AZN Gets FDA Nod, CORT Boosts Outlook Yet Again, SNSS Withdraws Vosaroxin MAA

(RTTNews) - The FDA has granted accelerated approval to AstraZeneca plc's (AZN) IMFINZI for use in previously treated patients with advanced bladder cancer. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

IMFINZI, known generically as Durvalumab, is also under investigation in a phase III trial as first-line treatment in urothelial carcinoma as monotherapy and in combination with tremelimumab.

AZN closed Monday's trading at $30.27, up 0.07%.

Cerecor Inc. (CERC) has reported positive topline clinical results from a small, proof-of-concept phase II trial of CERC-501 in treatment resistant depression.

In the study, which was sponsored by the National Institute of Mental Health of the National Institutes of Health, CERC-501 showed a clinically meaningful 2.0-point difference from placebo on the Hamilton Rating Scale for Depression - 6 - items, change from baseline to 72 hours, which served as the primary efficacy measure.

CERC closed Monday's trading at $0.53, up 20.50%.

Corcept Therapeutics Inc. (CORT) has raised its 2017 revenue guidance yet again. This is for the second time in three months, the Company has boosted its outlook.

The Company now expects 2017 revenue to range between $125 million and $135 million. The consensus forecast among analysts polled by Thomson Reuters is $124.04 million.

CORT closed Monday's trading at $9.67, up 1.36%.

LeMaitre Vascular Inc. (LMAT) is all set to join S&P SmallCap 600 GICS Health Care Equipment Sub-Industry index effective prior to the open on Wednesday, May 3, 2017.

LeMaitre is a medical device company providing vascular devices, implants and services for the treatment of peripheral vascular disease.

LMAT closed Monday's trading at $30.38, up 2.12%. In after-hours, the stock gained another 2.70% to $31.20.

Read more about LMAT at Company Spotlight

Luminex Corp. (LMNX) expects second quarter 2017 revenue to be between $74 million and $76 million. The consensus forecast among analysts polled by Thomson Reuters is $74.93 million.

Looking ahead to full year 2017, Luminex has raised its annual revenue guidance range to between $300 million and $310 million from between $295 million and $305 million. Analysts expect the Company to report revenue of $302.86 million for the year.

LMNX closed Monday's trading at $18.93, up 0.53%.

Shares of Sunesis Pharmaceuticals Inc. (SNSS) were down more than 13% in extended trading on Monday, following the Company's decision to withdraw its European Marketing Authorization Application for Vosaroxin as a treatment for relapsed/refractory acute myeloid leukemia.

During its recent interactions with the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP), the Company learnt that the committee was likely to formally adopt a negative opinion in its evaluation of the application.

The Company noted that it will continue to advance the development of Vosaroxin through a modest investment in investigator-sponsored group trials, and will carefully assess business development alternatives to support the conduct of another pivotal trial to achieve future regulatory approval of Vosaroxin.

The cash on hand is expected to be sufficient to fund the Company beyond Q1 2018.

SNSS closed Monday's trading at $3.66, down 5.43%. In after-hours, the stock cratered 13.93% to $3.15.

ZIOPHARM Oncology Inc. (ZIOP) will be presenting updated results from its phase I dose-escalation study of Ad-RTS-hIL-12 + veledimex in patients with recurrent or progressive glioblastoma at the 2017 American Society of Clinical Oncology Annual Meeting on June 5, 2017.

Phase I studies of Ad-RTS-hIL-12 + veledimex in pediatric brain cancer, as well as in combination with an anti-PD-1 checkpoint inhibitor in adult glioblastoma, are expected to be initiated in the first half of 2017.

ZIOP closed Monday's trading at $7.10, up 0.85%.