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Pre-Open Stock Movers 03/29: (HGEN) (FLY) (HMHC) Higher; (ORPH) (NMR) (CS) Lower (more...)

March 29, 2021 9:29 AM EDT

Today's Pre-Open Stock Movers:

Humanigen, Inc. (Nasdaq: HGEN) 65.3% HIGHER; announced positive topline results from its Phase 3 clinical trial evaluating the efficacy and safety of lenzilumab in patients hospitalized with COVID-19. Trial results showed that patients who received lenzilumab and other treatments, including steroids and/or remdesivir, had a 54% greater relative likelihood of survival without the need for IMV compared with patients receiving placebo and other treatments. These results are statistically significant.

Orphazyme A/S (NASDAQ: ORPH) 32% LOWER; announced its phase 2/3 trial evaluating arimoclomol for the treatment of inclusion body myositis (IBM), a progressively debilitating muscle-wasting disease, did not meet its primary and secondary endpoints. The primary goal was to evaluate the treatment effect on disease progression as measured by the inclusion body myositis functional rating scale (IBMFRS).

Fly Leasing Limited (NYSE: FLY) 26.7% HIGHER; entered into a definitive agreement to be acquired by an affiliate of Carlyle Aviation Partners, the commercial aviation investment and servicing arm within The Carlyle Group's $56 billion Global Credit platform. Under the terms of the Merger Agreement, FLY shareholders will receive $17.05 per share in cash, representing a total equity valuation of approximately $520 million. The total enterprise value of the transaction is approximately $2.36 billion. FLY's portfolio of 84 aircraft and seven engines is on lease to 37 airlines in 22 countries.

Houghton Mifflin Harcourt (NASDAQ: HMHC) 22.1% HIGHER; announced that it has entered into a definitive agreement to divest HMH Books & Media, its consumer publishing business, to HarperCollins Publishers, a division of News Corp (NASDAQ: NWS), a global, diversified media and information services company, for a cash purchase price of $349 million.The divestiture enables HMH to focus singularly on K12 education and accelerate growth momentum in digital sales, annual recurring revenue and free cash flow while paying down a significant portion of its debt.

Celldex Therapeutics, Inc. (NASDAQ: CLDX) 15.8% LOWER; reported interim data from the Companys ongoing, open label clinical trial of CDX-0159 in patients with antihistamine refractory cold contact urticaria (ColdU) and symptomatic dermographism (SD), the two most common forms of chronic inducible urticaria (CIndU). In all patients treated and assessed for at least 15 days after treatment (n=10), 8 of 10 patients (80%) experienced a complete response (CR) to provocation testing post-treatment and one patient experienced a partial response (PR). CDX-0159 was generally well tolerated. CDX-0159 is a humanized monoclonal antibody developed by Celldex that binds the KIT receptor with high specificity and potently inhibits its activity. The KIT receptor tyrosine kinase is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. Enrollment is currently being completed in the ColdU and SD cohorts (10 per cohort; 20 total). Based on these compelling results, the study will be expanded to also include 10 patients with cholinergic urticaria. The Company will host a conference call at 7:45 am ET today to discuss results and will be joined by Dr. Marcus Maurer, Professor of Dermatology and Allergy at Charité - Universitätsmedizin in Berlin, who is conducting the study.

Nomura Holdings, Inc. (NYSE: NMR) 14.2% LOWER; announced that on March 26, 2021, an event occurred that could subject one of its US subsidiaries to a significant loss arising from transactions with a US client. Nomura is currently evaluating the extent of the possible loss and the impact it could have on its consolidated financial results. The estimated amount of the claim against the client is approximately $2 billion based on market prices as of March 26. This estimate is subject to change depending on unwinding of the transactions and fluctuations in market prices. Nomura will continue to take the appropriate steps to address this issue and make a further disclosure once the impact of the potential loss has been determined.

Credit Suisse (NYSE: CS) 13.6% LOWER; Credit Suisse issued a trading update this morning to warn of a highly significant hit to its first-quarter results after a US hedge fund defaulted on margin calls.

Kazia Therapeutics Limited (NASDAQ: KZIA) 12.4% HIGHER; announced that it has entered into a licensing agreement with Simcere Pharmaceutical Group Ltd (Simcere) (HKSE: 2096) to develop and commercialise Kazia's investigational new drug, paxalisib, in Greater China.

uniQure N.V. (NASDAQ: QURE) 9.4% HIGHER; announced today the results of a comprehensive investigation into the case of hepatocellular carcinoma (HCC) diagnosed in one patient in the HOPE-B pivotal trial of etranacogene dezaparvovec. The results of the investigation found that it is highly unlikely the HCC was caused by etranacogene dezaparvovec.

Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) 7.5% HIGHER; announced today that data from a Phase 2 clinical study of IONIS-PKK-LRx met its primary and secondary endpoints, achieving significant reductions in the number of attacks suffered by patients with hereditary angioedema (HAE) compared to placebo. The study demonstrated a mean reduction of 90% in the number of monthly HAE attacks in weeks one to 17 of the study (p <0.001) and a mean reduction of 97% in the number of monthly HAE attacks in weeks five to 17 (p=0.003). In weeks five to 17, 92% of patients treated with IONIS-PKK-LRx were attack-free compared to 0% in the placebo group (p <0.001).

Shares of bluebird bio (NASDAQ: BLUE) 7.5% HIGHER; The company's Abecma therapy, developed together with Bristol-Myers Squibb (NYSE: BMY), received a green light from the U.S. Food and Drug Administration (FDA). Abecma is the first B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody, two companies said in a statement.

Silvergate Capital Corporation (NYSE: SI) 4.2% HIGHER; announced Fidelity Digital Assets, a leading institutional focused execution and custody services platform provider, as a custodian for SEN Leverage. SEN Leverage provides secure, institutional-grade access to capital through U.S. dollar (USD) loans collateralized by bitcoin.

Morgan Stanley (NYSE: MS) 3.9% LOWER; lower on potential exposure and collateral damage from Archegos Capital liquidation.

Wells Fargo & Company (NYSE: WFC) 3% LOWER; lower on potential exposure and collateral damage from Archegos Capital liquidation.

The Goldman Sachs Group, Inc. (NYSE: GS) 1.9% LOWER; lower on potential exposure and collateral damage from Archegos Capital liquidation. Goldman's direct exposure is said to be immaterial, according to Bloomberg.



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