08.03.2017 03:48:52
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Gainers & Losers Of Mar.7: AUPH, KURA, TEAR, AXSM, AKBA...
(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of March 7, 2017.
GAINERS
1. Aurinia Pharmaceuticals Inc. (AUPH)
Gained 32.46% to close Tuesday's (Mar.7) trading at $7.10.
News: No news
Recent event: On March 6th, the Company announced that it will be presenting its AURA-LV Phase IIb 48-week data of Voclosporin for the treatment of lupus nephritis at the National Kidney Foundation (NKF) 2017 Spring Clinical Meeting on April 20, 2017.
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.
2. Kura Oncology Inc. (KURA)
Gained 30.82% to close Tuesday's trading at $9.55, reversing yesterday's loss.
News: No news
Recent event: On March 6th, 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.
Anticipated event: The Company is scheduled to report Q4 and full year 2016 financial results after the close of U.S. financial markets on March 14, 2017.
3. Moleculin Biotech Inc. (MBRX)
Gained 16.04% to close Tuesday's trading at $1.23.
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.
4. Genocea Biosciences Inc. (GNCA)
Gained 11.85% to close Tuesday's trading at $5.57.
News: No news
Near-term catalysts:
-- End-of-phase II meeting with the FDA related to GEN-003 for the treatment of genital herpes infections this month. The company reported positive efficacy data from its Phase 2 clinical trial of GEN-003 last March and positive 6-month results from its Phase 2b clinical trial of GEN-003 in January of this year. -- Report 24-month data from Phase 2 clinical trial of GEN-003 in genital herpes in the second-half of 2017. -- Report 12-month data from phase 2b trial of GEN-003 in genital herpes in the second-half of 2017. -- Initiate phase III program of GEN-003 in genital herpes in Q4, 2017.
5. TearLab Corp. (TEAR)
Gained 10.18% to close Tuesday's trading at $4.60.
News: The Company's next-generation system has been granted CE Marking.
The TearLab next-generation platform offers eye care professionals the ability to assess multiple biomarkers in human tears with a single nanoliter volume tear collection.
Seph Jensen, CEO of TearLab added, "CE Marking of our next-generation platform is a groundbreaking achievement for TearLab. This platform offers a safe, convenient and quantitative method to diagnose diseases using human tears. This platform will allow us to iterate various disposable tests aimed at diagnosing both eye related and other systemic diseases without the need to replace and develop hardware for each new test.
LOSERS
President Trump's tweet "I am working on a new system where there will be competition in the Drug Industry. Pricing for the American people will come way down!" on March 7 at 5.45 am did send many of biotech stock prices lower.
1. Rennova Health Inc. (RNVA)
Lost 18.92% to close Tuesday's trading at $2.40.
News: No news
Recent event: A 1 for 30 reverse stock split of the company's common stock came into effect on February 23, 2017. The reverse stock split is intended to increase the per share trading price of the company's common stock to satisfy the $1.00 minimum bid price requirement for continued listing on The NASDAQ Capital Market.
2. Akebia Therapeutics Inc. (AKBA)
Lost 12.78% to close Tuesday's trading at $8.94.
News: The Company reported Q4 and full-year 2016 financial results
The net loss for Q4, 2016 widened to $37.9 million or $0.99 from $19.9 million or $0.66 per share in the year-ago quarter.
The company recognized collaboration revenue of $1.5 million for the fourth quarter of 2016, related to its agreement with Otsuka Pharmaceuticals for lead drug candidate Vadadustat. The deal, valued at over $1 billion, was executed on December 18, 2016.
Vadadustat is Akebia's lead product candidate currently in phase III development for the treatment of anemia associated with chronic kidney disease (CKD).
In December 2015, Akebia had signed a deal worth $350 million with Mitsubishi Tanabe Pharma to develop and commercialize Vadadustat in Asia. As per the deal terms, Akebia received $40 million in January 2016.
In a conference call held today, Jason Amello, the company CFO, said that the collaboration revenue in connection with the agreement with Mitsubishi Tanabe is expected to commence in the second half of 2017, following the results of its phase II studies being conducted in Japan. Even at the end of 2016, the $40 million received as upfront payment still remains as deferred revenue. (Source: Thomson Reuters StreetEvents).
3. Dextera Surgical Inc. (DXTR)
Lost 12.08% to close Tuesday's trading at $1.31. It's a pullback after a gain of 30% on March 6.
News: No news
Recent event: On March 6, 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. BioScrip Inc. (BIOS)
Lost 11.45% to close Tuesday's trading at $2.01. It's a pullback after a gain of over 23% on March 6.
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.
5. Axsome Therapeutics Inc (AXSM)
Lost 9.18% to close Tuesday's trading at $4.45.
News: The Company reported Q4 and full-year 2016 financial results.
Net loss in Q4, 2016 widened to $7.3 million or $0.38 per share from $3.4 million or $0.23 per share in the year-ago period.
Near-term catalysts:
-- Interim analysis results from a phase III trial of AXS-02 in knee osteoarthritis associated with bone marrow lesions, dubbed COAST-1, expected in 3Q, 2017. -- Interim efficacy analysis of a phase III trial of AXS-02 in Complex Regional Pain Syndrome, dubbed CREATE-1, in 4Q, 2017. -- Top line data from a phase III trial of AXS-05 for treatment resistant depression, dubbed STRIDE-1, anticipated in 1Q, 2018.
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Aktien in diesem Artikel
Akebia Therapeutics Inc | 1,93 | -2,77% | |
Axsome Therapeutics Inc | 93,88 | 1,38% | |
Kura Oncology Inc | 10,26 | 0,89% |