30.03.2018 04:57:07
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FOMX To Report Data In Q3, INNT Continues To Sizzle, All Eyes On GALT
(RTTNews) - The following are some of today's top gainers in the pharma/biotech sector.
1. Galectin Therapeutics Inc. (GALT)
Gained 25.40% to close Thursday's (Mar.29) trading at $4.74.
News: The Company reported financial results for the year ended December 31, 2017.
For the year ended December 31, 2017, the net loss applicable to common stockholders narrowed to $17.5 million or $0.49 per share from $22.4 million or $0.76 per share for 2016.
Near-term Catalysts:
-- The Company will be meeting with the FDA in early May 2018 to present the results of its phase IIb trial results of its proprietary compound GR-MD-02 in patients with NASH with cirrhosis. The purpose of the meeting is to seek agreement on a plan for a Phase 3 clinical trial. -- The Company has filed a request with the FDA to grant GR-MD-02 Breakthrough Therapy Designation as therapy for patients with NASH cirrhosis without esophageal varices. -- The Company has been selected to make an oral presentation at the International Liver Meeting in April 2018 in Paris. -- Discussions with a number of pharmaceutical companies about potential partnerships are underway.
2. Avid Bioservices Inc. (CDMO)
Gained 17.74% to close Thursday's trading at $2.92.
News: No news
Recent event:
-- On March 12, 2018, the Company reported financial results for the third quarter of fiscal year 2018 ended January 31, 2018. The Company was formerly known as Peregrine Pharmaceuticals Inc.
Avid's consolidated net loss attributable to common stockholders widened to $12.4 million or $0.28 per share for the third quarter of FY 2018 from $9.2 million or $0.25 per share for the same prior year quarter.
Contract manufacturing revenue from Avid's clinical and commercial biomanufacturing services was $6.8 million for the third quarter of FY 2018 compared to $10.7 million for the third quarter of FY 2017.
Looking ahead, the Company expects full fiscal year 2018 revenue to range between $50.0 million to $55.0 million. The full year fiscal 2017 revenue was $57.63 million.
3. Avinger Inc. (AVGR)
Gained 14.66% to close Thursday's trading at $1.33.
Avinger is a commercial-stage medical device company that designs, manufactures and sells image-guided, catheter-based systems that are used by physicians to treat patients with peripheral arterial disease, or PAD.
News: The Company announced that three patients have been successfully treated using its next generation image-guided atherectomy device with enhanced tissue removal capacity for treatment of peripheral artery disease.
This new device qualifies for commercial sale in the European Union under the existing CE Marking for Pantheris, noted the Company.
4. pSivida Corp. (PSDV)
Gained 14.02% to close Thursday's trading at $1.22.
News: The Company has acquired Icon Bioscience Inc., a privately-held specialty biopharmaceutical company whose lead product DEXYCU 9% is FDA approved for postoperative inflammation and is administered as a single dose at the end of ocular surgery.
Near-term Catalysts:
-- Effective April 2, 2018, pSivida takes on the name EyePoint Pharmaceuticals, and will trade under the new NASDAQ ticker symbol "EYPT". -- The Company plans to launch DEXYCU in the U.S. in the first half of 2019 following the successful scale up of commercial supplies. -- The Company's NDA for Durasert micro-insert for treatment of non-infectious posterior segment uveitis is under FDA review, with a decision expected on November 5, 2018.
5. Foamix Pharmaceuticals Ltd. (FOMX)
Gained 14% to close Thursday's trading at $5.13.
News: No news
Near-term Catalysts:
-- Top-line results from phase III study of FMX101 (Minocycline foam 4%) in patients with moderate-to severe acne are expected in the third quarter of 2018. -- Top-line results from two phase III studies of FMX103 (1.5% minocycline foam) in patients with moderate-to severe papulopustular rosacea are expected in late third quarter or early fourth quarter of 2018.
6. Aeglea BioTherapeutics Inc. (AGLE)
Gained 12.73% to close Thursday's trading at $9.92.
News: No news
Recent event:
-- On March 12, 2018, the Company reported encouraging repeat dose data from its phase 1/2 clinical trial of Pegzilarginase for two adult patients and single ascending dose data for one pediatric patient with Arginase 1 Deficiency.
Arginase 1 deficiency, a rare inherited disorder, is characterized by gradual accumulation of ammonia in the blood.
Near-term Catalyst:
-- Additional Arginase 1 Deficiency clinical data is expected to be presented at the 2018 ACMG Annual Clinical Genetics Meeting in April.
7. Innovate Biopharmaceuticals Inc. (INNT)
Gained 12.44% to close Thursday's trading at $27.38. The stock has gained over 420% this month.
News: No news
Pipeline:
The lead drug candidate is Larazotide acetate (INN-202), which has successfully met its primary endpoint in a phase 2b efficacy clinical trial for celiac disease. Also in the pipeline is INN-108, indicated for mild to moderate ulcerative colitis, which is entering Phase 2 trials this year, and INN-329, entering phase 3 trial for Magnetic Resonance Cholangiopancreatography (MRCP).
Near-term Catalyst:
-- Larazotide acetate is expected to move into phase III clinical trials in celiac disease in Q2 2018.
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Aktien in diesem Artikel
Avid Bioservices Inc Registered Shs | 11,70 | 0,00% | |
Galectin Therapeutics Inc | 1,99 | 8,15% |