07.03.2017 02:00:36

Gainers & Losers Of Mar.6: TGTX, CNCE, DXTR, KURA, ARGS...

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of March 6, 2017.

GAINERS

1. TG Therapeutics Inc. (TGTX)

Gained 90.65% to close Monday's (Mar.6) trading at $10.20.

News: The Company's phase III trial of TG-1101 in patients with high risk Chronic Lymphocytic Leukemia met its primary endpoint.

In the trial, dubbed GENUINE, TG-1101 in combination with Ibrutinib increased the Overall Response Rate by more than 70% over Ibrutinib alone.

A full analysis of the GENUINE data along with detailed efficacy and safety results will be submitted for presentation at a medical meeting in the first half of 2017.

2. Concert Pharmaceuticals Inc. (CNCE)

Gained 62.07% to close Monday's trading at $15.64.

News: The Company's investigational cystic fibrosis drug CTP-656 is to be acquired by Vertex Pharmaceuticals Inc. (VRTX)

Vertex will pay Concert $160 million in cash for all worldwide development and commercialization rights to CTP-656.

CTP-656 is currently in a phase II study in people with CF who have gating mutations. If CTP-656 is approved as part of a combination regimen to treat CF, Concert could receive up to an additional $90 million in milestones based on regulatory approval in the U.S. and reimbursement in the UK, Germany or France.

As part of the agreement, Vertex will acquire rights to all of Concert's other CF research and preclinical programs.

3. Dextera Surgical Inc. (DXTR)

Gained 30.70% to close Monday's trading at $1.49.

News: The Company reported encouraging data related to Microlobectomy procedure, enabled by the company's MicroCutter 5/80 surgical stapler. The results were that of 82 patients undergoing Microlobectomy.

According to the study results, for Microlobectomy procedures, the median hospital stay is reduced by at least two days compared to traditional open lobectomy procedures, with over 20 percent of patients going home the day after surgery.

The company's MicroCutter 5/80 surgical stapler for minimally invasive surgical procedures was launched last November.

4. Bellerophon Therapeutics Inc. (BLPH)

Gained 26.43% to close Monday's trading at $1.77.

News: No news

Near-term catalyst:

The company's proprietary technology is known INOpulse. The results from the two phase II trials of INOpulse therapy - pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (PH-COPD) and idiopathic pulmonary fibrosis (PH-IPF) - are expected to be reported this month.

5. BioScrip Inc. (BIOS)

Gained 23.37% to close Monday's trading at $2.27.

News: No news

Recent event: On March 3, 2017, the company reported Q4 and full-year 2016 financial results.

For the full-year 2017, BioScrip expects revenues to be in the range of $920.0 million to $950.0 million and adjusted EBITDA in the range of $45.0 million to $55.0 million. The company reported revenue of $935.6 million and adjusted EBITDA of $30.9 million in 2016.

6. Pieris Pharmaceuticals Inc. (PIRS)

Gained 18.92% to close Monday's trading at $2.64.

News: The Company is all set to present IND-enabling data, informing the trial design of a first-in-patient clinical trial for PRS-343 on April 4, 2017.

PRS-343 is being developed as the first 4-1BB based therapeutic to mediate the activation of tumor-specific T lymphocytes selectively within the tumor microenvironment (TME). 4-1BB is a potent costimulatory immunoreceptor and an established marker for tumor-specific infiltrating T lymphocytes (TILs), and is, therefore, an attractive target for cancer immunotherapy, according to the company.

7. Dipexium Pharmaceuticals, Inc. (DPRX)

Gained 17.39% to close Monday's trading at $1.35.

News: No news

Recent event: On December 22, 2016, Dipexium Pharma and privately held PLx Pharma Inc. entered into a definitive agreement under which PLx Pharma will merge with a wholly-owned subsidiary of Dipexium in an all-stock transaction.

The merger is expected to close during the second quarter of 2017. Following closing, Dipexium will be renamed PLx Pharma Inc.

8. Flex Pharma Inc. (FLKS)

Gained 16.35% to close Monday's trading at $4.91.

News: No news

Anticipated event:

The company is slated to report Q4 and full-year 2016 results on March 8, 2017.

Flex Pharma's most advanced product candidate is FLX-787, which is under exploratory Phase 2 studies in amyotrophic lateral sclerosis and multiple sclerosis in Australia. Results from the exploratory multiple sclerosis are expected to be reported by year end 2017.

9. Aurinia Pharmaceuticals Inc. (AUPH)

Gained 11.43% to close Monday's trading at $5.36.

News: The Company's AURA-LV 48-week data have been accepted for a late-breaking oral presentation at the National Kidney Foundation 2017 Spring Clinical Meetings.

AURA-LV is a phase IIb trial that evaluated the efficacy and safety of Voclosporin against placebo in achieving remission in patients with lupus nephritis.

On March 1, 2017, the company reported encouraging 48-week results from the AURA-LV trial.

At Week 48, the AURA-LV trial met the complete and partial remission endpoints, demonstrating statistically significantly greater complete remission (CR) and partial remission (PR) in patients in both low dose (23.7mg of Voclosporin twice daily) and high dose (39.5mg twice daily) cohorts versus the control group.

10. Merus B.V. (MRUS)

Gained 9.44% to close Monday's trading at $32.23.

News: No news

Near-term catalyst:

The company's key drug candidate is MCLA-128, whose potential is being explored in phase I/II trials in breast, colorectal and ovarian cancers.

Interim results from Part 2 of the phase I/II clinical trial of MCLA-128 in breast cancer are expected to be reported this month.

LOSERS

1. Kura Oncology Inc. (KURA)

Lost 27% to close Monday's trading at $7.30.

News: The Company presented updated results from its ongoing, phase II trial of Tipifarnib in HRAS mutant squamous cell carcinomas of the head and neck.

According to the company, as of February 28, 2017, two patients with HRAS mutant SCCHN with objective responses remain on study and are currently at treatment cycle 19 and cycle 12. Among the five patients with HRAS mutant salivary gland cancer, although no objective responses were observed, three patients experienced disease stabilization and were on study for 9, 10 and 14 cycles. In addition, Tipifarnib was generally well tolerated with adverse events consistent with its known safety profile.

2. CytomX Therapeutics Inc. (CTMX)

Lost 27% to close Monday's trading at $7.30.

News: No news

Near-term catalyst:

Enrollment in a Phase 1/2 clinical trial of the company's drug candidate CX-072 as monotherapy and in combination with Yervoy or Zelboraf in patients with all types of cancers, dubbed PROCLAIM-072, is underway. Clinical data is expected to begin to emerge in late 2017, and throughout 2018.

The company is expected to file IND for CX-2009 a first-in-class Probody drug conjugate targeting the highly expressed tumor antigen CD166, in the first half of 2017.

3. Spring Bank Pharmaceuticals Inc. (SBPH)

Lost 11.53% to close Monday's trading at $9.82.

News: No news

Near-term catalyst: Initial results from the first dosing cohort in phase II trial of SB9200 in chronic Hepatitis B, dubbed ACHIEVE, are expected in the second quarter of 2017.

4. Argos Therapeutics Inc. (ARGS)

Lost 10.34% to close Monday's trading at $1.30.

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.

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Aktien in diesem Artikel

CytomX 1,01 -2,88% CytomX
Kura Oncology Inc 9,02 -1,55% Kura Oncology Inc
Merus B.V. 40,20 0,50% Merus B.V.
TG Therapeutics Inc 30,13 3,47% TG Therapeutics Inc