BPC February 06 update

​MacroGenics MGNX shares soar 130% on breast cancer data

Price and Volume Movers

MacroGenics, Inc. (NASDAQ: MGNX) shares soared to close up 130% to $25.60 following news that its Phase 3 Sophia trial of margetuximab in HER2-positive metastatic breast cancer patients, met the primary endpoint of prolongation of progression-free survival (PFS) in patients treated with the combination of margetuximab plus chemotherapy compared to Herceptin plus chemotherapy. Patients in the margetuximab arm experienced a 24% risk reduction in PFS compared to patients in the Herceptin arm (HR=0.76, p=0.033). MacroGenics anticipates submitting a Biologics License Application (BLA) in 2H 2019.

Karyopharm Therapeutics Inc. (NASDAQ: KPTI) will appear before the FDA Oncologic Drugs Advisory Committee on February 26, 2019, from 12:30 p.m. to 5 p.m, to discuss the New Drug Application (NDA) for selinexor tablets for the treatment of patients with relapsed refractory multiple myeloma who have received at least three prior therapies. 

Aeglea BioTherapeutics, Inc., (Nasdaq:AGLE) shares closed down 19% to $7.60 following the pricing of its public offering of 3.75m shares of its common stock at a price to the public of $8 per share and warrants to purchase up to 3.75m shares at a purchase price of $7.9999 per warrant. Gross proceeds are expected to be approximately $60m. 

Sanofi SA (NASDAQ: SNY) announced that the FDA has approved Cablivi in combination with plasma exchange and immunosuppression for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP) in adults.  Cablivi is the first FDA approved therapy specifically indicated for the treatment of aTTP. 

Vanda Pharmaceuticals (NASDAQ: VNDA) shares closed down 20% to $20.06 on news that it is pursuing legal action against FDA for requiring unnecessary studies that would result in the death of dozens of dogs without legal authority. The FDA previously placed a partial clinical hold on its pipeline candidate, tradipitant, and requested nonrodent animal tests. 

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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:

Neon Therapeutics, Inc. (NTGN): $5.06; +19%.

BioXcel Therapeutics, Inc. (BTAI): $7.83; +19%.

XBiotech Inc. (XBIT): $9.85; +17%.

Axovant Sciences Ltd. (AXON): $1.35; +15%.

Mustang Bio, Inc. (MBIO): $4.41; +15%.

DECLINERS:

Catabasis Pharmaceuticals, Inc. (CATB): $4.62; -24%.

Aeglea BioTherapeutics, Inc. (AGLE): $7.60; -19%.

Zynerba Pharmaceuticals, Inc. (ZYNE): $5.14; -10%.

Therapix Biosciences Ltd. (TRPX): $4.12; -8%.

Conatus Pharmaceuticals Inc. (CNAT): $2.06; -8%.

 

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AXSM – Axsome Therapeutics Inc.
AXS-07 - MOMENTUM
Migraine

Phase 3 Phase 3 trial planned for 1Q 2019. SPA received February 6, 2019.
$294.6 million

CAPR – Capricor Therapeutics Inc.
CAP-1002 HOPE-2
Duchenne Muscular Dystrophy (DMD)

Phase 2 Phase 2 HOPE-2 resumption of dosing announced February 6, 2019.
$13 million

ENTA – Enanta Pharmaceuticals Inc.
EDP-305 ARGON-1
Non-alcoholic steatohepatitis (NASH)

Phase 2 Phase 2 initial data due 3Q 2019.
$1.9 billion

ENTA – Enanta Pharmaceuticals Inc.
EDP-938
Respiratory Syncytial Virus

Phase 2 Phase 2 preliminary data due mid-2019.
$1.9 billion

EYEN – Eyenovia Inc.
MicroPine
Myopia

Phase 3 Phase 3 trial to be initiated 1H 2019.
$53.7 million

GSK – GlaxoSmithKline PLC
GSK’916 (BCMA)
Multiple myeloma

Phase 3 Phase 3 data due 2H 2019.
$100.7 billion

GSK – GlaxoSmithKline PLC
Mepolizumab - SYNAPSE
Nasal polyps

Phase 3 Phase 3 data due 1H 2020.
$100.7 billion

GSK – GlaxoSmithKline PLC
Benlysta (belimumab) and rituximab
Systemic lupus erythematosus (SLE)

Phase 3 Phase 3 data due 2H 2020.
$100.7 billion

GSK – GlaxoSmithKline PLC
Daprodustat - ASCEND-D
Anemia

Phase 3 Phase 3 data due 2H 2020.
$100.7 billion

GSK – GlaxoSmithKline PLC
TSR-042 - GARNET
Endometrial cancer

Phase 1 Phase 1 data to be presented 1H 2019.
$100.7 billion

GSK – GlaxoSmithKline PLC
Niraparib - PRIMA
First-line ovarian cancer

Phase 3 Phase 3 data due 2H 2019.
$100.7 billion

GSK – GlaxoSmithKline PLC
Mepolizumab
Severe hypereosinophilic syndrome (HES)

Phase 3 Phase 3 data due 2H 2020.
$100.7 billion

IFRX – InflaRx N.V.
IFX-1
Hidradenitis Suppurativa

Phase 2b Phase 2b data due 2Q 2019.
$831.3 million

KMDA – Kamada Ltd.
Alpha-1 antitrypsin (AAT)
Prevention of lung transplant rejection

Phase 1/2 Phase 2 top-line data due 2H 2019.
$242.4 million

KPTI – Karyopharm Therapeutics Inc.
Selinexor
Quadruple Refractory Multiple Myeloma

PDUFA priority review PDUFA date under priority review April 6, 2019. Advisory Committee Meeting February 26, 2019 - 12:30pm. Briefing notes released February 22, 2019.
$307.8 million

LLY – Eli Lilly and Company
Ramucirumab
Non-small cell lung cancer

Phase 3 Phase 3 PFS readout due 2019.
$128.4 billion

LLY – Eli Lilly and Company
Tanezumab
Chronic low back pain

Phase 3 Phase 3 data released February 19, 2019. 10mg dose met primary endpoint. 5mg dose did not meet endpoint.
$128.4 billion

LLY – Eli Lilly and Company
Taltz (Ixekizumab)
Psoriasis

Phase 3 Phase 3 data due 2019.
$128.4 billion

LLY – Eli Lilly and Company
Taltz (Ixekizumab)
Non-radiographic axial spondyloarthritis

Phase 3 Phase 3 data due 2019.
$128.4 billion

LLY – Eli Lilly and Company
Tradjenta (linagliptin) - CAROLINA CV outcomes
Type 2 Diabetes

Phase 3 Phase 3 trial met primary endpoint of non-inferiority.
$128.4 billion

MGNX – MacroGenics Inc.
Margetuximab SOPHIA study
Metastatic breast cancer

Phase 3 Phase 3 data released February 6, 2019 met primary endpoint. BLA filing due 2H 2019.
$896.3 million

ORTX – Orchard Therapeutics plc
OTL-102
X-linked chronic granulomatous disease (X-CGD)

Phase 1/2 Phase 1/2 data to be presented February 24, 2019 12 noon CT.
$1.3 billion

ORTX – Orchard Therapeutics plc
OTL-101
Adenosine deaminase severe combined immunodeficiency (ADA-SCID)

Phase 1/2 Phase 1/2 data to be presented February 22, 2019 9:30a.m. CT.
$1.3 billion

REGN – Regeneron Pharmaceuticals Inc.
Evinacumab (ANGPTL3 Antibody)
Homozygous familial hypercholesterolemia (HoFH)

Phase 3 Phase 3 data due 2019.
$46.2 billion

REGN – Regeneron Pharmaceuticals Inc.
Dupixent (dupilumab)
Atopic dermatitis 6-11 year-olds

Phase 3 Phase 3 data due 4Q 2019.
$46.2 billion

RNN – Rexahn Pharmaceuticals Inc.
RX-3117
Bladder cancer

Phase 2a Phase 2a updated preliminary data presented at ASCO GU February 15, 2019. 1/31 ORR/CR.
$25.9 million

SNY – Sanofi
Caplacizumab
Acquired thrombotic thrombocytopenic purpura (aTTP)

Approved FDA Approval announced February 6, 2019.
$102.2 billion

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

Phase 3 Phase 3 top-line data due 2Q 2020.
$237.5 million

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

Phase 3 Phase 3 data due 2Q 2019.
$237.5 million

TBPH – Theravance Biopharma Inc.
Closed Triple - CAPTAIN
Asthma

Phase 3 Phase 3 data due 1H 2019.
$1.4 billion

VXRT – Vaxart Inc.
Norovirus vaccine
Norovirus

Phase 1 Phase 2 trial to be initiated 1H 2019.
$13.5 million

ZGNX – Zogenix Inc.
FINTEPLA (ZX008)
Dravet syndrom

NDA Filing Completion of rolling NDA submission announced February 6, 2019.
$2.1 billion