BPC June 19 update

Evoke EVOK receives FDA Approval - shares +61% AH

Price and Volume Movers

Evoke Pharma, Inc. (NASDAQ: EVOK) announced that the FDA approved the New Drug Application (NDA) for Gimoti (metoclopramide) nasal spray, the first and nasally-administered product indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Shares are currently trading up 61% to $3.79 after hours.

Acasti Pharma Inc. (NASDAQ: ACST) announced that the FDA has confirmed that its second Phase 3 TRILOGY 2 trial of CaPre, for the treatment of severe hypertriglyceridemia, will need to be performed on the full Intent to Treat (ITT) population. Depending on the outcome of TRILOGY 2, an additional clinical study may still be needed prior to an NDA submission. Its first trial, TRILOGY 1, failed to meet its primary endpoint. An update with its plan for the unblinding and reporting of the TRILOGY 2 results will be discussed during its earnings call on June 29. Shares closed down 19% to $0.73.

-

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

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

ADVANCERS:

Celldex Therapeutics, Inc. (CLDX): $13.41; +29%.

Mereo BioPharma Group plc (MREO): $3.40; +24%.

Strongbridge Biopharma plc (SBBP): $4.40; +22%.

DiaMedica Therapeutics Inc. (DMAC): $7.32; +22%.

Immuron Limited (IMRN): $9.38; +21%.

DECLINERS:

Athersys, Inc. (ATHX): $1.97; -31%.

BeyondSpring Inc. (BYSI): $13.55; -18%.

Ayala Pharmaceuticals, Inc. (AYLA): $10.67; -18%.

Rexahn Pharmaceuticals, Inc. (REXN): $2.98; -15%.

VIVUS, Inc. (VVUS): $1.04; -10%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AMPE – Ampio Pharmaceuticals Inc.
IV Ampion
COVID-19

Phase 1 Phase 1 trial to be initiated.
$108.8 million

DVAX – Dynavax Technologies Corporation
SCB-2019 + adjuvant system
COVID-19 vaccine

Phase 1 Phase 1 initiation announced June 19, 2020 with preliminary safety and immunogenicity data due August 2020.
$943.3 million

EVOK – Evoke Pharma Inc.
Gimoti - EVK-001
Diabetic gastroparesis

Approved FDA Approval announced June 19, 2020.
$91.9 million

NYMX – Nymox Pharmaceutical Corporation
NX-1207 Fexapotide
BPH

NDA Filing NDA filing planned for late-3Q / early-4Q 2020.
$262.5 million

QURE – uniQure N.V.
AMT-130
Huntington's disease

Phase 1/2 Phase 1/2 commencement of dosing announced June 19, 2020.
$2 billion

RHHBY – Roche Holding Ltd ADR (Sponsored)
Ipatasertib - IPATential150
Castration-resistant prostate cancer

Phase 3 Phase 3 data met one of two co-primary endpoints - June 19, 2020.
$299.8 billion

SGEN – Seattle Genetics Inc.
GSK’916 - belantamab mafodotin (BCMA)
Multiple myeloma

PDUFA priority review PDUFA date under priority review granted January 21, 2020. Oncologic Drugs Advisory Committee (ODAC) meeting July 14, 2020.
$29.3 billion

VERU – Veru Inc.
Zuclomiphene citrate
Hot flashes

Phase 2 Phase 3 trial to commence late-2020.
$234.7 million

VERU – Veru Inc.
VERU-100
Prostate cancer

Phase 2 Phase 2 trial to be initiated 3Q 2020.
$234.7 million

VERU – Veru Inc.
VERU-111
COVID-19 / Severe Acute Respiratory Syndrome

Phase 2 Phase 2 commencement of enrolment announced June 19, 2020.
$234.7 million