(RTTNews) – The following are some of the biotech stocks that made their way onto the Day’s Gainers & Losers’ list of June 28, 2017.
1. Cascadian Therapeutics Inc. (CASC)
Gained 18.33% to close Wednesday’s (June 28) trading at $4.26.
News: No news
The Company’s lead drug candidate is Tucatinib, under pivotal trial in patients with locally advanced or metastatic HER2-positive breast cancer, dubbed HER2CLIMB. Enrollment in this study is expected to be completed by mid-2019.
As for the regulatory strategy of Tucatinib for Europe is concerned, the Company plans to seek scientific advice from European Medicines Agency in the second half of this year.
Tucatinib is designated orphan drug by the FDA for the treatment of breast cancer patients with brain metastases.
2. Ra Pharmaceuticals Inc. (RARX)
Gained 12.38% to close Wednesday’s trading at $19.88.
News: The Company reported encouraging data from its global phase II study of RA101495 for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). In the phase II study, no safety or tolerability concerns were associated with RA101495, and no injection site reactions were observed. There was near-complete inhibition of hemolytic activity and rapid declines in lactate dehydrogenase (LDH).
Moreover, there was 100% compliance with once daily, subcutaneous self-administration, noted the Company. It must be noted that Soliris, the only approved treatment for PNH must be administered intravenously every two weeks by healthcare professionals.
3. Esperion Therapeutics Inc. (ESPR)
Gained 10.38% to close Wednesday’s trading at $48.28.
On June 26, 2017, the Company announced that the FDA recently confirmed the regulatory pathway to approval for the once-daily, oral combination pill of bempedoic acid 180 mg and Merck’s approved drug, Zetia (ezetimibe) for the treatment of cholesterol.
Based on the FDA feedback, Esperion plans to initiate a single global pivotal phase III bridging study for the bempedoic acid /ezetimibe combination pill in the fourth quarter of this year that will be conducted concurrently with the ongoing global pivotal phase III program for bempedoic acid.
The study is expected to enroll up to 350 patients with hypercholesterolemia and with atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH), including high cardiovascular risk primary prevention patients, whose LDL-C is not adequately controlled. The top line results from the planned study are expected by the end of 2018.
4. Ascendis Pharma A/S (ASND)
Gained 10.35% to close Wednesday’s trading at $27.71.
News: No news
— Enrollment in the Company’s phase III trial of TransCon Growth Hormone in pediatric growth hormone deficiency, dubbed heiGHt, is expected to be completed in the fourth quarter of 2017. — Phase I study of TransCon PTH for hypoparathyroidism is expected to be initiated in Q3, 2017. — IND or equivalent filing of TransCon CNP for Achondroplasia is expected in Q4, 2017.
5. TRACON Pharmaceuticals Inc. (TCON)
Gained 10.11% to close Wednesday’s trading at $2.45.
News: No news
The Company’s most advanced drug candidate is TRC105 for angiosarcoma, which is under phase III testing. It is also under phase II trials in the indications of renal cancer, liver cancer and Gestational Trophoblastic Neoplasia. Phase I studies of TRC105 in lung and breast cancers are underway.
The other investigational drugs are: — TRC102 for Glioblastoma and Mesothelioma under phase II testing — TRC102 for lung and solid tumors under phase I trials — DE-122 wet AMD under a phase 1/2 study, dubbed PAVE, in partnership with Santen Pharmaceutical Co. Ltd. — TRC253, in-licensed from Janssen, under phase 1/2 trial in prostate cancer.
— Complete DE-122 Phase 1/2 PAVE study in wet AMD in the second half of 2017. — Initiate dosing in DE-122 Phase 2 AVANTE study in wet AMD in the second half of 2017. — Top-line data from TRC105 randomized Phase 2 trial in renal cancer in the second half of 2017. — Complete dose escalation in TRC253 Phase 1/2 trial in prostate cancer in the second half of 2017.
1. Flex Pharma Inc. (FLKS)
Lost 10.12% to close Wednesday’s trading at $3.82.
The Company’s lead drug candidate is FLX-787, under phase II studies for Multiple Sclerosis and Amyotrophic Lateral Sclerosis in Australia.
— Initiate phase II parallel-design studies of FLX-787 for Amyotrophic Lateral Sclerosis and Charcot-Marie-Tooth in the U.S. this year. — Data readout from the Australian exploratory phase II study of FLX-787 in Multiple Sclerosis is expected by this year-end.
2. Alder Biopharmaceuticals Inc. (ALDR)
Lost 9.83% to close Wednesday’s trading at $12.15. This is the second straight day of loss after reporting positive results from PROMISE trial.
News: No news
On June 27, 2017, the Company reported positive results from its phase III pivotal clinical trial of Eptinezumab for migraine prevention, dubbed PROMISE.
The primary endpoint, demonstrating statistically significant reductions in monthly migraine days from baseline over weeks 1 through 12 was 4.3 monthly migraine days for 300mg and 3.9 days for 100mg compared to an average 3.2 days for placebo.
The second pivotal phase III study that focuses on chronic migraine, dubbed PROMISE 2, is enrolling participants, and the Company expects to submit the BLA for Eptinezumab in the second half of 2018.
Despite the positive results, the stock fell nearly 28% on June 27, 2017 as investors were disappointed with the data.
3. Omeros Corp. (OMER)
Lost 9.48% to close Wednesday’s trading at $20.34.
News: No news
Recent events: — On June 13, 2017, the FDA granted breakthrough therapy designation to the Company’s investigational drug OMS721 for the treatment of Immunoglobulin A (IgA) nephropathy. — On May 17, 2017, the Company reported additional positive results from the first stage of its phase II clinical trial of OMS721 for the treatment of serious kidney disorders.
The Company is preparing for its Phase 3 clinical trial of OMS721 in IgA nephropathy, and is continuing to conduct the second stage of its ongoing Phase 2 clinical trial in which OMS721 is evaluated in non-steroid-treated patients with IgA nephropathy.
OMS721 is also being evaluated in a Phase 3 clinical program for atypical hemolytic uremic syndrome and in a Phase 2 clinical program for hematopoietic stem cell transplant-associated thrombotic microangiopathy.
4. Minerva Neurosciences Inc. (NERV)
Lost 7.56% to close Wednesday’s trading at $7.95.
News: The Company has priced its public offering of 5 million shares of its common stock at $7.75 each.
Proceeds to Minerva from the offering are expected to be approximately $38.75 million. The offering is expected to close on or about July 5th, 2017, subject to customary closing conditions.
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