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 data released June 14 2017 - primary endpoint not met. However, Phase 3 trial is planned for 1H 2018 with data due 2H 2018.

Secondary hyperparathyroidism (SHPT)

Approved Approved February 7, 2017.

Zilretta - FX006
Osteoarthritis of the knee

Approved Approval announced October 6, 2017.

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

Phase 2 Phase 2 trial to be initiated in 4Q 2017 with data due 2H 2018.

GWP42006 (CBDV)

Phase 2 Phase 2 initiated May 2015. Data due late 2017 or early 2018.

Dravet Syndrome

NDA Filing Top line Phase 3 data released March 2016 met primary endpoint. NDA submission announced October 30, 2017.

Lennox-Gastaut syndrome (LGS)

NDA Filing First Phase 3 trial data released June 2016. Data from second Phase 3 trial also met endpoint - September 2016. NDA submission announced October 30, 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 data due 2018.

GWP42006 (CBDV)
Rett syndrome

Phase 2 Phase 2 trials to be initiated 1H 2018.