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Pre-market Movers In Healthcare Sector: KZIA, ZSAN, BNGO, VXRT, ADTX...

stockmarkets dec17 07aug20 lt

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

In the Green

1. Kazia Therapeutics Limited (KZIA) is up over 129% at $9.75 in pre-market trading Friday, following the receipt of FDA's Rare Pediatric Disease Designation for drug candidate Paxalisib for the treatment of Diffuse Intrinsic Pontine Glioma (DIPG), a rare and highly-aggressive childhood brain cancer. Paxalisib is under a phase I study in DIPG, with initial efficacy data anticipated during the second half of this year.

2. Zosano Pharma Corp. (ZSAN) is up over 32% at $1.81 in pre-market trading today, following a partnership agreement with EVERSANA to commercialize and distribute Qtrypta in the United States. Qtrypta, Zosano's transdermal microneedle product candidate for the acute treatment of migraine, is under FDA review, with a decision expected on October 20, 2020.

3. Bionano Genomics Inc. (BNGO) is up over 19% at $0.95 in pre-market trading on news that studies on COVID-19 disease susceptibility in China using the company's Saphyr genome imaging technology are progressing and generating high-quality data.

4. Vaxart Inc. (VXRT) is up over 11% at $10.15 in pre-market hours. Vaxart is developing an oral vaccine for COVID-19 and is planning to seek FDA clearance for conducting a phase I study of its oral COVID-19 vaccine soon. If all goes well, the clinical study is expected to be initiated this summer.

5. Arbutus Biopharma Corp. (ABUS) is up over 11% at $4.86 in pre-market trading. The company is scheduled to report second-quarter financial results today.

6. Curis Inc. (CRIS) is up over 9% at $1.50 in pre-market hours today. A phase I dose-escalation study of CA-4948 for the treatment of patients with R/R NHL, including patients with diffuse large B-cell lymphoma (DLBCL), Waldenström's macroglobulinemia (WM) and oncogenic MYD88 mutations, is underway. The updated efficacy data from the trial is anticipated by year-end.

7. Gritstone Oncology Inc. (GRTS) is up over 4% at $3.72 in pre-market trading. The company's pipeline includes GRANITE, a personalized neoantigen-based immunotherapy, and SLATE, an off-the-shelf immunotherapy, both of which have completed phase I studies. Initiation of a single-arm phase II expansion cohorts with GRANITE for patients with microsatellite stable colorectal cancer and gastroesophageal cancer and initiation of a single-arm phase II expansion cohorts with SLATE for patients with NSCLC following previous therapy with checkpoint inhibitors and patients with TP53 mutations are expected this year.

8. Ra Medical Systems Inc. (RMED) is up over 5% at $0.35 in pre-market trading Friday. The company is scheduled to report second-quarter 2020 financial results and provide a business update after the market close on Tuesday, August 11, 2020.

In the Red

1. Applied DNA Sciences Inc. (APDN) is down over 15% at $9.25 in pre-market trading. Yesterday, the company reported financial results for its third quarter of fiscal 2020 - incurring a net loss of $3.3 million, or $0.72 per share for the quarter ended June 30, 2020, compared with a net loss of $1.5 million or $1.55 per share, for the year-ago quarter. Revenues decreased 79% for the third quarter of fiscal 2020 to $432 thousand, compared with $2.1 million reported in the third quarter of fiscal 2019.

2. CTI BioPharma Corp. (CTIC) is down over 13% at $1.15 in pre-market trading today. A phase III trial evaluating the company's Pacritinib in hospitalized patients with severe COVID-19, dubbed PRE-VENT, is ongoing.

3. Adial Pharmaceuticals Inc. (ADIL) is down over 11% at $1.70 in pre-market trading today, giving back some of what it gained yesterday. On August 6, the company announced a third-party sales and distribution agreement with Brik LLC Rapid Result COVID-19 antibody test kits.

4. ADiTx Therapeutics Inc. (ADTX) is down more than 10% at $6.77 in pre-market hours Friday, giving back some of what it gained yesterday. The shares closed yesterday's trading at $7.60, up over 90% on completion of the validation studies for AditxtScore for COVID-19 to be used in detecting antibodies against SARS-CoV-2 antigens. The company plans to file for an Emergency Use Authorization (EUA) followed by a 510(K) application with the FDA by the end of the current quarter (Q3, 2020) and expects to make it commercially available starting in Q1, 2021.

5. Biocept Inc. (BIOC) is down nearly 9% at $1.04 in pre-market hours. The company is slated to release Q3 financial results after the market closes on Wednesday, August 12, 2020. On August 6, Biocept entered into an agreement with Aegea Biotechnologies to develop a highly sensitive PCR-based assay designed by Aegea for detecting the COVID-19 virus.

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