Abbott's Stent Gets Panel Nod, OPXA Awaits Data In Q4, It's A Yes For SPPI

(RTTNews) - An independent panel of experts convened by the FDA has given Abbott's (ABT) 'Absorb fully bioresorbable drug eluting coronary stent' positive review, voting 9 to 0, with one abstention that the benefits outweighed its risks.

Absorb is the first fully dissolving heart stent, which dissolves completely after 2 to 3 years, once it has done its job of keeping a clogged artery open and promoting healing of the artery. By contrast, metal stents are permanent implants that restrict vessel motion by caging the artery for the life of the individual treated, noted Abbott.

The FDA's decision on the Absorb dissolving stent is expected later this year.

ABT closed Tuesday's trading at $39.90, down 1.48%.

DelMar Pharmaceuticals Inc.'s (DMPI.OB) investigational drug candidate VAL-083 has been granted orphan drug status by the FDA for the second time - this time, in the treatment of medulloblastoma. VAL-083 previously received orphan drug designation for glioblastoma in the United States and in Europe.

A phase II clinical trial of VAL-083 in refractory glioblastoma multiforme is underway, and the company anticipates top-line overall survival data from this trial in the first half of 2016.

DMPI.OB closed Tuesday's trading at $0.77, down 8.82%.

Eli Lilly and Co. (LLY) has changed the primary endpoint for its phase III study of Solanezumab in people with mild Alzheimer's dementia to include a single primary endpoint of cognition.

Previously, the study, dubbed EXPEDITION3, included co-primary endpoints of cognition and function. The study's database lock occurs in the fourth quarter of 2016, according to the company.

LLY closed Tuesday's trading at $71.24, down 3.61%.

Galectin Therapeutics Inc.'s (GALT) drug candidate GR-MD-02 is under 2 phase II studies in non-alcoholic steatohepatitis, or NASH - one in NASH with cirrhosis, dubbed NASH-CX trial, and the other in NASH with advanced fibrosis, known as NASH-FX trial.

The company expects to report top-line data from its NASH-FX trial by the end of September of this year, and top-line data from the NASH-CX trial by the end of 2017.

GALT closed Tuesday's trading at $1.34, down 11.84%.

Kindred Biosciences Inc.'s (KIN) Zimeta is one step closer to approval, now that the final major technical section of the New Animal Drug Application has been submitted. Zimeta is being developed for the control of pyrexia (fever) in horses.

KIN closed Tuesday's trading at $3.51, down 1.68%.

Opexa Therapeutics Inc. (OPXA) expects top-line results from its ongoing phase 2b trial of investigational therapy Tcelna in secondary progressive multiple sclerosis, dubbed Abili-T, early in the fourth quarter of this year.

OPXA closed Tuesday's trading at $1.96, unchanged from the previous day's close.

Genentech, a member of the Roche Group (RHHB.OB), will get to know the FDA decision regarding its Atezolizumab, an investigational cancer immunotherapy for advanced bladder cancer by September 12, 2016.

RHHBY.OB closed Tuesday's trading at $31.08, down 0.72%.

Spectrum Pharmaceuticals' (SPPI) multiple myeloma treatment Evomela, which was denied approval last October, has been green lighted by the FDA in its second go-around.

EVOMELA has been approved for use in two indications: 1) use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation (ASCT) in patients with multiple myeloma (MM), and 2) for the palliative treatment of patients with MM for whom oral therapy is not appropriate. This is the first product to be FDA-approved for the high-dose conditioning indication in MM, noted the company.

Spectrum Pharma resubmitted its Evomela NDA last November and was assigned a decision date of May 9, 2016. Tuesday's approval comes nearly 2 months ahead of the decision date.

SPPI closed Tuesday's trading at $5.71, down 2.39%.