ANIK Expands Horizons, FENC Hits Study Goals, IMDZ Abuzz, One More For Opdivo

(RTTNews) - Today's Daily Dose brings you news about Restoration Robotics' closing of IPO; Immune Design's plans to initiate a pivotal phase 3 trial of CMB305 in patients with synovial sarcoma; Bristol-Myers' exploration of new indication for its blockbuster immunotherapy drug Opdivo and Fennec's SIOPEL 6 study results.

Read on…

Anika Therapeutics Inc.'s (ANIK) MONOVISC, a single injection viscosupplement for the treatment of pain associated with osteoarthritis of all synovial joints, including the hip and knee, has been approved in Australia.

MONOVISC is commercially available in over twenty countries, including the United States, Canada, and various European countries.

The Company is slated to issue its third-quarter 2017 financial results after the close of the market on Wednesday, October 25, 2017.

ANIK closed Monday's trading at $59.78, unchanged from the previous day's close.

Bristol-Myers Squibb Co.'s (BMY) supplemental Biologics License Application for blockbuster immunotherapy drug Opdivo to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection has been accepted for priority review by the FDA.

The FDA also previously granted Breakthrough Therapy Designation for this application, which is the seventh indication for which Opdivo has received this designation.

In the first half of 2017, Opdivo sales were $2.32 billion, up 50% over the year-ago period.

BMY closed Monday's trading at $63.65, down 2.51%.

Fennec Pharmaceuticals Inc.'s (FENC) (FRX.TO) phase III study of sodium thiosulfate for the prevention of platinum-induced ototoxicity in pediatric patients, dubbed SIOPEL 6, has met its primary endpoint.

The study demonstrated that the addition of sodium thiosulfate significantly reduces the incidence of cisplatin-induced hearing loss without any evidence of tumour protection.

The Company plans to pursue regulatory approvals with FDA and EMA for sodium thiosulfate.

FENC touched a 52-week intra-day low of $9.99 on Monday, before closing the day's trading at $10.56, down 12.29%.

Shares of Immune Design Corp. (IMDZ) were up over 11% in extended trading on Monday, following the Company's plans to initiate a pivotal phase 3 trial to support a Biologics License Application for CMB305, a novel cancer vaccine, in patients with synovial sarcoma.

The phase III trial will evaluate CMB305 monotherapy against placebo in patients with NY-ESO-1+ locally advanced unresectable or metastatic synovial sarcoma, a sub type of soft tissue sarcoma, who have no evidence of progression after first-line chemotherapy. The final analysis may occur as early as 24 months from the first patient dosed, added the Company.

IMDZ closed Monday's trading at $10.10, down 7.76%.

NuVasive Inc. (NUVA) has received an expanded FDA clearance for its TLX interbody system, used in spinal fusion surgery.

The new clearance introduces an expandable 20 degree cage and broader indications for use, including use with allogeneic bone graft and use in additional levels of the spine. Previously, TLX interbodies were available in 15 degree lordotic options and were only indicated for use with allograft.

NUVA closed Monday's trading at $52.18, up 2.68%.

Restoration Robotics Inc. (HAIR), a medical device company, has closed its initial public offering of 3.57 million shares of common stock at a public offering price of $7.00 each. The Company's common stock began trading on The NASDAQ Global Market on October 12, 2017.

The Company commercializes the ARTAS Robotic Hair Restoration System, which is CE-marked and FDA cleared.

HAIR closed Monday's trading at $8.95, down 9.78%.