What’s moving these stocks in the pre-market hours today?
In the Green
1. Titan Pharmaceuticals Inc. (TTNP) is up over 48% at $0.25 in pre-market trading Friday, adding to yesterday’s gain of over 34% on no news. The company is developing a six-month implantable formulation of Nalmefene, an opioid antagonist, intended for the prevention of relapse to opioid addiction, following opioid detoxification. An investigational New Drug Application for the Nalmefene implant is expected to be filed with the FDA in the first half of 2021.
2. Amarin Corporation plc (AMRN) is up more than 21% at $5.50 in pre-market hours today, following positive, statistically significant top-line results from a phase III clinical trial of VASCEPA conducted in China by the company’s partner, Edding. The study findings will aid Edding for seeking regulatory approval of VASCEPA in Mainland China. In the U.S., Vascepa received FDA approval in 2012 as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia, and in 2019 as an adjunct to statin therapy to reduce the risk of cardiovascular events.
3. Mesoblast Limited (MESO) is up over 18% at $14 in pre-market hours, following an exclusive worldwide license and collaboration agreement with Novartis (NVS) for the development, manufacture and commercialization of its product candidate Remestemcel-L. The initial focus will be on developing Remestemcel-L for acute respiratory distress syndrome (ARDS), the principal cause of mortality in COVID-19 infection.
4. NovaBay Pharmaceuticals Inc. (NBY) is up more than 16% at $0.68 in pre-market hours today on no news. The company markets AVENOVA for the eye care market, CELLERX for the aesthetic dermatology market and NEUTROPHASE for the wound care market. Net product revenue for the third quarter ended September 30, 2020, was $2.2 million, a 34% increase from $1.6 million for the third quarter of 2019. The Q3 results were reported last week.
5. Genfit SA (GNFT) is up over 14% at $4.83 in pre-market hours Friday on no news. The company’s lead investigational asset Elafibranor is under a phase III trial in Primary Biliary Cholangitis, dubbed ELATIVE, with results expected by early 2023. A workforce restructuring plan, which is underway to reduce the overall workforce by 40%, encompassing both the U.S and France, is expected to be completed by the end of the year.
6. BioNTech SE (BNTX) is up over 5% at $99.90 in pre-market hours. The company along with Pfizer Inc. (PFE) is developing an mRNA-based COVID-19 vaccine candidate BNT162b2. The companies are expected to file for emergency use authorization for BNT162b2 on Friday, reports CNN. 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.
7. Ocugen Inc. (OCGN) is up over 4% at $0.33 in pre-market hours on no news. On November 16, Roth Capital analyst initiated coverage of OCGN with a Buy rating and $1 price target. 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.
8. Moderna Inc. (MRNA) is up over 2% at $95.50 in pre-market hours today. The company’s COVID-19 vaccine candidate mRNA-1273 demonstrated an efficacy of 94.5% in its phase III trial. The European Medicines Agency has begun rolling review of mRNA-1273.
In the Red
1. Oragenics Inc. (OGEN) is down over 8% at $0.48 in pre-market trading Friday, following the commencement of a proposed underwritten public offering of its common stock. The company’s SARS-CoV-2 vaccine, Terra CoV-2, is under pre-clinical development.
2. Plus Therapeutics Inc. (PSTV) is down over 4% at $2.10 in pre-market hours today, adding to yesterday’s loss of 6%. Yesterday, the company announced positive new interim data from its ongoing Phase 1 clinical trial of its lead investigational asset, Rhenium NanoLiposome in patients with recurrent glioblastoma, dubbed ReSPECT.
3. Medigus Ltd. (MDGS) is down over 6% at $2.30 in pre-market hours today, giving back some of what it gained yesterday. Medigus is a technology company engaged in advanced medical solutions and innovative technology. The stock was up over 22% yesterday, following a non-binding memorandum of understanding signed with the founders of EMuze (a privately held company that designs and develops electric mobility micro vehicles), to invest in a joint venture, NewCo, to develop and potentially commercialize EV-based micro-mobility vehicles for urban and logistics transportation.
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