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 at EHA June 24, 2017 with further data due at ASH December 10, 2017. Pivotal trials to be initiated 1H 2018.

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

Phase 3 Phase 3 initiated 2Q 2017.

AGIO
Ivosidenib
IDH1m Relapsed/Refractory AML - cancer

Phase 3 NDA filing due by end of 2017.

ALXN
ALXN1210
atypical Hemolytic Uremic Syndrome (aHUS)

Phase 3 Phase 3 enrollment to be completed early 2018; Phase 3 trial in pediatric patients has also been initiated.

MYL
MYL-1401H
Neulasta biosimilar

CRL CRL issued October 10, 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. Preliminary data due 1Q 2019.

CUR
NSI-189
Major depressive disorder

Phase 2 Phase 2 data released July 25, 2017 - primary endpoint not met.

FGEN
Pamrevlumab (FG-3019)
Idiopathic pulmonary fibrosis

Phase 2 Phase 2 data released August 7, 2017 - primary endpoint met.

FGEN
Pamrevlumab (FG-3019)
Pancreatic cancer

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

GNCA
GEN-003
Genital herpes

Announced September 25, 2017 that development will be ceased.

TCON
TRC105 (TAPPAS)
Angiosarcoma cancer

Phase 3 Phase 3 dosage of first patient announced February 16, 2017. Interim analysis 2H 2018.

VRX
Brodalumab
Psoriasis

Approved Approved February 15, 2017.

XBIT
MABp1
Hidradenitis Suppurativa (HS)

Phase 2 Phase 2 data released February 16, 2017.