What’s moving these stocks in the pre-market hours today?
In the Green
1. Sorrento Therapeutics Inc. (SRNE) is up over 40% at $11.68 in pre-market trading Thursday, adding to yesterday’s gain of over 20%. The company has received FDA clearance for its phase 1 clinical trial for COVI-GUARD (STI-1499) in hospitalized COVID-19 patients. In preclinical studies, STI-1499 demonstrated a 100% in vitro neutralizing effect against SARS-CoV-2, preventing infection of healthy cells.
2. iBio Inc. (IBIO) is up more than 15% at $2.49 in pre-market hours today. Last week, the company selected IBIO-201, its LicKM-Subunit vaccine, as the leading candidate to advance into clinical testing for the prevention of SARS-CoV-2 infection.
3. Genocea Biosciences, Inc. (GNCA) is up over 15% at $3.16 in pre-market trading Thursday, as the company is all set to present additional clinical response and immunogenicity data from the first five patients vaccinated in Part B of the ongoing GEN-009 Phase 1/2a trial at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 today.
4. Vaxart Inc. (VXRT) is up over 11% at $8.23 in pre-market hours today, adding to yesterday’s gain of more than 13%. On September 14, the company announced the FDA clearance for its phase I clinical trial of its oral COVID-19 vaccine candidate, with recruitment expected to start this month. A hamster challenge study to provide efficacy data and insights into the optimal dose regimen of the oral COVID-19 vaccine candidate is ongoing, with data expected mid-October.
5. SCWorx Corp. (WORX) is up more than 8% at $1.66 in pre-market trading Thursday on no specific news.
6. Heat Biologics Inc. (HTBX) is up more than 9% at $1.52 in pre-market hours today, adding to yesterday’s gain of 23%. The company is developing a vaccine for COVID-19, which is currently under preclinical testing. The phase I trial of this vaccine candidate is expected to begin in early 2021.
7. Aytu BioScience Inc. (AYTU), a commercial-stage specialty pharmaceutical company, is up over 3% at $1.29 in pre-market trading. The company is slated to present its operational results for the fiscal fourth quarter ended June 30, 2020, on September 24, 2020, at 4:30 p.m. ET.
8. BioNTech SE (BNTX) is up over 3% at $68.20 in pre-market trading. The company’s vaccine candidate against SARS-CoV-2, BNT162b2, which is being developed in partnership with Pfizer, is under a phase III pivotal trial, with a conclusive readout on efficacy likely by the end of October.
In the Red
1. Xenetic Biosciences Inc. (XBIO) is down 14% at $0.90 in pre-market trading today, giving back almost all it gained yesterday.
2. Iterum Therapeutics plc (ITRM) is down nearly 9% at $0.60 in pre-market hours. The company announced topline phase III results of Sulopenem in complicated urinary tract infection and uncomplicated urinary tract infection in June this year. While the uncomplicated urinary tract infection trial produced mixed results, the complicated urinary tract infection trial failed to achieve the primary endpoint. A meeting with the FDA to discuss the regulatory filing of Sulopenem is scheduled for the end of the third quarter.
3. Novus Therapeutics Inc. (NVUS) is down over 8% at $0.92 in pre-market hours today, adding to yesterday’s loss of nearly 10%. Early this week, the company acquired 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.
4. Inovio Pharmaceuticals Inc. (INO) is down over 5% at $17.51 in pre-market trading Thursday, giving back some of what it gained yesterday. The company’s COVID-19 DNA vaccine INO-4800 is under a phase I study and positive interim data from the first two cohorts in the U.S. trial were reported in June. A phase 2/3 trial of INO-4800 is expected to start this month, subject to FDA clearance. A pivotal phase III trial of VGX-3100 for HPV-associated cervical dysplasia, dubbed REVEAL 1, is underway, with data on track to be reported in 4Q, 2020.
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