GALT In A Fix, SHPG Ends Biosimilar Deals, KTOV Moves Closer To File KIT-302 NDA

(RTTNews) - Shares of Galectin Therapeutics Inc. (GALT) were down nearly 50% in extended trading on Tuesday as its phase IIa trial of GR-MD-02 in nonalcoholic steatohepatitis patients with advanced fibrosis failed to meet the study goals.

The trial, dubbed NASH-FX, did not meet its primary biomarker endpoint as measured by LiverMultiScan, a magnetic resonance imaging test that evaluates inflammation and fibrosis, as well as its secondary endpoints that measure liver stiffness as a surrogate for fibrosis, with FibroScan and magnetic resonance elastography.

Meanwhile, a larger phase IIb clinical trial of GR-MD-02 in NASH cirrhosis, dubbed NASH-CX, is now completely enrolled, and top-line results are expected in December 2017.

GALT closed Tuesday's trading at $2.47, down 1.98%. In after-hours, the stock plunged 49.80% to $1.24.

Actinium Pharmaceuticals Inc. (ATNM) has initiated a phase II clinical trial of Actimab-A in elderly patients newly diagnosed with Acute Myeloid Leukemia, aged over 60.

The study will enroll 53 patients, and results are expected in 2017.

ATNM closed Tuesday's trading at $1.70, down 15.00%.

Shares of Kitov Pharmaceuticals Holdings LTD (KTOV) were up over 10% on Tuesday, following the successful completion of an additional pharmacokinetic bioequivalence study by its lead drug candidate KIT-302.

KIT-302, intended to treat pain caused by osteoarthritis as well as simultaneously treat hypertension, is a combination of approved Celebrex and Amlodipine. Celebrex is the only COX-2 selective NSAID approved in U.S., and Amlodipine is a well-known anti-hypertensive.

Kitov's previous pharmacokinetic bioequivalence study results for KIT-302 were announced in May of this year.

The company expects to file the NDA for KIT-302 within the coming months.

KTOV closed Tuesday's trading at $3.62, up 10.70%.

Shire plc (SHPG) is returning the rights to two biosimilar candidates namely, CHS-0214 and M923D to their respective owners - i.e. to Coherus BioSciences (CHRS) and Momenta Pharmaceuticals Inc. (MNTA), respectively.

CHS-0214 is a biosimilar candidate to Enbrel while M923 is a proposed biosimilar of Humira.

CHS-0214 and M923 came under Shire's fold following its June 2016 acquisition of Baxalta Inc.

Momenta expects to report top-line results from a phase III trial of M923 in late 2016 while Coherus remains on track to submit a Marketing Authorization Application for CHS-0214 to the European Medicines Agency in the fourth quarter of 2016.

SHPG closed Tuesday's trading at $200.22, up 0.57%.