Drug Pipeline Updates following earnings Thursday Given the

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OldSaltDawg
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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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