FDA Snubs DVAX, Keep An Eye On OCUL, It's All Green For BLUE

(RTTNews) - ARCA biopharma Inc. (ABIO) expects to enroll the 150th patient in its on-going phase 2B/3 clinical trial of Gencaro for atrial fibrillation in the first quarter of 2017. The trial, dubbed GENETIC-AF, is designed to enroll 620 patients. To date, 125 patients have been enrolled in the trial.

The interim efficacy analysis of the trial by the Data and Safety Monitoring Board is projected in the third quarter of 2017.

ABIO closed Monday's trading at $2.47, up 5.32%.

bluebird bio Inc. (BLUE) is all set to present interim data from its phase I study of bb2121 in patients with relapsed/refractory multiple myeloma on December 1, 2016 at the EORTC-NCI-AACR Molecular Targets and Cancer Therapies Symposium in Munich, Germany.

BLUE closed Monday's trading at $62.65, up 10.20%.

Cyclacel Pharmaceuticals Inc. (CYCC) expects topline results from its phase III study of oral Sapacitabine capsules in elderly patients with acute myeloid leukemia who are unfit for or refused intensive chemotherapy in the fourth quarter of 2016 or in early 2017.

CYCC closed Monday's trading at $3.91, up 8.91%.

Shares of Dynavax Technologies Corp. (DVAX) plunged over 64%, following FDA's refusal to approve HEPLISAV-B for immunization of adults 18 years and older against hepatitis B infection.

In its Complete Response Letter, the FDA has sought 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.

DVAX closed Monday's trading at $4.10, down 64.66%.

Nivalis Therapeutics Inc. (NVLS) has completed enrollment in its second phase II study of Cavosonstat for treatment of cystic fibrosis.

In the study, Cavosonstat is being evaluated as add-on therapy to Vertex Pharmaceuticals Inc.'s (VRTX) Kalydeco in adult patients who have one copy of the F508del mutation and a second mutation that results in a gating defect in the CFTR protein. The study has enrolled a total of 19 patients and topline results are expected in the first quarter of next year.

Another phase II study, which is evaluating Cavosonstat for the treatment of CF patients, who have two copies of the F508del mutation, when added to Vertex Pharmaceuticals' Orkambi is underway - with topline results expected by the end of this year.

NVLS closed Monday's trading at $6.18, down 3.13%.

Shares of Ocular Therapeutix Inc. (OCUL) jumped over 9% on Monday, following positive topline results from its phase III clinical trial of DEXTENZA for the treatment of post-surgical ocular inflammation and pain.

The trial successfully met its two primary efficacy endpoints for inflammation and pain, achieving statistically significant differences between the treatment group and the placebo group for the absence of inflammatory cells on day 14 and the absence of pain on day 8, respectively.

The company's request seeking approval of DEXTENZA for use in the treatment of ocular pain occurring after ophthalmic surgery was turned down by the FDA in July of this year.

Ocular plans to resubmit its NDA for DEXTENZA for the post-surgical ocular pain indication by the end of the year, and subject to potential approval, expects to submit an NDA supplement for DEXTENZA to include a post-surgical ocular inflammation indication.

OCUL closed Monday's trading at $7.49, up 9.02%.

SciClone Pharmaceuticals Inc. (SCLN) has received an acquisition proposal from a consortium led by GL Capital Management GP Limited and ABG Management Limited, valuing the outstanding shares of SciClone not already owned by the consortium for $11.18 per share in cash.

The proposal is expected to be reviewed by the company's Board of Directors and a suitable action taken based on the company's current strategic plan and growth initiatives.

SCLN closed Monday's trading at $10.35, up 5.08%.