After-Hours Stock Movers 09/20: (APRE) (SDC) Higher; (VRCA) (KAR) (LEN) Lower (more...)

September 20, 2021 6:47 PM EDT

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After-Hours Stock Movers:

Verrica Pharmaceuticals Inc. (Nasdaq: VRCA) 23% LOWER; announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum). The Company had previously disclosed that the FDA extended the Prescription Drug User Fee Act (PDUFA) goal date for the NDA by three months to September 23, 2021 to allow the Agency additional time to review information submitted by the Company in response to comments from the Agency regarding the Companys human factors study.

Aprea Therapeutics, Inc. (Nasdaq: APRE) 14.9% HIGHER; presented data at the European Society of Medical Oncology (ESMO) Congress 2021 from its Phase I/II clinical trial in advanced solid tumors. The trial is evaluating the safety and efficacy of eprenetapopt in combination with pembrolizumab.

SmileDirectClub, Inc. (Nasdaq: SDC) 4% HIGHER; announced today its plan to launch in France in the beginning of the fourth quarter of 2021. The Company will introduce its premium clear aligners, telehealth platform, and award-winning whitening system at its first France SmileShop in Paris, with additional locations to follow. This marks the Companys entry into its seventh European country as it pursues the global market opportunity for its innovative, effective, convenient, accessible and affordable oral care products. Also, downgraded to Hold at Stifel.

KAR Auction Services (NYSE: KAR) 3% LOWER; is withdrawing its previously provided financial outlook for fiscal 2021. The company expects $95 million to $100 million of Adjusted EBITDA for the third quarter 2021 and expects approximately 2.6 million vehicles sold in 2021. Due to the market uncertainty, the company does not intend to provide fourth quarter expectations at this time.

Lennar Corp. (NYSE: LEN) 2.3% LOWER; reported Q3 EPS of $3.27, $0.01 worse than the analyst estimate of $3.28. Revenue for the quarter came in at $6.94 billion versus the consensus estimate of $6.86 billion.



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Stifel, After-Hours Movers, PDUFA, FDA