BPC August 14 update

COVID vaccine developer CureVac CVAC debuts on NASDAQ; ​Mesoblast MESO rallies 51% on positive Adcom vote Thursday

Price and Volume Movers

Mesoblast Limited (NASDAQ:MESO) shares closed up 51% to $17.88 following Thursday’s positive vote where the FDA Oncologic Drugs Advisory Committee voted 8-2 in favor that the available data support the efficacy of Ryoncil (remestemcel-L) in pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD). The PDUFA date for a final decision by the FDA is September 30, 2020.

Novavax, Inc. (NASDAQ:NVAX) announced an agreement with the UK for the purchase of 60m doses of NVX-CoV2373, its COVID-19 vaccine, and a Phase 3 clinical trial to assess the efficacy of the vaccine in the UK population. Under the terms of the agreement, Novavax will supply 60m doses of NVX-CoV2373 to the UK beginning as early as the first quarter of 2021. Shares closed up 10% to $146.51.

CureVac (NASDAQ: CVAC), which began trading today with its Initial Public Offering (IPO), saw its shares close at $55.90, 249% above its listing price of $16. The company is in development of a COVID-19 vaccine, with data from its Phase 1 trial due next quarter.

BioXcel Therapeutics, Inc. (NASDAQ: BTAI) shares closed down 16% to $37.52 following the release of its second quarter earnings. In its pipeline update it noted data from its Tranquility trial in patients with dementia are now due in the fourth quarter of this year. Previous guidance was for data release during mid-2020.

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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:

Taiwan Liposome Company, Ltd. (TLC): $7.12; +39%.

Anchiano Therapeutics Ltd (ANCN): $1.16; +24%.

Zosano Pharma Corporation (ZSAN): $1.64; +21%.

Genprex, Inc. (GNPX): $4.29; +20%.

Merrimack Pharmaceuticals, Inc. (MACK): $4.30; +19%.

DECLINERS:

Biofrontera AG (BFRA): $16.09; -30%.

Acer Therapeutics Inc. (ACER): $3.85; -27%.

OptiNose, Inc. (OPTN): $5.29; -22%.

Equillium, Inc. (EQ): $7.24; -18%.

BioXcel Therapeutics, Inc. (BTAI): $37.52; -16%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

BPTH – Bio-Path Holdings Inc.
Prexigebersen
Solid tumors

Phase 1 Phase 1 trial to commence in 2H 2020.
$16.4 million

BTAI – BioXcel Therapeutics Inc.
BXCL501 (TRANQUILITY)
Agitation associated with dementia

Phase 1b Phase 1b data due 4Q 2020.
$1.1 billion

BTAI – BioXcel Therapeutics Inc.
BXCL701 and pembrolizumab
Advanced solid tumors

Phase 2 Phase 2 open label basket trial initial data due later in 2020.
$1.1 billion

BTAI – BioXcel Therapeutics Inc.
BXCL501 - RELEASE
Opioid Withdrawal Symptoms

Phase 1/2 Phase 1b/2 top-line data due 1Q 2021.
$1.1 billion

BTAI – BioXcel Therapeutics Inc.
BXCL501
Agitation associated with delirium (incl ICU patients with or without COVID-19)

Phase 2 Phase 2 trial to be initiated later in 2020.
$1.1 billion

CFRX – ContraFect Corporation
CF-301 exebacase
Serious infections caused byStaph aureus including MRSA

Phase 3 Phase 3 initiation of dosing announced January 10, 2020. Continues to enroll as of August 2020.
$159.3 million

CRTX – Cortexyme Inc.
COR388 - GAIN
Alzheimer’s disease

Phase 2/3 Phase 2/3 interim analysis to occur 4Q 2020. Final data due 4Q 2021.
$1.7 billion

OCGN – Ocugen, Inc.
OCU400 (AAV-NR2E3)
Retinitis Pigmentosa

Phase 1/2 Phase 1/2 trial to be initiated in 2H 2021 with data due in 2022.
$48.1 million

OTLK – Outlook Therapeutics Inc.
NORSE 1 (ONS-5010-001)
Wet age-related macular degeneration (wet AMD)

Phase 3 Phase 3 data released August 26, 2020. No statistical differences between Lucentis (ranibizumab) and ONS-5010.
$88.5 million

PLXP – PLx Pharma Inc.
VAZALORE 325 mg and 81 mg doses
Aspirin - cardiovascular and stroke patients patients

sNDA Filing sNDA filing due mid-November 2020.
$30.5 million

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

Phase 3 Phase 3 top-line data due 4Q 2020.
$59.7 million

VCNX – Vaccinex Inc.
VX15 - Signal
Huntington’s disease

Phase 2 Phase 2 top-line data due October 2020.
$113.5 million

VCNX – Vaccinex Inc.
Pepinemab (VX15/2503)
Alzheimer’s Disease (AD)

Phase 1 Phase 1 enrollment to commence September 2020.
$113.5 million

VRNA – Verona Pharma plc
Ensifentrine (RPL554) and tiotropium
Chronic obstructive pulmonary disease (COPD)

Phase 2b Phase 3 trial to be initiated 2H 2020.
$345.1 million