Pre-market Movers In Healthcare Sector: DBVT, ZOM, OBSV, BNGO, NVCN…

(RTTNews) – What moves these stocks today in the pre-market times?

Out in the open

1. DBV Technologies SA (DBVT) rose over 37% to $ 7.81 on the Tuesday before market launch. The company’s lead product candidate, Viaskin Peanut, a non-invasive, once-daily patch for the treatment of peanut allergies in children ages 4-11, was denied FDA approval last August. The company was asked to conduct a 6 month well-controlled safety and adhesion trial to evaluate the modified Viaskin peanut patch in the intended patient population.

2. Zomedica Corp. (ZOM) is up 23% to $ 1.21 ahead of the market today after Robert Cohen, chief executive officer, briefed shareholders on various key activities and events.

3. ObsEva SA (OBSV) is up over 20% to $ 4.89 today prior to market launch. The company’s lead product candidate, Yselty, for the treatment of uterine fibroids is currently under review by the European Medicines Agency. The new drug application for Yselty is expected to be submitted to the FDA in the first half of 2021. A phase III study with Yselty for the treatment of endometriosis, which is being carried out in Europe and the USA under the name EDELWEISS 3, is underway. Endpoint indication is expected in the fourth quarter of this year.

4. Avinger Inc (AVGR) is up over 14% to $ 1.68 on the Tuesday prior to trading. Avinger is a commercial medical device company that designs and develops the first catheter-based image-guided system that diagnoses and treats patients with peripheral artery disease (PAD). The company received FDA approval for Tigereye CTO last August. Full commercial launch begins on January 15, 2021. A 510 (k) registration for the Lightbox 3 Imaging Console is expected to be filed in the US during the first half of this year.

5. Novan Inc. (NOVN) was up 7% to $ 1.37 on the Tuesday prior to trading. The company expects to initiate human clinical trials of an intranasal formulation of berdazimer sodium for COVID-19 in the second half of 2021.

6. Bionano Genomics Inc. (BNGO) is up more than 9% to $ 9.07 ahead of market launch today as the five-day next-generation Cytogenomics Symposium concluded. The presentations focused on the applications of optical genome mapping (OGM) at Saphyr, the company’s research platform. On the last day of the symposium, i.e. yesterday, presentations by scientists and clinicians from various hospitals and research institutions in Europe and the United States showed that Saphyr could detect structural variants that can predispose to severe or mild COVID-19 disease.

Into the red

1. Neovasc Inc. (NVCN) fell more than 25% to $ 0.89 on Tuesday after the FDA received an “unapprovable” letter to submit a pre-approval application for Reducer, a medical device used to treat refractories Angina. The reducer is CE marked in the European Union for the treatment of refractory angina.

2. Assertio Holdings Inc. (ASRT) is down over 3% to $ 0.56 in pre-market times. On December 30, 2020, the company moved its listing from the Nasdaq Global Select Market to the Nasdaq Capital Market. The company has until June 28, 2021 to meet the bid price requirement of $ 1.00 to maintain its Nasdaq listing.

3. Senseonics Holdings Inc. (SENS) is down nearly 5% to $ 1.54 after entering into securities purchase agreements with several healthcare-focused and other institutional investors to purchase 40 million common shares in a registered direct offering Purchase price of $ 1.25 per share. The registered direct offering, which is expected to close on or about January 21, 2021, is expected to generate gross proceeds of $ 50.0 million.

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

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