BPC September 01 update

Jounce JNCE deal with Gilead GILD +56%; Athenex ATNX PDUFA February 28

Price and Volume Movers

Gilead Sciences, Inc. (NASDAQ:GILD) announced an agreement with Jounce Therapeutics, Inc. (NASDAQ:JNCE) to license JTX-1811, a monoclonal antibody designed to deplete immunosuppressive tumor-infiltrating T regulatory (TITR) cells. An Investigational New Drug (IND) application for JTX-1811 is due to be filed in 1H 2021. Gilead will make a $85m upfront payment and a $35m equity investment. Jounce is eligible for up to an additional $685m in milestone payments. Jounce shares closed up 56% to $7.53.

Athenex, Inc. (NASDAQ: ATNX) shares closed up 9% to $12.53 on news that the FDA granted priority review for its New Drug Application (NDA) for oral paclitaxel for the treatment of metastatic breast cancer. The PDUFA date is February 28, 2021.

Sanofi (NASDAQ: SNY) announced that the global Phase 3 trial investigating intravenously administered Kevzara (sarilumab) in severely or critically ill patients hospitalized with COVID-19 did not meet its primary endpoint and key secondary endpoint when Kevzara was compared to placebo added to usual hospital care.

Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT) shares closed down 11% to $44.53. The company announced in a SEC filing that it will be reducing its workforce by 25% or approximately 170 employees. The company was hit with a Complete Response Letter (CRL) by the FDA for its potential NASH treatment in June.

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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:

TRACON Pharmaceuticals, Inc. (TCON): $2.41; +28%.

Nurix Therapeutics, Inc. (NRIX): $27.27; +17%.

Plus Therapeutics, Inc. (PSTV): $2.83; +16%.

Surface Oncology, Inc. (SURF): $7.14; +10%.

Aptose Biosciences Inc. (APTO): $6.15; +10%.

DECLINERS:

Vir Biotechnology, Inc. (VIR): $33.89; -16%.

UroGen Pharma Ltd. (URGN): $21.32; -15%.

Trevi Therapeutics, Inc. (TRVI): $3.50; -13%.

Unum Therapeutics Inc. (UMRX): $2.49; -13%.

Entera Bio Ltd. (ENTX): $1.12; -13%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AKTX – Akari Therapeutics Plc
Nomacopan (Coversin)
Bullous Pemphigoid

Phase 3 Phase 3 trial to commence 1H 2021.
$58.6 million

AKTX – Akari Therapeutics Plc
Nomacopan
Hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA)

Phase 3 Phase 3 enrollment to commence 4Q 2020.
$58.6 million

ALT – Altimmune Inc.
ALT-801
Non-alcoholic steatohepatitis (NASH)

Phase 1 Phase 1 trial to be initiated in 4Q 2020.
$464.7 million

ANVS – Annovis Bio Inc.
ANVS401
Alzheimer’s disease (AD) and Parkinson’s disease (PD)

Phase 2 Phase 2 initial data due early 2021.
$36.6 million

APVO – Aptevo Therapeutics Inc.
APVO436
Acute myeloid leukemia (AML)

Phase 1 Phase 1 trial ongoing. Dosing in cohorts 1 through 6 has been completed.
$25.2 million

ARNA – Arena Pharmaceuticals Inc.
Etrasimod
Alopecia areata (AA)

Phase 2 Phase 2 commencement of dosing announced September 1, 2020 with data due in 2021.
$4.1 billion

ARPO – Aerpio Pharmaceuticals Inc.
Razuprotafib (I-SPY_COVID)
Acute Respiratory Distress Syndrome (ARDS) in COVID-19 patients

Phase 2 Phase 2 commencement of dosing announced September 1, 2020.
$63.1 million

ATNX – Athenex Inc.
Oral Paclitaxel
Metastatic breast cancer

PDUFA priority review PDUFA date under priority review February 28, 2021.
$1.2 billion

BCYC – Bicycle Therapeutics plc
THR-149 (KALAHARI)
Diabetic Macular Edema

Phase 2 Phase 2 initiation of dosing announced September 1, 2020.
$382.2 million

BMY – Bristol-Myers Squibb Company
CC-486-AML-001
AML Maintenance

Approved FDA approval announced September 1, 2020.
$133.6 billion

INMB – INmune Bio Inc.
Quellor
Immune mediated complications from COVID-19

Phase 2 Phase 2 trial planned.
$152.9 million

MIRM – Mirum Pharmaceuticals Inc.
Maralixibat
Alagille Syndrome (ALGS)

NDA Filing Rolling NDA initiation announced September 1, 2020. To be completed 1Q 2021.
$501.4 million

ORTX – Orchard Therapeutics plc
OTL-203
MPS I

Phase 1/2 Phase 1/2 primary endpoint data due 2021.
$504.5 million

REGN – Regeneron Pharmaceuticals Inc.
Kevzara (sarilumab)
Coronavirus COVID-19

Phase 3 Phase 3 global trial did not meet primary endpoint - September 1, 2020.
$59.1 billion

VRTX – Vertex Pharmaceuticals Incorporated
Elexacaftor, tezacaftor and ivacaftor
Children ages 6 to 11 years who have two F508del mutations and one F508del mutation and one minimal function mutation

PDUFA PDUFA date December 30, 2020.
$69.1 billion