What’s moving these stocks in the pre-market hours today?
In the Green
1. Aquestive Therapeutics Inc. (AQST) is up over 9% at $5.45 in pre-market trading Tuesday, gaining some of what is lost yesterday. The shares were down over 34% yesterday, following FDA’s refusal to approve the company’s Libervant Buccal Film for management of seizure clusters. The company is planning to resubmit New Drug Application for Libervant prior to the end of 2020, following a Type A meeting with the FDA.
2. Tonix Pharmaceuticals Holding Corp. (TNXP) is up over 9% at $0.93 in pre-market hours Tuesday, on news of the company completing the purchase of a 40,000 square foot facility in Massachusetts to house its new Advanced Development Center (ADC) for accelerated development and manufacturing of vaccines, including vaccines for COVID-19. The company’s lead vaccine candidate for COVID-19 is TNX-1800, which is under animal studies, with data anticipated in the fourth quarter of this year.
3. Sorrento Therapeutics Inc. (SRNE) is up over 8% at $10.97 in pre-market hours today, adding to yesterday’s gain of 5%. In preclinical studies of two antibodies STI-1499 and STI-2020, the results of which were announced yesterday, the two compounds demonstrated potent neutralizing activity against SARS-CoV-2 virus isolates, including the emerging Spike D614G variant virus. Sorrento has received FDA clearance for its Phase 1 clinical trial for STI-1499 in hospitalized COVID-19 patients and intends to submit an IND for STI-2020 as soon as possible.
4. Abeona Therapeutics Inc. (ABEO) is up over 7% at $1.17 in pre-market hours today, gaining some of what is lost yesterday. The stock lost over 40% yesterday on news of the company’s leadership and Board transitions. Abeona is exploring all strategic options and alternatives to maximize stakeholder value, including its sale.
5. Genfit SA (GNFT) is up over 6% at $5.88 in pre-market hours today, adding to yesterday’s gain. The company inked a five-year exclusive licensing agreement with LabCorp (LH) for NASH diagnostic test yesterday, sending the shares up over 30%. As part of the deal, LabCorp will develop and commercialize a blood-based molecular diagnostic test powered by GENFIT’s NIS4 technology throughout the U.S. and Canada to help identify patients with at-risk non-alcoholic steatohepatitis (NASH). The diagnostic test is expected to be available from LabCorp by early 2021.
6. Kitov Pharma Ltd (KTOV) is up over 6% at $4.53 in pre-market hours today, adding to yesterday’s gain of over 4%, on no news. A phase I/II clinical study of NT219 in advanced cancer patients is underway, with topline results anticipated in the second half of 2021. A one-for-ten reverse split of the company’s American Depositary Shares was implemented on August 21, 2020.
7. Precipio Inc. (PRPO) is up over 3% at $2.46 in pre-market hours today on no news. Last week, the company launched its proprietary HemeScreen AML (Acute Myeloid Leukemia) Molecular Panel for reference laboratories and physician office laboratories to test patient samples.
In the Red
1. Viking Therapeutics Inc. (VKTX) is down over 6% at $5.60 in pre-market trading Tuesday on no news. Early this month, the company initiated a phase I single ascending dose and multiple ascending dose clinical trial of VK0214, a potential treatment for X-linked adrenoleukodystrophy (X-ALD).
2. FSD Pharma Inc. (HUGE) is down over 7% at $2.56 in pre-market hours on no news. Yesterday, the company revealed that it will start dosing patients in its phase II study of FSD201 for treatment of COVID-19 in October 2020.
3. Inovio Pharmaceuticals Inc. (INO) is down more than 4% at $11.54 in pre-market hours Tuesday’s adding to yesterday’s loss of 28%. The stock got whacked yesterday, following the FDA’s decision to place the company’s planned phase II/III trial of COVID-19 vaccine candidate INO-4800 on partial hold. An expanded phase I study of INO-4800 in the U.S., and a phase I/II trial of INO-4800 in South Korea are underway, and they will not be impacted by the clinical hold.
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