BPC February 07 update

Kitov (KTOV) trading halted as investigation commences; Gilead (GILD) shares fall on poor earnings release; Flexion (FLXN) PDUFA date set for October

Price and Volume Movers

Trading of Kitov Pharmaceuticals Holdings Ltd. (Nasdaq:KTOV) was halted today by NASDAQ as "additional information was requested” from the company. The halt was enforced just before the opening of the trading session. Shares had dropped 27% to $1.85 in pre-market trading prior to the halt. The company announced following the trading halt that the Israeli Securities Authority has begun a formal investigation into its public disclosures around its lead drug candidate, KIT-302.

Gilead Sciences Inc. (NASDAQ: GILD) shares have dropped over 5% in the after-hours session to $69.15. Investors sold off shares of Gilead following disappointing earnings guidance issued after the bell. 4Q earnings fell from $4.7b to $3.1b, reflecting significantly lower sales of its Hepatitis C drugs Harvoni and Sovaldi. The company expects 2017 net product sales of $22.5b to $24.5b, well below analyst estimates.

Coherus BioSciences, Inc. (Nasdaq:CHRS) announced it has commenced an underwritten public offering of $125m of shares of its common stock. Shares are currently down 6% to $25 in the after-hours session.

Galena Biopharma, Inc. (NASDAQ:GALE) announced it has commenced an underwritten public offering to issue and sell shares of its common stock and warrants to purchase shares of its common stock. Shares have fallen 15% to 1.19 in the after-hours session.

Other major movers:


Acura Pharmaceuticals, Inc.(NASDAQ:ACUR): $1.62; +130%.

MYOS RENS Technology Inc (NASDAQ:MYOS): $4.72; +31%.

Benitec Biopharma Ltd (ADR) (NASDAQ:BNTC): $3.06; +23%.

Catalyst Biosciences Inc (NASDAQ:CBIO): $0.587; +20%.

Concordia International Corp (NASDAQ:CXRX): $3.49; +18%.


Delcath Systems, Inc (NASDAQ:DCTH): $0.251; -17%.

Dimension Therapeutics Inc (NASDAQ:DMTX): $1.65; -13%.

Moleculin Biotech Inc (NASDAQ:MBRX): $1.80; -10%.

Minerva Neurosciences Inc (NASDAQ:NERV): $10.15; -7%.

Alcobra Ltd (NASDAQ:ADHD): $1.21; -7%.


Full pipeline updates:

Pipeline Database Updates

Drug Stage Catalyst

Allergic conjunctivitis

Phase 2b Phase 2b enrollment initiation announced February 7, 2017. Data due 2H 2017.

Secondary hyperparathyroidism (SHPT)

Approved Approved February 7, 2017.

Zilretta - FX006
Osteoarthritis of the knee

PDUFA PDUFA date October 6, 2017.

Gemcabene - AZURE-1
Nonalcoholic steatohepatitis (NASH) / Nonalcoholic fatty liver disease (NAFLD)

Phase 2 Phase 2 trial to be initiated in 2H 2017.

GWP42006 (CBDV)

Phase 2 Phase 2 initiated May 2015. Data due 2H 2017.

Dravet Syndrome

Phase 3 Top line Phase 3 data released March 2016 met primary endpoint. NDA Filing due mid-2017.

Lennox-Gastaut syndrome (LGS)

Phase 3 First Phase 3 trial data released June 2016. Data from second Phase 3 trial also met endpoint - September 2016. NDA filing due mid 2017.

Tetrahydrocannabinol (THC) and cannabidiol (CBD)
Glioblastoma Multiform- cancer

Phase 2 Phase 2 data released February 7, 2017.

Tuberous Sclerosis Complex

Phase 3 Phase 3 trial ongoing as of February 7, 2017.

GWP42006 (CBDV)

Phase 2 Phase 2 trials to be initiated 2H 2017.