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

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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 million in the second quarter of 2017, compared with $82.0 million in the second quarter of 2016.

Looking ahead, the Company expects to report a profit for the full year of 2017. However, due to the timing of important reimbursement drivers being delayed, the Company now expects total revenue to range between $345 million and $355 million compared to its prior forecast range of $355 million to $370 million.

GHDX closed Tuesday's trading at $31.88, down 0.06%.

Nearly a year after getting FDA approval, Gilead Sciences Inc.'s (GILD) hepatitis C drug Epclusa has been greenlighted for an additional indication - for the treatment of adults with chronic hepatitis C virus (HCV) infection, to include use in patients co-infected with HIV.

Epclusa was approved for the treatment of adults with genotype 1-6 chronic HCV infection without cirrhosis or with compensated cirrhosis, or with decompensated cirrhosis in combination with Ribavirin, in the United States on June 28, 2016.

The drug netted sales of $1.75 billion in 2016, and $892 million in Q1, 2017.

GILD closed Tuesday's trading at $75.70, down 0.51%.

Intersect ENT Inc. (XENT) has reported a narrower loss on higher revenue for Q2, 2017, while raising its revenue outlook for full year 2017.

The net loss for Q2, 2017 shrunk to $2.27 million or $0.08 per share from $5.96 million or $0.21 per share in the year-ago quarter. Revenue for the recent second quarter was $24.0 million, a 24% increase over the second quarter 2016.

For the third quarter of 2017, the Company expects to achieve revenue of $21 million to $21.5 million.

Looking ahead to full year 2017, the Company has boosted its revenue outlook to $91-$93 million from the prior guidance of $89-$91 million.

XENT closed Tuesday's trading at $27.55, up 0.55%.

Seeking to enhance operations and reduce expenses, Ocular Therapeutix Inc. (OCUL) is reducing its headcount by approximately 19%. In conjunction with this initiative, Andy Hurley, Chief Commercial Officer, will be leaving the Company.

As previously planned, Antony Mattessich has assumed the role of Chief Executive Officer of the Company, effective immediately. Former CEO Amar Sawhney has transitioned to Executive Chairman of the Board, also as planned, and will continue to devote substantial business time to the Company.

As you may know, the Company's DEXTENZA, a proposed treatment for ocular pain following ophthalmic surgery, was rejected by the FDA last month.

OCUL closed Tuesday's trading at $6.46, up 2.05%.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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