(RTTNews) – What’s moving these stocks in the pre-market hours today?
In the Green
1. Novus Therapeutics Inc. (NVUS) is up over 158% at $0.98 in pre-market trading Tuesday, following news of its acquisition of Anelixis Therapeutics Inc., a privately-held clinical-stage biotechnology company developing a next-generation anti-CD40 Ligand (CD40L) antibody as a potential treatment for organ and cellular transplantation, autoimmune diseases, and neurodegenerative diseases.
2. Marinus Pharmaceuticals, Inc. (MRNS) is up more than 68% at $3.55 in pre-market hours, following positive top-line results from its phase III clinical trial of oral Ganaxolone in children and young adults with CDKL5 deficiency disorder (CDD), a rare, genetic epilepsy with refractory seizures. The company plans to submit an NDA for oral Ganaxolone in the treatment of CDD to the FDA in mid-2021 and a Marketing Authorization Application to the European Medicines Agency by the end of Q3 2021.
3. ARCA biopharma Inc. (ABIO) is up over 23% at $5.89 in pre-market hours today on no specific news. The company is due to file an Investigational New Drug application for AB201 as a potential treatment for COVID-19 this month and initiate a phase IIb trial as early as next quarter.
4. Immuron Limited (IMRN) is up over 9% at $8.62 in pre-market trading Tuesday. The company’s flagship product is Travelan, a novel, over the counter (“OTC”) product for the prevention of Travellers’ diarrhea.
5. Tiziana Life Sciences PLC (TLSA) is up over 10% at $3.59 in pre-market trading Tuesday. The company expects to initiate a clinical trial of TZLS-501 in COVID-19 patients by Q1 2021.
6. Cellectar Biosciences Inc. (CLRB) is up more than 8% at $1.30 in pre-market hours. The company is scheduled to make a presentation at the H.C. Wainwright 22nd Annual Global Investment Conference today at 3:30 pm Eastern Time.
7. Lipocine Inc. (LPCN) is up over 4% at $1.39 in pre-market hours. The company’s Tlando, an investigational testosterone replacement therapy, is under FDA review with a decision which was originally due on August 28. However, on August 28, the FDA informed the company that it needs some more time and that the review will be completed in the coming weeks.
8. DBV Technologies S.A. (DBVT) is up over 7% at $2.14 in pre-market hours. The company’s investigational Viaskin Peanut, a non-invasive, once-daily epicutaneous patch to treat peanut allergies in children ages 4 to 11 years, was denied FDA approval last month.
In the Red
1. Vaxart Inc. (VXRT) is down more than 6% at $7.30 in pre-market hours Tuesday, giving back some of what it gained yesterday. The stock had gained more than 46% yesterday, following FDA clearance for phase I clinical trial of its oral COVID-19 vaccine candidate. Recruitment in the study is expected to start next month.
2. Innate Pharma S.A. (IPHA) is down over 4% at $4.20 in pre-market trading Tuesday. A phase II trial of Lacutamab, dubbed TELLOMAK, for patients with Sézary syndrome and mycosis fungoides is underway. Data from this trial for mycosis fungoides is expected in 2021 and that of Sézary syndrome in 2022. A phase III trial of Monalizumab in combination with cetuximab in patients suffering from recurrent or metastatic head and neck squamous cell cancer is expected to be initiated in the second half of 2020.
3. Miragen Therapeutics, Inc. (MGEN) is down more than 3% at $0.90 in pre-market hours today. The company has appointed Lee Rauch as President and CEO, following the resignation of William Marshall. In addition, Miragen has decided to conduct a comprehensive review of available strategic alternatives with a focus on maximizing stockholder value.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.