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.


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

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


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%.


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.
Smoking cessation

Phase 2b Phase 2b data met primary endpoint in 3/4 arms - June 11, 2019.
$7.6 million

BPMX – BioPharmX Corporation

Phase 2b Phase 2b data June 25, 2019 met endpoints.
$5.5 million

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

Phase 2b Clinical development of Seladelpar discontinued - November 25, 2019.
$120.2 million

GLPG – Galapagos NV

Phase 2b Phase 2b data due 2H 2020.
$13.8 billion

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

Approved FDA Approval announced June 11, 2019.
$226.2 billion

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

Phase 3 Phase 2/3 Follicular lymphoma (FL) cohort met primary endpoint - October 28, 2019. NDA filing due soon.
$708.9 million

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

Phase 2 Phase 2 data due 1H 2020.
$130.6 million