Key Takeaways ZBIO shares plunged 51.9% on Jan. 5, even after its phase III INDIGO study met the primary endpoint.Obexelimab cut IgG4-RD flare risk by 56% vs. placebo over 52 weeks and met key secondary endpoints.ZBIO plans FDA BLA filing for obexelimab in Q2 2026 and an EMA application in 2H 2026 for IgG4-RD.Zenas BioPharma (ZBIO) announced that the phase III INDIGO study, which evaluated its lead pipeline candidate, obexelimab, for treating patients with immunoglobulin G4-related disease (IgG4-RD), has me ...

Core Insights - Moderna has submitted regulatory filings for its seasonal influenza vaccine mRNA-1010 in the US, EU, Canada, and Australia, targeting adults aged 50 and above, with plans to commercialize by next year [1][7] - The submissions are supported by late-stage study data indicating that mRNA-1010 generates immune responses comparable to existing flu vaccines from GSK and Sanofi [2][7] - Following the announcement, Moderna's stock rose over 4%, reflecting investor optimism regarding the potential product launch [3] Regulatory and Development Updates - The recent filings may also facilitate a future resubmission of Moderna's investigational COVID-19 and influenza combination vaccine, mRNA-1083, which had previously been withdrawn due to requests for additional efficacy data [4][7] - Moderna has faced challenges, including a 32% decline in stock over the past year, contrasting with a 15% growth in the industry [5][9] - The company has experienced setbacks, including the termination of a $766 million contract for a bird flu vaccine and the failure of its CMV vaccine in a late-stage study [9][10] Market Sentiment - The latest developments are seen as part of Moderna's strategy to improve negative market sentiment surrounding its stock [8]

Key Takeaways Galafold raked in $371.5M in the first nine months of 2025, accounting for over 80% of FOLD's product sales.Galafold benefits from broad global approvals and U.S. patent protection extending through 2038.FOLD's Pombiliti Opfolda delivered $77.5M sales in the first nine months of 2025, up 61% Y/Y.Amicus Therapeutics (FOLD) has made solid progress with its lead marketed product, Galafold (migalastat), which generates the majority of the company’s revenues.Galafold is approved for treating Fabry ...

The Tel Aviv Stock Exchange rose strongly today. The Tel Aviv 35 Index rose 2.86% to 3,845.39 points - a new record, the Tel Aviv 125 Index rose 2.55% to 3,8980.80 points; and the BlueTech Global Index rose 2.48% to 675.31 points. The All Bond corporate bond index rose 0.12% to 424.03 points. Turnover totalled NIS 5.44 billion in equities and NIS 8.35 billion in bonds. On the foreign exchange market, the representative shekel-dollar rate was set 0.19% higher from Monday, at NIS 3.164/$, and the representa ...

Corcept has also repeatedly assured investors that "[o]ur new drug application for relacorilant is progressing toward approval by the end of" 2025 and "[r]elacorilant's strong efficacy and safety profile gives us the potential to become the new standard of care for patients with hypercortisolism." Critically, Corcept's management also expressed confidence that "we're [more] confident than ever that we're on track to grow our hypercortisolism business from $3 billion to $5 billion in annual revenues in three ...

Key Takeaways Incyte's phase III study of Monjuvi combo met key goals versus R-CHOP alone in first-line DLBCL.INCY's Monjuvi/Minjuvi plus Revlimid with R-CHOP improved outcomes with no new or unexpected safety signals.Incyte plans an FDA filing seeking the label expansion of Monjuvi for first-line DLBCL treatment in H1 2026.Incyte (INCY) announced positive top-line results from a late-stage lymphoma study of Monjuvi/Minjuvi (tafasitamab), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, ...

The Stock Exchange of Hong Kong Limited and the Securities and Futures Commission take no responsibility for the contents of this announcement, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this announcement. 廣州新濟醫藥股份有限公司 Guangzhou Novaken Pharm Co., Ltd. (A joint stock company incorporated in the People's Republic of China with limited liability) WARNI ...

Alumis Inc. (NASDAQ:ALMS) stock is trading higher on Tuesday, with a session volume of 4.33 million compared to the average volume of 1.02 million as per data from Benzinga Pro.Alumis on Tuesday released topline results from its Phase 3 ONWARD1 and ONWARD2 clinical trials of envudeucitinib in patients with moderate-to-severe plaque psoriasis.Plaque psoriasis is the most common form of this chronic autoimmune skin condition, causing thick, red, inflamed patches (plaques) covered with silvery scales due to ra ...

, Inc. (NASDAQ:ARWR) on Tuesday shared interim results from two Phase 1/2a trials of ARO-INHBE and ARO-ALK7, the company’s investigational RNA interference (RNAi) therapeutics for obesity.Preliminary results showed meaningful reductions in multiple key measures, including visceral fat, total fat, and liver fat.What Is ARO-INHBE and ARO-ALK7 Therapy?Unlike current GLP-1 drugs (like Wegovy or Zepbound) that primarily reduce appetite, these candidates aim to change how the body stores and burns fat by silencin ...

Nimbus Therapeutics said on Tuesday it has entered into a multi-year research and licensing agreement with Eli Lilly to develop artificial intelligence-driven new oral treatments for obesity and other... ...