BSX Recalls Fetch 2 Catheter, CLVS Awaits FDA Panel Vote, LLY, AZN On Watch

(RTTNews) - Boston Scientific Corp. (BSX) is recalling all models of its Fetch 2 Aspiration Catheter, a thrombectomy catheter used during procedures to remove small blood clots from coronary arteries, due to complaints of shaft breakage.

The FDA has classified the recall as Class 1, meaning that the use of the device exposes the patient to a reasonable chance of a serious adverse health consequence or death.

The device was manufactured between June 11, 2014 and February 19, 2016, and there are currently 21,155 devices on the market subject to this recall, according to the company.

BSX closed Friday's trading at $19.31, up 0.10%.

Shares of Clovis Oncology Inc. (CLVS) dropped more than 17% on Friday after the FDA posted briefing materials in advance of the panel meeting to discuss accelerated approval of the company's New Drug Application for Rociletinib, scheduled for April 12, 2016.

Rociletinib is an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the T790M mutation.

The FDA panel will vote on the following tomorrow:

Is the observed Overall Response Rate and Duration of response for patients treated with Rociletinib better than available therapy for the proposed patient population, and is it likely to predict clinical benefit?

Are the risks of Rociletinib, particularly with respect to QTc prolongation leading to Torsades de pointes (specific type of abnormal heart rhythm that can lead to sudden cardiac death) and other serious ventricular arrhythmias, acceptable?

Is the benefit-risk profile favorable for the proposed patient population?

The FDA's final decision is slated for June 28, 2016.

CLVS closed Friday's trading at $15.77, down 17.74%. In after hours, the stock was up 1.78% to $16.05.

Eli Lilly and Co. (LLY) and AstraZeneca plc's (AZN) phase II/III study of AZD3293, currently in development as a potential treatment for early Alzheimer's disease, dubbed AMARANTH, will continue to phase III portion of the study.

Now that AZD3293 has moved into phase III testing, AstraZeneca will receive a milestone payment from Lilly. The payment will result in a second-quarter charge of $100 million (pre-tax) to Lilly's GAAP and non-GAAP research and development expense.

Lilly and AstraZeneca have also announced the planned initiation of a new phase III trial for AZD3293. The trial, named DAYBREAK, will study the safety and efficacy of AZD3293 in people with mild Alzheimer's dementia. DAYBREAK will begin enrolling participants in the third quarter of 2016.

LLY closed Friday's trading at $74.39, down 0.27%.