BPC April 05 update

Biotech stocks to watch at EASL 2019 meeting; Biotech week in Review

Weekly watchlist

This week’s biotech stock watch list focuses on the annual EASL The International Liver Congress where experts will gather to discuss the latest in liver research. Much focus will be on stocks such as Viking Therapeutics, Inc. (NASDAQ: VKTX) and its Phase 2 trial of VK2809 trial in Non-alcoholic fatty liver disease (NAFLD) and Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) with data from its Phase 3 trial for non-alcoholic steatohepatitis (NASH). The conference runs from 10-14 April, 2019.

First, let’s review the week that was with key price moving events.

Sangamo Therapeutics, Inc. (NASDAQ: SGMO) shares closed the week up 32% to $12.58 following promising interim data released Tuesday from its Phase 1/2 Alta trial evaluating SB-525 gene therapy for severe hemophilia A. Two patients demonstrated Factor III levels of 140% and 94% of normal (as measured by one-stage clotting assay) and 93% and 65% (as measured by chromogenic assay).

ADMA Biologics, Inc. (NASDAQ: ADMA) shares closed the week up 34% to $5.08 following news Monday the FDA approved Asceniv (RI-002) for the treatment of Primary Humoral Immunodeficiency Disease.

Evoke Pharma, Inc. (NASDAQ: EVOK) shares closed the week down 48% to $0.75 following news it received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for Gimoti for the relief of symptoms associated with acute and recurrent diabetic gastroparesis.

Recro Pharma, Inc. (NASDAQ: REPH) announced Thursday restructuring news which will result in the reduction of approximately 50 employees. Investors reacted positively to the news, considering its recent rejection late last month by the FDA for its New Drug Application (NDA) of intravenous (IV) meloxicam for the management of moderate to severe pain. Shares closed the week up 45% to $8.51.

Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) announced Thursday it is discontinuing development of MM-310, for the treatment of solid tumors. Shares closed Friday down 16% to $6.01.


Biotech stocks to watch at EASL 2019:

Drug Stage Catalyst Market Cap

ALBO – Albireo Pharma Inc.
Odevixibat (A4250) - PEDFIC- 1
Progressive familial intrahepatic cholestasis (PFIC)

Phase 3 Phase 3 top-line data due mid-2020.
$304.4 million

ALNY – Alnylam Pharmaceuticals Inc.
Givosiran
Acute hepatic porphyrias

PDUFA priority review PDUFA date under priority review February 4, 2020.
$9.5 billion

ALT – Altimmune Inc.
HepTCell
Hepatitis B

Phase 1 Phase 2 trial planned for 2020.
$32.5 million

ASMB – Assembly Biosciences Inc.
ABI-H0731
Hepatitis B virus (HBV)

Phase 2a Phase 2a 24-week data with with Nuc therapy due 4Q 2019.
$382.6 million

CNAT – Conatus Pharmaceuticals Inc.
Emricasan
NASH cirrhosis - ENCORE-PH trial

Phase 2 Phase 2b data released December 5, 2018 did not meet primary endpoint.
$12.1 million

ICPT – Intercept Pharmaceuticals Inc.
Ocaliva (Obeticholic acid (OCA)) - REGENERATE
Adult nonalcoholic steatohepatitis (NASH) patients.

NDA Filing NDA filing due 3Q 2019.
$2.3 billion

SBPH – Spring Bank Pharmaceuticals Inc.
Inarigivir and Vemlidy
Hepatitis B (HBV)

Phase 2 Phase 2 initial data to be presented 4Q 2019.
$62.1 million

VKTX – Viking Therapeutics Inc.
VK2809
Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease

Phase 2 Phase 2b trial to be initiated 2H 2019.
$519.9 million