(RTTNews) - What's moving these stocks in the pre-market hours today?
In the Green
1. Tonix Pharmaceuticals Holding Corp. (TNXP) is up over 45% at $1.18 in pre-market trading Monday. Last week, the Company entered into a research collaboration with Columbia University to develop precision medicine techniques for COVID-19 vaccines and therapeutics.
2. iBio Inc. (IBIO) is up more than 35% at $5.30 in pre-market trading today on no news. The Company has two vaccine candidates for COVID-19, under preclinical development. The two COVID-19 vaccine candidates are produced in modified tobacco leaves using a plant-based growing system known as "FastPharming." The vaccine candidates are being tested at Texas A&M University System ("TAMUS") laboratories.
3. Idera Pharmaceuticals Inc. (IDRA) is up more than 15% at $2.56 in pre-market trading. Last month, the Company reported preliminary data from the first 10 patients in the safety cohort of its phase II study of Tilsotolimod in combination with Opdivo and Yervoy in immunotherapy-naive micro-satellite stable colorectal cancer patients (MSS-CRC.), dubbed ILLUMINATE-206. The trial demonstrated the safety profile of this first-time triplet combination and based on the data to date, the Company plans to expand the study to further evaluate this triplet combination in MSS-CRC.
4. Heat Biologics Inc. (HTBX) is up over 15% at $2.83 in pre-market trading Monday on no news. Last month, the Company had said that it remains on track to complete the design and development of its COVID-19 vaccine in July, and initiate manufacturing in early August. The Company is collaborating with Waisman Biomanufacturing to manufacture its COVID-19 vaccine.
5. Vaccinex Inc. (VCNX) is up more than 14% at $9.10 in pre-market trading. The Company's lead drug candidate is Pepinemab, under a phase II trial in Huntington's patients with late prodromal and early manifest disease, dubbed SIGNAL. The topline data from the SIGNAL trial is anticipated in October of this year.
6. Allena Pharmaceuticals Inc. (ALNA) is up more than 8% at $2.34 in pre-market trading. The Company's lead drug candidate is Reloxaliase for patients with enteric hyperoxaluria (EH) in URIROX-2, the second pivotal phase III trial in its URIROX program. The interim analysis is expected in the first quarter of 2022 and topline data for potential BLA submission is anticipated in the third quarter of 2022.
7. Novavax Inc. (NVAX) is up over 4% at $146.50 in pre-market trading Monday. The Company's COVID-19 vaccine candidate NVX-CoV2373 is under a phase I trial. The phase I trial was initiated in May, with preliminary immunogenicity and safety results expected this month. If the results are promising, the phase II portion of the trial will be initiated quickly. A pivotal phase III trial of NVX-CoV2373 with up to 30,000 subjects is expected to commence beginning in the fall of 2020.
8. Moderna Inc. (MRNA) is up more than 3% at $98.50 in pre-market trading. The Company is all set to join the NASDAQ-100 Index beginning today. The NASDAQ-100 includes the 100 largest non-financial companies listed on the Nasdaq Stock Market, based on market capitalization. Moderna, the first to move its COVID-19 vaccine candidate mRNA-1273 in human trials in March, reported positive interim clinical data from its phase I study in May. A phase II study of the vaccine is underway and phase III study is expected to start this month.
In the Red
1. Verona Pharma plc (VRNA) is down more than 9% at $9.20 in pre-market trading on Monday, giving back some of what it gained Friday. The stock had soared as much as 232% on Friday to touch an intraday high of $15.71 before closing at $10.20 on news that the Company raised approximately $200 million in an oversubscribed private placement and subscription with new and existing institutional and accredited investors. The Company plans to initiate a phase III program of Ensifentrine in chronic obstructive pulmonary disease, dubbed ENHANCE, later this year.
2. Applied DNA Sciences Inc. (APDN) is down over 8% at $9.80 in pre-market trading today. On Friday, the stock had gained as much as 65% in intraday trading, following positive preclinical results from Linear-DNA forms of COVID-19 vaccine candidates. The vaccine candidates under development by the Company and partner Takis Biotech yielded strong antibody and T-cell responses even at very low doses of linear DNA. The vaccine candidates are expected to enter human trials in early autumn.
3. AcelRx Pharmaceuticals Inc. (ACRX) is down more than 8% at $1.15 in pre-market trading.
4. AstraZeneca PLC (AZN) is down over 3% at $61.11 in pre-market trading. The Company is developing a cornoavirus vaccine by the name AZD1222, in partnership with the University of Oxford. The phase I trial data of AZD1222 is expected to be published in The Lancet medical journal today.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.