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Pre-Open Stock Movers 03/01: (ALSN) (APEN) (VACQ) Higher; (ATNX) (CRMD) (OTRK) Lower (more...)

March 1, 2021 9:32 AM EST

Today's Pre-Open Stock Movers

Athenex, Inc., (NASDAQ: ATNX) 54.6% LOWER; announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the companys New Drug Application (NDA) for oral paclitaxel plus encequidar for the treatment of metastatic breast cancer. The FDA issues a CRL to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form.

ASLAN Pharmaceuticals (Nasdaq: ASLN) 51% HIGHER; announced positive interim unblinded data from the three dose cohorts of its ongoing randomised, double-blind placebo controlled multiple ascending dose study of ASLAN004 for the treatment of moderate to severe atopic dermatitis (AD). ASLAN004 was shown to be well tolerated across all doses and showed improvements compared to placebo in all efficacy endpoints, supporting its potential as a differentiated, novel treatment for AD.

CorMedix Inc. (NASDAQ: CRMD) 46.7% LOWER; announced today that the US Food and Drug Administration (FDA) cannot approve the New Drug Application (NDA) for DefenCath™ (taurolidine/heparin catheter lock solution) in its present form. FDA noted concerns at the third-party manufacturing facility after a review of records requested by FDA and provided by the manufacturing facility. FDA did not specify the issues and CorMedix intends to work with the manufacturing facility to develop a plan for resolution when FDA informs the facility of the specific concerns. When we are informed of the issues, we will schedule an investor conference call to provide an update on our expected timeline for resolution. Additionally, FDA is requiring a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from the vials despite an existing in-process control to demonstrate fill volume within specifications. CorMedix expects to be able to complete this requirement expeditiously.

Ontrak, Inc. (NASDAQ: OTRK) 42.3% LOWER; Record Quarterly Revenue of $29.3 million in Q4 2020, up 149% year over year and up 22% from Q3 2020

Apollo Endosurgery, Inc. (NASDAQ: APEN) 36.5% HIGHER; received a Breakthrough Device Designation from the U.S. Food and Drug Administration for the Orbera Intragastric Balloon, specifically for the indication for use in treating patients with BMI between 30-40 kg/m2 with noncirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis. The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.

Vector Acquisition Corporation (Nasdaq: VACQ) 27.8% HIGHER; Rocket Lab USA, Inc., a global leader in launch and space systems, and Vector Acquisition Corporation (Nasdaq: VACQ), a special purpose acquisition company backed by leading technology investor Vector Capital, announced today that they have entered into a definitive merger agreement that will result in Rocket Lab becoming a publicly traded company. The transaction is estimated to be completed in Q2 2021 and, at that time, Vector will change its name to Rocket Lab USA, Inc. and the combined company will trade under the Nasdaq ticker symbol RKLB.

SOS Limited (NYSE: SOS) 26.2% HIGHER; was recently attacked by short sellers with distorted, misleading, and unsubstantiated claims regarding the Company. The Company also believes certain social media accounts of some Company board members may have been impersonated or disabled for short periods of time. The Company believes these attacks were purposefully designed to manipulate the price of the Company's shares, with the aim of causing a stock price decline in order to economically benefit the short sellers, to the detriment of the Company's public shareholders.

Angion Biomedica (NASDAQ: ANGN) 25% HIGHER; H.C. Wainwright initiates coverage with a Buy rating and a price target of $100.00.

Morphic Therapeutic (Nasdaq: MORF) 24.9% HIGHER; announced positive interim results from its Phase 1 clinical trial of MORF-057, an oral small molecule inhibitor of the 47 integrin in development for the treatment of inflammatory bowel disease (IBD). 47 inhibition for the treatment of IBD is a clinically validated biologic mechanism but with no currently available oral treatment options. This single ascending dose (SAD) clinical trial was designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of MORF-057 in healthy volunteers.

Foresight Autonomous Holdings Ltd. (NASDAQ: FRSX) 17.8% HIGHER; announced today that its wholly owned subsidiary, Eye-Net Mobile Ltd., successfully completed a controlled trial of its Eye-Net Protect cellular-based accident prevention solution for the intelligent transport system division of a multi-billion-dollar global Japanese vehicle manufacturer.

Iteris, Inc. (NASDAQ: ITI) 14.7% HIGHER; Rekor Systems, Inc., (NASDAQ: REKR) announced today that on February 20, 2021, it had advised Iteris, Inc. (NASDAQ: ITI) that it was prepared to offer to purchase all of Iteris’ outstanding common stock. The offer to Iteris was for a combination of cash and common stock subject to confirmatory diligence and approval of both boards of directors. On February 26th, Rekor was advised that the board of directors of Iteris “has decided at this time the combination of the two companies would not be in the best interest of [Iteris’] shareholders.”

Marathon Digital Holdings, Inc. (NASDAQ: MARA) 12.9% HIGHER; bitcoin rebounds.

Riot Blockchain, Inc. (NASDAQ: RIOT) 11.1% HIGHER; bitcoin rebounds.

MicroStrategy (NASDAQ: MSTR) 6.9% HIGHER; bitcoin rebounds. MSTR buys more.



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