Core Insights - Immunome's experimental drug successfully met the primary endpoint in a late-stage study targeting patients with a rare type of tumor [1] Company Summary - The company is advancing its drug development efforts in the oncology sector, focusing on rare tumor types [1]

Core Insights - Orelabrutinib is the first BTK inhibitor to show significant clinical activity in a Phase 2 clinical trial for Systemic Lupus Erythematosus (SLE) [1] - Zenas BioPharma has acquired exclusive rights to develop, manufacture, and commercialize orelabrutinib for Multiple Sclerosis (MS) globally, and for non-oncology fields outside Greater China and Southeast Asia [1][5] Clinical Trial Results - In the Phase 2b study, 187 patients were randomized into three groups: orelabrutinib 75 mg once-daily, orelabrutinib 50 mg once-daily, and placebo [2] - The primary endpoint, SLE Response Index-4 (SRI-4) response rate at week 48, was met with the 75 mg group showing a response rate of 57.1% compared to 34.4% for placebo (p < 0.05) [2] - Secondary endpoints, including SRI-6 and British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response rates, were also significantly higher in the 75 mg group compared to placebo (p < 0.05) [3] Safety and Tolerability - Orelabrutinib was well tolerated, exhibiting a safety profile consistent with BTK inhibition and the disease biology of SLE [3] Development Pipeline - Zenas is advancing orelabrutinib into a Phase 3 trial for Primary Progressive MS (PPMS) and plans to initiate a Phase 3 trial for Secondary Progressive MS (SPMS) in Q1 2026 [6] - Orelabrutinib is already approved for B cell malignancies in mainland China and Singapore, marketed by InnoCare [6] Company Overview - Zenas BioPharma is a clinical-stage global biopharmaceutical company focused on developing transformative therapies for autoimmune diseases [7] - The company is advancing two late-stage molecules: obexelimab and orelabrutinib, with obexelimab being a bifunctional monoclonal antibody targeting CD19 and FcγRIIb [7][8]

Kyverna Therapeutics said on Monday its experimental cell therapy for treating patients with a rare movement disorder met the main goal of a mid-stage study, sending its shares surging 20% in premarke... ...

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]