BPC July 21 update

Mesoblast MESO Advisory Committee meeting set for August 13

Price and Volume Movers

Mesoblast Limited (NASDAQ:MESO) announced that the FDA Oncologic Drugs Advisory Committee (ODAC) has scheduled a meeting on August 13, 2020 to review data supporting the Biologics License Application (BLA) for Ryoncil (remestemcel-L) for the treatment of steroid-refractory acute graft versus host disease (SR-aGVHD) in children. The PDUFA date is slated for September 30, 2020.

Immuron Limited (NASDAQ:IMRN) shares closed up 42% to $14.81 following a press release regarding its in-vitro (laboratory) testing of IMM-124E demonstrated neutralizing activity against SARS-CoV-2. It also followed up with news of a registered direct offering of 1,066,668 American Depositary Shares ("ADSs"), for gross proceeds of $20m.

Miragen Therapeutics (NASDAQ:MGEN) shares closed up 9% to $1.11 following the initiation of analyst coverage by Brookline with a Buy rating and $6 price target.

CASI Pharmaceuticals, Inc. (NASDAQ:CASI) announced after hours that it has commenced an underwritten public offering of its common stock. Shares are trading down 10% after hours to $2.23.

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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:

Novan, Inc. (NOVN): $1.23; +78%

DelMar Pharmaceuticals, Inc. (DMPI): $1.40; +42%.

Onconova Therapeutics, Inc. (ONTX): $1.39; +28%.

Auris Medical Holding Ltd. (EARS): $1.17; +27%.

Moleculin Biotech, Inc. (MBRX): $1.33; +21%.

DECLINERS:

ACADIA Pharmaceuticals Inc. (ACAD): $44.69; -19%.

Heat Biologics, Inc. (HTBX): $3.02; -17%.

Dynavax Technologies Corporation (DVAX): $10.22; -13%.

Denali Therapeutics Inc. (DNLI): $24.70; -13%.

Progenity, Inc. (PROG): $9.05; -12%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ABBV – AbbVie Inc.
Upadacitinib
Atopic dermatitis

Phase 3 Phase 3 data met co-primary endpoints - June 18, 2020. Second Phase 3 trial also met primary endpoint - July 21, 2020.
$167.7 billion

ALEC – Alector Inc.
AL001
Frontotemporal Dementia

Phase 3 Phase 3 commencement of dosing announced July 24, 2020.
$1.1 billion

ARCT – Arcturus Therapeutics Holdings Inc.
LUNAR-COV19
COVID-19 vaccine

Phase 1 Phase 1 initiation announced August 11, 2020 with initial data due 4Q 2020.
$1.2 billion

AUPH – Aurinia Pharmaceuticals Inc
Voclosporin - AURORA
Lupus

PDUFA priority review PDUFA date under priority review of January 22, 2021
$1.8 billion

BHVN – Biohaven Pharmaceutical Holding Company Ltd.
Verdiperstat
Multiple system atrophy (MSA)

Phase 3 Phase 3 top-line data due 4Q 2021.
$3.5 billion

CERC – Cerecor Inc.
CERC-002
COVID-19 induced Acute Respiratory Distress Syndrome (ARDS)

Phase 2 Phase 2 commencement of enrolment announced July 21, 2020 with data due 4Q 2020.
$200.3 million

CYDY – CytoDyn Inc
Leronlimab
COVID-19 (Mild to Moderate)

Phase 2 Phase 2 data released August 11, 2020 did not report primary endpoint data (TCSS at Day 14). Day 3 subgroup showed clinical improvement but not mentioned to be statistically significant. Secondary NEWS2 was met. No data on other secondary endpoints.
$2.3 billion

IFRX – InflaRx N.V.
IFX-1
COVID-19

Phase 3 Phase 3 trial to be initiated in the coming months - noted July 21, 2020.
$112.5 million

IRWD – Ironwood Pharmaceuticals Inc.
IW-3718
Gastroesophageal reflux disease (GERD)

Phase 3 Phase 3 interim analysis due 4Q 2020. Top-line data due 1H 2021.
$1.6 billion

MESO – Mesoblast Limited
Remestemcel-L (MSC-100-IV)
acute graft versus host disease (aGVHD) in children

PDUFA priority review PDUFA date under priority review September 30, 2020. FDA Oncologic Drugs Advisory Committee meeting scheduled for August 13, 2020.
$1.4 billion

NMTR – 9 Meters Biopharma Inc.
NM-002
Short bowel syndrome

Phase 1/2 Phase 1b/2a top-line data due 1H 2021.
$66.4 million

NVS – Novartis AG
Kisqali - MONALEESA-2
Breast cancer

Phase 3 Phase 3 overall survival data due 2021.
$194 billion

NVS – Novartis AG
Lu-PSMA-617
Metastatic castration-resistant prostate cancer (mCRPC)

Phase 3 Phase 3 data due 1H 2021.
$194 billion

PSTI – Pluristem Therapeutics Inc.
PLX-PAD (stem cells)
Critical limb ischemia (CLI)

Phase 3 Phase 3 data due 4Q 2020.
$226 million