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Nxera Pharma Operational Highlights and Consolidated Results for the Fourth Quarter and Full Year 2025
Globenewswire· 2026-02-13 06:37
Core Insights - Nxera Pharma reported a disciplined execution and strategic progress in 2025, focusing on building a resilient biopharmaceutical business with a growing commercial presence in Japan and a maturing pipeline [2][3] Operational Highlights - PIVLAZ® sales in Japan increased, establishing it as the standard of care for preventing cerebral vasospasm, with market share rising from 69% in 2024 to 74% in 2025 [6] - Q4 2025 net sales for PIVLAZ® reached JPY 4,545 million (US$30.4 million), while FY 2025 net sales totaled JPY 13,511 million (US$90.3 million), reflecting a 6.8% growth compared to FY 2024 [6][17] - QUVIVIQ™ achieved FY 2025 net sales of JPY 4,327 million (US$28.9 million), marking a significant 223.9% growth from FY 2024 [7][17] - The company regained full rights to its GPR52 agonist program and plans to explore strategic opportunities for this asset [9] Financial Performance - Total revenue for FY 2025 was JPY 29,615 million (US$197.9 million), an increase of JPY 780 million (US$5.2 million) from the previous year [17] - R&D expenses rose to JPY 14,466 million (US$96.7 million), reflecting increased investment in clinical-stage pipelines and the obesity and metabolic disease area [17] - Operating loss for FY 2025 was JPY 8,462 million (US$56.5 million), compared to a loss of JPY 5,423 million (US$35.9 million) in the prior year [17] - Net loss totaled JPY 12,530 million (US$83.7 million), up from a loss of JPY 4,838 million (US$32.0 million) in the previous year [23] Strategic Initiatives - Nxera implemented a focused restructuring to enhance its path to profitability, concentrating resources on high-potential programs and reducing operating expenses [8] - The establishment of a Metabolic Advisory Council aims to provide guidance as Nxera advances its pipeline targeting obesity and metabolic disorders [11] - The company plans to submit a marketing authorization application for daridorexant in South Korea in Q1 2026, with approval expected in Q1 2027 [10]
OKYO Pharma Announces Pricing of $20 Million Public Offering of Ordinary Shares
Globenewswire· 2026-02-13 03:20
Core Viewpoint - OKYO Pharma Limited has announced a public offering of 10,815,000 ordinary shares at a price of $1.85 per share, aiming to raise approximately $20 million before expenses and discounts [1][2]. Group 1: Offering Details - The gross proceeds from the offering are expected to be around $20 million, with the potential to increase to approximately $23 million if the underwriter fully exercises its option to purchase additional shares [2]. - The offering is managed solely by Piper Sandler & Co., and is expected to close around February 17, 2026, pending customary closing conditions [3]. Group 2: Use of Proceeds - The net proceeds from the offering will primarily be used for clinical development of product candidates, general corporate purposes, and working capital [2]. Group 3: Company Overview - OKYO Pharma is a clinical-stage biopharmaceutical company focused on developing therapies for neuropathic corneal pain (NCP) and inflammatory eye diseases, with shares traded on the Nasdaq Capital Market [6]. - The company has recently completed a successful Phase 2 trial of its lead drug, urcosimod, for NCP and plans to initiate a Phase 2b/3 study involving approximately 150 subjects in the first half of the year [6].
Lakewood-Amedex Biotherapeutics(LABT) - Prospectus(update)
2026-02-13 02:56
As filed with the U.S. Securities and Exchange Commission on February 12, 2026. Registration No. 333-292664 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO.2 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ________________________________________ Lakewood-Amedex Biotherapeutics Inc. (Exact Name of Registrant as Specified in its Charter) ________________________________________ | Nevada | 2834 | 20-5274304 | | --- | --- | --- | | (State or Other Jurisd ...
InnoCare Announces First Patient Dosed in the Phase II/III Clinical Trial of Novel TYK2 Inhibitor Soficitinib for Chronic Spontaneous Urticaria in China
Globenewswire· 2026-02-13 02:21
Core Viewpoint - InnoCare Pharma has initiated the Phase II/III clinical trial for its TYK2 inhibitor soficitinib, targeting chronic spontaneous urticaria (CSU), while also advancing trials for other autoimmune conditions [1][2]. Group 1: Clinical Trials and Development - The first patient has been dosed in the Phase II/III clinical trial of soficitinib for CSU [1]. - Patient enrollment is complete for the Phase III trial of soficitinib for moderate to severe atopic dermatitis and the Phase II trial for vitiligo [2]. - Clinical trials for soficitinib are also underway for psoriasis and nodular prurigo [2]. Group 2: Mechanism and Indications - Soficitinib is a selective TYK2 inhibitor aimed at treating T-cell related autoimmune disorders, with a focus on dermatological applications [3]. - The drug works by blocking signaling pathways related to cytokines that cause mast cell activation and inflammation, thereby alleviating symptoms of CSU [4]. Group 3: Market Potential and Patient Demographics - CSU affects approximately 50 million patients globally, with the treatment market projected to reach $3 billion by 2029 [6]. - The condition is characterized by recurrent wheals and itching, often lasting two to five years, necessitating long-term treatment strategies [5]. Group 4: Company Overview - InnoCare is a biopharmaceutical company focused on developing first-in-class and best-in-class drugs for cancer and autoimmune diseases, with operations in multiple cities in China and the United States [6].
Appili Therapeutics Reports Financial and Operational Results for Third Quarter of Fiscal Year 2026
Globenewswire· 2026-02-12 23:15
Core Insights - Appili Therapeutics has made significant progress in advancing its infectious disease programs, with a focus on securing government funding to support its pipeline [2][4] - The company reported a net loss of CAD$1 million for the third quarter of fiscal year 2026, reflecting a decrease in government assistance and changes in expenses [14] Funding and Financials - Appili has secured over US$75 million in cumulative government funding and has an additional US$82 million in proposals under review [2] - The company received a US$40 million contract from NIAID to advance the development of VXV-01, a dual-antigen vaccine targeting multidrug-resistant Candida species [9][10] - As of December 31, 2025, Appili's cash balance was CAD$0.2 million, down from CAD$1.2 million as of March 31, 2025 [14] Product Development - ATI-1801, a topical formulation for cutaneous leishmaniasis, has a defined registration pathway following positive FDA feedback [3] - LIKMEZ (ATI-1501) has shown commercial momentum in the U.S. market, with steady sales growth since its re-launch in May 2025 [4][5] - ATI-1701, a vaccine candidate for tularemia, achieved key manufacturing milestones and may be eligible for a Priority Review Voucher upon FDA approval [6][7] Market Potential - VXV-01 addresses a critical global health need, with nearly 6.5 million people affected by invasive fungal infections annually, leading to approximately 3.8 million deaths [11]
Supernus Pharmaceuticals to Announce Fourth Quarter and Full Year 2025 Financial Results and Host Conference Call on February 24, 2026
Globenewswire· 2026-02-12 21:35
Core Viewpoint - Supernus Pharmaceuticals, Inc. is set to announce its fourth quarter and full year 2025 financial and business results on February 24, 2026, after market close [1] Group 1: Financial Results Announcement - The financial results will be presented by Jack Khattar, President and CEO, and Tim Dec, Senior Vice President and CFO, during a conference call scheduled for February 24, 2026, at 4:30 p.m. ET [2] - A live webcast of the conference call will be available on the Company's Investor Relations website [2] - Participants can pre-register for the call and will receive a personalized conference code for access [3] Group 2: Company Overview - Supernus Pharmaceuticals focuses on developing and commercializing products for the treatment of central nervous system (CNS) diseases [4] - The Company has a diverse neuroscience portfolio that includes approved treatments for various conditions such as ADHD, Parkinson's disease, postpartum depression, epilepsy, migraine, cervical dystonia, and chronic sialorrhea [5]
CRISPR Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2025 Financial Results
Globenewswire· 2026-02-12 21:30
Core Insights - CRISPR Therapeutics reported financial results for Q4 and full year 2025, highlighting progress in its clinical and preclinical pipeline, including advancements in autoimmune diseases and oncology, as well as the global uptake of its therapy CASGEVY [1][2] Financial Performance - CASGEVY generated Q4 2025 revenue of $54 million and full year revenue of $116 million, with a significant increase in patient initiations and first cell collections, nearly tripling from 2024 to 2025 [5] - Cash, cash equivalents, and marketable securities totaled $1,975.8 million as of December 31, 2025, up from $1,903.8 million in 2024, primarily due to common share issuance and interest income [14] - R&D expenses for Q4 2025 were $83.5 million, an increase from $71.7 million in Q4 2024, driven by higher licensing fees [14] - The net loss for Q4 2025 was $130.6 million, compared to a net loss of $37.3 million in Q4 2024 [14] Pipeline Developments - The company is advancing its in vivo liver editing portfolio and has made progress with its siRNA collaboration with Sirius Therapeutics [2][4] - CTX310, targeting ANGPTL3, is in Phase 1b trials for severe hypertriglyceridemia and refractory hypercholesterolemia, with updates expected in H2 2026 [5] - CTX460, targeting SERPINA1 for alpha-1 antitrypsin deficiency, is expected to enter clinical trials in mid-2026 [5] - Zugo-cel is in ongoing Phase 1 trials for autoimmune diseases and hematologic malignancies, with updates anticipated in H2 2026 [10][17] Market Expansion - CASGEVY is approved in multiple regions, including the U.S., EU, and several Middle Eastern countries, with approximately 90% of U.S. patients having reimbursed access [5] - The company is expanding its regenerative medicine portfolio, including CTX213 for Type 1 diabetes, which has shown promising preclinical efficacy [9] Collaborations - CRISPR Therapeutics has a strategic collaboration with Vertex Pharmaceuticals for CASGEVY, with Vertex leading global development and commercialization [13] - The collaboration with Sirius Therapeutics focuses on developing siRNA therapies, with CTX611 being a key program targeting FXI for thromboembolic disorders [19]
NervGen Pharma Announces Retirement of Chief Financial Officer, Bill Adams
Globenewswire· 2026-02-12 21:15
VANCOUVER, British Columbia, Feb. 12, 2026 (GLOBE NEWSWIRE) -- NervGen Pharma Corp. (“NervGen” or the “Company") (TSXV: NGEN) (NASDAQ: NGEN), a clinical-stage biopharmaceutical company developing first-in-class neuroreparative therapeutics for spinal cord injury (SCI) and other neurotraumatic and neurologic conditions, today announced that Bill Adams will retire as Chief Financial Officer, effective March 15th, 2026. The Company has engaged a leading executive search firm to identify a successor, and Mr. Ad ...
BBOT to Participate in Upcoming Investor Healthcare Conferences
Globenewswire· 2026-02-12 21:05
SOUTH SAN FRANCISCO, Calif., Feb. 12, 2026 (GLOBE NEWSWIRE) -- BridgeBio Oncology Therapeutics, Inc. (“BBOT”) (Nasdaq: BBOT), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, today announced that members of its leadership team will participate in two investor conferences in the upcoming months. Details of the company’s participation are as follows: Oppenheimer 36th Annual Healthcare Life Sciences ConferencePresentation: Wednesday, February 25, 2026, at 10:40 a.m. ET. Leerink G ...
CONTACT: INVESTOR ALERT: Pomerantz Law Firm Reminds Investors with Losses on their Investment in Quantum Biopharma Ltd. of Class Action Lawsuit and Upcoming Deadlines - QNTM
Prnewswire· 2026-02-12 21:02
CONTACT: INVESTOR ALERT: Pomerantz Law Firm Reminds Investors with Losses on their Investment in Quantum Biopharma Ltd. of Class Action Lawsuit and Upcoming Deadlines - QNTM [Accessibility Statement] Skip NavigationNEW YORK, Feb. 12, 2026 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed on behalf of shareholders of Quantum Biopharma Ltd. ("Quantum" or the "Company") (NASDAQ: QNTM). Such investors are advised to contact Danielle Peyton at [[email protected]] or 646-581-9980, ...