What’s moving these stocks in the pre-market hours today?
In the Green
1. BIOLASE Inc. (BIOL) is up over 12% at $0.32 in pre-market hours Thursday. The company develops and sells lasers to dentistry and medicine. In the second quarter ended June 30, 2020, the results of which were reported last month, net revenue was $2.9 million, a decrease of 66% from the comparable year-ago quarter.
2. Otonomy Inc. (OTIC) is up over 8% at $3.70 in pre-market trading today on no news. The company expects results from its phase I/II trial of OTO-413 in hearing loss next quarter and results from phase III trial of OTIVIDEX in Ménière’s disease in the first quarter of 2021.
3. AnPac Bio-Medical Science Co., Ltd. (ANPC) is up more than 5% at $4.90 in pre-market trading Thursday on no specific news. A 14-month sales contract was inked between the company and Beijing Yuan Jian Health Management Co., Ltd. last month to provide AnPac Defense Medical Examination (ADME) tests to end customers at multiple locations in China.
4. Chembio Diagnostics Inc. (CEMI) is up over 3% at $4.49 in pre-market trading today, gaining some of what it lost yesterday. Early this month, the company submitted its application for Emergency Use Authorization to the FDA for its new rapid antibody test system, DPP SARS-CoV-2 IgM/IgG. The new antibody test system is designed to provide results in 15 minutes from Finger Stick, Venous Whole Blood, Plasma, or Serum samples.
5. OPKO Health Inc. (OPK) is up over 2% at $3.13 in pre-market hours Thursday. Last week, the company initiated a phase II trial with its marketed drug RAYALDEE as a treatment for mild-to-moderate COVID-19. The study, dubbed REsCue, is designed to enroll 160 symptomatic patients infected with SARS-CoV-2, many with stage 3 or 4 chronic kidney disease (CKD) who are at higher risk for developing more severe illness. Data from this trial is expected before year-end.
In the Red
1. NanoVibronix Inc. (NAOV) is down over 16% at $0.88 in pre-market trading Thursday, adding to yesterday’s loss of 12%. On September 22, the company announced that the FDA exercised its Enforcement Discretion to allow the distribution of its UroShield device in the United States for use during the COVID-19 pandemic. UroShield is an ultrasound-based product that is designed to reduce the risk of catheter-associated urinary tract infection and to decrease pain and discomfort associated with urinary catheter use. The same day, the company had announced a bought deal offering of $1.8 million.
2. Predictive Oncology Inc. (POAI) is down over 14% at $0.54 in pre-market hours today, giving back nearly all it gained yesterday. The company secured a license for an additional 71 unique ovarian cancer cell lines from UK-based Ximbio, the world’s largest non-profit dedicated to life science reagents of all kinds, yesterday, bringing the total of unique Patient-Derived Cells (PDCs) from ovarian cancer patients to 96.
3. 9 Meters Biopharma Inc. (NMTR) is down over 7% at $0.67 in pre-market hours Thursday, giving back some of what it gained yesterday. The company’s lead product candidate is Larazotide, under a phase III trial for celiac disease, with interim analysis expected in the second half of 2021. A phase 1b/2a clinical trial of NM-002 for the treatment of short bowel syndrome is ongoing, with topline results expected in the first quarter of 2021.
4. Qualigen Therapeutics Inc. (QLGN) is down more than 6% at $4.62 in pre-market hours today on no news. The company is planning to file an IND application with the FDA to commence clinical testing of AS1411 as a therapeutic against COVID-19 in the fourth quarter of 2020.
5. Lipocine Inc. (LPCN) is down over 5% at $1.35 in pre-market hours today, adding to yesterday’s loss of 7% on no news. A phase II study of LPCN 1144 in confirmed non-cirrhotic non-alcoholic steatohepatitis subjects, dubbed LiFT, is underway, with primary endpoint results anticipated in January 2021 The company’s Tlando, an investigational testosterone replacement therapy, is still awaiting the FDA decision which was originally due on August 28, 2020.
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