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28.02.2017 04:24:28

Gainers & Losers Of Feb.27: LJPC, NVAX, KTOV, CYCC, ARGS...

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of February 27, 2017.

GAINERS

1. HTG Molecular Diagnostics Inc. (HTGM)

Gained 158.54% to close Monday's (Feb.27) trading at $3.18.

News: The company is in the final stages of launching its new direct-target sequencing technology and an initial DNA mutation panel chemistry in its VERI/O lab, and the panel will be made available to service customers for research uses by the end of this quarter.

The new chemistry is designed for direct sequencing of specified DNA and, in the future, RNA targets with the same high sensitivity and specificity as the company's current HTG EdgeSeq chemistry applications. The initial panel planned for the VERI/O laboratory will detect common mutations in the EGFR, KRAS and BRAF genes for retrospective research studies.

Anticipated event: The company is scheduled to report Q4 and full-year 2016 financial results on March 22, 2017.

2. La Jolla Pharmaceutical Co. (LJPC)

Gained 76.75% to close Monday's trading at $35.12.

News: The company's phase III trial of LJPC-501 in patients with catecholamine resistant hypotension met the primary endpoint.

Catecholamine-resistant hypotension or CRH is an acute, life-threatening condition in which blood pressure drops to dangerously low levels and is unresponsive to current treatments.

In the phase III trial, dubbed ATHOS-3, the percentage of LJPC-501-treated patients achieving a pre-specified target blood pressure response, was highly statistically significant. In addition, a trend toward longer survival was observed namely, a 22% reduction in mortality risk through day 28 for LJPC-501-treated patients.

La Jolla plans to submit the NDA for LJPC-501 in the second half of this year.

3. ImmunoGen Inc. (IMGN)

Gained 21.03% to close Monday's trading at $3.28.

News: No news

Near-term catalysts:

-- Initial data from phase 1b/2 trial of Mirvetuximab soravtansine in combination with Avastin, carboplatin, Doxil or Keytruda in ovarian cancer, dubbed FORWARD II, are expected in Q2, 2017. -- Pooled data from over 100 ovarian cancer patients treated in multiple Mirvetuximab soravtansine phase 1 cohorts and data from phase I steroid eye drop expansion cohort are anticipated in Q2, 2017. -- Initial phase I data for IMGN779 for the treatment of acute myeloid leukemia are expected in mid-2017.

4. Novavax Inc. (NVAX)

Gained 18.12% to close Monday's trading at $1.63.

News: The company reported Q4 and year-end 2016 financial results

Novavax Q4, 2016 net loss narrowed to $57.1 million or $0.21 per share from the year-ago quarterly net loss of $78.8 million or $0.29 per share, on reduced expenses. But the company's revenue in the fourth quarter of 2016 decreased 8% to $5.4 million compared to $5.9 million for the same period in 2015 on lower HHS BARDA revenue.

Anticipated event: The company plans to move its Zika and nanoparticle influenza vaccine programs into the clinic later this year.

5. Kura Oncology Inc. (KURA)

Gained 17.83% to close Monday's trading at $7.60.

News: The company announced that it will be presenting preliminary evidence of clinical activity with Tipifarnib in squamous cell carcinomas of the head & neck (SCCHN) with HRAS mutations at the 15th International Congress on Targeted Anticancer Therapies on March 6, 2017.

Near-term catalysts:

-- Additional data from phase II study of Tipifarnib in HRAS mutant squamous cell carcinomas of the head & neck expected in the first half of this year. -- Data from phase II study of Tipifarnib in peripheral T-cell lymphoma (PTCL) are also expected in the first half of this year.

6. Moleculin Biotech Inc. (MBRX)

Gained 17.65% to close Monday's trading at $1.20.

News: No news

Near-term catalyst:

-- Report data from phase II trial evaluating Annamycin as a potential treatment for relapsed or refractory acute myeloid leukemia by the second half of 2017.

7. Atara Biotherapeutics Inc. (ATRA)

Gained 17.39% to close Monday's trading at $16.20.

News: No news

Near-term catalysts:

-- Two phase III trials of ATA129 in rituximab-refractory EBV-Associated Post Transplant Lymphoproliferative Disorder (EBV-PTLD) are expected to be initiated this year. -- Initial multiple sclerosis data from phase I trial of autologous EBV-specific Cytotoxic T Lymphocytes (CTL) are expected to be presented this year.

8. Galmed Pharmaceuticals Ltd. (GLMD)

Gained 15.12% to close Monday's trading at $4.95.

News: No news

Anticipated event: The company is scheduled to report Q4 and full-year 2016 financial results on March 20, 2017.

Near-term catalyst:

-- Results from phase IIb study of Aramchol in non-alcoholic steatohepatitis, or NASH, dubbed ARREST, are anticipated to be announced in Q2 2018.

9. Kitov Pharmaceuticals Holdings LTD (KTOV)

Gained 12.43% to close Monday's trading at $1.90.

News: No news

Near-term catalyst:

-- The company's New Drug Application for KIT-302, which was developed to simultaneously treat pain caused by osteoarthritis and hypertension, is expected to be submitted to the FDA at the end of this quarter (Q1, 2017).

10. Cymabay Therapeutics Inc. (CBAY)

Gained 12.41% to close Monday's trading at $3.26.

News: No news

Near-term catalysts:

- The results from phase II study of its investigational drug Seladelpar in primary biliary cholangitis are expected in 3Q 2017. - The company's most advanced product candidate is Arhalofenate for treatment of gout, which has completed phase II studies. The drug candidate is licensed to Kowa Pharmaceuticals America, Inc. in the U.S. Licensing discussions for other territories are underway.

11. Epizyme Inc. (EPZM)

Gained 12.35% to close Monday's trading at $13.65.

News: No news

Anticipated event: Q4 and full-year 2016 financial results are expected to be reported on March 9, 2017.

Analysts polled by Thomson Reuters expect the company to incur a loss per share of $0.65 on revenue of $490 thousand in Q4, 2016. The company posted a net loss of $22.22 million or $0.53 per share on revenue of $555 thousand in Q4, 2015.

Near-term catalysts:

-- Data from a phase II study of Tazemetostat in non-Hodgkin lymphoma and another phase II study of Tazemetostat in genetically defined solid tumors are expected to be reported in the first half of 2017.

LOSERS

Cyclacel Pharmaceuticals Inc. (CYCC)

Lost 12.76% to close Monday's trading at $3.42.

New: No news

Recent event:

On Feb.23, 2017, the company announced that its phase III study of Sapacitabine in elderly patients with acute myeloid leukemia, dubbed SEAMLESS, did not reach statistically significant improvement in the primary endpoint of overall survival.

The shares have been on a decline since the failed trial news.

Argos Therapeutics Inc. (ARGS)

Lost 12.24% to close Monday's trading at $1.08.

News: No news

Recent event:

Argos' shares have been on the decline since the IDMC recommendation to discontinue the pivotal phase III trial of Rocapuldencel-T on Feb.22, 2017.

In the company's pivotal phase III trial, dubbed ADAPT, Rocapuldencel-T in combination with sunitinib/standard-of-care was tested for the treatment of metastatic renal cell carcinoma (mRCC).

Based on an interim data analysis, the Independent Data Monitoring Committee found that the study was unlikely to achieve primary endpoint, and recommended the discontinuation of the study.

Argos shares have lost more than 75% f their value since the Feb.22nd announcement.

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Aktien in diesem Artikel

Cyclacel Pharmaceuticals Inc 6 % Conv Pfd Shs 6,49 -6,48% Cyclacel Pharmaceuticals Inc 6 % Conv Pfd Shs
CymaBay Therapeutics Inc 30,00 2,04% CymaBay Therapeutics Inc
Galmed Pharmaceuticals Ltd. 2,89 5,09% Galmed Pharmaceuticals Ltd.
Kura Oncology Inc 10,25 -0,92% Kura Oncology Inc