BPC June 11 update

Achieve ACHV and CymaBay CBAY shares fall on mid-stage data

Price and Volume Movers

Merck (NYSE: MRK) announced that the FDA approved further indications for Keytruda, as monotherapy in patients whose tumors express PD-L1 or in combination with platinum and fluorouracil (FU), for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

Achieve Life Sciences, Inc. (Nasdaq: ACHV) shares closed down 25% to $2.90 following the release of data from its Phase 2 ORCA-1 dose-selection trial of cytisinicline for smoking cessation. The trial met the primary endpoint of a reduction in daily smoking, in three arms but failed to meet the endpoint in the fourth.

CymaBay Therapeutics, Inc. (NASDAQ: CBAY) announced 12-week top-line data from its ongoing 52-week Phase 2b trial of seladelpar for the treatment of nonalcoholic steatohepatitis (NASH). Treatment with seladelpar resulted in minimal reductions in liver fat that were not significant when compared to placebo. Shares shed 46% of their value, closing down at $6.05.

Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE) shares closed up 17% to $13.50 on news that it received a U.S. patent for its treatment of Autism Spectrum Disorder with cannabidiol.

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Major price movers (stocks priced > $1.00, volume > 50k):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume

ADVANCERS:

Jaguar Health, Inc. (JAGX): $10.14; +36%.

ContraVir Pharmaceuticals, Inc. (CTRV): $9.50; +36%.

Hemispherx Biopharma, Inc. (HEB): $5.55; +24%.

Ocular Therapeutix, Inc. (OCUL): $3.90; +20%.

Osmotica Pharmaceuticals plc (OSMT): $2.76; +18%.

DECLINERS:

NovaBay Pharmaceuticals, Inc. (NBY): $2.21; -29%.

TherapeuticsMD, Inc. (TXMD): $2.38; -21%.

Oncternal Therapeutics, Inc.(ONCT): $5.86; -17%.

Crinetics Pharmaceuticals, Inc. (CRNX): $22.26; -15%.

Genfit SA (GNFT): $20.58; -14%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ACHV – Achieve Life Sciences Inc.
Cytisine
Smoking cessation

Phase 2b Phase 2b data met primary endpoint in 3/4 arms - June 11, 2019. Data to be presented at SRNT-E Conference, September 12-14, 2019.
$16.2 million

BPMX – BioPharmX Corporation
BPX-04
Rosacea

Phase 2b Phase 2b data June 25, 2019 met endpoints.
$8.5 million

CBAY – CymaBay Therapeutics Inc.
Seladelpar
Non-alcoholic steatohepatitis (NASH)

Phase 2b Phase 2b top-line data noted reductions in liver fat that were not significant compared with placebo - June 11, 2019. 52-week histology results likely due 1H 2020.
$471.2 million

GLPG – Galapagos NV
GLPG1972 - ROCCELLA
Osteoarthritis

Phase 2 Phase 2 completion of enrolment announced June 11, 2019.
$6.9 billion

MRK – Merck & Company Inc. (new)
Keytruda KN-048
Head and neck squamous cell carcinoma (HNSCC)

Approved FDA Approval announced June 11, 2019.
$219.5 billion

TGTX – TG Therapeutics Inc.
TG-1101 and TGR-1202 - UNITY-NHL study
Non-Hodgkin Lymphoma (NHL)

NDA Filing NDA filing to be submitted by the end of 2019.
$620.4 million

ZYNE – Zynerba Pharmaceuticals Inc.
ZYN002 (Zygel) - BRIGHT
Autism Spectrum Disorder (ASD)

Phase 2 Phase 2 data due 1H 2020.
$264.5 million