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Gainers & Losers Of June 14: OMER, EPZM, ALXN, SBBP, GBT...


The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of June 14, 2017.


1. NeuroDerm Ltd. (NDRM)

Gained 15.46% to close Wednesday's (June 14) trading at $28.75.

News: No news

Near term catalysts:

-- Initiation of two PK trials of ND0612 expected in the second half of 2017.
ND0612 is the company's continuous, subcutaneously delivered levodopa/carbidopa (LD/CD) proprietary liquid formulation for the treatment of Parkinson's disease.

Last December, the Company was allowed by the FDA to replace its two large, phase III efficacy trials of ND0612 with small pharmacokinetic trials.

-- Completion of phase III efficacy trial of ND0612, dubbed iNDiGO, in parallel with a long-term phase II safety trial of ND0612, dubbed BeyoND study, expected in 2018.

2. Omeros Corporation (OMER)

Gained 12.21% to close Wednesday's trading at $21.97.

News: No news

Recent events:

-- On June 13, 2017, the FDA granted breakthrough therapy designation to the Company's investigational drug OMS721 for the treatment of Immunoglobulin A (IgA) nephropathy.
-- On May 17, 2017, the Company reported additional positive results from the first stage of its phase II clinical trial of OMS721 for the treatment of serious kidney disorders.

The Company is preparing for its Phase 3 clinical trial of OMS721 in IgA nephropathy, and is continuing to conduct the second stage of its ongoing Phase 2 clinical trial in which OMS721 is evaluated in non-steroid-treated patients with IgA nephropathy.

OMS721 is also being evaluated in a Phase 3 clinical program for atypical hemolytic uremic syndrome and in a Phase 2 clinical program for hematopoietic stem cell transplant-associated thrombotic microangiopathy.

3. Epizyme Inc. (EPZM)

Gained 10.76% to close Wednesday's trading at $12.35.

News: The Company reported positive interim efficacy data from its ongoing phase II trial of Tazemetostat as a single-agent treatment for relapsed or refractory patients with follicular lymphoma or diffuse large B-cell lymphoma.

According to the interim data as of June 1, 2017, the subset of follicular lymphoma patients with EZH2 activating mutations have a 92 percent objective response rate. Patients with follicular lymphoma with EZH2 wild-type have an objective response rate of 26 percent. Promising activity was also observed in diffuse large B-cell lymphoma patients with EZH2 mutations, which includes recently enrolled patients, with an objective response rate of 29 percent, added the Company.

4. Alexion Pharmaceuticals Inc. (ALXN)

Gained 9.26% to close Wednesday's trading at $118.00.

News: Ever since the Company announced on June 13, 2017 about the appointment of Paul Clancy as its Chief Financial Officer, the stock has been on the rise.

Clancy will join the company on July 10, 2017 and will assume the role of CFO effective July 31, 2017. Clancy has been employed by Biogen where he has served as CFO for the last ten years. Prior to Biogen, he spent 13 years with PepsiCo in various executive positions.

Clancy will succeed Dave Anderson, who will continue to serve as CFO until July 31, 2017. To ensure a smooth transition, Anderson will then become a Senior Advisor to the Chief Executive Officer and will remain with Alexion until the end of August, the Company added.

5. XBiotech Inc. (XBIT)

Gained 9.09% to close Wednesday's trading at $4.80.

News: No news

Recent event:

-- On June 9, 2017, an Independent Data Monitoring Committee recommended termination of the Company's phase III study of Xilonix for the treatment of colorectal cancer, dubbed XCITE.

The Independent Data Monitoring Committee, which performed its second prospectively planned, unblinded analysis of the XCITE study, found that the findings were not sufficient to meet efficacy or the threshold for continuation of the study. The news had sent XBIT down 66.03% to $3.20 that day.

Last month, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended against approving Xilonix in Europe.

6. Roka Bioscience Inc. (ROKA)

Gained 8.24% to close Wednesday's trading at $2.89.

Upcoming event:

The Company will make a presentation at the 2017 MARCUM MICROCAP CONFERENCE on June 16, 2017 at 10:30am.

During this presentation, the Company's operations, strategies and prospects may be discussed.

Recent event:

On May 11, Roka reported Q1, 2017 financial results.

Net loss for the first quarter of 2017 was $7.6 million, or $1.53 per share, compared with a net loss of $8.2 million, or $4.66 per share, in the first quarter of 2016. Revenue for Q1, 2017, was $2.0 million compared with $1.6 million for the first quarter of 2016 and $1.9 million for the fourth quarter of 2016.

The Company attributed the increase in first quarter revenue year-over-year to a 26% increase in the number of pathogen detection tests sold to customers.


1. Strongbridge Biopharma plc (SBBP)

Lost 7.53% to close Wednesday's trading at $4.30.

News: No news

Recent event:

Launched Keveyis in April 2017. Strongbridge acquired the U.S. rights to Keveyis from a subsidiary of Taro Pharmaceutical Industries Ltd. last December.

Keveyis was approved by the FDA in August 2015 to treat all forms of Primary Periodic Paralysis, which is a group of rare hereditary disorders that causes potentially severe episodes of muscle weakness and/or paralysis. Taro launched Keveyis in September 2015, but ceased promotion last May.


Strongbridge's pipeline includes RECORLEV for treating endogenous Cushing's syndrome under phase III trial, and Veldoreotide for treatment of patients with acromegaly under phase II testing.

Near-term catalysts:

-- Enrollment in a phase III trial of RECORLEV (COR-003) for the treatment of endogenous Cushing's syndrome, dubbed SONICS, is expected to be completed by end of Q2 2017, and top-line data is anticipated in Q1 2018.
-- A phase III trial, dubbed LOGICS, which will supplement the long-term efficacy and safety data from SONICS, is anticipated to begin enrollment next quarter and top-line data are expected in the third quarter of 2018.

2. Global Blood Therapeutics Inc. (GBT)

Lost 7.48% to close Wednesday's trading at $27.85.

News: No news

Near-term catalysts:

-- Global Blood's lead product candidate is GBT440, which is under a phase III trial in people with sickle cell disease. The study, dubbed HOPE, is expected to enroll up to 400 adults and adolescents with SCD who have had at least one episode of vaso-occlusive crisis (VOC) in the previous year. Top-line data from the HOPE study are anticipated in the first half of 2019.

GBT440 is also being explored as a potential treatment for acute and chronic hypoxemic pulmonary disorders.

-- A phase IIa trial of GBT440 for the treatment of hypoxemia in patients with idiopathic pulmonary fibrosis (IPF) who are on supplemental oxygen at rest, initiated last November, is underway. This study, known as ZEPHYR, is designed to enroll a total of 16 IPF patients, 45 to 80 years of age - with data expected to be announced in the second half of this year.
-- Another phase IIa trial evaluating the effect of GBT440 in adults with idiopathic pulmonary fibrosis (IPF) and hypoxemia, initiated last June, is also ongoing - with trial results expected in the second half of this year.
-- The hypoxemic program of the Company also includes an open label study evaluating the safety of GBT440 and its effect on oxygen saturation in fit healthy volunteers at rest and following maximal exercise under normoxic (normal levels of oxygen in the blood) and hypoxic conditions. This study is known as BASECAMP, and data from this trial are also anticipated in the second half of 2017.

by RTTNews Staff Writer

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