Key Takeaways Outlook Therapeutics stock sank after the FDA issued a third CRL rejecting the ONS-5010 BLA for wet AMD.OTLK's November 2025 resubmission was rejected for insufficient efficacy data, seeking confirmatory evidence.OTLK has secured EU and UK approval for Lytenava and launched the drug in Germany and the UK in 2025.Shares of Outlook Therapeutics (OTLK) have tumbled 66.5% in a week. The massive crash was observed after the FDA issued a third complete response letter (CRL) in late December, rejecti ...

In a parallel action, the U.S. Attorney’s Office for the District of New Jersey also filed a variety of criminal charges (including securities fraud, insider trading, and a variety of conspiracy charges) against the six men.None of the allegations have been proven in court.In its complaint, the regulator alleged that between June 2020 and February 2024, Kim — a San Francisco-based investment banker — tipped Saad Shoukat to nine potential merger and acquisition deals that he learned about at work.In turn, Sh ...

Market Overview - U.S. stocks showed mixed performance, with the Dow Jones index declining approximately 0.2% on Wednesday [1] Company Highlights - Monte Rosa Therapeutics Inc (NASDAQ:GLUE) experienced a significant increase in share price, rising 45.2% to $23.25 after announcing interim data from a Phase 1 clinical study for MRT-8102 [1] - Ventyx Biosciences Inc (NASDAQ:VTYX) shares surged 37.5% to $13.82 following reports of advanced acquisition talks with Eli Lilly & Co. (NYSE:LLY) for over $1 billion [2] - Neumora Therapeutics Inc (NASDAQ:NMRA) saw a rise of 24.7% to $2.27 [2] - Regencell Bioscience Holdings Ltd (NASDAQ:RGC) increased by 21.1% to $40.00 [2] - Erasca Inc (NASDAQ:ERAS) rose 17.1% to $4.25, with Piper Sandler initiating coverage with an Overweight rating and a price target of $5 [2] - Anywhere Real Estate Inc (NYSE:HOUS) gained 15.6% to $16.71 [2] - AXT Inc (NASDAQ:AXTI) increased by 13.8% to $22.96 [2] - Immuneering Corp (NASDAQ:IMRX) rose 13.1% to $7.60 [2] - Compass Therapeutics Inc. (NASDAQ:CMPX) gained 13.1% to $5.56 [2] - MBX Biosciences Inc (NASDAQ:MBX) rose 11.2% to $31.90 [2] - Rezolve AI PLC (NASDAQ:RZLV) increased by 10.8% to $3.36 [2] - United Microelectronics Corp (NYSE:UMC) gained 10.4% to $8.96 after reporting sales growth for December and the full year [2] - PBF Energy Inc (NYSE:PBF) rose 9.2% to $29.73 [2] - Navan Inc (NASDAQ:NAVN) increased by 8.3% to $18.42 [2] - Ascentage Pharma Group International (NASDAQ:AAPG) gained 8.3% to $28.17 after announcing IND clearance for BTK Degrader APG-3288 by the U.S. FDA [2] - Intel Corp (NASDAQ:INTC) rose 6.4% to $42.60 as the company is enhancing its gaming strategy by developing a new chip for handheld gaming devices [2]

Core Insights - Amgen has acquired Dark Blue Therapeutics for approximately $840 million, enhancing its oncology pipeline [1][8] - The acquisition adds a preclinical small-molecule degrader targeting MLLT1/3 proteins associated with specific types of acute myeloid leukemia (AML) [2][8] - Amgen currently does not market any therapies for AML but has Blincyto approved for acute lymphoblastic leukemia (ALL) and is developing bispecific T-cell engagers for AML [3][8] Amgen's Oncology Pipeline - Amgen has a diverse oncology portfolio, including drugs like Blincyto, Imdelltra, Lumakras, Vectibix, Kyprolis, Nplate, and Xgeva [6] - Key candidates in its late-stage oncology pipeline include bemarituzumab for gastric cancer and xaluritamig for metastatic castrate-resistant prostate cancer [6] - Ongoing phase III studies are evaluating Imdelltra in small cell lung cancer and biosimilars for Opdivo, Keytruda, and Ocrevus [6] Competitive Landscape - Major competitors in the oncology space include Pfizer, AstraZeneca, Merck, Johnson & Johnson, and Bristol-Myers [9] - Pfizer's oncology sales account for about 28% of total revenues, with a 7% increase in the first nine months of 2025 [10] - AstraZeneca's oncology segment comprises around 43% of total revenues, with a 16% increase in sales during the same period [11] - Merck's Keytruda, a key oncology drug, generated $23.3 billion in sales in the first nine months of 2025, up 8% year over year [12] - Bristol-Myers' Opdivo accounts for approximately 20% of its total revenues, with sales rising 8% to $7.54 billion [13] - Johnson & Johnson's oncology sales represent around 27% of total revenues, with a 20.6% operational increase in the first nine months of 2025 [14]

HUTCHMED (China) Limited (NASDAQ:HCM) on Tuesday shared data from the Phase 3 registration part of the ESLIM-02 clinical trial of sovleplenib in adult patients with warm antibody autoimmune hemolytic anemia (wAIHA).wAIHA is a condition where the immune system mistakenly makes IgG antibodies that attack and destroy red blood cells at normal body temperature, leading to anemia, fatigue, paleness, and shortness of breath.The trial conducted in China met its primary endpoint of durable hemoglobin (Hb) response ...

Building on the success of its investment portfolio, Oramed's Board of Directors has approved a cash dividend payment of $0.25 per share to reward shareholders. The dividend will have an ex-dividend date of January 16, 2026, with disbursement scheduled for January 26, 2026. The dividend is expected to result in an aggregate distribution of approximately $10.5 million based on the current number of shares outstanding. The dividend will be funded with surplus capital. About Oramed Pharmaceuticals Oramed Pharm ...

GM demonstrated strategic discipline by reducing EV investments amid changes in the regulatory environment and shifting consumer preferences, ending a $10 billion robotaxi program that will save $1 billion annually, and refocusing autonomous efforts on personal vehicles and Super Cruise.General Motors faced an unimaginable year of volatility after “Liberation Day” was announced in April. But under CEO Mary Barra’s stewardship, the auto company kept delivering, expected to lead U.S. sales among all manufactu ...

Media: Investors: Gabby Tarbert (224) 244-0111 [email protected] Liz Shea (847) 935-2211 [email protected] SOURCE AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more inform ...

– Common warts affects approximately 22 million patients in the United States alone, and there are no FDA approved prescription therapies for what is believed to be a multibillion-dollar market opportunity– – Verrica has global rights to YCANTH for all indications in all territories outside of Japan – WEST CHESTER, Pa., Jan. 07, 2026 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing and selling medications for skin diseases requiring m ...

Core Insights - Veeva Systems has announced that Novo Nordisk's International Operations business unit will implement Veeva Vault CRM to enhance its commercial capabilities with advanced AI technology [1][2][3] Group 1: Partnership and Technology - The partnership between Veeva and Novo Nordisk aims to leverage AI-driven technology to improve the delivery of innovative medicines for chronic diseases [2] - Vault CRM is designed to support effective commercial execution across both personal and digital channels, addressing specific business and compliance needs in various countries [2][3] Group 2: Company Overview - Veeva Systems provides cloud-based solutions for the life sciences industry, serving over 1,500 customers, including major biopharmaceutical companies and emerging biotech firms [4] - The company is committed to innovation and balancing the interests of all stakeholders, including customers, employees, and shareholders [4]