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

(RTTNews) - 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, according to analysts. However, it is not over until it is over.

Neratinib is an investigational therapy for the extended adjuvant treatment of early stage HER2-positive breast cancer that has previously been treated with a trastuzumab (Herceptin) containing regimen.

No specific PDUFA (decision) date has been notified for Neratinib. However, the U.S. regulatory agency's decision is expected to be announced in the third quarter of 2017.

On May 15, 2017, Robert Charnas resigned from his post of Senior Vice President, Regulatory Affairs, due to health reasons.

PBYI closed Monday's trading at $52.60, up 39.15%.

The FDA has expanded the approved use of Roche's (RHHBY.OB) subcutaneous Actemra to treat adults with giant cell arteritis.

Giant cell arteritis is a form of vasculitis, a group of disorders that results in inflammation of blood vessels. This inflammation causes the arteries to narrow or become irregular, impeding adequate blood flow.

The subcutaneous Actemra becomes the first FDA-approved therapy to specifically treat giant cell arteritis. Actemra in subcutaneous formulation was previously approved for the treatment of moderate to severely active rheumatoid arthritis.

Intravenous Actemra was also previously approved for the treatment of moderate to severely active rheumatoid arthritis, systemic juvenile idiopathic arthritis and polyarticular juvenile idiopathic arthritis. Intravenous administration is not approved for giant cell arteritis.

Sales of Actemra (marketed as RoActemra in Europe) came in at 1,697 million Swiss francs in 2016, up 16% over the previous year.

The FDA has approved Sanofi (SNY) and Regeneron Pharmaceuticals Inc.'s (REGN) Kevzara for the treatment of moderately to severely active rheumatoid arthritis in adult patients.

Kevzara may be used as monotherapy or in combination with MTX or other conventional disease modifying antirheumatic drugs.

The recommended dosage of Kevzara is 200 mg once every two weeks given as a subcutaneous injection, which can be self-administered. The dosage can be reduced from 200 mg to 150 mg once every two weeks, as needed, to help manage certain laboratory abnormalities, the companies noted.

The U.S. Wholesale Acquisition Cost (WAC) of Kevzara is $39,000/year for the 200 mg and 150 mg doses, and is approximately 30 percent lower than the WAC for the two most widely used TNF-alpha inhibitors.

REGN touched a new 52-week high of $464.40, before closing the day's trading at $460.99, up 2.44%.

Spring Bank Pharmaceuticals Inc. (SBPH) plans to host a conference call on Wednesday, May 24, 2017, at 8:00 a.m. ET, to discuss top-line results from the initial 25mg monotherapy dosing cohort of the Phase 2a segment of its ACHIEVE trial.

The first segment of the ACHIEVE trial is a Phase 2a placebo-controlled, sequential-cohort, double-blind trial to evaluate increasing doses of SB 9200 as monotherapy for 12 weeks followed by Gilead Sciences Inc's Viread 300 mg for an additional 12 weeks. The Phase 2b segment of the ACHIEVE trial is designed to examine the concomitant use of SB 9200 and Viread in approximately 200 HBV patients.

SBPH closed Monday's trading at $12.00, unchanged from the previous day's close. In after-hours, the stock was up 2.94% to $12.35.