Pre-Open Stock Movers 11/30: (CPIX) (IMGN) (VIR) Higher; (JKS) (LIZI) (SEDG) Lower (more...)
Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) 129% HIGHER; announced the U.S. Food and Drug Administration (FDA) has approved expanded labeling for Caldolor®, an intravenously delivered formulation of ibuprofen, to now include use in pre-operative administration. The non-narcotic pain reliever may now be administered just prior to surgery to enable patients to wake up from their procedure in significantly less pain.
ImmunoGen Inc. (Nasdaq: IMGN) 45.5% HIGHER; announced positive top-line data from the pivotal SORAYA trial evaluating the safety and efficacy of mirvetuximab soravtansine (mirvetuximab) monotherapy in patients with folate receptor alpha (FR)-high platinum-resistant ovarian cancer who have been previously treated with Avastin® (bevacizumab).
Vir Biotechnology (NASDAQ: VIR) 17.3% HIGHER; H.C. Wainwright raised the price target to $200.00 (from $135.00) while maintaining a Buy rating.
MEI Pharma, Inc. (NASDAQ: MEIP) 13.9% HIGHER; announced that the pivotal Phase 2 TIDAL study evaluating zandelisib as a single agent for follicular lymphoma (FL) patients who received at least two prior systemic therapies demonstrated a 70.3% objective response rate (ORR) as determined by Independent Review Committee (IRC) assessment in the primary efficacy population (n=91). In addition, 35.2% of patients achieved a complete response. The data are currently insufficiently mature to accurately estimate duration of response (DOR). In line with previously reported data from the Phase 1B study, zandelisib was generally well tolerated. With 9.4 months (range: 0.8-24) median duration of follow-up in the total study population (n=121), interim data demonstrated a discontinuation rate due to any drug related adverse event of 9.9%. Patients enrolled in the study will continue to be followed for safety and DOR. Zandelisib is an investigational selective phosphatidylinositol 3-kinase delta ("PI3K") inhibitor in clinical development for the treatment of B-cell malignancies.
Adagene Inc. (Nasdaq: ADAG) 12.1% HIGHER; announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to proceed with a Phase 1b/2 clinical trial of its anti-CTLA-4 monoclonal antibody (mAb), ADG116, in combination with the anti-PD-1 antibody, pembrolizumab. The global trial (ADG116-P001 / KEYNOTE-C97) will evaluate patients with advanced/metastatic solid tumors at multiple sites in the U.S. and Asia Pacific (APAC).
JinkoSolar (NYSE: JKS) 8% LOWER; reported Q3 EPS of $0.08, $0.06 better than the analyst estimate of $0.02. Revenue for the quarter came in at $1.33 billion versus the consensus estimate of $1.34 billion. JinkoSolar sees Q4 2021 revenue of $1.8-2.2 billion, versus the consensus of $2.24 billion.
Outset Medical, Inc. (Nasdaq: OM) 5.6% HIGHER; announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for a new sterilization method of the cartridge utilized in its TabloÂ® Hemodialysis System, enabling full production in North America. The Tablo cartridge is a single-use disposable that works in concert with the console to deliver dialysis treatment. Its 'one-touch' design speeds and simplifies treatment set-up and take-down.
LIZHI INC. (NASDAQ: LIZI) 4.8% LOWER; Reports Q3 Revenues of $78.4M, Average Total MAUs of 58.9M, Adjusted Net Loss of $4.2M
Krystal Biotech, Inc. (NASDAQ: KRYS) 4.3% HIGHER; adds to 121% intra-day gains after it announced that it has commenced a $200 million underwritten public offering of its common stock.
ERYTECH Pharma (Nasdaq: ERYP) 4% HIGHER; announced the granting of US patent 11,141,468, covering methods of treating solid tumors by administering methioninase and asparaginase. In total, ERYTECHs IP portfolio now includes 16 global patent families with over 310 patents and 45 applications. These patent families protect ERYTECHs proprietary red blood cell encapsulation technology (ERYCAPS®), its therapeutics for Oncology, Rare Metabolic Diseases, and Immune Modulation, as well as its methods for producing Cargo-Loaded Red Cell Extracellular Vesicles (CLRCEV).
SolarEdge Technologies (NASDAQ: SEDG) 3.4% LOWER; Morgan Stanley downgraded from Overweight to Equalweight but raised the price target to $338.00 (from $318.00).
Rocket Lab USA (NASDAQ: RKLB) 2.7% HIGHER; BofA Securities initiates coverage with a Buy rating and a price target of $20.00.
Intuit (Nasdaq: INTU) 2.5% LOWER; announced today that certain entities affiliated with Dan Kurzius, co-founder of Mailchimp have commenced an underwritten secondary offering of 1,548,700 shares of the Company's common stock.
R.R. Donnelley & Sons (NYSE: RRD) 2.2% HIGHER; Chatham Asset Management, LLC, a private investment firm which manages funds that beneficially own approximately 14.9% of the outstanding common stock of R.R. Donnelley & Sons Company (NYSE: RRD) and which is the largest bondholder of the Company, today responded to a press release issued by RRD regarding the expiration of its go-shop period and receipt of an offer from a strategic party to acquire RRD at a price equal to $10.00 per share in cash.
Golub Capital BDC (NASDAQ: GBDC) 2.1% HIGHER; reported Q4 EPS of $0.42, $0.12 better than the analyst estimate of $0.30.
Square (NYSE: SQ) 1% HIGHER; BofA Securities upgraded from Underperform to Neutral.