Pre-market Movers In Healthcare Sector: ZOM, BNTX, PFE, MESO, OVID…
What’s moving these stocks in the pre-market hours today?
In the Green
1. iBio Inc. (IBIO) is up over 24% at $1.81 in pre-market trading Wednesday on being selected to produce Belgium-based ATB Therapeutics’ bioengineered antibody-toxin fusion proteins using its FastPharming System. The fusion proteins, called atbodies, are being designed for the treatment of cancers.
2. Zomedica Corp. (ZOM) is up more than 9% at $0.19 in pre-market hours today on no news, adding to yesterday’s gain of over 21%. The company expects to begin commercialization of its TRUFORMA point-of-care diagnostic platform on March 30, 2021. The TRUFORMA diagnostic device, which is smaller than a desktop printer, has been designed to provide highly sensitive, species-optimized initial assays for the diagnosis of thyroid disease in dogs and cats, and adrenal disease in dogs.
3. Moderna Inc. (MRNA) is up over 5% at $149 in pre-market hours today. The company’s COVID-19 vaccine candidate mRNA-1273 is under rolling review of the U.K. regulator, Medicines & Healthcare Products Regulatory Agency (MHRA). In the U.S., the vaccine candidate is also set to be reviewed by the FDA’s Vaccines and Related Biological Products Advisory Committee on December 17.
4. BioNTech SE (BNTX) is up over 7% at $122.13 in pre-market trading Wednesday, following news of the U.K. regulator, Medicines & Healthcare Products Regulatory Agency (MHRA), granting a temporary authorization for emergency use for the COVID-19 vaccine BNT162b2. The company is co-developing the COVID-19 vaccine candidate along with Pfizer. The vaccine will be made available across the UK from next week. In the U.S, BNT162b2 is all set to be reviewed by the FDA’s Vaccines and Related Biological Products Advisory Committee on Dec. 10.
5. Mesoblast Limited (MESO) is up more than 4% at $15.76 in pre-market trading Wednesday, on receipt of the US FDA’s Fast Track designation for Remestemcel-L in the treatment of acute respiratory distress syndrome (ARDS) due to COVID-19 infection. A phase III trial of Remestemcel-L in up to 300 ventilator-dependent patients with moderate to severe COVID-19 ARDS is ongoing. The company has a $1.35 billion deal in place with Novartis for the development of Remestemcel-L for COVID-19 ARDS.
6. Pfizer Inc. (PFE) is up over 3% at $40.87 in pre-market hours today, following clearance from the UK for the COVID-19 vaccine BNT162b2, being co-developed with its German partner BioNTech SE (BNTX). The vaccine will be made available across the UK from next week.
In the Red
1. Ovid Therapeutics Inc. (OVID) is down more than 53% at $3.06 in pre-market hours Wednesday, on news of its phase III trial of OV101 for the treatment of Angelman syndrome, dubbed NEPTUNE, failing to meet the primary endpoint.
2. Auris Medical Holding Ltd. (EARS) is down more than 20% at $4.17 in pre-market trading today, giving back some of what it gained yesterday. The stock rose more than 370% yesterday following positive “in vitro” efficacy data for AM-301 in protecting against Sars-CoV-2 infection. AM-301 is a drug-free nasal spray being developed by the company’s affiliate Altamira Medica for protection against airborne pathogens and allergens.
3. Moleculin Biotech Inc. (MBRX) is down more than 11% at $0.88 in pre-market hours today, erasing some of yesterday’s gain. The stock was up over 26% yesterday on news of the FDA approving the company’s request for a “Rare Pediatric Disease” designation for its drug candidate WP1066, which is in early stage of development. The designation entitles Moleculin to receive a transferrable Priority Review Voucher (PRV) upon New Drug Approval for each of three indications, including diffuse intrinsic pontine glioma (DIPG), medulloblastoma and atypical teratoid rhabdoid tumor.
4. Cocrystal Pharma Inc. (COCP) is down more than 7% at $1.52 in pre-market trading Wednesday, adding to yesterday’s loss of over 23% on no news. The company anticipates the selection of a lead preclinical molecule for its COVID-19 coronavirus program by the end of 2020. Its fully owned drug candidate CC-42344 for Influenza A is expected to complete the ongoing IND-enabling studies and enter into clinical trials in 2021. The company is pursuing partnering opportunities for Hepatitis C drug candidate CC-31244, which has completed phase IIa clinical trial.
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