What’s moving these stocks in the pre-market hours today?
In the Green
1. Shares of CTI BioPharma Corp. (CTIC) are up over 168% at $2.82 in pre-market trading Wednesday on news that the company is all set to proceed with the rolling New Drug Application submission for the potential accelerated approval of Pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia. The completion of NDA submission is expected in Q1, 2021. Pacritinib is also being tested in a phase III trial in hospitalized patients with severe COVID-19.
2. Seelos Therapeutics Inc. (SEEL) is up more than 24% at $1.29 in pre-market hours today on no news. The company has two drug candidates in clinical testing – SLS-002, which is expected to enter into a Proof of Concept (PoC) study for Acute Suicidal Ideation and Behavior in patients with Major Depressive Disorder, in the fall of 2020 and SLS-005, under a phase IIb/III trial for the treatment of Amyotrophic lateral sclerosis or Lou Gehrig’s disease. Last week, the company entered into a research agreement with Duke University for gene therapy studies of SLS-004 in Parkinson’s disease. SLS-004 is under preclinical testing.
3. Ra Medical Systems Inc. (RMED), a medical device company, is up over 23% at $0.35 in pre-market hours today on no news. For the second quarter of 2020, the results of which were announced last month, net revenue was $0.9 million compared to $2.2 million in the year-ago quarter.
4. Bionano Genomics Inc. (BNGO) is up over 10% at $0.66 in pre-market trading Wednesday, on news that the company’s Saphyr system has been adopted by two renowned hospitals in Australia and Slovenia to improve the diagnosis and treatment of leukemias. The two hospitals are the Royal North Shore Hospital in Northern Sydney, New South Wales, Australia; and the University Medical Center Ljubljana in Ljubljana, Slovenia.
5. Evogene Ltd. (EVGN), a computational biology company targeting to revolutionize product development for life-science based industries, is up over 10% at $4.49 in pre-market trading Wednesday on no news. Early this month, the company received a $10 million equity investment by ARK Investment Management, LLC and Alpha Capital Anstalt.
6. Eton Pharmaceuticals Inc. (ETON) is up over 7% at $8.37 in pre-market trading today on news of FDA approval of ALKINDI SPRINKLE oral granules as replacement therapy for Adrenocortical Insufficiency in children under 17 years of age. The product is expected to be available in the fourth quarter of 2020, and its market opportunity in the United States is estimated to be greater than $100 million annually.
7. Genfit SA (GNFT) is up over 6% at $5.80 in pre-market hours on no news. The company inked a five-year exclusive licensing agreement with LabCorp (LH) for NASH diagnostic test on Sep.28, which sent the stock up over 30% to $5.50 that day. As part of the deal, LabCorp will develop and commercialize a blood-based molecular diagnostic test powered by GENFIT’s NIS4 technology throughout the U.S. and Canada to help identify patients with at-risk non-alcoholic steatohepatitis (NASH). The diagnostic test is expected to be available from LabCorp by early 2021.
In the Red
1. Adial Pharmaceuticals Inc. (ADIL) is down over 17% at $2.50 in pre-market trading Tuesday, giving back some of what is gained yesterday. The company’s Assure/FaStep COVID-19 IgG/IgM Rapid Test Device was given emergency use authorization by the FDA yesterday, which sent the stock soaring over 100% to $3.03.
2. Acasti Pharma Inc. (ACST) is down more than 5% at $0.20 in pre-market hours. Yesterday, the company announced that it has commenced a formal process to explore and evaluate strategic alternatives to enhance shareholder value and that it has engaged Oppenheimer & Co., Inc., as its financial advisor to assist in the process.
3. Tonix Pharmaceuticals Holding Corp. (TNXP) is down over 6% at $0.83 in pre-market hours on no news. The company is conducting a phase III study of TNX-102 SL 5.6 mg for the management of fibromyalgia, dubbed RELIEF. The topline results from this study are anticipated in the fourth quarter of 2020. Another phase III trial of TNX-102 SL for the management of fibromyalgia, named RALLY, is also underway, with topline data expected in the second half of 2021. The company’s lead vaccine candidate for COVID-19 is TNX-1800, which is under animal studies, with data anticipated in the fourth quarter of this year.
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