Pre-market Movers In Healthcare Sector: HUGE, ADXS, DBVT, AEZS, BNTX…

(RTTNews) - What's moving these stocks in the pre-market hours today?

In the Green

1. FSD Pharma Inc. (HUGE) is up over 26% at $1.72 in pre-market trading Tuesday on no news. On September 25, the company received FDA clearance to initiate a phase 2 clinical trial for the use of FSD201 to treat COVID-19. As of September 30, 2020, the company had cash & non-cash assets of C$56.2 million and short & long term liabilities of C$13.6 million.

2. Iterum Therapeutics PLC (ITRM) is up over 20% at $0.69 in pre-market hours today on no news. The company expects to submit its New Drug Application for oral Sulopenem for the treatment of uncomplicated urinary tract infections (uUTIs) due to quinolone-resistant pathogens to the FDA in the coming weeks. Cash and cash equivalents as of Sep.30, 2020, totaled $8.6 million.

In the Red

1. Advaxis Inc. (ADXS), a clinical-stage biotechnology company, is down more than 18% at $0.32 in pre-market hours Tuesday, following a proposed public offering of common stock and warrants to purchase common stock.

2. DBV Technologies S.A. (DBVT) is down more than 9% at $2.46 in pre-market hours. The company's Chief Scientific Officer Hugh Sampson has decided to step down from his role, effective December 1, 2020, to return to his research program at the Jaffe Food Allergy Institute at Mount Sinai. The company's non-invasive, once-daily epicutaneous patch to treat peanut allergies in children, Viaskin Peanut, is under review by the European Medicines Agency. The FDA had refused to approve Viaskin Peanut in August this year.

3. Aeterna Zentaris Inc. (AEZS) is down more than 8% at $0.38 in pre-market trading on no news. The company markets macimorelin, an approved oral drug indicated for the diagnosis of adult growth hormone deficiency (AGHD), and is currently marketed in the United States under the tradename Macrilen, by Novo Nordisk. A phase II pilot study of repeated oral administration of macimorelin at different doses daily for 1 week for the treatment of cancer cachexia is ongoing. Preparations are underway to initiate a trial of macimorelin for the diagnosis of childhood-onset growth hormone deficiency (CGHD) in collaboration with Novo Nordisk.

4. Ocugen Inc. (OCGN) is down more than 4% at $0.28 in pre-market hours today, adding to yesterday's loss of 4.68%. The company's biologic product candidate OCU200 is in preclinical development for treating severely sight-threatening diseases like Diabetic Macular Edema, Diabetic Retinopathy, and Wet Age-Related Macular Degeneration. Its first gene therapy product candidate, OCU400, for retinitis pigmentosa, is expected to enter the clinic next year. On November 16, Roth Capital analyst initiated coverage of OCGN with a Buy rating and $1 price target.

5. BioNTech SE (BNTX) is down over 3% at $102.70 in pre-market trading Tuesday, on no news. The company and Pfizer (PFE) have sought Emergency Use Authorization from the FDA for their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2. BioNTech CEO Ugur Sahin believes that BNT162b2 could gain emergency nod in the U.S. by the middle of December and conditional approval in the European Union in the second half of December, according to Reuters TV.