(RTTNews) - What's moving these stocks in the pre-market hours today?
In the Green
1. Arbutus Biopharma Corp (ABUS) is up more than 11% at $3.33 in pre-market trading Tuesday, on no news. In May, the Company announced positive follow-up data from a Phase 1a/1b clinical trial of 60 mg single-dose subcutaneous injection AB-729 in patients having a chronic Hepatitis B Virus infection. The Company is also exploring an additional 90 mg single-dose cohort, with results anticipated in the second half of 2020.
2. iBio Inc. (IBIO) is up more than 18% at $7.60 in pre-market trading today. The Company has two vaccine candidates for COVID-19, under preclinical development. The two COVID-19 vaccine candidates are produced in modified tobacco leaves using a plant-based growing system known as "FastPharming." The vaccine candidates are being tested at Texas A&M University System ("TAMUS") laboratories.
3. Immuron Limited (IMRN) is up over 99% at $20.73 in pre-market trading Tuesday, adding to yesterday's gain of more than 60%. Yesterday, the Company provided an update related to the Pre-IND meeting with FDA regarding a new therapeutic against campylobacter and ETEC (E-Coli). The new therapeutic is being developed by the US DoD Naval Medical Research Center (NMRC) in collaboration with Immuron. The NMRC plans to file an investigational new drug application later this year and commence two phase II trials of the new therapeutic, a Hyper-immune product, in 2021, with one trial in moderate to severe campylobacteriosis and the other in Enterotoxigenic Escherichia coli (ETEC) infections. Immuron's flagship product is Travelan, a novel, over the counter ("OTC") product for the prevention of Travellers' diarrhea. For the third quarter of fiscal 2020, which ended on March 31, 2020, global sales of Travelan were A$983 thousand compared to A$616 thousand in the year-ago quarter.
4. Onconova Therapeutics Inc. (ONTX) is up more than 30% at $1.42 in pre-market trading on no news. The Company's lead drug candidate is Rigosertib, under a phase III trial in patients with myelodysplastic syndromes, dubbed INSPIRE. The topline survival data from the trial is expected to be reported in the second half of 2020. Last month, a phase I/IIa trial of oral Rigosertib plus Bristol-Myers' Opdivo in advanced metastatic KRAS mutated (KRAS+) lung adenocarcinoma was initiated.
5. Oragenics Inc. (OGEN) is up over 18% at $1.74 in pre-market trading. On July 10, the Company announced that it has decided to cease further development of AG013 in oral mucositis by discontinuing its phase II trial and withdrawing the applicable Investigational New Drug application. Instead, it will use the available cash to continue the development of TerraCoV2, its COVID-19 vaccine candidate with the goal of advancing it into human clinical trials by early 2021. The Company also awaits Biomedical Advanced Research and Development Authority ("BARDA") and other federal and state non-dilutive grant decisions for the development of TerraCoV2.
6. OPKO Health Inc. (OPK) is up more than 12% at $5.57 in pre-market trading on news that its BioReference Laboratories has been chosen by the CDC as one of the antibody testing and service providers for the national serological survey. Under the contract with the CDC, BioReference will perform antibody testing to determine COVID-19 seroprevalence and will provide results with key demographic information and analysis in collaboration with the CDC. The agreement's period of performance is from July 20, 2020 through November 19, 2020.
7. Qualigen Therapeutics Inc. (QLGN) is up more than 24% at $6.19 in pre-market trading on no news, adding to yesterday's gain of 13%. The Company's core FastPack System is an immunoassay testing system, which is FDA-approved and has been in use for almost 20 years. The FastPack System includes tests for prostate cancer, thyroid function, and metabolic disorders. The Company intends to commence commercial distribution of FastPack SARS-CoV-2 IgG test for COVID-19 antibodies later this month. This test has already been submitted to the FDA for Emergency Use Authorization.
8. Tonix Pharmaceuticals Holding Corp. (TNXP) is up over 24% at $1.93 in pre-market trading today. Last week, the Company entered into a research collaboration with Columbia University to develop precision medicine techniques for COVID-19 vaccines and therapeutics.
In the Red
1. Nabriva Therapeutics plc (NBRV) is down more than 10% at $0.77 on no news. Last week, the Company announced that its partner, Sunovion Pharmaceuticals Canada Inc., received approval from Health Canada to market oral and intravenous formulations of XENLETA to treat adults with community-acquired bacterial pneumonia. Sunovion acquired the rights to market XENLETA in Canada from Nabriva in March 2019. XENLETA received FDA approval for the same indication in the U.S. in August 2019. The Company's resubmitted New Drug Application seeking marketing approval of CONTEPO for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis, was turned down by the FDA last month.
2. Genetic Technologies Limited (GENE) is down more than 6% at $4.03 in pre-market trading. The Company today announced the closing of its previously announced registered direct offering of 1.02 million American Depositary Shares at a purchase price of US$5.00 per ADS or AU$0.012 per ordinary share for gross proceeds of about US$5.1 million. On July 15, the stock had soared as much as 355 percent to touch an intraday high of $10.30, following an update on the development of the Company's COVID-19 Severity Risk Test. The test is intended to predict 'disease severity' using a combination of genetic and clinical information. A provisional patent for the COVID-19 Severity Risk Test has been filed by the Company with the Patent Office in Australia. The Company has also held discussions with Centers for Medicare and Medicaid Services (CMS) and the National Association of Testing Authorities, Australia for regulatory Approval for the COVID-19 Severity Risk Test in the United States and Australia.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.