BPC March 23 update

Milestone MIST shares slide on late-stage trial fail; COVID-19 - ADMA shares add 36%

Price and Volume Movers

Milestone Pharmaceuticals Inc. (Nasdaq: MIST) announced that its Phase 3 trial of NODE-301, in patients with paroxysmal supraventricular tachycardia (PSVT), did not achieve its primary endpoint of time to conversion of supraventricular tachycardia (SVT) to sinus rhythm (SR) compared to placebo. Shares have slid after hours, currently trading down 76% to $3.30.

ADMA Biologics (NASDAQ: ADMA) shares closed up 36% to $3.06. The company previously received FDA Approval in April 2019 for Asceniv, a plasma based product approved for the treatment of primary humoral immunodeficiency disease. The FDA noted late last week that it is investigating using blood plasma from recovered patients to develop a treatment for COVID-19.

Eli Lilly and Company (NYSE: LLY) announced that due to the COVID-19 pandemic, it will delay most new study starts and pause enrollment in most ongoing studies. Lilly is continuing ongoing clinical trials for patients who are already enrolled. Readers should expect to see more similar announcements during the coming weeks.

Hoth Therapeutics Inc. (NASDAQ:HOTH) shares closed up normal trading hours 35% to $3.74, before announcing after hours that it intends to offer shares of its common stock in an underwritten public offering, subject to market and other conditions. Shares are trading down 6% to $3.50 after hours. The company had earlier noted it will form a joint venture with Voltron Therapeutics to commence preclinical trials for the development of vaccine prospects for COVID-19 based upon VaxCelerate, a self-assembling vaccine platform.

Baudax Bio, Inc. (Nasdaq: BXRX) announced after hours it has commenced an underwritten public offering of its common stock and warrants. Shares are trading down 18% to $3.60 after hours.

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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:

Passage Bio, Inc. (PASG): $12.06; +23%.

Cyclerion Therapeutics, Inc. (CYCN): $3.14; +19%.

Immunovant, Inc. (IMVT): $11.01; +19%.

UroGen Pharma Ltd. (URGN): $16.22; +19%.

Mersana Therapeutics, Inc. (MRSN): $5.20; +18%.

DECLINERS:

Bellerophon Therapeutics, Inc. (BLPH): $12.12; -33%.

Viela Bio, Inc. (VIE): $31.10; -30%.

Precigen, Inc. (PGEN): $2.28; -23%.

IMV Inc. (IMV): $1.40; -20%.

Alector, Inc. (ALEC): $23.81; -19%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ABBV – AbbVie Inc.
Venclexta (VIALE-A)
Acute Myeloid Leukemia (AML)

Phase 3 Phase 3 trial met dual primary endpoints of overall survival and composite complete remission rate - March 23, 2020.
$174.9 billion

ACIU – AC Immune SA
ACI-3024
Alzheimer’s disease

Phase 1 Phase 1 data due 2H 2020.
$493 million

AXLA – Axcella Health Inc.
AXA1665
Hepatic encephalopathy

Phase 2/3 Phase 2b/3 trial to be initiated 4Q 2020.
$183 million

BHVN – Biohaven Pharmaceutical Holding Company Ltd.
Vazegepant
Acute treatment of migraine

Phase 3 Phase 3 trial to be initiated mid-2020.
$4.2 billion

DMAC – DiaMedica Therapeutics Inc.
DM199 - Remedy
Acute ischaemic stroke

Phase 2 Phase 2 primary safety and tolerability endpoints met - May 13, 2020.
$101.4 million

DMAC – DiaMedica Therapeutics Inc.
DM199
Chronic Kidney Disease (African Americans)

Phase 2 Phase 2 initiation announced December 17, 2019. Enrolment has been slower than expected - noted March 23, 2020.
$101.4 million

EIGR – Eiger BioPharmaceuticals Inc.
Lonafarnib
Hutchinson-Gilford Progeria Syndrome (HGPS)

PDUFA priority review PDUFA date under priority review November 20, 2020.
$238.8 million

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

Phase 3 Phase 3 top-line data released March 23, 2020 did not meet primary endpoint.
$93.3 million

OBSV – ObsEva SA
Linzagolix OBE2109 - PRIMROSE 1
Uterine fibroids

Phase 3 Phase 3 data trial met primary endpoint - July 6, 2020. Placebo adjusted rates lower than competition.
$151.4 million

OBSV – ObsEva SA
OBE022 - PROLONG
Pre-term labor

Phase 2a Phase 2a data due 2H 2020.
$151.4 million

OBSV – ObsEva SA
Linzagolix (OBE2109)- EDELWEISS 2
Endometriosis

Phase 3 Phase 3 initiation announced May 9, 2019. New patient screening and randomization on hold due to COVID-19 - noted March 22, 2020.
$151.4 million

SLRX – Salarius Pharmaceuticals Inc.
Seclidemstat
Solid tumors

Phase 1 Phase 1 data due before the end of 2020.
$20.9 million

SLRX – Salarius Pharmaceuticals Inc.
Seclidemstat
Ewing sarcoma

Phase 1 Phase 1/2 data due 2020.
$20.9 million

STOK – Stoke Therapeutics Inc.
STK-001
Dravet syndrome

Phase 1/2 Phase 1/2 trial to be initiated 2H 2020 with data due 2021.
$764 million