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Posted On: 08/11/2017 8:47:21 AM
Post# of 106743
Drug Pipeline Updates following earnings Thursday
Given the large number of companies reporting Thursday, today's update focuses on pipeline updates made from earnings releases.
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:
Aevi Genomic Medicine (NASDAQ:GNMX): $1.31; +14%.
Sangamo Therapeutics Inc (NASDAQ:SGMO): $9.50; +12%.
vTv Therapeutics Inc (NASDAQ:VTVT): $4.25; +11%.
Galapagos NV (ADR) (NASDAQ:GLPG): $81.06; +11%.
Impax Laboratories Inc (NASDAQ:IPXL): $18.20; +10%.
DECLINERS:
Invivo Therapeutics (NASDAQ:NVIV): $1.23; -30%.
Kura Oncology Inc (NASDAQ:KURA): $6.55; -28%.
Arca Biopharma Inc (NASDAQ:ABIO): $1.45; -15%.
Aclaris Therapeutics Inc (NASDAQ:ACRS): $23.02; -15%.
Cempra Inc (NASDAQ:CEMP): $43.13; -14%.
Main Pipeline updates below:
DRUG STAGE CATALYST
TICKER: ALRN
ALRN-6924
Peripheral T-cell lymphoma (PTCL)
PHASE 2A Phase 2a interim data due 1H 2018.
TICKER: ANAB
ANB020
Moderate-to-severe adult atopic dermatitis
PHASE 2 Phase 2a trial initiated 1Q 2017 with data due 2H 2017.
TICKER: ARDM
Linhaliq (Pulmaquin)
Non-cystic fibrosis bronchiectasis (non-CF BE).
NDA FILING Phase 3 data released December 1, 2016. One of two trials met primary endpoint. NDA filing announced July 28, 2017.
TICKER: AVEO
TIVO-3 - tivozanib
Third line treatment of patients with renal cell cancer
PHASE 3 Phase 3 completion of enrollment noted June 20, 2017. Futility analysis due August or September, 2017. Top-line data due 1Q 2018.
TICKER: AVXS
AVXS-101
Spinal muscular atrophy (SMA)
PHASE 1/2 Phase 1/2 trial to be initiated 3Q 2017.
TICKER: AVXS
AVXS-101
Spinal muscular atrophy (SMA) Type 1
PHASE 1 Initiate pivotal trial in 3Q 2017 - potency assay data due to FDA in August, 2017.
TICKER: BOLD
AT342 - VALENS
Crigler-Najjar
PHASE 1/2 Phase 1/2 preliminary data due 4Q 2017.
TICKER: BOLD
AT132 - ASPIRO
X-Linked Myotubular Myopathy
PHASE 1/2 Phase 1/2 preliminary data due 4Q 2017.
TICKER: CHMA
Mycapssa - OPTIMAL
Acromegaly
PHASE 3 Phase 3 trial to commence enrollment 2H 2017 with data due 2019.
TICKER: CHMA
Mycapssa - MPOWERED
Maintenance treatment of adult acromegaly
PHASE 3 Phase 3 data due 2020.
TICKER: CLBS
CLBS03
Type 1 diabetes
PHASE 2 Phase 2 top-line data due 1Q 2018.
TICKER: EARS
Keyzilen (AM-101) - TACTT3
Acute inner ear tinnitus
PHASE 3 Phase 3 TACTT3 enrollment resumption announced January 26, 2017 with top-line data 1Q 2018.
TICKER: EARS
AM-111 ASSENT
Acute inner ear hearing loss
PHASE 3 Phase 3 ASSENT data due 2H 2018.
TICKER: EARS
AM-111 HEALOS
Acute inner ear hearing loss
PHASE 3 Phase 3 HEALOS completion of enrollment announced June 5, 2017. Data due 4Q 2017.
TICKER: GILD
Bictegravir/F/TAF
HIV
PDUFA PRIORITY REVIEW PDUFA date under priority review February 12, 2018.
TICKER: HSGX
NeoCart
Cartilage defects in the knee
PHASE 3 Phase 3 completion of enrollment announced June 27, 2017. Top-line data and potential BLA filing 3Q 2018.
TICKER: KMPH
KP415
ADHD
PHASE 2 Phase 1 trial completed December 2016. Pivotal efficacy trials to commence 2H 2017.
TICKER: RDHL
BEKINDA
IBS-D
PHASE 2 Phase 2 top-line data due September 2017.
TICKER: RDHL
RIZAPORT (RHB-103)
Migraine
NDA FILING Planned NDA resubmission due October 2017.
TICKER: RDHL
RHB-104
Nontuberculous mycobacteria (NTM) infections
PHASE 3 Phase 3 trial to be initiated 1Q 2018.
TICKER: RXII
Samcyprone - RXI-SCP-1502
Cutaneous warts
PHASE 2 Phase 2 early read outs due before the end of 2017.
TICKER: RXII
RXI-109-1402
Connective tissue growth factor (CTGF)
PHASE 2 Phase 2 final readout due 2H 2017.
TICKER: RXII
RXI-109-1501
Retinal scarring
PHASE 1/2 Phase 2 completion of enrollment announced June 21, 2017. Data due early 2018.
TICKER: SPHS
Topsalysin (PRX302)
Localized low to intermediate risk prostate cancer
PHASE 2 Phase 2b six-month biopsy data for all patients in 1Q 2018 with final biopsy data due 4Q 2018.
TICKER: TGTX
TG-1101 and TGR-1202 - UNITY-DLBCL study
Diffuse large B-cell lymphoma (DLBCL) cancer
PHASE 2B Phase 2b enrollment commenced June 2016. First interim analysis August 10, 2017 determined that enrollment in TGR-1202 arm will stop but continue in TG-1101 + TGR-1202 arm. TGR-1202 arm replaced by combo of TG-1101, TGR-1202, and bendamustine.
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Given the large number of companies reporting Thursday, today's update focuses on pipeline updates made from earnings releases.
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:
Aevi Genomic Medicine (NASDAQ:GNMX): $1.31; +14%.
Sangamo Therapeutics Inc (NASDAQ:SGMO): $9.50; +12%.
vTv Therapeutics Inc (NASDAQ:VTVT): $4.25; +11%.
Galapagos NV (ADR) (NASDAQ:GLPG): $81.06; +11%.
Impax Laboratories Inc (NASDAQ:IPXL): $18.20; +10%.
DECLINERS:
Invivo Therapeutics (NASDAQ:NVIV): $1.23; -30%.
Kura Oncology Inc (NASDAQ:KURA): $6.55; -28%.
Arca Biopharma Inc (NASDAQ:ABIO): $1.45; -15%.
Aclaris Therapeutics Inc (NASDAQ:ACRS): $23.02; -15%.
Cempra Inc (NASDAQ:CEMP): $43.13; -14%.
Main Pipeline updates below:
DRUG STAGE CATALYST
TICKER: ALRN
ALRN-6924
Peripheral T-cell lymphoma (PTCL)
PHASE 2A Phase 2a interim data due 1H 2018.
TICKER: ANAB
ANB020
Moderate-to-severe adult atopic dermatitis
PHASE 2 Phase 2a trial initiated 1Q 2017 with data due 2H 2017.
TICKER: ARDM
Linhaliq (Pulmaquin)
Non-cystic fibrosis bronchiectasis (non-CF BE).
NDA FILING Phase 3 data released December 1, 2016. One of two trials met primary endpoint. NDA filing announced July 28, 2017.
TICKER: AVEO
TIVO-3 - tivozanib
Third line treatment of patients with renal cell cancer
PHASE 3 Phase 3 completion of enrollment noted June 20, 2017. Futility analysis due August or September, 2017. Top-line data due 1Q 2018.
TICKER: AVXS
AVXS-101
Spinal muscular atrophy (SMA)
PHASE 1/2 Phase 1/2 trial to be initiated 3Q 2017.
TICKER: AVXS
AVXS-101
Spinal muscular atrophy (SMA) Type 1
PHASE 1 Initiate pivotal trial in 3Q 2017 - potency assay data due to FDA in August, 2017.
TICKER: BOLD
AT342 - VALENS
Crigler-Najjar
PHASE 1/2 Phase 1/2 preliminary data due 4Q 2017.
TICKER: BOLD
AT132 - ASPIRO
X-Linked Myotubular Myopathy
PHASE 1/2 Phase 1/2 preliminary data due 4Q 2017.
TICKER: CHMA
Mycapssa - OPTIMAL
Acromegaly
PHASE 3 Phase 3 trial to commence enrollment 2H 2017 with data due 2019.
TICKER: CHMA
Mycapssa - MPOWERED
Maintenance treatment of adult acromegaly
PHASE 3 Phase 3 data due 2020.
TICKER: CLBS
CLBS03
Type 1 diabetes
PHASE 2 Phase 2 top-line data due 1Q 2018.
TICKER: EARS
Keyzilen (AM-101) - TACTT3
Acute inner ear tinnitus
PHASE 3 Phase 3 TACTT3 enrollment resumption announced January 26, 2017 with top-line data 1Q 2018.
TICKER: EARS
AM-111 ASSENT
Acute inner ear hearing loss
PHASE 3 Phase 3 ASSENT data due 2H 2018.
TICKER: EARS
AM-111 HEALOS
Acute inner ear hearing loss
PHASE 3 Phase 3 HEALOS completion of enrollment announced June 5, 2017. Data due 4Q 2017.
TICKER: GILD
Bictegravir/F/TAF
HIV
PDUFA PRIORITY REVIEW PDUFA date under priority review February 12, 2018.
TICKER: HSGX
NeoCart
Cartilage defects in the knee
PHASE 3 Phase 3 completion of enrollment announced June 27, 2017. Top-line data and potential BLA filing 3Q 2018.
TICKER: KMPH
KP415
ADHD
PHASE 2 Phase 1 trial completed December 2016. Pivotal efficacy trials to commence 2H 2017.
TICKER: RDHL
BEKINDA
IBS-D
PHASE 2 Phase 2 top-line data due September 2017.
TICKER: RDHL
RIZAPORT (RHB-103)
Migraine
NDA FILING Planned NDA resubmission due October 2017.
TICKER: RDHL
RHB-104
Nontuberculous mycobacteria (NTM) infections
PHASE 3 Phase 3 trial to be initiated 1Q 2018.
TICKER: RXII
Samcyprone - RXI-SCP-1502
Cutaneous warts
PHASE 2 Phase 2 early read outs due before the end of 2017.
TICKER: RXII
RXI-109-1402
Connective tissue growth factor (CTGF)
PHASE 2 Phase 2 final readout due 2H 2017.
TICKER: RXII
RXI-109-1501
Retinal scarring
PHASE 1/2 Phase 2 completion of enrollment announced June 21, 2017. Data due early 2018.
TICKER: SPHS
Topsalysin (PRX302)
Localized low to intermediate risk prostate cancer
PHASE 2 Phase 2b six-month biopsy data for all patients in 1Q 2018 with final biopsy data due 4Q 2018.
TICKER: TGTX
TG-1101 and TGR-1202 - UNITY-DLBCL study
Diffuse large B-cell lymphoma (DLBCL) cancer
PHASE 2B Phase 2b enrollment commenced June 2016. First interim analysis August 10, 2017 determined that enrollment in TGR-1202 arm will stop but continue in TG-1101 + TGR-1202 arm. TGR-1202 arm replaced by combo of TG-1101, TGR-1202, and bendamustine.
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