JUNO Implodes As ROCKET Is Put On Hold Again, LLY's Expedition Fails

(RTTNews) - Cascadian Therapeutics Inc. (CASC) is all set to implement a 1-for-6 reverse stock split on November 29, 2016. A proposal authorizing the board of directors of the company to effect a reduction in the number of authorized shares of common stock from 200.0 million shares to 66.7 million shares has also been approved by the stockholders.

The company believes that the above two actions will make its stock more attractive to a wider range of institutional investors, benefiting all stockholders.

Cascadian's most advanced drug candidate is Tucatinib, which is under a phase II trial in women with HER2+ breast cancer. The trial is expected to enroll approximately 180 patients, and its primary endpoint is progression free survival.

CASC closed Wednesday's trading at $1.04, down 2.80%.

Shares of Eli Lilly & Co. (LLY) were down 10% on Thursday, following the failure of its phase III study of Solanezumab in people with mild dementia due to Alzheimer's disease.

In the trial, known as EXPEDITION3, patients treated with Solanezumab did not experience a statistically significant slowing in cognitive decline compared to patients treated with placebo.

Lilly has thrown in the towel on developing Solanezumab for the treatment of mild dementia due to Alzheimer's disease and is not going to pursue regulatory submissions for the same.

The EXPEDITION3 study outcome is expected to result in a fourth-quarter charge of about $150 million (pre-tax), or approximately $0.09 per share (after-tax), according to the company.

LLY closed Wednesday's trading at $68.00, down 10.51%.

Shares of Juno Therapeutics Inc (JUNO) plunged over 24% on Wednesday after it put on hold its phase II trial of JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia following two patient deaths.

This is for the second time this year that the phase II trial, dubbed "ROCKET", has been disrupted. On July 7, 2016, the FDA placed a hold on the trial after three patients died from cerebral edema that appeared to be treatment-related. The news sent the company's stock down 27% that day.

However, within less than a week, i.e. on July 12th, the FDA lifted the clinical hold after the company revised its preconditioning regimen back to cyclophosphamide-only on the trial.

When the company began the ROCKET trial, its chemotherapy preconditioning consisted of only cyclophosphamide. Later the company added Fludarabine also as part of preconditioning regimen to improve the efficacy. But with an increase in the incidence of severe neurotoxicity, which resulted in deaths, ever since the addition of Fludarabine, the company switched its preconditioning regimen to cyclophosphamide-only.

However, the revised preconditioning regimen too is doing no good for the ROCKET trial as it is the same old story as far as the adverse events are concerned.

JUNO closed Wednesday's trading at $22.56, down 24.50%.

OPKO Health Inc. (OPK) will commence shipments of its kidney disease drug Rayaldee to distributors in the United States on Tuesday, November 29, 2016. The product will be available nationwide at retail pharmacies as early as Wednesday, November 30, 2016.

Rayaldee, approved by the FDA for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease in June of this year, is the first product developed by OPKO to be commercialized by our own marketing and sales teams.

OPK closed Wednesday's trading at $10.70, up 4.90%.