The Nasdaq-100 Index has announced its annual reconstitution, adding six new companies and removing six, effective Dec. 22.Six Stocks Added, Six Dropped From IndexThe six companies being added to the index are: Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) , Ferrovial SE (NASDAQ:FER) , Insmed Inc. (NASDAQ:INSM) , Monolithic Power Systems, Inc. (NASDAQ:MPWR) , Seagate Technology Holdings plc (NASDAQ:STX) and Western Digital Corp. (NASDAQ:WDC) .The six companies being removed from the index are: Biogen Inc. (NA ...

FDA confirmed that data from single-arm studies in rare diseases, such as in ultra-rare deadly pediatric cancer osteosarcoma, could support a Biologics Licensing Application (BLA) under Accelerated Approval Program pathway, as stated in FDA guidance documentsFDA proposed confirmatory study design include additional osteosarcoma disease settings such as prevention of recurrence following primary tumor resection, where a randomized controlled study may be feasible and that the confirmatory study would have t ...

U.S. stock futures are up early Monday morning, following a mixed week that saw rotation out of expensive tech stocks in favor of value, despite the third consecutive interest rate cut on Wednesday. Investors on Monday will be eagerly awaiting the results of the Empire State Manufacturing Survey, alongside the speeches of Federal Reserve Governor Stephen Miran and New York Fed President John Williams, both scheduled early in the day, ahead of a slew of other economic data that is set to be released over the ...

Core Insights - Swedish Orphan Biovitrum (Sobi) has agreed to acquire US-based Arthrosi Therapeutics for Skr9.1bn ($950m) in cash, with potential additional payments of up to Skr5.3bn ($550m) based on milestones [1][5] Group 1: Acquisition Details - The acquisition aims to enhance Sobi's presence in the gout treatment market [1] - Sobi will finance the upfront payment primarily through debt, utilizing existing credit facilities and a new credit facility from Handelsbanken and Danske Bank [4] - The transaction is expected to close in the first half of 2026, subject to customary closing conditions [3] Group 2: Product and Market Impact - Arthrosi is developing pozdeutinurad, a next-generation urate transporter 1 (URAT1) inhibitor, currently in two Phase III trials for managing progressive and tophaceous gout, with results expected in 2026 [2][3] - The therapy aims to lower serum urate levels, reduce gout flares, and address tophi in patients with progressive forms of the disease [3] - The acquisition is anticipated to positively impact Sobi's mid to long-term growth and margin profile [5]

For Climb Bio Inc. (CLYM), 2026 promises to be a data-rich year, with study results from two of its core programs poised to shape the company's strategy and guide subsequent development phases.The company is focused on delivering disease-modifying medicines for individuals living with immune-mediated diseases. Its drug candidates in focus are Budoprutug and CLYM116.Budoprutug is an anti-CD19 monoclonal antibody (mAb) designed to result in potent and durable B cell depletion, with a long dosing interval and ...

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Core Insights - CytomX Therapeutics (CTMX) is approaching a significant trial readout for CX-2051, an antibody-drug conjugate being evaluated for colorectal cancer [1] Group 1: Company Overview - CTMX was rated a buy in October, indicating positive sentiment towards the stock ahead of the trial results [1] Group 2: Industry Context - The focus is on trading around key events such as trial results and regulatory approvals, highlighting the volatility and potential investment opportunities in the biotech sector [1]

Core Viewpoint - argenx SE has announced the discontinuation of the Phase 3 UplighTED studies evaluating efgartigimod for moderate to severe thyroid eye disease (TED) based on an Independent Data Monitoring Committee's recommendation due to futility [1][2] Group 1: Study Discontinuation - The Phase 3 UplighTED studies were halted after an interim analysis indicated that the trials did not meet the desired outcomes [2][3] - The decision reflects a responsible evaluation of the study's future likelihood of success, emphasizing the company's commitment to disciplined resource management [3] Group 2: Study Design and Objectives - The UplighTED studies were randomized, double-masked, placebo-controlled trials designed to assess the efficacy, safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of efgartigimod in adults with active, moderate-to-severe TED [4] - The primary endpoint was the percentage of participants who were proptosis responders at week 24, with key secondary endpoints including changes in proptosis measurement and quality of life scores [4] Group 3: Background on Thyroid Eye Disease - Thyroid Eye Disease (TED) is an autoimmune condition associated with Graves' disease and characterized by symptoms such as proptosis, diplopia, and potential vision loss, significantly impacting patient quality of life [5] Group 4: About Efgartigimod - Efgartigimod is a human IgG1 antibody fragment that reduces circulating IgG autoantibodies and is the first approved FcRn blocker for various autoimmune diseases [6]

On December 8, Kevin Mahn of Hennion & Walsh appeared on CNBC’s ‘Closing Bell Overtime’ to discuss the potential for another bullish year, but with more volatility. Mahn noted the possibility of a hawkish cut from the Fed coming up on Wednesday, which he believes could bode well for the markets. He supported this with historical data and stated that since 1950, the Fed has cut interest rates on 23 different occasions when the S&P 500 was within 2% of its all-time high, as it is currently. In all 23 of those ...

Core Insights - Wave Life Sciences Ltd. (NASDAQ: WVE) experienced a significant surge in share price, nearly tripling week-on-week, driven by positive results from its obesity drug clinical trial [1][2]. Clinical Trial Results - The first phase of the clinical trial for WVE-007 showed promising results, with a 4.5% total fat loss, 9.4% visceral fat reduction, and a 3.2% increase in lean mass over three months [3]. - No serious adverse reactions were reported during the trial, which contributed to investor confidence in the drug's safety and tolerability [3]. Future Expectations - Wave Life Sciences plans to release results from the second round of the clinical trial, which will include six-month data for the 240 mg single-dose cohort and three-month follow-up data for the 400 mg single-dose cohort [4][5]. - The company aims to evaluate WVE-007 as both a monotherapy and an add-on therapy for patients with higher BMI and related co-morbidities in phase 2 of the trial [5].