FDA Nod For AGIO’s IDHIFA, BMY Expands Opdivo Use, OCUL Reduces Headcount

Today’s Daily Dose brings you news about FDA approval of AML therapy developed by Agios and Celgene; expanding indications of Bristol-Myers’ immunotherapy wonder drug Opdivo and Gilead’s hepatitis C drug Epclusa; Corcept’s near-term catalysts; Genomic’s financial health and reduction in Ocular’s workforce.

Read on…

The FDA, on Tuesday, approved IDHIFA, the first oral targeted therapy, for the treatment of patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase 2 (IDH2) mutations, well ahead of the decision date of August 30, 2017.

IDHIFA, known generically as Enasidenib, is jointly developed by Agios Pharmaceuticals Inc. (AGIO) in collaboration with Celgene Corp. (CELG).

Acute myeloid leukemia, or AML, is a cancer of the blood and bone marrow marked by rapid disease progression. IDH2 mutations are present in about 8-19% of AML cases.

AGIO closed Tuesday’s trading at $58.65, up 4.84%.

Bristol-Myers Squibb Co.’s (BMY) immunotherapy wonder drug Opdivo has been approved by the FDA for the expanded indication in microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer in adult and pediatric patients.

Opdivo, which works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body’s immune cells and some cancer cells), is already approved for a number of indications like melanoma, metastatic, non-small cell lung cancer, renal cell carcinoma, Hodgkin’s lymphoma, head and neck cancer, and urothelial carcinoma.

The drug brought home sales of $3.77 billion in 2016 compared to $942 million the prior year. In the first quarter of 2017, Opdivo sales totaled $1.13 billion, up from $704 million in the year-ago quarter.

BMY closed Tuesday’s trading at $56.11, down 1.39%.

Corcept Therapeutics Inc. (CORT) has a couple of events to watch out for in the coming months.

The CLIA-validation of the Company’s FKBP5 gene expression assay for diagnosing and optimally treating patients with Cushing’s syndrome is expected this quarter.

The Company expects to report results from its phase II trial of CORT125134 for Cushing’s syndrome in the first quarter 2018.

CORT closed Tuesday’s trading at $12.30, down 1.36%.

Genomic Health Inc. (GHDX) reported improved top-and bottom-line results for Q2, 2017 and has forecast a profit for the full year of 2017.

Net loss narrowed to $2.7 million or $0.08 per share in Q2, 2017 from $6.1 million or $0.18 cents per share in the year-ago quarter. Total revenue was $85.5…

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