What’s moving these stocks in pre-market hours today?
In the Green
1. Ocugen Inc. (OCGN) is up nearly 79% at $3.29 in pre-market hours Monday. The company along with India-based Bharat Biotech is co-developing Covaxin, a Covid-19 vaccine. The vaccine was approved for emergency use in India yesterday. A vaccine scientific advisory board comprised of leading academic and industry experts in the vaccine field was appointed by Ocugen last month to evaluate the clinical and regulatory path to approval of Covaxin in the US market.
2. Bionano Genomics Inc. (BNGO) is up nearly 60% at $4.91 in pre-market hours today, adding to last week’s gain of 250%. On Dec.30, the Nasdaq granted the company an additional 180-day compliance period, or until June 28, 2021, for it to regain compliance with the minimum $1.00 closing bid price per share requirement. Saphyr system, the company’s flagship product, is used for basic and translational research of DNA.
3. Check-Cap Ltd. (CHEK) is up over 56% at $0.72 in pre-market trading today on no news. The company is developing C-Scan, the first and a patient-friendly preparation-free screening test to detect polyps before they may transform into colorectal cancer. An Investigational Device Exemption (IDE) application was submitted to the FDA on November 18, 2020 for pivotal study of C-Scan.
4. Jaguar Health Inc. (JAGX) is up over 20% at $0.97 in pre-market trading on no news. The company markets Mytesi, an FDA-approved product, for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy.
5. AzurRx BioPharma Inc. (AZRX) is up more than 12% at $1.09 in pre-market hours on no news. A phase IIb trial evaluating the company’s investigational drug, MS1819, as a monotherapy and a phase II trial in combination with the current standard of care, porcine-derived pancreatic enzyme replacement therapy (PERT), for the treatment of severe exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis are underway. The topline data from the monotherapy trial is expected this quarter and that from the combination therapy trial are anticipated in the second quarter of this year.
In the Red
1. Aethlon Medical Inc. (AEMD) is down nearly 9% at $2.25 in pre-market trading on no news. The first-in-human Early Feasibility Study (EFS) evaluating the company’s HEMOPURIFIER in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck is underway. Last June, the FDA approved a supplement to the existing Investigational Device Exemption for the Hemopurifier in viral disease to allow for the testing of the device in patients with SARS-CoV-2/COVID-19 in a new feasibility study. The SARS-CoV-2 trial is expected to be initiated this year.
2. AIkido Pharma Inc. (AIKI) is down over 7% at $0.81 in pre-market hours on no news. The company is currently in the process of developing an innovative therapeutic drug platform through partnerships.
3. Immutep Limited (IMMP) is down over 6% at $2.95 in pre-market trading Monday. The company has announced the resignation of Tom Bloomfield as the joint Company Secretary. Ms Indira Naidu has been appointed as the new Joint Company Secretary, effective today.
4. SELLAS Life Sciences Group Inc. (SLS) is down over 5% at $5.49 in pre-market trading Monday on no news. Last month, the company announced promising initial data from two clinical studies of Galinpepimut-S (GPS) in combination with checkpoint inhibitor therapies in patients with two different types of advanced solid cancers who had exhausted their standard therapy options. A phase 3 study of GPS in patients with AML who have achieved complete remission after second-line anti-leukemic therapy (CR2), dubbed REGAL, is ongoing, with interim data readout scheduled for late 2021 or early 2022.
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