Workflow
Biotechnology
icon
Search documents
Silence Therapeutics Announces Leadership Changes
Businesswire· 2025-12-15 13:13
Silence Therapeutics is a global clinical-stage biotechnology company committed to transforming people's lives by silencing diseases through precision engineered medicines created with proprietary siRNA (short interfering RNA) technology. Silence leverages its mRNAi GOLDâ"¢ platform to create innovative siRNAs designed to precisely target and silence disease-associated genes in the liver, which represents a substantial opportunity. Silence focuses on areas of high unmet medical need with programs advancing ...
Argenx, ServiceNow And Other Big Stocks Moving Lower In Monday's Pre-Market Session - argenx (NASDAQ:ARGX), Celldex Therapeutics (NASDAQ:CLDX)
Benzinga· 2025-12-15 13:06
U.S. stock futures were higher this morning, with the Dow futures gaining around 200 points on Monday.Shares of argenx SE – ADR (NASDAQ:ARGX) fell sharply in pre-market trading after the company discontinued its Phase 3 UplighTED studies of efgartigimod SC in thyroid eye disease following a futility review.argenx shares dipped 6% to $825.00 in pre-market trading.Here are some other stocks moving lower in pre-market trading.TryHard Holdings Ltd (NASDAQ:THH) shares tumbled 15.2% to $13.16 in pre-market tradin ...
FibroBiologics Announces $1.7 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
Globenewswire· 2025-12-15 13:00
HOUSTON, Dec. 15, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics” or the “Company”), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced it has entered into definitive agreements for the issuance and sale of an aggregate of 5,227,275 shares of its common stock at an offering price of $0.33 per share ...
Lexaria Bioscience Corp. Announces $3.5 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
Thenewswire· 2025-12-15 13:00
Core Viewpoint - Lexaria Bioscience Corp. has announced a definitive agreement for a registered direct offering of 2,661,600 shares of common stock at a price of $1.315 per share, along with a concurrent private placement of unregistered warrants to purchase the same number of shares at an exercise price of $1.19 per share [1][2]. Group 1: Offering Details - The total gross proceeds from the offering are expected to be approximately $3.5 million before deducting fees and expenses [2]. - The offering is being conducted under a "shelf" registration statement that was declared effective by the SEC on January 30, 2025 [3]. - The warrants will be immediately exercisable and will expire five years from the effectiveness of the resale registration statement [1]. Group 2: Use of Proceeds - The net proceeds from the offering are intended to advance research and development efforts, fund working capital, and cover other general corporate purposes [2]. Group 3: Company Background - Lexaria Bioscience Corp. specializes in drug delivery platforms, particularly its patented DehydraTECH™ technology, which enhances the absorption of drugs through oral delivery [6][7]. - The company holds a robust intellectual property portfolio with 56 patents granted and additional patents pending worldwide [7].
Swedish Orphan Biovitrum AB (publ) (SWOBY) M&A Call Transcript
Seeking Alpha· 2025-12-15 12:59
Core Viewpoint - The company has announced the acquisition of Arthrosi Therapeutics, pending regulatory clearance, which will enhance its gout treatment pipeline with the addition of Pozdeutinurad AR882, a next-generation URAT1 inhibitor [1][3]. Group 1: Acquisition Details - The acquisition aims to integrate Pozdeutinurad AR882 into the company's gout pipeline, which is expected to provide a novel best-in-class therapy for patients suffering from progressive gout [3][4]. - Pozdeutinurad has demonstrated clinically meaningful efficacy and a strong safety profile in several large Phase II trials, indicating its potential as a significant advancement in gout treatment [4]. Group 2: Strategic Rationale - The strategic rationale for the acquisition includes the opportunity to leverage Pozdeutinurad's unique properties as a once-daily oral medication, which could address unmet needs in the gout treatment market [4].
TuHURA Biosciences Announces its Release of Kintara's Contingent Value Right (CVR) as Kintara's REM-001 Meets Primary Safety Endpoint Achieving Contractual Milestone
Prnewswire· 2025-12-15 12:50
TuHURA's lead innate immune agonist, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA has initiated a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) compared to Keytruda® plus placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma. In addition to its innate immune agonist product candidates, TuHURA acquired TBS-2025 in its merger with Kineta Inc. on Jun ...
Medicus Pharma Ltd. Completes Enrolment of Ninety (90) Patients for Phase 2 Clinical Study (SKNJCT-003) to Non-Invasively Treat Basal Cell Carcinoma (BCC) of the Skin
Globenewswire· 2025-12-15 12:30
THE COMPANY EXPECTS TO RELEASE TOPLINE RESULTS FOR SKNJCT-003 PHASE 2 CLINICAL TRIAL BEFORE THE END OF Q1 2026 AND REQUEST END-OF-PHASE 2 (EOP2) WITH THE FOOD AND DRUG ADMINISTRATION (FDA) IN H1 2026 PHILADELPHIA, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, is pleased to announce that its Phase 2 clinical study ...
Immunome's experimental drug meets main goal in late-stage study
Reuters· 2025-12-15 12:16
Core Insights - Immunome's experimental drug successfully met the primary endpoint in a late-stage study targeting patients with a rare type of tumor [1] Company Summary - The company is advancing its drug development efforts in the oncology sector, focusing on rare tumor types [1]
Zenas BioPharma's Partner, InnoCare Pharma, Announces Achievement of Primary Endpoint in Phase 2b Study of Orelabrutinib, a BTK Inhibitor, for Systemic Lupus Erythematosus
Globenewswire· 2025-12-15 12:05
Core Insights - Orelabrutinib is the first BTK inhibitor to show significant clinical activity in a Phase 2 clinical trial for Systemic Lupus Erythematosus (SLE) [1] - Zenas BioPharma has acquired exclusive rights to develop, manufacture, and commercialize orelabrutinib for Multiple Sclerosis (MS) globally, and for non-oncology fields outside Greater China and Southeast Asia [1][5] Clinical Trial Results - In the Phase 2b study, 187 patients were randomized into three groups: orelabrutinib 75 mg once-daily, orelabrutinib 50 mg once-daily, and placebo [2] - The primary endpoint, SLE Response Index-4 (SRI-4) response rate at week 48, was met with the 75 mg group showing a response rate of 57.1% compared to 34.4% for placebo (p < 0.05) [2] - Secondary endpoints, including SRI-6 and British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response rates, were also significantly higher in the 75 mg group compared to placebo (p < 0.05) [3] Safety and Tolerability - Orelabrutinib was well tolerated, exhibiting a safety profile consistent with BTK inhibition and the disease biology of SLE [3] Development Pipeline - Zenas is advancing orelabrutinib into a Phase 3 trial for Primary Progressive MS (PPMS) and plans to initiate a Phase 3 trial for Secondary Progressive MS (SPMS) in Q1 2026 [6] - Orelabrutinib is already approved for B cell malignancies in mainland China and Singapore, marketed by InnoCare [6] Company Overview - Zenas BioPharma is a clinical-stage global biopharmaceutical company focused on developing transformative therapies for autoimmune diseases [7] - The company is advancing two late-stage molecules: obexelimab and orelabrutinib, with obexelimab being a bifunctional monoclonal antibody targeting CD19 and FcγRIIb [7][8]
Kyverna's cell therapy meets main goal of mid-stage study
Reuters· 2025-12-15 11:42
Kyverna Therapeutics said on Monday its experimental cell therapy for treating patients with a rare movement disorder met the main goal of a mid-stage study, sending its shares surging 20% in premarke... ...