Pre-Open Stock Movers 10/20: (SESN) (LRN) (UAL) Higher; (NVAX) (MITO) (EAT) Lower (more...)

October 20, 2021 9:27 AM EDT

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Pre-Open Stock Movers:

Novavax (NASDAQ: NVAX) 22.3% LOWER; manufacturing problems are jeopardizing billions of doses earmarked for poor and middle-income countries - Politico

Stealth BioTherapeutics Corp (Nasdaq: MITO) 16% LOWER; announced that it received a Refusal to File letter from the United States Food and Drug Administration (FDA) regarding Stealth's New Drug Application (NDA) for elamipretide, a mitochondria-targeted therapy for the treatment of Barth syndrome.

Sesen Bio (NASDAQ: SESN) 13.9% HIGHER; disclosed: On the morning of October 19, 2021, the US Food & Drug Administration (FDA) granted Sesen Bio, Inc.s (the Company) request for a Type A meeting to discuss the Chemistry, Manufacturing and Controls (CMC) issues raised in the FDAs Complete Response Letter (CRL) regarding the Companys Biologics License Application (BLA) for Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (the CMC Type A Meeting). The CMC Type A Meeting has been scheduled for October 29, 2021. During the CMC Type A Meeting, the Company intends to align on a path forward with the FDA related to the CMC issues raised in the CRL.

ATI Physical Therapy (NYSE: ATIP) 13.7% LOWER; Reports Prelim. Q3 Results, Lowers FY Revenue Guidance.

Brinker International, Inc. (NYSE: EAT) 11.1% LOWER; sales in the first quarter of fiscal 2022 increased to $859.6 million as compared to $728.2 million in the first quarter of fiscal 2021. Net income per diluted share, excluding special items, in the first quarter of fiscal 2022 increased to $0.34 as compared to $0.28 in the first quarter of fiscal 2021.(Consensus sees Q1 EPS of $0.71 on revenue of $875.3 million)

WD-40 Co. (NASDAQ: WDFC) 8.9% LOWER; reported Q4 EPS of $0.61, $0.62 worse than the analyst estimate of $1.23. Revenue for the quarter came in at $115.2 million versus the consensus estimate of $117.47 million.

Akero Therapeutics, Inc. (Nasdaq: AKRO) 5.7% HIGHER; announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead program investigating efruxifermin (EFX) for the treatment of non-alcoholic steatohepatitis (NASH).

Stride Inc. (NYSE: LRN) 5.3% HIGHER; reported Q1 EPS of ($0.15), $0.01 worse than the analyst estimate of ($0.14). Revenue for the quarter came in at $400.2 million versus the consensus estimate of $359.48 million. Stride Inc. sees FY2022 revenue of $1.56-1.6 billion, versus the consensus of $1.47 billion.

Jasper Therapeutics (NASDAQ: JSPR) 4% HIGHER; BMO Capital initiates coverage with an Outperform rating and a price target of $19.00.

United Airlines (NASDAQ: UAL) 1.9% HIGHER; reported Q3 EPS of ($1.02), $0.27 better than the analyst estimate of ($1.29). Revenue for the quarter came in at $7.8 billion versus the consensus estimate of $7.85 billion.

Western Union Co. (NYSE: WU) 1.5% HIGHER; BTIG downgraded from Buy to Neutral.



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