced August 1, 2017.
TICKER: BMY
CM-142 – Opdivo
(dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer (CRC)
APPROVED Approval announced August 1, 2017.
TICKER: CELG
IDHIFA (enasidenib) - AG-221
Relapsed/Refractory IDH2 mutant-positive Acute Myeloid Leukemia -
APPROVED Approval announced August 1, 2017.
TICKER: CTIC
Pacritinib - PAC203
Myelofibrosis
PHASE 3 PERSIST-2 data released August 2016. One of two primary endpoints met. Additional trial commenced enrollment - noted August 1, 2017.
TICKER: EDGE
EG-1962
Improving patient outcomes following an aneurysmal subarachnoid hemorrhage (aSAH)
PHASE 3 Phase 3 ongoing. Futility analysis late 2017. Interim top-line data due 1Q 2018. Full top-line data due late 2018.
TICKER: EYEG
EGP-437
Ocular inflammation and pain post cataract surgery
PHASE 2B Phase 1/2 top-line data released July 2016. Further data released December 5, 2016. Phase 2b commencement of enrollment announced August 1, 2017.
TICKER: FLKS
FLX-787 - COMMEND US trial
Amyotrophic lateral sclerosis (ALS)
PHASE 2 Phase 2 start noted August 1, 2017. Data due mid-2018.
TICKER: MDGL
MGL-3196
Non-alcoholic steatohepatitis (NASH)
PHASE 2 Phase 2 completion of enrollment announced August 1, 2017. Top-line data due end of 2017.
TICKER: MRNS
Ganaxolone
CDKL5 disorder
PHASE 2 Phase 2 preliminary CDKL5 cohort data released January 23, 2017. Top-line data due 3Q 2017.
TICKER: MRNS
Ganaxolone
Postpartum depression
PHASE 2 Phase 2 data due in 2H 2017.
TICKER: SPPI
SPI-2012 (ROLONTIS)
Chemotherapy-Induced Neutropenia
PHASE 3 Phase 3 completion of enrollment announced August 1, 2017 with top-line data due 1Q 2018.
TICKER: TGTX
TG-1101 - ULTIMATE I and ULTIMATE II
Multiple Sclerosis
PHASE 3 Phase 3 to be initiated 3Q 2017 under SPA.
TICKER: XLRN
ACE-083
Charcot-Marie-Tooth disease (CMT)
PHASE 2 Phase 2 commencement of dosing announced August 1, 2017.
TICKER: ZYNE
ZYN002
Fragile X syndrome
PHASE 2 Phase 2 trial initiation announced January 3, 2017. Data are due September 2017.
TICKER: ZYNE
ZYN002 - STOP
Osteoarthritis
PHASE 2 Phase 2 initiated September 2016. Data are due August 2017 (following epilepsy data).
TICKER: ZYNE
ZYN002 - STAR 1
Adult Epilepsy Patients with Refractory Focal Seizures
PHASE 2 Phase 2 dosing commenced August 2016. Data are due likely early August, 2017 - estimate August 15 as last possible date.
'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
