Zacks Investment Research | Jun 20, 2018 08:32AM ET
The biotech sector was in focus with regular pipeline updates. While Sarepta Therapeutics, Inc. (NASDAQ:SRPT) and Solid Biosciences (NASDAQ:SLDB) gained on positive data, Anika Therapeutics, Inc. (NASDAQ:ANIK) and Ziopharm Oncology, Inc. (NASDAQ:ZIOP) declined on dismal results.
Recap of Important Stories
Sarepta, Solid Biosciences Surge: The going has been good for the Duchenne muscular dystrophy (DMD) market. Shares of Sarepta surged significantly after the company reported impressive preliminary results from its phase I/IIa gene therapy trial assessing AAVrh74.MHCK7.micro-Dystrophin in individuals with DMD. The biopsies performed at the end of day 90 showed robust micro-dystrophin expression in muscle measured by all methods and observed in all three patients. The patients enrolled also showed a significant decrease in serum creatine kinase (CK) levels, with a mean reduction of CK of over 87% at Day 60. (Read more:the complete list of today’s Zacks #1 Rank stocks here .
Anika Plunges on Disappointing Data: Shares of Anika Therapeutics have dropped in after-market trading after the company reported disappointing results from a phase III trial on Cingal, which is being conducted to support registration in the United States. The 16-02 trial compared Cingal, a combination of cross-linked HA and triamcinolone hexacetonide (TH), with TH alone and cross-linked HA in treating patients with osteoarthritis in the knee. The primary endpoint was a comparison of the pain reduction when treated with Cingal compared with only TH at 26 weeks. However, the results did not show any statistical significance even though Cingal achieved greater pain reduction numerically at every time point in the study. Cingal is Anika’s third-generation visco supplement, along with Orthovisc and Monovisc products, to treat pain associated with osteoarthritis of the knee.
Ziopharm Oncology Plunges As FDA Places Clinical Hold on CAR T Therapy: Shares of Ziopharm Oncology declined after the FDA placed a clinical hold on its phase I trial evaluating CD19-specific CAR-T therapies manufactured under point-of-care. The FDA has requested additional information relative to Chemistry, Manufacturing and Controls in support of the investigational new drug (IND) application for the trial. The therapy is being evaluated as an investigational treatment for patients with relapsed or refractory, CD19+ leukemias and lymphomas.
Amgen Got European Nod For Addition of Data to Blincyto: Amgen (NASDAQ:AMGN) announced that the European Commission (EC) has granted a full marketing authorization for Blincyto (blinatumomab) based on encouraging overall survival (OS) data from the phase III study, TOWER, in adult patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Results showed that Blincyto demonstrated a superior improvement in median OS over standard-of-care (SOC) chemotherapy. Median OS was 7.7 months for Blincyto versus four months for SOC.
Performance
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