WASHINGTON (dpa-AFX) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of June 19, 2017.
1. Arena Pharmaceuticals Inc. (ARNA)
Gained 970.99% to close Monday's (June 19) trading at $14.03.
News: The Company's common stock began trading on a 1-for-10 reverse split adjusted basis beginning with the opening of trading today.
-- Data readout from a phase I trial comparing current twice-daily formulation of Ralinepag with a new once-daily formulation in healthy volunteers are expected in current quarter. -- Data readout from a phase II trial of Ralinepag in pulmonary arterial hypertension expected in July 2017. -- Data readout from a phase II trial of Etrasimod in ulcerative colitis expected by year-end 2017.
2. Novadaq Technologies Inc. (NVDQ) (NDQ.TO)
Gained 95% to close Monday's trading at $11.70.
News: The Company has agreed to be acquired by Stryker Corp.
Stryker has agreed to acquire Novadaq for US$11.75 per share in cash, implying a total equity value of approximately US$701 million.
The transaction will be carried out by way of a court approved plan of arrangement under the Canada Business Corporations Act.
3. Clovis Oncology Inc. (CLVS)
Gained 46.54% to close Monday's trading at $87.88.
News: The Company's confirmatory phase 3 trial of Rucaparib in ovarian cancer, dubbed ARIEL3, met the primary endpoint in all three primary efficacy analyses: tumor BRCA-mutant, HRD-positive and overall intent-to-treat populations.
Rucaparib received FDA approval last December as monotherapy for treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more prior chemotherapies.
The Company intends to submit a sNDA for Rucaparib as a second line or later maintenance treatment indication in ovarian cancer based on the ARIEL3 data within the next four months, and also files a Marketing Authorization Application (MAA) in Europe for the maintenance indication.
4. ReWalk Robotics Ltd. (RWLK)
Gained 44% to close Monday's trading at $1.80.
News: The Company showcased the prototype, called Restore, for a soft suit exoskeleton intended to assist stroke survivors on Yahoo Finance.
Restore is developed in collaboration with Harvard's Wyss Institute. The Company announced a focus on the development of the soft suit as its core goal for FY2017. Anticipated delivery of a commercial Restore soft suit is slated for 2018.
5. NantHealth Inc. (NH)
Gained 21.85% to close Monday's trading at $4.35.
News: No news
NantHealth is a personalized healthcare company. It derives revenue from sales of licensed software and maintenance, software-as-a-service, hardware, services, and its universal diagnostics solution GPS Cancer to healthcare providers, payors and self-insured employers. The Company made its debut on the NASDAQ Global Select Market on June 2, 2016, offering its shares at a price of $14.00 each.
On May 10th, the Company reported financial results for its first quarter ended March 31, 2017.
Net loss widened to $41.1 million or $0.34 per share in Q1, 2017 from $33.1 million or $0.36 per share in the year-ago quarter. For the 2017 first quarter, total net revenue increased 16% to $22.5 million from $19.5 million in Q1, 2016.
6. Mirati Therapeutics Inc. (MRTX)
Gained 13.33% to close Monday's trading at $3.40.
News: No news
The company's clinical programs include Glesatinib, under phase II study in non-small cell lung cancer; Sitravatinib, under phase 1b trial for the treatment of genetically-selected non-small cell lung cancer and other solid tumors, and Mocetinostat, under a phase 1b/2 trial in patients with advanced solid tumors and NSCLC.
-- Additional update on the Glesatinib program is expected in the second half of 2017 -- Additional update on the Sitravatinib program is anticipated in Q3 2017 and -- Additional update on the Mocetinostat program is expected in mid-year 2017.
7. Intellia Therapeutics Inc. (NTLA)
Gained 14.30% to close Monday's trading at $14.07.
Intellia is a genome editing company, focused on the development of proprietary, potentially curative therapeutics using the CRISPR/Cas9 system.
News: China's State Intellectual Property Office has indicated that it will grant the Company a patent broadly covering CRISPR/Cas9 single-guide gene editing methods and compositions.
The European Patent Office and the United Kingdom's Intellectual Property Office have previously issued patents from the same underlying international patent application.
8. Bellicum Pharmaceuticals Inc. (BLCM)
Gained 13.86% to close Monday's trading at $12.90.
News: No news
The company's lead product candidate is BPX-501, which is being evaluated in multiple phase 1/2 clinical trials in adults and pediatric patients with leukemias, lymphomas, and genetic blood diseases in the U.S. and Europe.
9. Fibrocell Science Inc. (FCSC)
Gained 13.92% to close Monday's trading at $3.52.
News: No news
On June 12, 2017, the Company's gene therapy candidate for the treatment of moderate to severe localized scleroderma FCX-013 was granted Rare Pediatric Disease Designation by the FDA.
The Rare Pediatric Disease Designation augments the Orphan Drug Designation previously granted by the FDA to FCX-013 for the treatment of localized scleroderma, which includes linear scleroderma.
-- The Company expects to submit an investigational new drug application for FCX-013 to the FDA in the fourth quarter of 2017.
1. Celsion Corp. (CLSN)
Lost 23.44% to close Monday's trading at $2.45.
News: The Company has announced a $5.4 million registered direct offering.
An aggregate of about 2 million shares of common stock, or pre-funded warrants in lieu thereof, will be sold in the registered direct offering at a price of $2.75 per common share or warrant share, respectively.
The closing of this offering is expected to take place on or about June 22, 2017.
2. Kura Oncology Inc. (KURA)
Lost 9.43% to close Monday's trading at $7.20.
News: No news
Kura Oncology's lead drug candidate is Tipifarnib, which is currently being studied in multiple Phase 2 clinical trials.
-- Additional data from Phase 2 trial of Tipifarnib in HRAS mutant SCCHN Squamous Cell Carcinoma of the Head and Neck expected in the second half of 2017. -- Additional preclinical and clinical data for Tipifarnib in PTCL (Peripheral T-cell Lymphoma), anticipated in the second half of 2017. -- Data from Phase 2 trial of Tipifarnib trials in lower risk myelodysplastic syndromes (MDS) and in chronic myelomonocytic leukemia (CMML) are anticipated in the first half of 2018.
3. Roka Bioscience Inc. (ROKA)
Lost 7.41% to close Monday's trading at $2.50.
News: No news
Last month, the Company reported first quarter 2017 financial results.
Net loss for the first quarter of 2017 was $7.6 million or $1.53 per share compared with a net loss of $8.2 million, or $4.66 per share in the first quarter of 2016.
Revenue for the recent first quarter was $2.0 million compared with $1.6 million for the first quarter of 2016 and $1.9 million for the fourth quarter of 2016.
As of March 31, 2017, the Company had cash and cash equivalents and marketable securities of $16.2 million.
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