What’s moving these stocks in pre-market hours today?
In the Green
1. DBV Technologies S.A. (DBVT) is up over 37% at $7.81 in pre-market hours Tuesday. The company’s lead product candidate Viaskin Peanut, a non-invasive, once-daily epicutaneous patch to treat peanut allergy in children ages 4 to 11 years, was denied FDA approval last August. The company has been asked to conduct a 6-month, well-controlled safety and adhesion trial to assess the modified Viaskin Peanut patch in the intended patient population.
2. Zomedica Corp. (ZOM) is up 23% at $1.21 in pre-market hours today, following a letter from Robert Cohen, Chief Executive Officer, updating the shareholders regarding several key activities and events.
3. ObsEva SA (OBSV) is up over 20% at $4.89 in pre-market hours today on no news. The company’s lead product candidate Yselty for the treatment of Uterine Fibroids is under review by the European Medicines Agency. The New Drug Application for Yselty is expected to be filed with the FDA during the first half of 2021. A phase III trial of Yselty for the treatment of Endometriosis, being conducted in Europe and the U.S., dubbed EDELWEISS 3, is progressing, with primary endpoint readout expected in the fourth quarter of this year.
4. Avinger Inc (AVGR) is up over 14% at $1.68 in pre-market trading Tuesday. Avinger is a commercial-stage medical device company that designs and develops the first-ever image-guided, catheter-based system that diagnoses and treats patients with peripheral artery disease (PAD). The company received FDA clearance for Tigereye CTO last August, with full commercial launch beginning on Jan.15, 2021. A 510 (k) filing for Lightbox 3 Imaging Console is expected to be submitted in the U.S. in the first half of this year.
5. Novan Inc. (NOVN) is up 7% at $1.37 in pre-market trading Tuesday, on no news. The company expects initiating human clinical trials with 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% at $9.07 in pre-market hours today, as it wrapped up the five-day Next-Generation Cytogenomics Symposium. The presentations covered the applications of optical genome mapping (OGM) with Saphyr, the company’s research use only platform. In the last day of the symposium, i.e., yesterday, the presentations by scientists and clinicians from various hospitals and research institutions in Europe and the US showed that Saphyr was able to detect structural variants that may predispose to severe or mild COVID-19 disease.
In the Red
1. Neovasc Inc. (NVCN) is down more than 25% at $0.89 on Tuesday, following the receipt of a “not-approvable” letter from the FDA regarding its Premarket Approval application submission for Reducer, a medical device for the treatment of refractory 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% at $0.56 in pre-market hours on no news. On Dec.30, 2020, the company transferred its s listing to the Nasdaq Capital Market from the Nasdaq Global Select Market. The company has time until June 28, 2021, to satisfy the $1.00 bid price requirement to maintain Nasdaq listing.
3. Senseonics Holdings Inc. (SENS) is down nearly 5% at $1.54 on news of the company entering into securities purchase agreements with several healthcare-focused and other institutional investors to purchase 40 million shares of its common stock in a registered direct offering at a purchase price of $1.25 per share. The registered direct offering, which is slated to close on or about January 21, 2021, is expected to rake in gross proceeds of $50.0 million.
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