What’s moving these stocks in pre-market hours today?
In the Green
1. Isoray Inc. (ISR) is up over 177% at $1.47 in pre-market hours Wednesday, following FDA 510(k) clearance for the use of C4 Imaging’s Sirius positive-signal MRI Markers with the company’s Cesium-131, brachytherapy seeds. Brachytherapy, or internal radiation therapy, is a cost-effective option for the treatment of prostate cancer. Isoray is the world’s only producer of Cesium-131, commercially known as Cesium Blu, brachytherapy seeds.
2. Guardion Health Sciences Inc. (GHSI) is up over 47% at $0.81 in pre-market hours today on no news. The company is involved in developing medical foods and medical devices in the ocular health space and also nutraceutical products. Bret Scholtes will take over as President and CEO and as a director of the company effective January 6, 2021.
3. 9 Meters Biopharma Inc. (NMTR) is up over 30% at $1.40 in pre-market hours today, adding to yesterday’s gain of 27%, on no news. The company’s lead drug candidate Larazotide is expected to advance into phase I trial in Australia for COVID-19 respiratory complications this year. The drug candidate is also 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 this quarter (Q1, 2021).
4. PolarityTE Inc. (PTE), a biotechnology company developing regenerative tissue products and biomaterials, is up over 9% at $0.84 in pre-market hours today as it gears up to make a presentation at the H.C. Wainwright Virtual Bioconnect Conference on January 11, 2021.
5. Aerpio Pharmaceuticals Inc. (ARPO) is up more than 6% at $1.14 in pre-market hours on news of the company exploring a range of strategic alternatives to maximize shareholder value. The strategic options being reviewed by the company include partnering its programs, as well as, the potential for an acquisition, company sale, merger, business combination, asset sale, in-license, out-license or others.
6. Check-Cap Ltd. (CHEK) is up over 5% at $1.82 in pre-market trading today, adding to yesterday’s gain of 19%, on no news. The company has time until June 28, 2021 to regain compliance with minimum bid price rule for continued listing on the Nasdaq.
In the Red
1. Synthetic Biologics Inc. (SYN) is down over 17% at $0.52 in pre-market hours Wednesday, giving back some of what it gained yesterday, on no news. A phase 1b/2a clinical trial of SYN-004 in allogeneic hematopoietic cell transplant (HCT) recipients is expected to commence in the first quarter of 2021. The company has time until May 25, 2021 to regain compliance for continued listing on the NYSE.
2. Zosano Pharma Corporation (ZSAN) is down more than 11% at $0.71 in pre-market hours today, erasing some of its gains made yesterday. The stock was up over 38% yesterday on news of the company requesting a Type A meeting with the FDA related to the resubmission of Qtrypta 505(b)(2) New Drug Application following the Complete Response Letter that was issued last October. Qtrypta is a transdermal microneedle patch proposed for the acute treatment of migraine.
3. Onconova Therapeutics Inc. (ONTX) is down 12% at $0.72 in pre-market hours, giving back some of what it gained yesterday, on no news. The company plans to begin enrollment of patients with HR+ HER2- metastatic breast cancer and other tumors in U.S. Phase 1 trial of ON 123300, in the first half of 2021.
4. Brickell Biotech Inc. (BBI) is down 13% at $1.06 in pre-market hours today, after yesterday’s gain of over 48%. A phase III program, comprising of two pivotal studies, evaluating Sofpironium bromide gel, 15% in subjects aged nine and older with primary axillary (underarm) hyperhidrosis is underway. The topline results from these two studies are expected in the fourth quarter of 2021.
5. Kintara Therapeutics Inc. (KTRA) is down over 7% at $1.30 in pre-market hours today on no news. The company is slated to make a presentation at the H.C. Wainwright Bioconnect 2021 Virtual Conference on January 11, 2021.
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