Core Insights - The FDA has approved AKEEGA, a dual-action tablet combining niraparib and abiraterone acetate, plus prednisone for treating patients with BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC), marking it as the first precision medicine combination treatment for this patient group [1][11][5] Group 1: Clinical Study and Efficacy - The approval is based on positive results from the AMPLITUDE study, which demonstrated that AKEEGA plus prednisone and androgen deprivation therapy (ADT) significantly reduced the risk of radiographic progression or death by 54% compared to the current standard of care [3][7] - AKEEGA plus prednisone and ADT also significantly prolonged the time to symptomatic progression by 59% [3][7] - The AMPLITUDE study enrolled 696 participants from 32 countries, focusing on patients with deleterious germline or somatic homologous recombination repair gene alterations [9] Group 2: Unmet Medical Need - Patients with BRCA2 mutations experience faster disease progression and shorter survival compared to those without the mutation, highlighting a significant unmet medical need [2][10] - Approximately 25% of patients with mCSPC have homologous recombination repair gene alterations, including BRCA mutations, which negatively impact outcomes [10] Group 3: Safety Profile - The safety profile of AKEEGA plus prednisone was consistent with the known safety profiles of each monotherapy, with common adverse reactions including decreased hemoglobin, musculoskeletal pain, and fatigue [4][39] - Serious adverse reactions occurred in 36% of patients treated with AKEEGA, with fatal adverse reactions reported in 4.9% of patients [38][39] Group 4: Company Commitment and Support - Johnson & Johnson emphasizes its commitment to providing personalized and effective treatment options for prostate cancer, supported by strong clinical data [5] - The company offers a patient support program, J&J withMe, to assist patients in accessing treatments and providing educational resources at no cost [6]

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InMed Provides Update on BayMedica Commercial BusinessDecember 12, 2025 5:31 PM EST | Source: InMed PharmaceuticalsVancouver, British Columbia--(Newsfile Corp. - December 12, 2025) - InMed Pharmaceuticals Inc. (NASDAQ: INM) ("InMed" or the "Company"), a pharmaceutical company focused on developing a pipeline of proprietary small molecule drug candidates for diseases with high unmet medical needs, today released the following statement. Recently, H.R. 5371, the "Continuing Appropriations, Agric ...

Core Viewpoint - Theralase® Technologies Inc. has initiated a non-brokered private placement to raise up to $CAN 2,000,000 for advancing its clinical studies and working capital needs [1][3]. Group 1: Offering Details - The private placement consists of units priced at $CAN 0.17, each unit includes one common share and one warrant [2]. - Each warrant allows the holder to purchase one common share at an exercise price of $CAN 0.21 for 60 months following the closing date [2]. - The offering is expected to close around the week of December 15, 2025, pending necessary approvals [4]. Group 2: Use of Proceeds - Proceeds from the offering will be utilized to further the Phase II Non-Muscle Invasive Bladder Cancer clinical study and for general working capital [3]. Group 3: Regulatory and Compliance - The offering is available to accredited investors in Canada and U.S. persons under specific exemptions from registration requirements [5]. - All securities issued will be subject to a hold period of four months and one day from the closing date [3]. Group 4: Finder's Fees - The company will pay a finder's fee of 7% of gross proceeds and issue non-transferable finder warrants equal to 7% of the total units issued [6]. Group 5: Company Overview - Theralase® is a clinical stage pharmaceutical company focused on developing light, radiation, sound, and drug-activated therapeutics for treating cancer, bacteria, and viruses [9].

WALTHAM, Mass.--(BUSINESS WIRE)--Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (NASDAQ: INVA), today announced that the U.S. Food and Drug Administration (FDA) has approved NUZOLVENCE® (zoliflodacin) for oral suspension, a first-in-class, single-dose oral medication for the treatment of uncomplicated urogenital gonorrhea in adults and pediatric patients 12 years and older weighing at least 35 kg. The development of NUZOLVENCE was part of a private, not-for-profit collaboration. ...

Group 1 - GSK's shares have increased by 12.5% over the past two months, indicating positive market sentiment towards the company [1] - The article titled "GSK's Hidden Growth Engines Beyond HIV and Oncology" suggests that there are additional growth opportunities for GSK beyond its current focus areas [1] Group 2 - Allka Research has over two decades of experience in investment, specializing in identifying undervalued assets across various sectors including ETFs, commodities, technology, and pharmaceuticals [2] - The firm aims to simplify investment strategies for both seasoned and novice investors, promoting financial empowerment and informed decision-making [2] - Allka Research contributes analyses and insights to the Seeking Alpha community, focusing on demystifying investment complexities [2]

NEW YORK, Dec. 12, 2025 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Telix Pharmaceuticals Ltd. ("Telix Pharmaceuticals Ltd." or the "Company") (NASDAQ: TLX) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Telix Pharmaceuticals Ltd. investors who were adversely affected by alleged securities fraud between February 21, 2025 and August 28, 2025. Follow the link below to get more information and be contacted by a member of our team: ht ...

Core Viewpoint - Teva Pharmaceutical Industries Ltd. is preparing to release its Q4 2025 results on January 28, 2026, and has made an Aide Memoire available to assist investors in understanding the company's performance and outlook [1][2]. Group 1: Company Overview - Teva is transforming into a leading innovative biopharmaceutical company, supported by a strong generics business [3]. - The company has a long-standing commitment of over 120 years to innovate in neuroscience, immunology, and provide complex generic medicines, biosimilars, and pharmacy brands globally [3]. - Teva emphasizes its dedication to addressing patients' needs both now and in the future [3]. Group 2: Upcoming Financial Results - The Q4 2025 Aide Memoire is based on prior results, management commentary, and data from independent sources to prepare investors for the upcoming financial results [2]. - The Q4 2025 results are scheduled to be released at 7am ET, followed by a conference call at 8am ET on January 28, 2026 [2].

Core Points - Teva Pharmaceutical Industries Ltd. will release its fourth quarter 2025 financial results on January 28, 2026, at 7:00 a.m. ET, followed by a conference call at 8:00 a.m. ET [1] - A live webcast of the conference call will be available on Teva's website, with a replay accessible within 24 hours after the call [2] - Teva is transforming into a leading innovative biopharmaceutical company, supported by a strong generics business, focusing on neuroscience, immunology, complex generics, biosimilars, and pharmacy brands [3]

This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers a deep-dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33. ...