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Pre-market Movers In Healthcare Sector: BCRX, NOVN, STRO, ENLV, BioNTech…

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

In the Green

1. BioCryst Pharmaceuticals Inc. (BCRX) is up over 25% at $6.49 in pre-market trading Friday, following FDA approval of the company's Orladeyo (berotralstat) for prophylaxis to prevent attacks of hereditary angioedema in adults and pediatric patients 12 years and older. Orladeyo becomes the first oral treatment for preventing Hereditary Angioedema attacks. This drug is also under review in Japan and Europe, with a decision expected this month and March, respectively. The company expects Orladeyo to achieve global peak sales of greater than $500 million.

2. Novan Inc. (NOVN) is up over 28% at $0.72 in pre-market hours today on no news. The company's lead product candidate, SB206, is currently being evaluated in a pivotal Phase 3 study in molluscum contagiosum, dubbed B-SIMPLE4, with topline data targeted for Q2, 2021. In October of this year, Novan announced positive in vitro results showing the potential efficacy of its NITRICIL platform technology as an antiviral against SARS-CoV-2. A potential IND filing is targeted in 2021. The company has time until May 3, 2021, to satisfy the $1.00 bid price requirement to maintain Nasdaq listing.

3. Sutro Biopharma Inc. (STRO) is up over 17% at $20 in pre-market hours today, following encouraging results from an ongoing dose-escalation phase I study of STRO-002 for patients with ovarian cancer.

4. Enlivex Therapeutics Ltd. (ENLV) is up nearly 7% at $12.15 in pre-market hours Friday, adding to yesterday's gain. The stock was up more than 37% yesterday, following positive interim results from a phase II clinical trial evaluating immunotherapy product candidate, Allocetra, in severe and critical COVID-19 patients.

In the Red

1. DBV Technologies S.A. (DBVT) is down more than 5% at $2.59 in pre-market hours Friday, giving back some of what it gained yesterday, on no news. 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.

2. BioNTech SE (BNTX) is down over 2% at $116.06 in pre-market hours today on no news. The company along with Pfizer Inc. (PFE) is developing a COVID-19 mRNA vaccine by the name BNT162b2. This vaccine secured Emergency Use Authorization from the UK regulator, Medicines & Healthcare Products Regulatory Agency, on Dec.2. The vaccine is also set to be reviewed by the U.S. FDA's Vaccines and Related Biological Products Advisory Committee on Dec. 10.

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