BPC March 13 update

AERI FDA Approval +5%; Axovant AXGT offering

Price and Volume Movers

Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) announced after-hours Tuesday that the FDA approved Rocklatan 0.02%/0.005% to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Shares closed Wednesday up 5% to $47.97.

Akari Therapeutics, Plc (Nasdaq: AKTX) shares, which were in nano-cap territory prior to today, closed up 224% to $5.90 on the back of news that it will commence a pivotal trial for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA), in 4Q 2019, following pre-IND discussions with the FDA.

Axovant Sciences (Nasdaq: AXGT) announced that it has commenced an underwritten public offering of its common shares. Shares are trading down 10% to $1.58 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:

Conatus Pharmaceuticals Inc. (CNAT): $2.89; +26%.

Diffusion Pharmaceuticals Inc. (DFFN): $6.00; +23%.

Nabriva Therapeutics plc (NBRV): $2.81; +16%.

Curis, Inc. (CRIS): $1.29; +14%.

NuCana plc (NCNA): $15.08; +13%.

DECLINERS:

INSYS Therapeutics, Inc. (INSY): $4.25; -25%.

Amphastar Pharmaceuticals, Inc. (AMPH): $20.68; -14%.

Seelos Therapeutics, Inc. (SEEL): $3.30; -14%.

Fibrocell Science, Inc. (FCSC): $1.75; -14%.

Tonix Pharmaceuticals Holding Corp. (TNXP): $2.58; -13%.


Pipeline Database Updates

Drug Stage Catalyst Market Cap

AERI – Aerie Pharmaceuticals Inc.
Roclatan
Glaucoma

Approved FDA Approval announced March 12, 2019.
$2.1 billion

CORV – Correvio Pharma Corp.
Brinavess
Atrial fibrillation (AF)

NDA Filing NDA filing to be resubmitted 2Q 2019.
$121.1 million

CRNX – Crinetics Pharmaceuticals Inc.
CRN00808 - ACROBAT EVOLVE
Acromegaly

Phase 1 Phase 2 dosing of first patients announced March 19, 2019.
$542.1 million

CRNX – Crinetics Pharmaceuticals Inc.
CRN01941
Neuroendocrine tumors

Phase 1 Phase 1 trial to be initiated in 2019 with top-line data due late 2019 or early 2019.
$542.1 million

CTIC – CTI BioPharma Corp.
Pacritinib - PAC203
Myelofibrosis

Phase 2/3 Phase 2 top-line data due by the end of 2019 with Phase 3 trial to commence following meeting with FDA mid-2019.
$54.6 million

EIGR – Eiger BioPharmaceuticals Inc.
Pegylated Interferon Lambda (LIMT HDV)
Hepatitis delta virus (HDV)

Phase 2 Phase 2 LIMT postive data released October 17, 2018. Late breaker presentation at Liver Congress April 11, 4:45 pm CET.
$260.6 million

FENC – Fennec Pharmaceuticals Inc.
Pedmark (sodium thiosulfate)
Cisplatin-induced ototoxicity

NDA Filing Rolling NDA initiation announced December 20, 2018. Full NDA filing due late 2019 to early 2020.
$104.5 million

GLMD – Galmed Pharmaceuticals Ltd.
Aramchol - ARREST
Non-Alcoholic Steatohepatitis (NASH)

Phase 2b Phase 2b data released June 12, 2018 - mixed data. Pivotal trial to commence late-2Q/early 3Q 2019.
$179 million

LXRX – Lexicon Pharmaceuticals Inc.
LX9211
Neuropathic pain

Phase 1b Phase 1b trial to be initiated 1Q 2019 with top-line data due 2H 2019.
$594.6 million

MGEN – Miragen Therapeutics Inc.
MRG-110
Incisional complications

Phase 1 Phase 1 data due 2019.
$94.9 million

MGEN – Miragen Therapeutics Inc.
MRG-110
Heart failure; Cardiovascular Diseases

Phase 1 Phase 1 data due 2019.
$94.9 million

MGEN – Miragen Therapeutics Inc.
Cobomarsen - SOLAR
Cutaneous T-Cell Lymphoma/Mycosis Fungoides

Phase 2 Phase 2 trial to be initiated early 2019 with data due 2H 2020.
$94.9 million

MGEN – Miragen Therapeutics Inc.
Cobomarsen MRG-106
Chronic Lymphocytic Leukemia (CLL); Diffuse Large B-Cell Lymphoma (DLBCL); Cutaneous T-cell Lymphoma (CTCL)

Phase 1 Phase 1 additional data due 1H 2019.
$94.9 million

MGEN – Miragen Therapeutics Inc.
MRG-201 Remlarsen
Cutaneous fibrosis

Phase 2 Phase 2 data due 2H 2019.
$94.9 million

MOR – MorphoSys AG
Bendamustine + MOR208 - B-MIND
Relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL)

Phase 3 Phase 3 interim analysis 2H 2019.
$2.9 billion

MOR – MorphoSys AG
MOR202
Multiple Myeloma (MM)

Phase 2 Pivotal trial to be initiated 2019.
$2.9 billion

MOR – MorphoSys AG
MOR208
Front-line diffuse large B cell lymphoma (DLBCL)

Phase 1b Phase 1b trial to be initiated 2H 2019.
$2.9 billion

MOR – MorphoSys AG
MOR208 + idelalisib (COSMOS)
Chronic Lymphocytic Leukemia

Phase 2 Phase 2 data to be presented in 2019.
$2.9 billion

NTRP – Neurotrope Inc.
Bryostatin
Alzheimer's disease

Phase 2 Phase 2 completion of enrolment announced March 13, 2019. Top-line data due 2H 2019.
$65 million

PRTO – Proteon Therapeutics Inc.
Vonapanitase (PRT-201)
Peripheral artery disease (PAD)

Phase 1 Phase 1 enrolment to be completed by the end of 2019.
$67.4 million

PRTO – Proteon Therapeutics Inc.
Vonapanitase (PRT-201) PATENCY-2
Chronic kidney disease (CKD) patients undergoing surgical placement of an arteriovenous fistula (AVF)

Phase 3 Phase 3 data due March 2019.
$67.4 million

SLDB – Solid Biosciences Inc.
SGT-001
Duchenne Muscular Dystrophy

Phase 1/2 Phase 1/2 negative initial data released February 7, 2019. Additional data due later in 2019.
$362.7 million

SVRA – Savara Inc.
Molgradex - IMPALA
Autoimmune pulmonary alveolar proteinosis (PAP)

Phase 3 Phase 3 data due late-2Q 2019.
$282.3 million

SVRA – Savara Inc.
AeroVanc - AVAIL
MRSA in cystic fibrosis

Phase 3 Phase 3 top-line data due 2Q 2020.
$282.3 million

VCNX – Vaccinex Inc.
VX15 - Signal
Huntington’s disease

Phase 2 Phase 2 cohort A publication of data due 2H 2019 with cohort B top-line data due 2H 2020.
$56.9 million

VCNX – Vaccinex Inc.
VX15 and avelumab
Non-small cell lung cancer (NSCLC)

Phase 1/2 Phase 1/2 trial initial data due at ASCO 2019.
$56.9 million

VKTX – Viking Therapeutics Inc.
VK2809
Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease

Phase 2 Phase 2 additional NAFLD data to be presented at EASL April 11-14, 2019 with Phase 2b trial to be initiated 2H 2019.
$583.4 million