Pre-Open Stock Movers 06/17: (KULR) (CLSD) (STSA) Higher; (CVAC) (CRTD) (NOVN) Lower (more...)
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Pre-Open Stock Movers
CureVac N.V. (Nasdaq: CVAC) 45.9% LOWER; announced results of the second interim analysis of its international pivotal Phase 2b/3 study in approximatively 40,000 subjects (the HERALD study) of CureVac's first-generation COVID-19 vaccine candidate, CVnCoV. In the unprecedented context of at least 13 variants circulating within the study population subset assessed at this interim analysis, CVnCoV demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria. Initial analyses suggest age and strain dependent efficacy. Available data were communicated with the European Medicines Agency (EMA). The Data Safety Monitoring Board (DSMB) confirmed a favorable safety profile for CVnCoV. The study is continuing to the final analysis and the totality of the data will be assessed for the most appropriate regulatory pathway.
KULR Technology Group Inc. (NYSE: KULR) 31.3% HIGHER; received a special permit from the U.S. Department of Transportation (DoT) authorizing the transport of prototype lithium cells and batteries aboard cargo aircrafts. Prototype lithium batteries are only authorized to be transported on cargo carrying aircrafts to, from or within the US when approved by DOT. The special permit authorizes the manufacture, mark, sale and use of KULRs specially designed packaging for the transportation of prototype lithium cells and batteries, and prototype lithium cells and batteries contained in or packed with equipment.
Clearside Biomedical (NASDAQ: CLSD) 26.7% HIGHER; Wedbush raised the price target to $18.00 (from $6.00) while maintaining an Outperform rating.
Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA) 15.8% HIGHER; announced positive pharmacokinetic, tolerability and safety results from a Phase 1 trial of STS101. The Phase 1 data showed that all three dose strengths (5.2 mg and two higher dose strengths) administered with Satsumas improved second-generation nasal delivery device were well-tolerated and achieved the target pharmacokinetic profile. Based on results from this Phase 1 trial and other data, including preliminary results to date from the ongoing Phase 3 ASCEND long-term, open-label safety trial of STS101 5.2 mg, Satsuma is initiating its SUMMIT Phase 3 efficacy trial with the 5.2 mg dosage strength of STS101. As previously communicated, top-line results from the SUMMIT trial are expected in the second half of 2022.
Creatd, Inc. (Nasdaq: CRTD) 15.5% LOWER; announced that it has commenced an underwritten public offering of its common stock.
NANOX IMAGING LTD (NASDAQ: NNOX) 10% HIGHER; announced today that the Company has submitted a 510(k) premarket notification application to the U.S. Food and Drug Administration (FDA) for the first version of its multi-source Nanox.ARC 3-D digital tomosynthesis system.
Novan, Inc. (NASDAQ: NOVN) 10% LOWER; announced a proposed underwritten public offering of its common stock (the Offering). All shares to be sold in the Offering will be sold by Novan. The Company also expects to grant to the underwriter for the Offering a 30-day option to purchase up to an additional 15 percent of the number of shares of common stock offered in the public offering. The Offering is subject to market conditions, and there can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the Offering.
Acorda Therapeutics (NASDAQ: ACOR) 9.5% HIGHER; upgrade to Buy at H.C. Wainwright with a $10 price target.
The Honest Company Inc. (NASDAQ: HNST) 7.4% LOWER; reported Q1 EPS of ($0.05). Revenue for the quarter rose 12% to $81.03 million, versus $72.37 million reported last year.
Lordstown Motors (NASDAQ: RIDE) 7% LOWER; issued a clarification saying it does not have any binding purchase orders or commitments from customers.
Ford (NYSE: F) 2.3% HIGHER; announced today its adjusted earnings before interest and taxes in the second quarter will come ahead of expectations and “significantly better” than results recorded a year ago.
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