FDA Approves 1st Drug For GCA, Puma Leaps, Will SBPH Spring A Surprise?

Today’s Daily Dose brings you news about the spike in Puma’s shares ahead of FDA panel review; FDA approval of expanded indication of Roche’s subcutaneous Actemra; FDA approval of Sanofi’s Kevzara; upcoming catalyst of Spring Bank Pharma and secondary offering of GlycoMimetics.

Read on…

The Centers for Medicare and Medicaid Services has approved a new billing code for EDAP TMS SA’s (EDAP) HIFU ablation of prostate tissue.

The Ablatherm HIFU device is indicated for non-invasive treatment for prostate cancer. Ablatherm-HIFU is approved for commercial distribution in Europe and some other countries including Mexico and Canada, and has received 510(k) clearance by the U.S. FDA.

The C-code is a significant achievement and opens the door to broader coverage from different payers, including private and commercial payers, according to the Company.

EDAP closed Monday’s trading at $3.00, up 7.14%.

Shares of GlycoMimetics Inc. (GLYC) plunged more than 17% on Monday after the Company announced that it intends to offer and sell, subject to market conditions, 6 million shares of its common stock in an underwritten public offering.

Read more about GLYC at our Company Spotlight column.

GLYC closed Monday’s trading at $11.01, down 13.71%.

Intersect ENT Inc.’s (XENT) New Drug Application for SINUVA Steroid Releasing Sinus Implant has been accepted for review by the FDA, with a decision date set for January 7, 2018.

The SINUVA implant, previously known as the RESOLVE product, is designed to provide a less invasive treatment option for patients with recurrent ethmoid sinus obstruction, including polyps, that might otherwise warrant a repeat surgical procedure.

XENT closed Monday’s trading at $23.20, up 1.98%.

Shares of Puma Biotechnology Inc. (PBYI) soared more than 39% on Monday, on speculation that the Company’s breast cancer drug Neratinib will win the backing of an FDA panel, scheduled to meet on May 24, 2017.

The briefing documents posted on the FDA website hint of a positive outcome,…

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