BPC February 16 update

FDA approves brodalumab ​(Valeant VRX); Neuralstem (CUR) +19% following trial update - MDD data now due 3Q

Price and Volume Movers

Valeant Pharmaceuticals International, Inc. (NYSE: VRX) announced that the FDA has approved its Biologics License Application (BLA) for SILIQ (brodalumab) injection, for subcutaneous use, in patients with moderate-to-severe plaque psoriasis. As expected, a black box warning for the risks in patients with a history of suicidal thoughts or behaviour was included. Shares of the company closed down 3.8% to $16.22.

Neuralstem, Inc. (Nasdaq:CUR) provided an update today regarding its Phase 2 clinical trial of NSI-189 for the treatment of major depressive disorder (MDD). Enrollment of the final patient has been completed and data are now due in 3Q 2017. Shares spiked to over $4 in early trading before settling down to close up 19% to $3.77.

Evoke Pharma (NASDAQ: EVOK) announced the pricing of its public offering of 2.41m common shares priced at $2.90 per share. Shares closed down 12% to $2.99.


Other major price movers:

ADVANCERS:

X T L Biopharmaceuticals Ltd (NASDAQ:XTLB): $3.88; +19%.

Crispr Therapeutics AG (NASDAQ:CRSP): $18.49; +16%.

Peregrine Pharmaceuticals (NASDAQ:PPHM): $0.443; +15%.

ContraFect Corp (NASDAQ:CFRX): $2.00; +14%.

Albireo Pharma, Inc. (NASDAQ:ALBO): $22.59; +11%


DECLINERS:

Anavex Life Sciences Corp (NASDAQ:AVXL): $5.44; -12%.

Genocea Biosciences Inc (NASDAQ:GNCA): $4.44; -10%.

OHR Pharmaceutical Inc (NASDAQ:OHRP): $0.95; -10%.

Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN): $4.27; -9%.

Moleculin Biotech Inc (NASDAQ:MBRX): $1.21; -9%.

 

Full pipeline updates:

Pipeline Database Updates

Drug Stage Catalyst

AGIO
AG-348
Pyruvate kinase deficiency

Phase 2 Phase 2 first data released at EHA meeting June 2016. Updated data due 2H 2017. Pivotal trial design update due 3Q 2017.

AGIO
AG-120 and VIDAZA
Frontline Acute myeloid leukemia (AML) harboring an IDH1 mutation - cancer

Phase 3 Phase 3 to be initiated 1H 2017

AGIO
AG-120
IDH1m Relapsed/Refractory AML - cancer

NDA Filing NDA filing due by end of 2017.

ALXN
ALXN1210
atypical Hemolytic Uremic Syndrome (aHUS)

Phase 3 Phase 3 enrollment to be completed 2017; expects to initiate a Phase 3 trial in pediatric patients 2Q 2017.

MYL
MYL-1401H
Neulasta biosimilar

PDUFA PDUFA date October 9, 2017.

CLSD
Suprachoroidal CLS-TA - SAPPHIRE
Macular edema associated with retinal vein occlusion (RVO)

Phase 3 Announced enrollment of the first patient in its Phase 3 trial - February 16, 2017.

CUR
NSI-189
Major depressive disorder

Phase 2 Phase 2 data are due 3Q 2017.

FGEN
Pamrevlumab (FG-3019)
Idiopathic pulmonary fibrosis

Phase 2 Phase 2 data due 3Q 2017.

FGEN
Pamrevlumab (FG-3019)
Pancreatic cancer

Phase 2 Phase 2 ongoing. Data due late 2017 or 1Q 2018.

GNCA
GEN-003
Genital herpes

Phase 2b Phase 2b data released January 6, 2017. 12-month data due 2H 2017. Phase 3 to commence 4Q 2017.

TCON
TRC105 (TAPPAS)
Angiosarcoma cancer

Phase 3 Phase 3 dosage of first patient announced February 16, 2017.

VRX
Brodalumab
Psoriasis

Approved Approved February 15, 2017.

XBIT
MABp1
Hidradenitis Suppurativa (HS)

Phase 2 Phase 2 data released February 16, 2017.