BPC June 22 update

​Myovant MYOV Phase 3 data to be released pre-market Tuesday; Karyopharm KPTI FDA Approval

Price and Volume Movers

Evoke Pharma, Inc. (NASDAQ: EVOK) shares closed up 62% to $3.80. The company announced on Friday that the FDA approved the New Drug Application (NDA) for Gimoti (metoclopramide) nasal spray, for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.

Myovant Sciences (NYSE:MYOV) announced that it will host a conference call to discuss top-line data from the Phase 3 SPIRIT 1 trial of once-daily relugolix combination therapy in women with pain associated with endometriosis. The call will be held on Tuesday June 23 at 8:30am EST. The company also announced that its New Drug Application (NDA) for once-daily, oral relugolix for the treatment of men with advanced prostate cancer has been accepted for Priority Review by the FDA. The PDUFA date is December 20, 2020.

Five Prime Therapeutics, Inc. (NASDAQ:FPRX) shares closed up 45% to $6.39. Analysts at Wedbush upgraded their rating of the stock from Neutral to Outperform and raised their price target from $5 to $9.

Karyopharm Therapeutics Inc. (Nasdaq:KPTI) announced that the FDA approved oral Xpovio (selinexor), for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Evelo Biosciences, Inc. (NASDAQ: EVLO) shares closed up 18% to $4.42 on news it will be moving EDP1815 into a Phase 2/3 trial for the treatment of patients with COVID-19.

Celsion Corporation (NASDAQ:CLSN) announced an offering of 2,666,667 shares of its common stock at a price of $3.75 per share, for gross proceeds of $10m. Shares closed down 20% to $4.19.

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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:

NantKwest, Inc. (NK): $11.13; +26%.

Athersys, Inc. (ATHX): $2.47; +25%.

Lipocine Inc. (LPCN): $1.14; +19%.

Atossa Therapeutics, Inc. (ATOS): $3.65; +15%.

MannKind Corporation (MNKD): $2.21; +15%.

DECLINERS:

Crinetics Pharmaceuticals, Inc. (CRNX): $19.26; -17%.

Millendo Therapeutics, Inc. (MLND): $2.40; -13%.

Tiziana Life Sciences PLC (TLSA): $6.09; -10%.

Protara Therapeutics, Inc. (TARA): $31.63; -10%.

MediWound Ltd. (MDWD): $2.46; -10%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ABBV – AbbVie Inc.
Botox
Neurogenic Detrusor Overactivity

PDUFA sBLA filing accepted June 22, 2020. PDUFA date 1Q 2021.
$174.3 billion

ARQT – Arcutis Biotherapeutics Inc.
ARQ-154
Seborrheic dermatitis

Phase 2 Phase 2 completion of enrolment announced June 22, 2020 with data due 4Q 2020.
$1.2 billion

AUPH – Aurinia Pharmaceuticals Inc
Voclosporin ophthalmic solution (VOS) - AUDREY
Dry eye syndrome

Phase 2/3 Phase 2/3 data due 4Q 2020.
$1.8 billion

BNTX – BioNTech SE
BNT122
Solid tumors

Phase 1/2 Phase 1 data noted ORR of 8% - June 22, 2020.
$14.3 billion

CRBP – Corbus Pharmaceuticals Holdings Inc.
Lenabasum
Cystic Fibrosis

Phase 2b Phase 2b data due 3Q 2020.
$576.3 million

EVLO – Evelo Biosciences Inc.
EDP1815 - TACTIC-E
COVID-19

Phase 2/3 Phase 2/3 interim data due 4Q 2020.
$162.6 million

KPTI – Karyopharm Therapeutics Inc.
Selinexor
Diffuse Large B-Cell Lymphoma (DLBCL)

Approved FDA Approval announced June 22, 2020.
$1.4 billion

MYOV – Myovant Sciences Ltd.
Relugolix - HERO
Advanced prostate cancer

PDUFA priority review PDUFA date under priority review December 20, 2020.
$1.8 billion

MYOV – Myovant Sciences Ltd.
Relugolix - SPIRIT 1
Endometriosis-associated pain

Phase 3 Phase 3 data met co-primary endpoints June 23, 2020.
$1.8 billion

ONTX – Onconova Therapeutics Inc.
Rigosertib and Nivolumab
KRAS+ Lung Adenocarcinoma

Phase 1/2 Phase 1/2a initiation announced June 22, 2020.
$97.7 million

PFE – Pfizer Inc.
Pneumococcal polysaccharide conjugate vaccine
Pneumococcal Disease

Phase 3 Phase 3 initiation announced June 22, 2020.
$191.7 billion

PFNX – Pfenex Inc.
PCV-15 (V114)
Pneumococcal disease

Phase 3 Phase 3 trial met safety and immunogenicity objectives - June 22, 2020.
$285.3 million

SWTX – SpringWorks Therapeutics Inc.
Nirogacestat and Belantamab
Multiple Myeloma

Phase 1b Phase 1b commencement of dosing announced June 22, 2020.
$1.7 billion

ZIOP – ZIOPHARM Oncology Inc
Ad-RTS-hIL-12 plus veledimex plus Libtayo
Refractory glioblastoma multiforme (GBM)

Phase 2 Phase 2 completion of enrolment announced June 22, 2020.
$694.3 million