After-Hours Stock Movers 06/16: (STSA) (TWO) Higher; (CVAC) (CRTD) (NOVN) Lower (more...)

June 16, 2021 5:59 PM EDT
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Price: $54.17 -1.65%

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After-Hours Stock Movers

CureVac N.V. (Nasdaq: CVAC) 49.6% 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.

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.

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.

Two Harbors Investment Corporation (NYSE: TWO) 2.5% HIGHER; will replace Cardtronics plc (NASDAQ: CATM) in the S&P SmallCap 600 effective prior to the opening of trading on Tuesday, June 22

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