PDUFA target action date set to 10 June 2026 LUND, Sweden, Jan. 9, 2026 /PRNewswire/ -- Camurus (NASDAQ STO: CAMX) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's resubmission of the New Drug Application (NDA) for Oclaizâ"¢ (CAM2029), octreotide extended-release injection, for the treatment of patients with acromegaly. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of 10 June 2026. "We look forward to the continued coll ...

Core Viewpoint - Ping An Biomedical Co., Ltd has entered into a non-binding investment memorandum with Future Biotechnology Group, involving an initial cash investment of US$30 million and potential future acquisitions totaling US$60 million, contingent on performance targets over a three-year evaluation period [1][2][6]. Investment Details - The initial investment is set at US$30 million in cash, with subsequent acquisitions amounting to US$60 million, which will be settled in cash and share issuances [2]. - The performance targets for the target company are as follows: - For 2026: Achieve audited revenue of no less than RMB 750 million [2][3]. - For 2027: Achieve audited revenue of no less than RMB 1.3 billion [3]. - For 2028: Achieve audited revenue of no less than RMB 2.3 billion [3]. - The consideration shares will be held in escrow and released based on the achievement of these performance targets, with adjustments made if targets are not met [4]. Company Overview - Future Biotechnology Group focuses on the biopharmaceutical sector, including R&D, genetic testing, medical devices, and pharmaceutical sales, while integrating AI into its operations to enhance efficiency [5]. - Ping An Biomedical's strategic investment aligns with its long-term goal of leveraging technology to empower healthcare, aiming to enhance competitiveness in the biopharmaceutical industry through collaboration with Future Biotechnology Group [6][7]. Industry Context - The biopharmaceutical industry is transitioning towards high-quality development, with a focus on industrial integration and clear technological pathways, which is expected to unlock long-term growth potential [7].

Core Insights - CG Oncology has announced that topline data from the Phase 3 PIVOT-006 clinical trial is now expected in the first half of 2026, nearly one year ahead of schedule due to rapid enrollment [1][2][3] - The PIVOT-006 trial is the first randomized registrational study evaluating an investigational therapy for intermediate-risk non-muscle invasive bladder cancer (IR NMIBC) [1][3] Company Overview - CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing therapies for bladder cancer, aiming to improve the quality of life for patients [5] - The company is developing cretostimogene grenadenorepvec, an investigational oncolytic immunotherapy, which has been studied in over 400 patients with non-muscle invasive bladder cancer [4] Clinical Trial Details - The PIVOT-006 study involves more than 360 patients and compares adjuvant intravesical cretostimogene grenadenorepvec against surveillance following bladder tumor removal [3] - The trial encompasses a broad range of patient types according to AUA/SUO Guidelines, including high-grade Ta solitary lesions less than 3 cm [1][3] Market Potential - The IR NMIBC patient population in the U.S. is estimated to exceed 50,000, indicating a significant unmet medical need [2][4] - The rapid enrollment across over 90 sites highlights the real-world relevance of the trial and the demand for effective treatment options in this patient demographic [2][3]

Core Viewpoint - Clene Inc. has announced a registered direct offering priced above market, raising over $28 million from new and existing investors to support its clinical-stage biopharmaceutical efforts in treating neurodegenerative diseases, particularly ALS and MS [1][2][3] Financing Details - The offering includes an oversubscribed registered direct offering to new, existing, and insider investors, with an initial financing tranche of over $6 million expected to fund operations into Q3 2026 [3] - Two additional financing tranches totaling over $22 million are contingent on the acceptance and approval of the New Drug Application (NDA) by the FDA, providing sufficient capital into early 2027 for potential commercialization of CNM-Au8 in ALS [3] - The gross proceeds from the offering are expected to be approximately $28 million, with BTIG, LLC acting as the sole placement agent [7] Warrant Details - The offering includes Series A Warrants and Series B Warrants, both with an initial exercise price of $6.00 per share, which can increase based on specific conditions related to the company's stock price and FDA announcements [4][5][6] - The potential gross proceeds from the exercise of the Series A Warrants total approximately $6.7 million, while the Series B Warrants could generate around $15.6 million, expected to fund commercialization efforts [5][6] Company Overview - Clene Inc. is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including ALS, Parkinson's disease, and MS [10] - CNM-Au8 is an investigational therapy designed to enhance neuronal health by increasing energy production and reducing oxidative stress [11]

Core Viewpoint - The article emphasizes the urgent need for policymakers to take swift action to support millions of Americans suffering from chronic pain, highlighting the importance of expanding access to non-opioid therapies [1][4]. Industry Overview - Chronic pain affects one in four American adults and is a leading cause of disability, resulting in over $720 billion in annual costs to the U.S., including approximately $190 billion in lost worker productivity [2]. - More than 20 million individuals experience high-impact chronic pain that significantly disrupts daily activities and work capabilities [2]. Legislative Developments - The Relief of Chronic Pain Act has been introduced in the U.S. Senate, aiming to ensure Medicare coverage for non-opioid medications for specific chronic pain conditions and to reduce barriers to timely care access [3]. Company Initiatives - Lexicon Pharmaceuticals is actively exploring partnerships to prioritize chronic pain on the legislative agenda and to promote new pain relief methods, emphasizing the societal importance of non-opioid treatments [4]. - The company is committed to forming a coalition of stakeholders, including patients, caregivers, and advocacy groups, to facilitate access to safe and effective non-opioid treatments for over 60 million Americans living with chronic pain [4]. Demographic Impact - Chronic pain affects diverse demographics across rural, suburban, and urban communities, necessitating a bipartisan and nationwide effort to address the issue effectively [5]. Company Background - Lexicon Pharmaceuticals is a biopharmaceutical company focused on pioneering innovative medicines through its Genome5000™ program, which has identified over 100 protein targets with therapeutic potential across various diseases [6]. - The company has advanced multiple medicines to market and has a pipeline of promising drug candidates in areas such as heart failure, neuropathic pain, obesity, cardiology, and diabetes [6].

Core Insights - CorMedix Therapeutics will present a corporate overview at the 44th annual J.P. Morgan Healthcare Conference on January 12, 2026, at 4:30pm PST [1][2] Company Overview - CorMedix Therapeutics is focused on developing and commercializing therapeutic products for life-threatening diseases and conditions [2] - The company is commercializing DefenCath® for the prevention of catheter-related bloodstream infections in adult patients undergoing hemodialysis via a central venous catheter [2] - Following the acquisition of Melinta Therapeutics LLC in August 2025, CorMedix is also commercializing a portfolio of anti-infective products, including MINOCIN®, REZZAYO®, VABOMERE®, ORBACTIV™, BAXDELA®, and KIMYRSA®, as well as TOPROL-XL® [2] Clinical Studies and Developments - CorMedix has ongoing clinical studies for DefenCath in Total Parenteral Nutrition (TPN) and Pediatric Hemodialysis populations [3] - The company intends to develop DefenCath as a catheter lock solution for use in other patient populations [3] - REZZAYO is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of invasive fungal disease (IFD) in adult patients undergoing allogeneic bone marrow transplantation (BMT) [3] - Topline results of the Phase III study for REZZAYO are expected in Q2 2026 [3]

Core Insights - Cellectar Biosciences plans to submit for conditional marketing approval for iopofosine I 131 in Europe by Q3 2026, following guidance from the EMA [1][5] - The company aims to present final results from the Phase 2 CLOVER WaM clinical study of iopofosine I 131 and initiate a Phase 1b study for CLR 125 targeting triple-negative breast cancer in early 2026 [1][6] Clinical Development - Cellectar received positive feedback from the EMA's SAWP supporting a Conditional Marketing Authorization filing for iopofosine I 131 based on the CLOVER WaM study [5] - The FDA granted Breakthrough Designation for iopofosine I 131 in relapsed/refractory Waldenstrom's Macroglobulinemia [5] - A Phase 1b clinical study for CLR 125 has been initiated, targeting triple-negative breast cancer [5] Regulatory Milestones - The company plans to submit a CMA application to the EMA for iopofosine I 131 in WM in Q3 2026, with potential approval in early 2027 [6] - Preparations for a New Drug Application (NDA) for U.S. accelerated approval of iopofosine I 131 are underway [6] - The company is actively enrolling patients for the Phase 1b study of CLR 125, with interim data expected in mid-2026 [6] Financial Strategy - Cellectar raised approximately $15.2 million through financings and warrant exercises to support pipeline development and regulatory milestones [5] - The company is focused on disciplined capital management and exploring non-dilutive funding opportunities [7] - The anticipated conditional marketing approval in 2027 from the EMA could impact around thirty countries, potentially expanding the patient population significantly compared to the U.S. [7]

-- EMA approval decision for obicetrapib and obicetrapib/ezetimibe fixed dose combo expected in 2H26 -- -- Phase 3 PREVAIL CVOT overall event rate tracking in line with observed rate in BROADWAY -- -- First patient enrolled in RUBENS Phase 3 trial of obicetrapib and obicetrapib/ezetimibe fixed dose combo (FDC) in patients with metabolic syndrome -- -- Year-end cash, cash equivalents and marketable securities balance of approximately $729 million (unaudited) -- NAARDEN, the Netherlands and MIAMI, Jan. 09, 2 ...

Agreement expands Madrigal’s pipeline and strengthens its leadership in pioneering MASH therapiesDGAT-2 inhibition represents a complementary mechanism of action with Rezdiffra® (resmetirom) for potential additive therapeutic benefit in MASHMadrigal to present at the 44th Annual J.P. Morgan Healthcare Conference at 1:30 p.m. PST (4:30 p.m. EST) on Monday, January 12, 2026 CONSHOHOCKEN, Pa., Jan. 09, 2026 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a biopharmaceutical company focused o ...

-- Q4 2025 preliminary net product revenues from global sales of IMCIVREE® (setmelanotide) of approximately $57 million for the fourth quarter of 2025, an 11% increase over Q3 2025 -- -- FY 2025 preliminary net product revenue of approximately $194 million, approximately 50% increase from FY2024 -- -- March 20, 2026 PDUFA goal date for sNDA for setmelanotide in acquired hypothalamic obesity -- -- On track to report topline data from 12-patient Japanese cohort of setmelanotide Phase 3 trial in acquired hypo ...