BPC August 28 update

​AstraZeneca AZN delivers further positive late-stage data

Price and Volume Movers

AstraZeneca (NYSE: AZN) announced that its Phase 3 ETHOS trial for triple-combination therapy Breztri Aerosphere, in patients with moderate to very severe chronic obstructive pulmonary disease (COPD), met the primary endpoint. The treatment demonstrated a statistically-significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies Bevespi Aerosphere and PT009.

Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) announced that Janssen Pharmaceuticals, has begun dosing in a Phase 2b trial (REEF-1) of JNJ-3989 (formerly ARO-HBV), and/or JNJ-6379, for the treatment of chronic hepatitis B virus infection, earning Arrowhead a $25m milestone payment from Janssen. Shares closed up 4% to $34.36.

Intec Pharma Ltd. (NASDAQ: NTEC) shares closed up 31% to $0.68 following notification of the purchase of 100,000 shares of the company's stock by its CEO.

-

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

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

ADVANCERS:

Plus Therapeutics, Inc. (PSTV): $19.25; +29%.

Outlook Therapeutics, Inc. (OTLK): $1.60; +21%.

PhaseBio Pharmaceuticals, Inc. (PHAS): $9.44; +17%.

Nabriva Therapeutics plc (NBRV): $2.10; +17%.

scPharmaceuticals Inc. (SCPH): $6.14; +11%.

DECLINERS:

Neoleukin Therapeutics, Inc. (NLTX): $3.12; -8%.

Seres Therapeutics, Inc. (MCRB): $3.87; -7%.

Milestone Pharmaceuticals Inc. (MIST): $22.08; -6%.

Endo International plc (ENDP): $2.41; -5%.

Capricor Therapeutics, Inc. (CAPR): $2.44; -5%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ARWR – Arrowhead Pharmaceuticals Inc.
ARO-HBV / JNJ-3989
Hepatitis B (HBV)

Phase 2b Phase 2b initiation announced August 28, 2019.
$2.8 billion

ASND – Ascendis Pharma A/S
TransCon hGH
Growth hormone deficiency in children

BLA Filing BLA filing due 1H 2020.
$5 billion

ASND – Ascendis Pharma A/S
TransCon
Hypoparathyroidism

Phase 2 Phase 2 top-line data due 4Q 2019.
$5 billion

ASND – Ascendis Pharma A/S
TransCon CNP - ACcomplisH
Achondroplasia

Phase 2 Phase 2 trial has been initiated.
$5 billion

AZN – Astrazeneca PLC
Breztri - (ETHOS)
Chronic obstructive pulmonary disease (COPD)

Phase 3 Phase 3 data released August 28, 2019. Primary endpoint met.
$116.9 billion

MIRM – Mirum Pharmaceuticals Inc - Ordinary Shares
Maralixibat - MARCH
Progressive Familial Intrahepatic Cholestasis (PFIC)

Phase 3 Phase 3 data due by the end of 2020.
$214.7 million

SNGX – Soligenix Inc.
SGX942 (dusquetide)
Oral Mucositis in Patients with Head & Neck Cancer

Phase 3 Phase 3 interim analysis August 28, 2019 noted DMC recommended trial to continue with top-line data due 1H 2020.
$18.9 million

TRVN – Trevena Inc.
Oliceridine (TRV130)
Moderate to severe acute pain

NDA Filing CRL issued November 2, 2018. QT interval data data due 4Q 2019, with NDA to be resubmitted 1Q 2020.
$93.5 million