Pre-market Movers In Healthcare Sector: XTNT, BNTX, GLYC, ALNA, MGEN, IOVA, ARTL…

stockmarkets jan11 06oct20

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

In the Green

1. Xtant Medical Holdings Inc. (XTNT) is up over 23% at $1.88 in pre-market hours Tuesday on no news. On October 1, after the bell, the company announced the completion of its previously announced debt restructuring transaction. This debt restructuring transaction has significantly reduced the company's total indebtedness to less than $16 million under its credit facility. The news had sent the stock up as much as over 200% to $2.50 in intraday trading on Oct.2.

2. CHF Solutions Inc. (CHFS) a medical device company, is up over 12% at $0.42 in pre-market hours today on no news. The company markets the Aquadex SmartFlow system for ultrafiltration therapy. Aquadex therapy has been deployed in COVID-19 frontline hospitals as an adjunct therapy.

3. BioNTech SE (BNTX) is up over 12% at $90.40 in pre-market trading Tuesday on news of initiation of a rolling submission to the European Medicines Agency for COVID-19 vaccine candidate BNT162b2. The vaccine candidate BNT162b2, being developed in collaboration with Pfizer, is under phase III trial, with key data expected by the end of this month.

4. DBV Technologies S.A. (DBVT) is up over 13% at $1.87 in pre-market trading Tuesday on no news. In August of this year, the FDA had refused to approve the company's investigational Viaskin Peanut, a noninvasive, once-daily epicutaneous patch to treat peanut allergies in children ages 4 to 11 years. The stock has lost nearly 60% of its value since then.

5. GlycoMimetics Inc. (GLYC) is up over 5% at $3.46 in pre-market hours on news of the FDA granting Rare Pediatric Disease designation to the company's investigational drug Rivipansel for the treatment of sickle cell disease in patients 18 years old and younger. A pivotal trial of Rivipansel in patients aged six and older with sickle cell disease who were hospitalized for a vaso-occlusive crisis, dubbed RESET, the results of which were announced last August, had failed to meet its primary and key secondary efficacy endpoints.

6. Allena Pharmaceuticals Inc. (ALNA) is up nearly 6% at $1.97 in pre-market hours today, adding to yesterday's gain of over 11%. A phase I clinical trial of ALLN-346 in development for the treatment of Hyperuricemia in patients with gout and advanced chronic kidney disease is underway, with initial data expected this quarter. On Sep.30, the company entered into a $25 million convertible debt financing agreement with Pontifax Medison Finance, extending Allena's cash runway into 4Q 2021. Yesterday, the company announced the appointment of Ann Miller, to its board of directors.

7. Acasti Pharma Inc. (ACST) is up over 4% at $0.21 in pre-market trading Tuesday on no news. On September 29, the company announced the commencement of a formal process to explore and evaluate strategic alternatives to enhance shareholder value and engagement of Oppenheimer & Co., Inc., as its financial advisor to assist in the process.

8. ADiTx Therapeutics Inc. (ADTX) is up nearly 4% at $2.10 in pre-market hours today on no news. Under a collaboration agreement with Salveo Diagnostics Inc., signed last month, the company has plans to commercialize AditxtScore Platform starting this quarter. AditxtScore for COVID-19 is designed for use in detecting antibodies against SARS-CoV-2 antigens. The application seeking Emergency Use Authorization for AditxtScore was submitted to the FDA on Aug.24.

In the Red

1. Miragen Therapeutics Inc. (MGEN) is down more than 25% at $0.57 in pre-market trading Tuesday on news of the company's decision to discontinue further internal development of Cobomarsen, its clinical product candidate for the treatment of certain cancers.

2. Iovance Biotherapeutics Inc. (IOVA) is down over 20% at $25.47 in pre-market trading today on news of a possible delay in the submission of its Biologics License Application for Lifileucel as a treatment for metastatic melanoma. The company now expects to submit the BLA only in 2021 and not by the end of 2020 as previously expected.

3. Artelo Biosciences Inc. (ARTL) is down over 11% at $0.96 in pre-market hours today, giving back some of what it gained yesterday. The company recently received Ethics Committee approval in the U.K to commence a Phase 1/2 Trial of synthetic cannabinoid ART27.13 in patients with cancer anorexia and weight loss. The company intends to open its clinical sites and initiate patient enrollment in the trial later this year.

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