Pre-market Movers In Healthcare Sector: TLSA, PRTA, CRBP, VXRT, BCRX, FMS...

(RTTNews) - What's moving these stocks in pre-market hours today?

In the Green

1. Tiziana Life Sciences PLC (TLSA) is up over 50% at $5.89 in pre-market trading Tuesday, following positive data from the exploratory clinical study in Brazil investigating nasally administered Foralumab in COVID-19 patients. Foralumab works by modulating the immune system and not by directly targeting COVID-19, and this therapeutic approach might also be useful for newly identified Covid-19 variants in UK, South Africa and Brazil, according to the company.

2. Prothena Corporation plc (PRTA) is up over 40% at $15.73 in pre-market trading Tuesday, as it is all set to move its lead drug candidate Birtamimab into a phase III trial in patients with Mayo Stage IV AL amyloidosis, dubbed AFFIRM-AL. The planned AFFIRM-AL study of Birtamimab is expected to be initiated in mid-2021.

3. Corbus Pharmaceuticals Holdings Inc. (CRBP) is up over 21% at $2.70 in pre-market hours today, adding to yesterday's gain of 21%, on no news. The company's lead drug candidate is Lenabasum, which is under a phase III trial in Dermatomyositis, dubbed DETERMINE, with data from the trial anticipated in the second quarter of 2021. A phase II trial of Lenabasum in Systemic lupus erythematosus is underway, with enrollment expected to be completed in the first half of this year.

4. Atossa Therapeutics Inc. (ATOS) is up over 9% at $2.59 in pre-market hours Tuesday, adding to yesterday's gain of 7%. The company's AT-301 COVID-19 nasal spray is under phase I development, with final data expected this quarter. A phase II MBD (mammographic breast density) study of oral Endoxifen is also expected to be launched this quarter.

5. Artelo Biosciences Inc. (ARTL) is up over 40% at $1.46 in pre-market hours today on no news. Last November, the company received Clinical Trial Authorization in the UK to initiate a phase I/II trial of synthetic cannabinoid ART27.13 in patients with cancer anorexia and weight loss, dubbed CAReS. Enrollment in this trial is expected to be initiated in the first half of this year.

6. VYNE Therapeutics Inc. (VYNE) is up 12% at $2.59 in pre-market hours today, following FDA approval to update the label of the company's flagship product AMZEEQ topical foam, 4%, which is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older. The updated label includes the new information referencing the low propensity of P. acnes strains to develop resistance to minocycline, the active ingredient in AMZEEQ.

7. Vaxart Inc. (VXRT) is up over 10% at $17.20 in pre-market trading today, adding to yesterday's gain of nearly 30%. The company is slated to report data from its phase I trial of oral COVID-19 vaccine this week.

8. BioCryst Pharmaceuticals Inc. (BCRX) is up 13% at $13.41 in pre-market trading today, adding to yesterday's gain of 39%, on no news. On January 22, 2021, the company received approval for its oral, once-daily ORLADEYO 150 mg for prophylactic treatment of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older in Japan. The drug was approved in the U.S. on Dec.3, 2020. An approval decision on ORLADEYO in the EU is expected next quarter. The drug is expected to generate peak sales of $500 million. The company is also developing an antiviral Galidesivir for the treatment of COVID-19.

9. Dynavax Technologies Corporation (DVAX) is up nearly 12% at $11.50 in pre-market hours, as its parner Clover Biopharmaceuticals is moving ahead with its plan to initiate a global phase 2/3 efficacy trial with the S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax's CpG 1018 plus alum in the first half of 2021. The interim analysis for vaccine efficacy could potentially occur in the middle of 2021. Yet another partner of Dynavax, Valneva SE, has been informed that the UK Government has exercised its option to order an additional 40 million doses of Valneva's SARS-CoV-2 adjuvanted vaccine candidate, VLA2001. Valneva 's vaccine candidate, VLA2001, also uses Dynavax's CpG 1018 adjuvant.

In the Red

1. Fresenius Medical Care AG & Co. KGaA (FMS) is down nearly 13% at $33.90 in pre-market hours Tuesday on news of the company announcing that its 2021 net income is going to be significantly impacted from accelerated COVID-19 related excess mortality of dialysis patients. The net income before potential restructuring measures is expected to decline by up to 25 percent and revenue to grow up to mid-single digits.

2. Monopar Therapeutics Inc. (MNPR) is down 8% at $7.30 in pre-market trading Tuesday, adding to yesterday's loss of nearly 6%, on no news. A phase 2b/3 clinical trial of Validive for the prevention of chemoradiotherapy-induced severe oral mucositis in patients with oropharyngeal cancer, dubbed VOICE, is underway.

3. Adamas Pharmaceuticals Inc (ADMS) is down nearly 12% at $6.01 in pre-market trading Tuesday, erasing most of what it gained yesterday. The stock was up nearly 15% at $6.79 yesterday, following FDA approval for the company's flagship product GOCOVRI as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing OFF episodes. This is the second indication for the drug. GOCOVRI is already approved for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medicines.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


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