BioPharm Update,,,this is typically a weekly update on BioPharm upcoming trial dates. Sometimes fascinating to watch the pps move relevant to this list as the dates get closer to trial disclosure time.
Trial failures for Regeneron (REGN) Zynerba (ZYNE) Ophthotech (OPHT); CEL-SCI (CVM) clinical hold lifted
Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE) shares closed down 9% to $6.42 following its release that top line data from its Phase 2 STOP trial of ZYN002 (cannabidiol gel) for the treatment of osteoarthritis did not meet its primary endpoint. However, the company still intends to initiate a Phase 3 trial following promising data from secondary endpoints.
CEL-SCI Corporation (NYSE: CVM) noted that the FDA has removed the clinical hold on the Phase 3 cancer trial of Multikine. A partial clinical hold was announced September 2016 with a full clinical hold noted May 2017. Shares spiked to close up 30% to $3.00.
Omeros Corporation (NASDAQ: OMER) announced that it has commenced a registered underwritten public offering of 3m shares of its common stock.
Amarin Corporation plc (NASDAQ:AMRN) announced that the independent data monitoring committee (DMC) recommended that its REDUCE-IT cardiovascular outcomes trial continue as planned without modification. Data are expected in Q2 or Q3 2018.
Lipocine Inc. (NASDAQ:LPCN) received a PDUFA date of February 8, 2018 from the FDA for the resubmission of its NDA for TLANDO, for testosterone replacement therapy (TRT) in adult males. The company was issued a Complete Response Letter (CRL) in June 2016.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that its Phase 3 trial of suptavumab (REGN2222), an antibody to respiratory syncytial virus (RSV), did not meet its primary endpoint. The company plans to discontinue further clinical development.
Ophthotech Corporation (Nasdaq:OPHT) announced that it did not meet the primary endpoint in its third Phase 3 trial of Fovista for the treatment of wet age-related macular degeneration (AMD). The company had previously indicated a low likelihood of success given the failure of two previous trials.
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:
Dova Pharmaceuticals Inc (NASDAQ:DOVA): $21.81; +20%.
Marinus Pharmaceuticals Inc (NASDAQ:MRNS): $2.83; +17%.
Anavex Life Sciences Corp. (NASDAQ:AVXL): $4.10; +14%.
Theravance Biopharma Inc (NASDAQ:TBPH): $27.48; +14%.
Soligenix, Inc. (NASDAQ:SNGX): $2.32; +14%.
DECLINERS:
KemPharm Inc (NASDAQ:KMPH): $2.75; -14%.
Lantheus Holdings Inc (NASDAQ:LNTH): $17.15; -10%.
Eleven Biotherapeutics Inc (NASDAQ:EBIO): $1.32; -9%.
Arca Biopharma Inc (NASDAQ:ABIO): $1.33; -9%.
Achieve Life Sciences Inc (NASDAQ:ACHV): $3.09; -7%.
Pipeline updates below:
DRUG STAGE CATALYST
TICKER: ACST
CaPre
Hypertriglyceridemia
PHASE 3 Phase 3 to be initiated 2H 2017.
TICKER: AMRN
Vascepa REDUCE-IT outcomes trial
High Triglycerides With Mixed Dyslipidemia
– Interim analysis announced September 12, 2016 - trial to proceed. Second interim analysis August 14, 2017 also recommended trial to continue. Final data due 2Q or 3Q 2018.
TICKER: CNAT
Emricasan
NASH fibrosis - ENCORE-NF trial
PHASE 2 Phase 2 completion of enrollment noted August 14, 2017. Data are due 1H 2019.
TICKER: CVM
Multikine
Head and Neck cancer
PHASE 3 Initiated Dec 2010. Announced partial clinical hold September 27, 2016. Full clinical hold noted May 2017. Clinical hold released - August 14, 2017.
TICKER: EBIO
Vicinium
Non-muscle invasive bladder cancer (NMIBC)
PHASE 3 Phase 3 enrollment to be completed 1Q 2018, with 3-month top-line data due mid-2018 and 12-month data due 2Q 2019.
TICKER: FATE
ProHema - PROTECT
Acute graft-versus-host disease (GvHD) undergoing hematopoietic cell transplantation (HCT)
PHASE 1/2 Phase 2 efficacy part of trial to be initiated September 2017.
TICKER: GTXI
Enobosarm
Breast cancer - advanced AR+ TNBC
PHASE 2 Noted August 14, 2017 that trial will not continue due to insufficient clinical benefit response (CBR).
TICKER: LPCN
LPCN 1021
Men with low testosterone (Low T)
PDUFA CRL issued June 2016. NDA resubmitted with new PDUFA February 8, 2017.
TICKER: OPHT
Fovista
Wet age-related macular degeneration (Wet-AMD)
PHASE 3 Phase 3 data released December 12, 2016 - primary endpoint not met. Data from third trial released August 14, 2017- primary endpoint not met.
TICKER: MBRX
Annamycin
Acute myeloid leukemia (AML) - cancer
PHASE 1/2 Phase 1/2 data due 2018.
TICKER: REGN
REGN2222
Respiratory syncytial virus (RSV)
PHASE 3 Phase 3 data released August 14, 2017 - primary endpoint not met.
TICKER: RETA
Omaveloxolone - MOXIe
Friedreich’s ataxia (FA)
PHASE 2 Phase 2 initial data released June 1, 2017. Primary endpoint not met. Part 2 due to be enroll 2H 2017.
TICKER: SPPI
QAPZOLA - Apaziquone
Bladder cancer
CRL Failed to meet primary endpoint in Phase 3 trial - Apr 2012. PDUFA date December 11 2016. Advisory Committee Meeting September 14 2016 voted 14 - 0 against approval. CRL issued November 17, 2016. New Phase 3 trial initiation announced August 14, 2017.
TICKER: TNXP
TNX-102 SL
Post-traumatic stress disorder (PTSD)
PHASE 3 Initiation of first of two Phase 3 trials announced March 28, 2017 in military-related PTSD 1Q 2017. Interim analysis due 1H 2018 with top-line data due 2H 2018.
TICKER: VBLT
VB-111
Recurrent glioblastoma (rGBM) cancer
PHASE 3 Phase 3 completion of enrollment announced January 6, 2017. Interim analysis due late September 2017. Top-line data due 1Q 2018.
TICKER: VBLT
VB-111
Recurrent platinum resistant ovarian cancer
PHASE 3 Phase 3 trial to be initiated by end of 2017.
TICKER: ZYNE
ZYN002 - STOP
Osteoarthritis
PHASE 2 Phase 2 data released August 14, 2017 - primary endpoint not met. However, company still intends to initiate Phase 3 trial pending discussions with FDA.
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