Biotechnology
Search documents
GI Cancer Immunotherapy Breakthroughs Signal New Treatment Era
Financialpost· 2025-12-12 15:35
Article contentDISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and a ...
Regeneron (REGN) Just Flashed Golden Cross Signal: Do You Buy?
ZACKS· 2025-12-12 15:35
Core Viewpoint - Regeneron (REGN) is showing potential for a bullish trend as it has recently surpassed the 20-day moving average and reached a key support level, indicating a positive short-term outlook [1][4]. Technical Analysis - REGN has recently moved above the 20-day moving average, which is a significant indicator for short-term traders, suggesting a bullish trend [1][2]. - The stock has increased by 7.5% over the past four weeks, reinforcing the positive technical outlook [4]. Earnings Estimates - There have been 8 upward revisions in earnings estimates for the current fiscal year, with no downward revisions, indicating strong positive sentiment among analysts [4]. - The consensus earnings estimate for REGN has also increased, further supporting the bullish case for the stock [4]. Investment Consideration - Given the positive technical indicators and favorable earnings estimate revisions, investors are encouraged to consider adding REGN to their watchlist [5].
MoonLake Immunotherapeutics Class Action: Levi & Korsinsky Reminds MoonLake Investors of the Pending Class Action Lawsuit with a Lead Plaintiff Deadline of December 15, 2025 - MLTX
Prnewswire· 2025-12-12 14:00
NEW YORK, Dec. 12, 2025 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in MoonLake Immunotherapeutics ("MoonLake" or the "Company") (NASDAQ: MLTX) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of MoonLake investors who were adversely affected by alleged securities fraud between March 10, 2024 and September 29, 2025. Follow the link below to get more information and be contacted by a member of our team: https://zlk.com/pslra-1/moonlake-lawsui ...
Morgan Stanley Analyst Is Bullish On Thermo Fisher Scientific Inc. (TMO)
Yahoo Finance· 2025-12-12 13:50
Thermo Fisher Scientific Inc. (NYSE:TMO) is among the 13 Best Nanotechnology Stocks to Buy Now. Morgan Stanley Analyst Is Bullish On Thermo Fisher Scientific Inc. (TMO) According to The Fly, on December 2, 2025, Morgan Stanley analyst Kallum Titchmarsh established a price objective of $670, up from $656. He initiated coverage of Thermo Fisher Scientific Inc. (NYSE:TMO) with an Overweight rating. According to Titchmarsh, the end markets for Life Science Tools and Diagnostics are starting to show potential ...
Emergent BioSolutions Receives U.S. FDA Approval for Drug Product Manufacturing of raxibacumab at its Winnipeg, Canada Site
Globenewswire· 2025-12-12 13:30
Core Viewpoint - Emergent BioSolutions has received FDA approval for its supplemental Biologics License Application (sBLA) to manufacture and test raxibacumab at its Winnipeg facility, enhancing its manufacturing capabilities for inhalational anthrax treatment [1][2]. Company Developments - The approval supports Emergent's multi-year transformation strategy aimed at creating a flexible and customer-focused manufacturing network [2]. - The Winnipeg facility, with over 45 years of experience, will consolidate operations alongside the Lansing, Michigan site as part of a new operational plan announced in May 2024 [2]. Product Information - Raxibacumab is indicated for treating and preventing inhalational anthrax in adults and pediatric patients when alternative therapies are unavailable [3]. - The effectiveness of raxibacumab is based on animal model studies, with no pediatric studies conducted [4]. Safety Information - Hypersensitivity reactions, including anaphylaxis, have been reported with raxibacumab administration, necessitating monitoring during infusion [5]. - Common adverse reactions in healthy adults include injection site reactions, headache, and rash, among others [6]. Company Mission - Emergent BioSolutions focuses on delivering life-saving solutions for various health threats, including anthrax, and aims to prepare communities for current and future health challenges [7].
Natera and MEDSIR to Collaborate on the MiRaDoR Trial in Breast Cancer
Businesswire· 2025-12-12 13:00
Core Insights - Natera, Inc. and MEDSIR are collaborating on the MiRaDoR study, a phase II clinical trial focused on HR+/HER2- breast cancer, which accounts for approximately 70% of all breast cancer cases globally [1][2] - The study aims to evaluate the efficacy of various therapeutic approaches using Signatera Genome to monitor circulating-tumor DNA (ctDNA) levels as a predictive marker of treatment response [2][3] - Enrollment for the MiRaDoR trial is currently underway, with several sites in the U.K. active and further expansions expected in Europe by 2026 [3] Study Design and Objectives - The MiRaDoR study will enroll up to 60 patients who are Signatera-positive without evidence of disease recurrence, assigning them to one of four treatment arms [2][6] - The primary endpoint is the proportion of patients achieving a 90% decrease or clearance in baseline ctDNA after three months of treatment, with follow-up testing at 6, 9, and 12 months [2] - The trial will compare the effectiveness of specific therapy combinations against standard endocrine treatment [2] Company Background - Natera is recognized as a leader in cell-free DNA and precision medicine, focusing on oncology, women's health, and organ health, with a commitment to integrating personalized genetic testing into standard care [4] - MEDSIR specializes in oncology research and clinical trial management, operating in Spain and the U.S., and aims to promote independent research through strategic partnerships [8]
BioCryst Announces FDA Approval of ORLADEYO® (berotralstat) Oral Pellets, First and Only Oral Prophylactic Treatment for Patients with HAE Aged 2 to
Globenewswire· 2025-12-12 12:00
–ORLADEYO now first and only targeted oral prophylactic therapy for patients with HAE aged 2 and older–-Oral pellet formulation provides child-friendly method of administration- –Showed early and sustained reductions in monthly attack rates in APeX-P– RESEARCH TRIANGLE PARK, N.C., Dec. 12, 2025 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for the use of an oral pellet formulation ...
BioCryst Announces FDA Approval of ORLADEYO® (berotralstat) Oral Pellets, First and Only Oral Prophylactic Treatment for Patients with HAE Aged 2 to <12 Years
Globenewswire· 2025-12-12 12:00
–ORLADEYO now first and only targeted oral prophylactic therapy for patients with HAE aged 2 and older–-Oral pellet formulation provides child-friendly method of administration- –Showed early and sustained reductions in monthly attack rates in APeX-P– RESEARCH TRIANGLE PARK, N.C., Dec. 12, 2025 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for the use of an oral pellet formulation ...
ImmunityBio Receives Conditional Marketing Authorization Recommendation from the European Medicines Agency for ANKTIVA® with BCG for Non-Muscle Invasive Bladder Cancer Carcinoma in Situ—A First in Europe
Businesswire· 2025-12-12 11:10
Core Viewpoint - ImmunityBio has received a recommendation from the European Medicines Agency for conditional marketing authorization of ANKTIVA® in combination with BCG for treating BCG-unresponsive non-muscle invasive bladder cancer [1] Company Summary - ImmunityBio is a leading immunotherapy company focused on innovative treatments for cancer [1] Industry Summary - The recommendation from the European Medicines Agency is expected to facilitate early access to new medicines addressing significant unmet medical needs in cancer treatment [1]
沃森生物(300142.SZ):冻干带状疱疹病毒mRNA疫苗获药物临床试验批准
智通财经网· 2025-12-12 10:49
智通财经APP讯,沃森生物(300142.SZ)公告,公司子公司北京沃森创新生物技术有限公司、云南疫苗实 验室有限公司、玉溪沃森生物技术有限公司与复旦大学、上海蓝鹊生物医药有限公司(简称"蓝鹊生物") 联合研发并共同申请临床试验的冻干带状疱疹病毒mRNA疫苗,于近日获得国家药品监督管理局签发的 《药物临床试验批准通知书》。经审查,2025年9月18日受理的冻干带状疱疹病毒mRNA疫苗符合药品 注册的有关要求,同意开展预防带状疱疹的临床试验。 ...