It's A No For PTCT As Expected, SRPT Revises Outlook Higher, TSRO Gets FDA Nod

(RTTNews) - Today's Daily Dose brings you news about Anika's viscosupplement for the treatment of symptoms associated with osteoarthritis of the knee; GSK's shingles vaccine Shingrix; FDA ruling on PTC Therapeutics' Ataluren; Saepta's rosy outlook and FDA approval of TESARO's intravenous formulation of Rolapitant for the prevention of chemotherapy-induced nausea and vomiting.

Read on...

Anika Therapeutics Inc. (ANIK) has completed enrollment in its second pivotal Phase III trial evaluating CINGAL, its novel HA-corticosteroid combination viscosupplement, for the treatment of symptoms associated with osteoarthritis of the knee.

The study is designed to evaluate the safety of CINGAL as well as its effectiveness in improving pain, function, and quality of life measures over a 26-week period, in comparison to MONOVISC and triamcinolone hexacetonide. The study involves 576 patients with mild to moderate knee osteoarthritis.

Anika expects to complete the CINGAL second pivotal Phase III trial in the first half of 2018 and anticipates FDA approval the following year.

ANIK closed Wednesday's trading at $58.57, down 1.71%.

GlaxoSmithKline plc's (GSK) shingles vaccine Shingrix has received positive recommendation from CDC's Advisory Committee on immunization practices as preferred vaccine for prevention of Shingles.

Shingrix, which contains Agenus Inc.'s (AGEN) proprietary immune adjuvant, QS-21 Stimulon, was approved by the FDA on October 20, 2017 for use in adults aged 50 years and older.

AGEN closed Wednesday's trading at $3.73, unchanged from the previous day's close.

Kala Pharmaceuticals Inc. (KALA) has submitted a New Drug Application to the FDA for INVELTYS, a topical twice-a-day product candidate for the treatment of inflammation and pain in patients who have undergone ocular surgery.

If approved, Kala expects INVELTYS would be the first twice-daily ocular corticosteroid indicated for the treatment of post-operative ocular inflammation and pain.

KALA closed Wednesday's trading at $16.50, unchanged from the previous day's close.

The FDA has declined to approve PTC Therapeutics Inc.'s (PTCT) Ataluren for the treatment of nonsense mutation dystrophinopathies, in line with the advisory committee's opinion.

In its Complete Response Letter, the U.S. regulatory agency has asked the Company to provide evidence of effectiveness from an additional adequate and well-controlled clinical trial(s).

On September 28, 2017, an FDA panel voted 10-1 that the data provided by the Company was inconclusive to recommend approval of Ataluren. The panel also stated that the Company needs to provide more data to prove the drug's efficacy.

Ataluren under brand name Translarna is approved within the European Union (EU) Member States, Iceland, Liechtenstein, Norway, Israel and South Korea to treat patients aged 5 years and older with Duchenne muscular dystrophy who are able to walk. Ever since its launch in December 2014, Translarna has had substantial year-over-year net sales growth.

Sales of Translarna, which were $34 million in 2015, more than doubled to $81 million in 2016. Looking ahead to full-year 2017, the Company expects Translarna to bring home sales between $120 million and $140 million.

PTCT closed Wednesday' trading at $17.30, up 7.19%. In after-hours, the stock was down 1.10% to $17.11.

Sarepta Therapeutics Inc. (SRPT) now expects annual 2017 revenue to between $150 million and $155 million. The Company had previously forecast annual revenue in the range of $125 million to $130 million.

Commenting on the third quarter results and rosy outlook, Douglas Ingram, Sarepta's president and CEO, said, "Driven by continued exceptional execution, physician adoption, and adherence, EXONDYS 51 achieved strong performance in the third quarter. For the third straight quarter, we have been in a position to raise our annual revenue guidance".

SRPT closed Wednesday's trading at $48.36, down 1.23%. In after-hours, the stock was up 3.39% to $50.00.

The FDA has approved TESARO Inc.'s (TSRO) intravenous formulation of Rolapitant for the prevention of chemotherapy-induced nausea and vomiting.

An oral formulation of Rolapitant was approved by the FDA under brand name Varubi on September 1st, 2015, and has been available in the U.S. since November 2015. Sales of Varubi totaled $5.02 million in the first half of 2017.

The intravenous formulation of Rolapitant is meant to provide oncologists additional flexibility in their choice of antiemetic regimens.

Tesaro obtained an exclusive, royalty bearing, sublicensable worldwide license, to research, develop, manufacture, market and sell Rolapitant from Opko Health Inc. (OPK) in December 2010.

TSRO closed Wednesday's trading at $110.03, down 2.10%. In after-hours, the stock was up 4.52% to $115.00.