BPC July 23 update

Novavax NVAX COVID-19 vaccine data due first week of August; Milestone MIST shares surge on regulatory update +167%

Price and Volume Movers

Milestone Pharmaceuticals Inc. (NASDAQ:MIST) announced an update on its Etripamil nasal spray program for patients with paroxysmal supraventricular tachycardia (PSVT) following meetings with the FDA. The company noted that the FDA indicated that its recently completed NODE-301 and ongoing NODE-301B trials could be used as two efficacy studies supporting a future NDA submission. Data from the NODE-301B trial (renamed the RAPID study) are due late-2021/early 2022. The company also announced a $25m private placement. Shares closed up 167% to $8.91.

Novavax (NASDAQ: NVAX) announced that initial data from its Phase 1/2 clinical trial of its COVID-19 vaccine candidate NVX-CoV2373, will be released during the first week of August, a slight delay from previous guidance of “late-July”.

CymaBay Therapeutics, Inc. (NASDAQ: CBAY) announced that the FDA lifted clinical holds on seladelpar for Investigational New Drug (IND) Applications in Nonalcoholic Steatohepatitis (NASH), Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC). A Phase 3 trial for PSC is planned. Shares closed up 25% to $4.39.

Arbutus Biopharma Corporation (NASDAQ: ABUS) shares spiked late in the session, reacting to a ruling from the U.S. Patent Trial and Trademark Office which denied a claim by Moderna, Inc (NASDAQ:MRNA) that a patent held by Arbutus was invalid. In a statement, Moderna said that it is not aware of any significant intellectual property impediments for any product it plans to commercialize, including mRNA-1273, its COVID-19 vaccine candidate. Arbutus shares closed up 120% to $6.20 while Moderna shares fell 9% to $75.33.

-

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

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

ADVANCERS:

Eyenovia, Inc. (EYEN): $4.24; +16%.

Tonix Pharmaceuticals Holding Corp. (TNXP): $1.51; +16%.

Entera Bio Ltd. (ENTX): $2.20; +15%.

AMAG Pharmaceuticals, Inc. (AMAG): $10.07; +15%.

Genocea Biosciences, Inc. (GNCA): $3.60; +15%.

DECLINERS:

Aurinia Pharmaceuticals Inc. (AUPH): $13.95; -16%.

BioNTech SE (BNTX): $88.51; -15%.

Aravive, Inc. (ARAV): $9.00; -13%.

DelMar Pharmaceuticals, Inc. (DMPI): $1.12; -13%.

BiondVax Pharmaceuticals Ltd. (BVXV): $40.71; -12%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AMPE – Ampio Pharmaceuticals Inc.
IV Ampion
COVID-19

Phase 1 Phase 1 commencement of enrolment announced July 23, 2020.
$145.5 million

ARAV – Aravive Inc.
AVB-500 and paclitaxel
Ovarian cancer

Phase 1b Phase 1b interim analysis due 2021.
$93.9 million

CBAY – CymaBay Therapeutics Inc.
Seladelpar
Primary biliary cholangitis (PBC)

Phase 3 Phase 3 trial met primary endpoint - August 3, 2020.
$387.1 million

CORT – Corcept Therapeutics Incorporated
Relacorilant plus Abraxane
Ovarian cancer

Phase 2 Phase 2 data due 1H 2021.
$1.5 billion

DVAX – Dynavax Technologies Corporation
CpG 1018 and Medicago candidate
COVID-19 vaccine

Phase 1 Phase 1 preliminary safety and immunogenicity results are expected in October 2020.
$758.9 million

INCY – Incyte Corporation
Ruxolitinib - REACH 3
Steroid-refractory chronic GVHD (Graft versus host disease)

Phase 3 Phase 3 trial met primary and secondary endpoints - July 23, 2020.
$20.6 billion

MIST – Milestone Pharmaceuticals Inc.
NODE-301B - RAPID
Paroxysmal supraventricular tachycardia (PSVT)

Phase 3 Data due late 2021/early 2022.
$223.6 million

MYOK – MyoKardia Inc.
Mavacamten (MYK-461) - EXPLORER-HCM
Hypertrophic cardiomyopathy (HCM)

Phase 3 Phase 3 data met endpoints - May 11, 2020. Data to be presented at ESC meeting August 29, 2020 at 6:30 CET. NDA filing due August 4, 2020.
$5.3 billion

NVAX – Novavax Inc.
NVX-CoV2373
COVID-19 vaccine

Phase 1/2 Phase 1 preliminary data released August 4, 2020. Well-tolerated and elicited robust antibody responses.
$7.3 billion

PIRS – Pieris Pharmaceuticals Inc.
PRS-343 and atezolizumab (Tecentriq)
HER2-positive solid tumors

Phase 1 Phase 1 dose escalation data to be presented at ESMO September 20, 2020, 10:32 AM EDT.
$165.6 million

VERU – Veru Inc.
Tadalafil and Finasteride combo
Benign prostatic hyperplasia (BPH)

NDA Filing NDA filing due 4Q 2020 or early 2021.
$213.4 million

VERU – Veru Inc.
VERU-111 (bisindole)
Castration Resistant Prostate Cancer

Phase 1/2 Phase 1b/2 data to be presented at ESMO September 19-21, 2020.
$213.4 million