Pre-Open Stock Movers 04/09: (CELC) (AFMD) (GLSI) Higher; (PRVB) (ITRM) (JKS) Lower (more...)
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Today's Pre-Open Stock Movers
Celcuity Inc. (Nasdaq: CELC) 63% HIGHER; reported preliminary data for the 103 patients enrolled in the expansion portion of an ongoing Phase 1b clinical trial evaluating gedatolisib, a first-in-class PI3K/mTOR inhibitor, plus Ibrance and endocrine therapy, in ER+/HER2- advanced or metastatic breast cancer patients. As of the January 11, 2021 data cut-off date, 53 of the 88 evaluable patients (60%) had an objective response. Gedatolisib was also generally well tolerated, with the majority of treatment-related adverse events (TRAE) being Grade 1 or 2. The most common Grade 3 or 4 TRAEs related to gedatolisib were stomatitis and rash. In addition, announced it has entered into a global licensing agreement with Pfizer Inc. (NYSE: PFE) granting Celcuity exclusive rights to Pfizers gedatolisib, a Phase 1b pan-PI3K/mTOR inhibitor. Gedatolisib is in clinical development for the treatment of patients with ER+/HER2-negative advanced or metastatic breast cance
Provention Bio, Inc. (Nasdaq: PRVB) 41% LOWER; announced that the Company received a notification on April 2, 2021 from the U.S. Food and Drug Administration (FDA), stating that, as part of its ongoing review of the Company's Biologic License Application (BLA) for teplizumab for the delay or prevention of clinical type 1 diabetes, the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. The FDA stated in the correspondence that the notification does not reflect a final decision on the information under review.
Affimed N.V. (Nasdaq: AFMD) 34.2% HIGHER; announced today positive initial clinical data from an investigator-sponsored study at The University of Texas MD Anderson Cancer Center evaluating cord blood-derived natural killer (cbNK) cells pre-complexed with Affimeds innate cell engager (ICE®) AFM13 (CD16A/CD30).
Greenwich LifeSciences, Inc. (Nasdaq: GLSI) 22.8% HIGHER; announced the abstract results of the final 5 year immune response data of the Phase IIb clinical trial at the 2021 AACR Annual Meeting. Immune response is the primary mechanism of action and is critical to developing dosing and booster treatment strategies that are designed to achieve and sustain peak immunity and to prevent metastatic breast cancer recurrences.
Iterum (NASDAQ: ITRM) 15.5% LOWER; says FDA needs more time to review materials in support of NDA for sulopenem etzadroxil/probenecid
JinkoSolar (NYSE: JKS) 10.5% LOWER; reported Q4 EPS of $0.11, $0.25 worse than the analyst estimate of $0.36. Revenue for the quarter came in at $1.44 billion versus the consensus estimate of $1.38 billion. JinkoSolar sees Q1 2021 revenue of $1.18-1.3 billion, versus the consensus of $1.31 billion.
PLx Pharma (NASDAQ: PLXP) 10% HIGHER; Oppenheimer initiates coverage with an Outperform rating and a price target of $20.00.
WD-40 Co. (NASDAQ: WDFC) 7% LOWER; reported Q2 EPS of $1.24, $0.08 worse than the analyst estimate of $1.32. Revenue for the quarter came in at $111.9 million versus the consensus estimate of $114.33 million.
Sunworks, Inc. (NASDAQ: SUNW) 6.8% HIGHER; announced that they have entered into a denitive agreement pursuant to which a subsidiary of Sunworks will acquire Solcius, valued at $51.8 million on a cash-free and debt-free basis, in an all-cash transaction.
Academy Sports and Outdoor (NASDAQ: ASO) 6.5% HIGHER; highlighted as a Wallstreetbets/Reddit stock on CNBC. Also, an analyst from Evercore ISI called the stock "too cheap" amid re-opening.
DiaMedica Therapeutics Inc. (NASDAQ: DMAC) 6.2% HIGHER; Oppenheimer initiates coverage with an Outperform rating and a price target of $27.00.
fuboTV Inc. (NYSE: FUBO) 6% HIGHER; acquired the exclusive live streaming rights to the Qatar World Cup 2022 Qualifying matches of South American Football Confederation.
Assertio Therapeutics (NASDAQ: ASRT) 5.8% HIGHER; Gabelli upgraded from Hold to Buy.
Vascular Biogenics Ltd. (NASDAQ: VBLT) 5.8% LOWER; announced that it intends to offer and sell ordinary shares and, to certain investors in lieu thereof, pre-funded warrants to purchase ordinary shares in an underwritten public offering.
Global Ship Lease, Inc. (NYSE: GSL) 4.6% LOWER; announced today that KEP VI (Newco Marine), Ltd. and KIA VIII (Newco Marine), Ltd., both affiliates of Kelso & Company, a U.S. private equity firm, intend to offer for sale in an underwritten public offering Class A common shares, par value $0.01 per share, of the Company. The Selling Shareholders expect to grant the underwriters a 30-day option to purchase up to an additional 15% of the Common Shares offered in the Offering. The Company will not receive any proceeds from the sale of Common Shares by the Selling Shareholders.
Clover Health Investments (NASDAQ: CLOV) 3.5% HIGHER; adds to 20% intra-day gain after Clover Health Partners LLC was approved a CMS direct contracting entity.
TherapeuticsMD, Inc. (NASDAQ: TXMD) 3.8% HIGHER; announced that BIJUVE® has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for use in the United Kingdom and, from the Federal Agency for Medicines and Health Products (FAMHP) for use in Belgium under BIJUVA.
Levi (NYSE: LEVI) 3.2% HIGHER; reported Q1 EPS of $0.34, $0.07 better than the analyst estimate of $0.27. Revenue for the quarter came in at $1.3 billion versus the consensus estimate of $1.25 billion. The company raised its fiscal first-half 2021 reported net revenues outlook to 24-to-25 percent growth compared to the first half of 2020 and raised its first-half Adjusted EPS estimate to 41-to-42 cents. The company plans to share additional details during its investor conference call. The company’s outlook assumes no significant worsening of the COVID-19 pandemic or dramatic incremental closure of global economies.
RumbleOn, Inc. (Nasdaq: RMBL) 1.2% LOWER; announced that it is proposing to offer and sell, subject to market conditions, shares of its Class B Common Stock in an underwritten public offering.
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