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DCPH Soars On ASCO Data, AVXL Braces For Busy Year, GHDX In Good Health


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(RTTNews.com) - The following are some of today's top gainers in the pharma/biotech sector.

1. Deciphera Pharmaceuticals Inc. (DCPH)

Gained 47.86% to close Monday's (June 4) trading at $38.31.

News: The Company presented encouraging updated data from its ongoing Phase 1 clinical trial of DCC-2618 in patients with gastrointestinal stromal tumors (GIST) at the American Society of Clinical Oncology (ASCO) Annual Meeting on Saturday.

The Objective Response Rate of 24% with DCC-2618 observed to date in second and third line GIST patients is higher than that reported for Pfizer's Sutent in second line patients (7.0%) or Bayer's Stivarga in third line patients (4.5%).

The Company is expected to initiate a phase III trial of DCC-2618 in second line GIST patients this year.

In related news, Deciphera announced that it has commenced a proposed public offering of 3.75 million in shares of its common stock.

2. Anavex Life Sciences Corp. (AVXL)

Gained 31.71% to close Monday's trading at $3.78.

News: No news

Pipeline:

The lead drug candidate is ANAVEX2-73, which recently completed a successful a Phase 2a clinical trial for Alzheimer's disease.

Near-term Catalysts:

-- The Company plans to submit an IND to the FDA within the first half of this year for the planned Alzheimer's Phase 2/3 study of ANAVEX2-73. This study will be conducted in Australia and North America. -- A phase II clinical trial with ANAVEX2-73 in Rett syndrome is expected to be initiated in the second half of this year. -- A phase II clinical trial of ANAVEX2-73 in Parkinson's disease Dementia is also anticipated to be initiated in the second half of this year.

3. Genomic Health Inc. (GHDX)

Gained 23.07% to close Monday's trading at $48.84.

News: Results from TAILORx study, published in The New England Journal of Medicine, demonstrate that the Company's Oncotype DX Breast Recurrence Score Test definitively identifies the 70% of Women with early-stage breast cancer who receive no Benefit from chemotherapy, and the 30% of women for whom chemotherapy benefit can be life-saving.

The TAILORx trial was independently designed and conducted by ECOG-ACRIN under the sponsorship of the NCI, part of the National Institutes of Health. All major cancer clinical research groups with trial sites in the United States, Canada, Ireland, Peru, New Zealand and Australia participated in the study.

Investigators used Genomic Health's flagship product, the Oncotype DX Breast Recurrence Score test on every patient to assign treatment or randomization in order to determine whether chemotherapy would be beneficial or not.

4. Rocket Pharmaceuticals Inc. (RCKT)

Gained 15.87% to close Monday's trading at $23.00.

News: No news

Pipeline:

Rocket Pharma is a gene therapy company. The most advanced product candidate in the pipeline is LVV-based gene therapy RP-L102 for Fanconi Anemia (FA), under phase I/II development.

Fanconi Anemia is a rare genetic disease. Individuals with Fanconi anemia have an increased risk of developing a cancer of blood-forming cells in the bone marrow called acute myeloid leukemia (AML) or tumors of the head, neck, skin, gastrointestinal system, or genital tract. (Source: Genetics Home Reference).

Recent event:

On May 18, 2018, the Company presented encouraging updated data of the ongoing phase I/II trial of RP-L102 in Fanconi Anemia. Five patients have been treated to date, and the updated data involved all the 5 patients.

All patients demonstrated continued improvement in engraftment following administration of RP-L102, according to the Company.

Near-term Catalysts:

-- Additional patient data from the Fanconi Anemia program is expected over the next 12-18 months. -- Based on the promising preliminary results, Rocket will engage with regulatory authorities to progress RP-L102 towards a potential global registrational study in 2019.

5. ProQR Therapeutics N.V. (PRQR)

Gained 13.91% to close Monday's trading at $6.55.

News: No news

Near-term Catalyst:

-- A phase I/II clinical trial of QR-110 in adults and children with Leber congenital amaurosis 10, an eye disorder that affects the retina, is underway - with interim data expected in the second half of 2018, and full data expected during 2019.


6. Evolus Inc. (EOLS)	

Gained 11.77% to close Monday's trading at $30.49. The stock has been hitting new highs.


News: No news

Recent events:

-- On May 16, 2018, the FDA rejected the Company's Biologics License Application for DWP-450 for the treatment of glabellar lines, also known as frown lines, in adult patients.

There were deficiencies in items related to Chemistry, Manufacturing, and Controls ("CMC") processes that led to the rejection. However, no deficiencies were related to clinical or non-clinical matters. Evolus expects to respond with a complete submission to FDA within 90 days.

-- The same day, i.e., on May 16, 2018, the Company also announced good news related to favorable completion of FDA's pre-approval inspection of Daewoong's manufacturing facility in South Korea which was purpose built for production of DWP-450.

7. Arcturus Therapeutics Ltd. (ARCT)

Gained 11.55% to close Monday's trading at $6.28.

News: No news

Recent events:

-- On February 2, 2018, Joseph Payne was terminated as President and Chief Executive Officer. Payne owns about 13.7% of the issued and outstanding shares in the Company. He had sought Court's intervention to prohibit the attempt of the Arcturus board of directors to undertake a highly dilutive equity financing.

Certain directors were attempting to sell 24.9% of Arcturus' share capital to a single purchaser at a purchase price that was more than 40% below the trading price of Arcturus common shares prior to the termination of Payne.

The Court also found that the board's decision to sell shares was not being undertaken to raise necessary working capital, and that the members of the Arcturus board are motivated by their own self-interests instead of the interests of Arcturus and its shareholders.

-- On May 29, 2018, the Company reached a settlement agreement with Joseph Payne. -- On May 31, 2018, Peter Farrell was named as Chairman of the Board of Directors of the Company. Joseph Payne was reinstated as President and CEO and Pad Chivukula was reinstated as Chief Scientific Officer and Chief Operating Officer.


Read the original article on RTTNews (http://www.rttnews.com/2901571/dcph-soars-on-asco-data-avxl-braces-for-busy-year-ghdx-in-good-health.aspx)


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