BPC June 03 update

​Amgen AMGN delivers positive early lung data - Mirati MRTX shares benefit closing up 32%

Price and Volume Movers

Amgen (NASDAQ: AMGN) announced data from its Phase 1 trial evaluating AMG 510, a KRAS G12C inhibitor, in patients with predominantly Non-Small Cell Lung Cancer (NSCLC) or Colorectal Cancer (CRC) Five out of 10 evaluable patients with NSCLC experienced a partial response (PR), and another four had stable disease (SD), for a disease control rate (DCR) of 90% (9/10) and an overall response rate of 50%. 13 of 18 evaluable patients with CRC achieved SD. The data released were better than its initial abstract last month, where 30% of lung cancer patients exhibited an overall response. Shares closed up 3.4% to $172.36 on the news.

Mirati Therapeutics, Inc. (NASDAQ: MRTX), which is developing its own KRAS G12C inhibitor, MRTX849, saw its shares close up 32% to $89.20. Data are due later this year.

Avenue Therapeutics, Inc. (NASDAQ: ATXI) shares closed up 15% to $5.98 on news that its second pivotal Phase 3 trial of IV tramadol achieved the primary endpoint of a statistically significant improvement in Sum of Pain Intensity Difference over 24 hours (SPID24) compared to placebo in patients with postoperative pain following abdominoplasty surgery.

Vical Incorporated (Nasdaq:VICL) and Brickell Biotech, Inc. a privately-held medical dermatology company, announced a merger agreement where existing Vical stockholders will own 40% of the combined company and Brickell stockholders will own 60%. Shares of Vical closed down 19% to $0.93. The combined company would operate under the name, Brickell Biotech, Inc. and trade on the Nasdaq Capital Market under a new ticker symbol still to be determined.

DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) announced a registered direct offering of 1,170,000 shares and warrants to purchase 760,500 shares of common stock. The combined purchase price for one share of common stock and each warrant will be $3.10, for aggregate gross proceeds of $3.6 million. Shares closed down 50% to $2.05 on the news.

Merck (NYSE:MRK) announced that the FDA approved its supplemental New Drug Application (sNDA) for the use of Zerbaxa (ceftolozane and tazobactam) for the treatment of patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).

Orchard Therapeutics (Nasdaq: ORTX) announced after hours a proposed public offering of 9m American Depositary Shares (“ADSs”) representing 9m ordinary shares.

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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:

Navidea Biopharmaceuticals, Inc (NAVB): $1.72; +38%.

ARCA biopharma, Inc. (ABIO): $7.36; +27%.

NantKwest, Inc. (NK): $1.29; +25%.

Genocea Biosciences, Inc. (GNCA): $6.71; +20%.

Odonate Therapeutics, Inc. (ODT): $24.03; +12%.

DECLINERS:

Aduro BioTech, Inc. (ADRO): $1.94; -40%.

Five Prime Therapeutics, Inc. (FPRX): $6.82; -19%.

Zynerba Pharmaceuticals, Inc. (ZYNE): $10.46; -15%.

IMV Inc. (IMV): $3.73; -14%.

SCYNEXIS, Inc. (SCYX): $1.09; -11%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AGIO – Agios Pharmaceuticals Inc.
Ivosidenib and azacitidine ( Vidaza)
Newly diagnosed AML with an IDH1 mutation

Phase 1 Phase 1 updated data at ASH December 9, 2019 at 10:30 a.m. ET.
$2.8 billion

AGLE – Aeglea BioTherapeutics Inc.
Pegzilarginase (AEB1102)
Arginase I deficiency

Phase 3 Phase 3 trial initiation announced June 3, 2019 with data due 1Q 2021.
$228.4 million

AMGN – Amgen Inc.
AMG 510
Solid tumors

Phase 1 Phase 1 update at ESMO noted 54% PR rate for NSCLC patients (960mg); 1/12 for CRC patients. Next update due in 2020.
$138.9 billion

BPMC – Blueprint Medicines Corporation
BLU-667 - ARROW
RET-altered solid tumors

Phase 1 Phase 1 updated data at ASCO 2019 - 60% ORR in post-platinum RET-fusion NSCLC and 63% ORR in RET-mutant MTC patients. NDA filing due 1Q 2020.
$3.9 billion

CNST – Constellation Pharmaceuticals Inc.
CPI-0610 and ruxolitinib
Myelofibrosis

Phase 2 Phase 2 additional data due at ASH December 9, 2019 at 11:15 AM.
$1.1 billion

FBIO – Fortress Biotech Inc.
Intravenous (IV) tramadol
Postoperative pain following bunionectomy surgery

NDA Filing NDA filing due YE 2019.
$140.9 million

IRWD – Ironwood Pharmaceuticals Inc.
MD-7246
Irritable Bowel Syndrome

Phase 2 Phase 2 top-line data due mid-2020.
$2 billion

MRK – Merck & Company Inc. (new)
ZERBAXA(ceftolozane and tazobactam)
Hospital-acquired bacterial pneumonia (HABP)

Approved FDA approval announced June 3, 2019.
$226.2 billion

NK – NantKwest Inc.
CD19-t-haNK
B-cell lymphoma

Phase 1 IND clearance announced June 5, 2019.
$155.4 million

NVS – Novartis AG
Xolair (omalizumab)
Chronic rhinosinusitis with nasal polyps (CRSwNP)

Phase 3 Phase 3 trials met primary endpoints - June 3, 2019.
$208.5 billion

ODT – Odonate Therapeutics Inc.
Tesetaxel - CONTESSA
Metastatic breast cancer (MBC)

Phase 3 Phase 3 top-line data due 3Q 2020.
$994.9 million

SGEN – Seattle Genetics Inc.
Enfortumab vedotin
Urothelial cancer

PDUFA priority review PDUFA date under priority review is March 15, 2020.
$20.1 billion

XNCR – Xencor Inc.
XmAb22841
Solid tumors

Phase 1 Phase 1 commencement of dosing announced June 3, 2019.
$2.3 billion