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Gainers & Losers Of June 12: GTXI, XBIT, NDRM, CHRS, ZYNE...


The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of June 12, 2017.


1. GTx Inc. (GTXI)

Gained 99.03% to close Monday's (June 12) trading at $6.15.

News: The Company reported positive preliminary results from its ongoing Phase 2 Proof-of-Concept trial of Enobosarm 3 mg (GTx-024) in postmenopausal women with stress urinary incontinence.

The clinical findings from the first seven patients enrolled in the study following their completion of treatment revealed that:

-- Each of the women treated with Enobosarm showed a clinically significant reduction in incontinence episodes per day
-- Reductions in incontinence episodes were sustained well beyond the stopping of study drug at Week 12
-- Women reported improved quality of life in the Patient Global Impression of Improvement (PGI-I) and Female Sexual Function Index and
-- Reported adverse events were minimal with none above Grade I

2. XBiotech Inc. (XBIT)

Gained 31.25% to close Monday's trading at $4.20, recovering some losses after plunging 66% on Friday.

News: No news

Recent event:

On Friday (June 9), 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% on Friday.

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


Gained 15.94% to close Monday's trading at $3.71.

News: No news

Recent event:

On May 22, 2017, the Centers for Medicare and Medicaid Services approved a new billing code for the Company's HIFU ablation of prostate tissue.

The Ablatherm HIFU device is indicated for non-invasive treatment for prostate cancer. Ablatherm-HIFU is approved for commercial distribution in Europe and some other countries including Mexico and Canada, and has received 510(k) clearance from the FDA.

The C-code is a significant achievement and opens the door to broader coverage from different payers, including private and commercial payers, according to the Company.

4. NeuroDerm Ltd. (NDRM)

Gained 14.94% to close Monday's trading at $25.00.

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.

5. Omeros Corporation (OMER)

Gained 11.84% to close Monday's trading at $17.10.

News: No news

Recent event:

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.

6. Syros Pharmaceuticals Inc. (SYRS)

Gained 9.86% to close Monday's trading at $16.15.

News: The Company has appointed Srinivas Akkaraju, M.D., Ph.D., to its board of directors.

Dr. Akkaraju currently serves as chairman of the board of Versartis and as a director of Intercept Pharmaceuticals, Seattle Genetics and aTyr Pharma.


The Company has two lead product candidates - SY-1425 for genomically defined subsets of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) under phase II testing, and SY-1365 for certain solid tumors, under phase I testing.

Near-term catalyst:

-- Initial clinical data from the ongoing Phase 2 clinical trial of SY-1425 are anticipated in the fall of 2017.


1. Coherus Biosciences Inc. (CHRS)

Lost 23.73% to close Monday's trading at $15.75.

News: The FDA has issued a complete response letter for the Company's product candidate CHS-1701.

CHS-1701 is a proposed biosimilar to Amgen's (AMGN) blockbuster Neulasta that was approved in 2002. Neulasta is used to treat neutropenia, a lack of certain white blood cells caused by cancer chemotherapy. The drug generated sales of $4.65 billion in sales for Amgen last year.

In its complete response letter to Coherus, the FDA has requested for a reanalysis of a subset of subject samples with a revised immunogenicity assay, and has also sought certain additional manufacturing related process information.The regulatory agency has not made any request for a patient study.

2. Vital Therapies Inc. (VTL)

Lost 10.16% to close Monday's trading at $2.87.

News: No news

Near-term catalyst:

-- The top line data from a phase III study of ELAD System in subjects with severe alcoholic hepatitis, dubbed VTL-308, are anticipated around mid-2018.

3. Zynerba Pharmaceuticals Inc. (ZYNE)

Lost 8.74% to close Monday's trading at $16.61.

News: A SEC filing dated June 9, 2017, reveals that Zynebra has entered into an Open Market Sale Agreement with Jefferies LLC as placement agent, pursuant to which the Company may, from time to time, issue and sell shares of its common stock, par value $0.001 per share, in an aggregate offering price of up to $50.0 million.

by RTTNews Staff Writer

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