BPC September 06 update

Biotech week in Review; ESMO presentations to watch

Weekly watchlist

The shortened trading week saw a number of clinical readouts, regulatory and other price-moving news releases.

This week we highlight, predominantly, mid-large cap stocks with presentations at this month’s ESMO Congress, regarded as Europe's leading medical oncology meeting. The conference will be held from September 27 – October 01.

Global Blood Therapeutics, Inc. (NASDAQ: GBT) shares closed Thursday up 11% to $52.66 following news the FDA has accepted its New Drug Application (NDA) seeking accelerated approval for voxelotor, for the treatment of sickle cell disease (SCD). The PDUFA date under priority review is February 26, 2020. The company noted that the FDA indicated that it is not currently planning to hold an advisory committee meeting.

Mallinckrodt Plc (NYSE: MNK) closed the week down 28% to $1.87 on reports by Bloomberg that it is exploring options to absorb potential costs from lawsuits related to the opioid epidemic and it may choose to seek bankruptcy protection.

Ardelyx, Inc. (Nasdaq: ARDX) announced Tuesday that it met the primary endpoint in its Phase 3 AMPLIFY trial of tenapanor in combination with phosphate binders in patients with chronic kidney disease (CKD) on dialysis whose hyperphosphatemia was not previously controlled with binders alone. Shares closed the week up 43% to $4.87.

Abeona Therapeutics Inc. (NASDAQ:ABEO) was one of a number of companies to announce that it is reviewing strategic alternatives, including potential partnership or sale/merger options. Shares closed the week up 94% to $2.98.

Emergent BioSolutions Inc. (NYSE:EBS) announced Tuesday that it has been awarded a contract by the U.S. Department of Health and Human Services (HHS) valued at approximately $2b over 10 years for the continued supply of ACAM2000, (Smallpox Vaccine, Live) into the U.S. Strategic National Stockpile (SNS). Shares closed the week up 28% to $56.08.

The Medicines Company (NASDAQ: MDCO) shares closed the week up 13% to $47.49 following the presentation of data from its Phase 3 ORION-11 trial of inclisiran, a treatment to reduce low-density lipoprotein cholesterol (LDL-C). For the primary endpoints, inclisiran delivered placebo-adjusted LDL-C reductions of 54% (p<0.0001) at day 510 and demonstrated time-averaged placebo-adjusted LDL-C reductions of 50% (p<0.0001) from days 90 through 540.

ESMO sessions to watch:

Drug Stage Catalyst Market Cap

ABBV – AbbVie Inc.
Veliparib
Ovarian cancer

Phase 3 Phase 3 presentation at ESMO 28 September 2019.
$126.7 billion

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.
$131.1 billion

AZN – Astrazeneca PLC
Lynparza + Avastin- PAOLA-1
First-line ovarian cancer

Phase 3 Phase 3 data met primary endpoint - August 14, 2019. Presentation at ESMO noted PFS HR 0.59.
$123 billion

CALA – Calithera Biosciences Inc.
CB-839 + AFINITOR (everolimus)‎ - ENTRATA
Clear cell renal cell carcinoma

Phase 2 Phase 2 data at ESMO 2019 noted HR 0.64. PFS 3.8 months.
$169.4 million

DCPH – Deciphera Pharmaceuticals Inc.
Ripretinib DCC-2618 - INVICTUS
Gastrointestinal Stromal Tumors (GIST) - fourth-line

NDA Filing NDA filing due 1Q 2020.
$2.5 billion

GSK – GlaxoSmithKline PLC
Niraparib - PRIMA
First-line ovarian cancer

Phase 3 Phase 3 data released July 15, 2019 met primary endpoint. Presentation at ESMO 2019 noted PFS, HR 0.62.
$110.4 billion

GTHX – G1 Therapeutics Inc.
Trilaciclib
Triple-negative breast cancer

Phase 2 Phase 2 data at ESMO 2019 noted OS of 20.1 months, compared with 12.6 months for chemotherapy.
$863 million

IMMU – Immunomedics Inc.
SACITUZUMAB GOVITECAN - TROPHY U-01
Urothelial cancer

Phase 2 Phase 1/2 interim data presented at ESMO September 2019 noted 29% ORR.
$3.3 billion

INCY – Incyte Corporation
Pemigatinib (FIGHT-202)
Cholangiocarcinoma

NDA Filing NDA filing to be submitted 4Q 2019.
$18.3 billion

INCY – Incyte Corporation
INCB001158
Solid tumors

Phase 1/2 Phase 1/2 data at ESMO 2019 noted - 7% PR rate.
$18.3 billion

MRK – Merck & Company Inc. (new)
Keytruda KN-522
Triple negative breast cancer (TNBC)

Phase 3 Phase 3 data released July 29, 2019. Complete response endpoint met. Event-free survival (EFS) HR=0.63.
$212 billion

MRK – Merck & Company Inc. (new)
Pembrolizumab vs chemotherapy
Malignant pleural mesothelioma (MPM)

Phase 3 Phase 3 data presented at ESMO September 2019.
$212 billion