FDA Nod For TEVA, Cheers For PRTK, SRNE Hits Goal, SNY Launches Kids Toothpaste

(RTTNews) - Bristol-Myers Squibb Co.'s (BMY) phase III clinical trial evaluating the efficacy and safety of its blockbuster drug Opdivo in patients with first recurrence of glioblastoma multiforme, dubbed CheckMate -143, has failed to meet its primary endpoint of improved overall survival over bevacizumab monotherapy.

Opdivo is already approved for the treatment of advanced melanoma, advanced non-small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, advanced squamous cell carcinoma of the head and neck, and urothelial carcinoma.

Global sales of Opdivo in 2016 were $3.77 billion, up from $942 million in 2015.

BMY closed Monday's trading at $54.21, down 0.31%.

Dynavax Technologies Corp.'s (DVAX) resubmitted NDA for HEPLISAV-B, an experimental vaccine candidate for immunization against hepatitis B infection in adults 18 years of age and older, is scheduled to be reviewed by an FDA panel on July 28, 2017.

The U.S. regulatory agency's decision on HEPLISAV-B is expected on August 10, 2017.

This is HEPLISAV-B's third go-around with the FDA.

Last November, the FDA refused to approve HEPLISAV-B, seeking information regarding several topics, including clarification regarding specific adverse events of special interest (AESIs), a numerical imbalance in a small number of cardiac events in a single study (HBV-23), new analyses of the integrated safety data base across different time periods, and post-marketing commitments.

In February 2013 too, the FDA had rejected HEPLISAV-B, and requested additional data before it could be approved.

DVAX closed Monday's trading at $5.85, down 1.68%.

A heart disease trial using Mesoblast Ltd.'s (MESO) proprietary allogeneic mesenchymal precursor cells to grow heart muscle in children with hypoplastic left heart syndrome has been cleared by the FDA.

The 24-patient trial is sponsored and funded by the Boston Children's Hospital with support from Bulens and Capozzi Foundation and the Ethan Lindberg Foundation.

Mesoblast's product candidate MPC-150-IM is currently being evaluated in a phase III trial in up to 600 patients with New York Heart Association (NYHA) Class II/III chronic heart failure (CHF) and in a United States National Institutes of Health (NIH)-funded phase IIb trial of 159 patients with NYHA Class IV CHF in conjunction with implantation of a left ventricular assist device (LVAD).

MESO closed Monday's trading at $8.94, down 0.45%.

Shares of Paratek Pharmaceuticals Inc. (PRTK) were up more than 32% in extended trading on Monday, following positive top-line results from its phase III study comparing once-daily oral and IV Omadacycline to Moxifloxacin in the treatment of patients with community-acquired bacterial pneumonia.

In the study, dubbed OPTIC, Omadacycline met the FDA-specified primary endpoint of statistical non-inferiority compared to Moxifloxacin at the early clinical response 72-120 hours after initiation of therapy. The ECR rates for the Omadacycline and Moxifloxacin treatment arms were 81.1 % and 82.7%, respectively.

The OPTIC study represents the second positive phase III registration study of Omadacycline, which will be used to support marketing applications to the FDA and the European Medicines Agency.

The results of the first study, dubbed OASIS, were reported last June. In the OASIS study, the efficacy and safety of an IV to oral once-daily Omadacycline was compared against twice daily Linezolid over a 7 to 14-day course of therapy in 645 treated patients with acute bacterial skin and skin structure infections. The study too had met the primary efficacy endpoint of early clinical response.

Another phase III study of oral-only Omadacycline in acute bacterial skin and skin structure infections is underway - with top-line data expected this quarter.

PRTK closed Monday's trading at $18.60, down 3.38%. In after-hours, the stock was up 32.80% to $24.70.

Sorrento Therapeutics Inc.'s (SRNE) phase Ib single arm trial testing its anti-CEA CAR-T therapy administered regionally by hepatic artery infusion, followed by selective internal radiation therapy in heavily pre-treated patients with CEA positive liver metastases has demonstrated promising clinical activity and safety.

The primary objective of the study was to establish the safety of the CAR-T/selective internal radiation therapy combination. Secondary objectives included response assessed by modified RECIST (mRECIST), immune-related response criteria (irRC), and tumor marker kinetics.

SRNE closed Monday's trading at $3.60, down 8.86%. In after-hours, the stock was up 8.33% to $3.90.

Sucampo Pharmaceuticals Inc. (SCMP) has acquired privately-held rare disease company Vtesse, Inc. for an upfront consideration of $200 million.

Sucampo funded the acquisition through the issuance of 2,782,678 shares of Sucampo Class A common stock and $170 million of cash on hand.

Vtesse is focused on developing VTS-270 for the treatment of Niemann-Pick Disease Type C (NPC). VTS-270 is under a pivotal phase II/III trial.

SCMP closed Monday's trading at $10.65, down 3.18%.

Sanofi (SNY) has launched ACT Kids Toothpaste, a new anti-cavity fluoride toothpaste that is specially developed for kids two years of age and older.

With its bubble gum and fruit punch flavors, 4 out of 5 parents say ACT Kids Toothpaste motivates their kids to brush their teeth, says the Company.

The ACT Kids Toothpaste will be available in retail locations, including select Walmart, Walgreens, and Target locations.

SNY closed Monday's trading at $45.14, down 0.24%.

The FDA has approved Teva Pharmaceutical Industries Ltd.'s (TEVA) AUSTEDO tablets for the treatment of chorea associated with Huntington's disease.

AUSTEDO, formerly known as SD-809, represents the first new treatment option for chorea associated with Huntington's disease in nearly a decade. The drug, which is tagged an Orphan Drug by the FDA, is expected to be available in the U.S. within the next 3 weeks.

Chorea, which refers to involuntary, random and sudden, twisting and/or writhing movements, is a major symptom for many living with Huntington disease, a rare and fatal neurodegenerative disorder.

Teva's first attempt to get AUSTEDO approved was turned down by the FDA last May.

TEVA closed Monday's trading at $32.19, up 0.31%.

Versartis Inc.'s (VSAR) three-year safety and efficacy data on Somavaratan is in line with historical U.S. daily recombinant human growth hormone data in pediatric growth hormone deficiency - on key parameters, including height velocity, bone maturation and other key measures of catch-up growth, as well as IGF-I response, metabolic parameters, and safety.

Bradley S. Miller, Associate Professor in the Department of Pediatric Endocrinology at the University of Minnesota Masonic Children's Hospital said, "These results reinforce the 3.5 mg/kg twice-monthly dose selected for the ongoing Phase 3 VELOCITY trial, with mean peak IGF-I SDS at this dose in the upper half of the normal therapeutic range and no unexpected safety concerns. It is highly encouraging that the three-year results are in line with results from U.S. registries, and this represents an incremental advancement of our knowledge of long-term treatment with Somavaratan."

VELOCITY is a phase III trial of Somavaratan in pediatric GHD, and top-line results from this trial are anticipated in Q3 2017.

VSAR closed Monday's trading at $21.30, down 0.23%.