What’s moving these stocks in pre-market hours today?<\/p>\n
In the Green<\/b><\/p>\n
1. Merus N.V. (MRUS) is up over 39% at $22.50 in pre-market trading Friday, following FDA’s Fast Track Designation to Zenocutuzumab for the treatment of patients with metastatic solid tumors harboring NRG1 gene fusions (NRG1+ cancers) that have progressed on standard of care therapy. A phase I\/II trial evaluating Zenocutuzumab monotherapy in patients with NRG1+ cancers, in three cohorts: non-small cell lung cancer; pancreatic cancer; and other solid tumors, is underway.<\/p>\n
2. Oragenics Inc. (OGEN) is up more than 7% at $0.90 in pre-market hours today, adding to yesterday’s gain of 35%. Yesterday, the company entered into a material transfer agreement with Adjuvance Technologies Inc. for use of the adjuvant TQL1055 in Terra CoV-2 vaccine against COVID-19. Oragenics’ Terra CoV-2 vaccine is in preclinical studies.<\/p>\n
3. Jaguar Health Inc. (JAGX) is up 7% at $2.87 in pre-market trading today, adding to yesterday’s gain of 33%. The company markets<\/span> Mytesi, an FDA-approved product, for the symptomatic relief of noninfectious diarrhea in adults with HIV\/AIDS on antiretroviral therapy.<\/p>\n 4. CureVac N.V. (CVAC) is up over 6% at $107.65 in pre-market hours Friday, adding to yesterday’s gain of 16%. The company has a collaboration and services agreement with Bayer that was inked yesterday. Per the deal, Bayer will support CureVac in numerous areas, including development and supply of its COVID-19 vaccine candidate CVnCoV. The vaccine candidate moved into a global pivotal Phase 2b\/3 trial last month.<\/p>\n In the Red<\/b><\/p>\n 1. Sarepta Therapeutics Inc. (SRPT) is down over 47% at $89.13 in pre-market trading Friday, following top-line results from Part 1 of a phase II trial of investigational gene therapy SRP-9001 in patients with Duchenne muscular dystrophy, dubbed Study 102. Although the study met the primary biological endpoint of micro-dystrophin protein expression at 12 weeks post-treatment, it failed to achieve statistical significance on the primary functional endpoint.<\/p>\n 2. Bionano Genomics, Inc. (BNGO) is down 12% at $4.39 in pre-market hours today, following a proposed underwritten public offering of common stock. Oppenheimer & Co. Inc. is acting as the sole book-running manager for the offering.<\/p>\n 3. Brickell Biotech Inc. (BBI) is down more than 5% at $1.01 in pre-market hours. A phase III program, comprising of two pivotal studies, evaluating Sofpironium bromide gel, 15% in subjects aged nine and older with primary axillary (underarm) hyperhidrosis is underway. The topline results from these two studies are expected in the fourth quarter of 2021. The company’s partner AnGes is currently conducting Phase 1\/2 clinical studies with its vaccine candidate in Japan. Results from the studies are expected to be received through the first quarter of 2021. <\/p>\n 4. DBV Technologies S.A. (DBVT) is down 5% at $3.39 in pre-market trading Friday. The company is planning to reduce its workforce by more than 200 jobs, resulting in a remaining global team of 90 individuals. All head-count reductions are expected to be completed by the end of the first quarter of 2021. 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 last August.<\/p>\n 5. Ocugen Inc. (OCGN) is down 3% at $2.70 in pre-market hours Friday, giving back some of what it gained yesterday, on no news. The company’s partner Bharat Biotech secured emergency use approval for its COVID-19 vaccine, Covaxin, in India as recently as January 3, 2021. Covaxin is currently in phase III trials in India. Last month, Ocugen appointed a vaccine scientific advisory board comprised of leading academic and industry experts in the vaccine field to evaluate the clinical and regulatory path to approval of Covaxin in the U.S. <\/p>\n