Bullish Options Activity in AstraZeneca (AZN) Targets Upside into September -Susquehanna

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Morgan Stanley Sees Favorable Entry Point On Clovis Oncology (CLVS)

May 2, 2017 9:02 AM EDT

Morgan Stanley maintains Overweight on Clovis Oncology (NASDAQ: CLVS) price target of $79.00.

Analyst Andrew Berens tells clients that today offers a favorable entry point into the stock ahead of Wednesday's earnings call. He expects inventors to remain focused on ARIEL3 completion guidance and... More

AstraZeneca (AZN) Confirms IMFINZI Receives FDA Accelerated Approval for Previously Treated Patients with Advanced Bladder Cancer

May 1, 2017 2:28 PM EDT

AstraZeneca (NYSE: AZN) and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to IMFINZI (durvalumab). IMFINZI is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery. IMFINZI is approved under the FDAs accelerated approval pathway, based on tumor response rate and durability of response. Continued approval for this... More

FDA Approves AstraZeneca's (AZN) Durvalumab to Treat Patients With Locally Advanced or Metastatic Urothelial Carcinoma

May 1, 2017 12:47 PM EDT

On May 1, 2017, the U.S. Food and Drug Administration granted accelerated approval to durvalumab (IMFINZI, AstraZeneca UK Limited (NYSE: AZN ) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

The FDA also approved the VENTANA PD-L1 (SP263) Assay (Ventana Medical Systems, Inc.) as a complementary diagnostic for the assessment of the PD-L1 protein in formalin-fixed, paraffin-embedded urothelial carcinoma tissue.

Approval was based on one single-arm trial of 182 patients with locally... More