BPC July 31 update

​Amarin AMRN expects no Advisory Committee; Adamis ADMP offering

Price and Volume Movers

Amarin Corporation plc (NASDAQ:AMRN) announced in its second quarter earnings release that it assumes an Advisory Committee meeting is unlikely to be held in regard to the FDA review of its sNDA for Vascepa. The PDUFA date under priority review is September 28, 2019.

Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) announced that it intends to offer shares of its common stock and warrants to purchase shares of its common stock in an underwritten public offering. Shares are trading down 17% to $0.95 after hours.

Merck (NYSE: MRK) announced a further label expansion for Keytruda, approving the use for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus.

Theravance Biopharma, Inc. (NASDAQ: TBPH) shares closed up 5% to $20.85 following its report of second quarter earnings. Total revenue for the quarter was $26.2m compared to $23.5m in the same period in 2018.

Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) shares continued their slide, with second quarter earnings missing expectations. Revenues for the quarter decreased to $9.7m from $13.8m for the corresponding period in 2018. Shares closed down 19% to $1.35.

BioTime, Inc. (NYSE American and TASE: BTX) announced it will changed its company name to Lineage Cell Therapeutics, Inc., effective August 12, 2019 and will trade under a new ticker, “LCTX".

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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:

Aravive, Inc. (ARAV): $6.55; +12%.

Sesen Bio, Inc. (SESN): $1.23; +7%.

Mirati Therapeutics, Inc. (MRTX): $105.80; +7%.

NewLink Genetics Corporation (NLNK): $1.77; +7%.

UroGen Pharma Ltd. (URGN): $34.10; +6%.

DECLINERS:

Aclaris Therapeutics, Inc. (ACRS): $1.28; -26%.

Acasti Pharma Inc. (ACST): $2.41; -17%.

Abeona Therapeutics Inc. (ABEO): $2.59; -13%.

Translate Bio, Inc. (TBIO): $8.02; -11%.

OptiNose, Inc. (OPTN): $5.37; -11%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ACAD – ACADIA Pharmaceuticals Inc.
Pimavanserin - Harmony
Alzheimer’s disease psychosis

Phase 3 Phase 3 trial stopped early after meeting primary endpoint - September 9, 2019. Data presented at CTAD meeting December 4, 2019 noted HR =0.353, one-sided p=0.0023.
$7.9 billion

BHVN – Biohaven Pharmaceutical Holding Company Ltd.
Verdiperstat
Multiple system atrophy (MSA)

Phase 3 Phase 3 commencement of enrolment announced July 31, 2019.
$2.9 billion

CMRX – Chimerix Inc.
DSTAT (CX-01)
Acute Myeloid Leukemia (AML)

Phase 3 Phase 3 trial to be initiated mid-2020.
$151 million

ELOX – Eloxx Pharmaceuticals Inc.
ELX-02
Cystic fibrosis

Phase 2 Phase 2 top-line data due 1H 2020.
$205.2 million

EXEL – Exelixis Inc.
CABOMETYX (cabozantinib) with Opdivo and Yervoy - CheckMate 9ER
First-line renal cell carcinoma

Phase 3 Phase 3 data due early 2020.
$5.3 billion

LXRX – Lexicon Pharmaceuticals Inc.
LX9211
Neuropathic pain

Phase 1 Phase 1 data December 5, 2019 noted drug was well tolerated. Proof of concept trial to be initiated 2020.
$517.5 million

MGNX – MacroGenics Inc.
Margetuximab SOPHIA study
Metastatic breast cancer

Phase 3 Second interim overall survival analysis noted OS 21.6 months vs 19.8 months; HR 0.885; p=0.326. Presentation at SABCS December 10-14, 2019. BLA filing due 4Q 2019.
$473.5 million

MRK – Merck & Company Inc. (new)
Keytruda KN-181
Esophageal Cancer

Approved FDA Approval announced July 31, 2019.
$226.2 billion

NVS – Novartis AG
Kisqali plus fulvestrant: MONALEESA-3
Breast cancer - (post-menopausal)

Phase 3 Phase 3 data presented at ESMO 2019 noted HR=0.724.
$208.5 billion

SBBP – Strongbridge Biopharma plc
COR-003 (levoketoconazole) - LOGICS
Endogenous Cushing’s syndrome

Phase 3 Phase 3 top-line data expected 2Q or 3Q 2020.
$98.1 million

SLS – SELLAS Life Sciences Group Inc.
Galinpepimut-S and Keytruda (pembrolizumab)
Solid tumors

Phase 1/2 Phase 1/2 interim data due 1Q 2020.
$19.8 million

TBIO – Translate Bio Inc.
MRT5005
Cystic fibrosis

Phase 1/2 Phase 1/2 MAD data due 2020.
$599.6 million

TBPH – Theravance Biopharma Inc.
TD-8236
Asthma

Phase 1 Phase 1 Part C data due 1H 2020. Phase 2 initiation of dosing announced December 3, 2019.
$1.2 billion

TPTX – Turning Point Therapeutics Inc.
TPX-0022
Solid tumors

Phase 1 Phase 1 interim data due 2H 2020.
$1.8 billion

VRTX – Vertex Pharmaceuticals Incorporated
VX-814
alpha-1 antitrypsin (AAT) deficiency

Phase 2 Phase 2 trial planned for 4Q 2019 with data due in 2020.
$57.4 billion