BPC January 09 update

​Axsome AXSM shares pull back 15% following two-day run

Price and Volume Movers

Axsome Therapeutics, Inc. (NASDAQ: AXSM), which saw its shares gain 238% through Monday and Tuesday, took a breather Wednesday with shares retracing 15% to $7.55.  The company announced Monday that it met the primary endpoint in its Phase 2 trial of AXS-05 for the treatment of major depressive disorder (MDD).

Atossa Genetics Inc. (NASDAQ:ATOS) shares closed up 30% to $1.60 on news that final data from its Phase 1 trial of Endoxifen for the treatment of breast health conditions in men, confirmed earlier preliminary data that the safety and tolerability objectives have been met. The stock, however, does struggle to hold on to its gains following the release of data, which in this case was very much at the lower end of price-moving data.

Sangamo Therapeutics, Inc. (NASDAQ: SGMO) shares closed down 14% to $10.99. The company made a presentation today at the J.P. Morgan Healthcare Conference, which seems to have been the catalyst for the move. The company is due to release preliminary safety and biochemical data at WORLDSymposium on February 7 from its two trials of SB-318 and SB-913 for MPS Type 1 and 2, with more meaningful data due later in 2019.

-

Major price movers (stocks priced > $1.00, volume > 50k):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume

ADVANCERS:

SELLAS Life Sciences Group, Inc. (SLS): $1.66; +26%.

AzurRx BioPharma, Inc. (AZRX): $2.21; +18%.

Fortress Biotech, Inc. (FBIO): $1.21; +15%.

Curis, Inc. (CRIS): $1.08; +15%.

Acasti Pharma Inc. (ACST): $1.05; +14%.

DECLINERS:

vTv Therapeutics Inc. (VTVT): $2.83; -9%.

Corvus Pharmaceuticals, Inc. (CRVS): $4.32; -9%.

Assembly Biosciences, Inc. (ASMB): $22.00; -9%.

ASLAN Pharmaceuticals Limited (ASLN): $4.40; -8%.

Tyme Technologies, Inc. (TYME): $2.94; -8%.

 

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ATNX – Athenex Inc.
Oraxol
Metastatic breast cancer

Phase 3 Phase 3 data due mid-2019.
$807.6 million

ATOS – Atossa Genetics Inc.
Endoxifen
Male breast cancer and Gynecomastia

Phase 1 Phase 1 preliminary data September 13, 2018 noted drug met safety and tolerability objectives. Final data January 9, 2019 confirmed objectives met.
$23.9 million

HALO – Halozyme Therapeutics Inc.
HALO-301
Pancreatic cancer

Phase 3 Phase 3 data due 2H 2019.
$2.4 billion

HALO – Halozyme Therapeutics Inc.
PEGPH20 and atezolizumab
Cholangiocarcinoma

Phase 1b Phase 1b trial ongoing. 42/70 patients have enrolled as of December 2018.
$2.4 billion

HALO – Halozyme Therapeutics Inc.
PEGPH20 and atezolizumab
Pancreatic cancer

Phase 1/2 Phase 1b/2 open label trial ongoing - noted January 9, 2019.
$2.4 billion

HALO – Halozyme Therapeutics Inc.
DARZALEX (Daratumumab) using ENHANZE
Multiple myeloma

Phase 3 Regulatory filing due 2H 2019.
$2.4 billion

MNOV – MediciNova Inc.
MN-166
Glioblastoma

Phase 2 Phase 2 initiation announced January 8, 2019.
$357.6 million

NK – NantKwest Inc.
haNK + avelumab + N-803
Merkel cell carcinoma (MCC)

Phase 2 Phase 2 initiation announced January 9, 2018.
$105.2 million

NKTR – Nektar Therapeutics
NKTR-181
Lower back pain

PDUFA PDUFA date extended three months to August 29, 2019.
$6 billion

NKTR – Nektar Therapeutics
NKTR-214 + OPDIVO (nivolumab) - PIVOT-2
Urothelial carcinoma, Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancers

Phase 1/2 Phase 1/2 updated data February 11, 2019 noted ORR to 48% (13/27) in patients with urothelial carcinoma.
$6 billion

NKTR – Nektar Therapeutics
NKTR-262 and NKTR-214 - REVEAL
Solid tumors

Phase 1/2 Phase 1/2 initial data March 1, 2019 noted ORR 2/11 ( 18%) - maximum tolerated dose has not been reached.
$6 billion

PTGX – Protagonist Therapeutics Inc.
PTG-300
Beta-thalassemia

Phase 2 Phase 2 initiation announced January 9, 2019 with initial data due 2H 2019.
$304.4 million