Workflow
Biopharmaceuticals
icon
Search documents
NeOnc Technologies Secures Strategic PIPE Investment led by $10 Million Investment from Cinctive Capital Management
Globenewswire· 2026-01-30 14:00
Investment led by Cinctive Co-Founder Richard Schimel underscores institutional confidence in NeOnc’s biotech pipelineCALABASAS, Calif., Jan. 30, 2026 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) (“NeOnc” or the “Company”), a multi-Phase 2 clinical-stage biopharmaceutical company developing novel therapies for central nervous system (CNS) cancers, today announced that it has entered into a securities purchase agreement for a private investment in public equity ("PIPE") for the purcha ...
Ultragenyx Resubmits Biologics License Application for UX111 AAV Gene Therapy to Treat Sanfilippo Syndrome Type A (MPS IIIA) to U.S. FDA
Globenewswire· 2026-01-30 13:30
Company expects up to six-month review period per FDA guidelines New longer-term clinical data demonstrating durable positive brain biochemical and clinical effect for as long as 8.5 years to be presented at WORLDSymposium™ 2026 "Today, with no approved treatment options to address the relentless progression of Sanfilippo syndrome type A, families must watch helplessly as their children lose the ability to communicate, play, move, and even eat before ultimately succumbing to this devastating and fatal disea ...
Jyong Biotech Subsidiary Announces Phase II Clinical Data on Cholesterol and LDH Indicators for MCS-8 (PCP), Indicating Potential in Prostate Cancer Prevention and Metabolic Value
Globenewswire· 2026-01-30 13:30
New Taipei City, Taiwan, Jan. 30, 2026 (GLOBE NEWSWIRE) -- Jyong Biotech Ltd. (Nasdaq: MENS) (the “Company” or “Jyong Biotech”), a science-driven biotechnology company based in Taiwan committed to developing and commercializing innovative and differentiated new drugs (plant-derived) mainly specializing in the treatment of urinary system diseases, with an initial focus on the markets of the U.S., the EU and Asia, today announced updated statistical analyses for key blood biochemical markers from its Phase II ...
IO Biotech Provides Corporate Update
Globenewswire· 2026-01-30 13:05
Raymond James engaged as financial advisorReduction in force implemented NEW YORK, Jan. 30, 2026 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, today announced that it has retained Raymond James & Associates, Inc. to serve as exclusive financial advisor to assist the company in its previously announced exploration of strategic alternatives. The company also announced that it is impleme ...
Press Release: Sanofi's Rezurock recommended for EU approval by the CHMP to treat chronic graft-vs-host disease
Globenewswire· 2026-01-30 12:00
Sanofi’s Rezurock recommended for EU approval by the CHMP to treat chronic graft-vs-host disease Recommendation supported by safety and efficacy results from several clinical studies and real-world evidenceIf approved, Rezurock would offer a new treatment option in the EU for adult patients and in children aged 12 years and older in late line chronic GVHD Paris, January 30, 2026. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending ...
Press Release: Sanofi’s Rezurock recommended for EU approval by the CHMP to treat chronic graft-vs-host disease
Globenewswire· 2026-01-30 12:00
Sanofi’s Rezurock recommended for EU approval by the CHMP to treat chronic graft-vs-host disease Recommendation supported by safety and efficacy results from several clinical studies and real-world evidenceIf approved, Rezurock would offer a new treatment option in the EU for adult patients and in children aged 12 years and older in late line chronic GVHD Paris, January 30, 2026. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending ...
Lexicon Announces Pricing of Approximately $94.6 Million Public Offering and Concurrent Private Placement
Globenewswire· 2026-01-30 07:50
THE WOODLANDS, Texas, Jan. 30, 2026 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) (“Lexicon”) today announced the pricing of its previously announced underwritten public offering of 32,000,000 shares of its common stock, par value $0.001. The shares of common stock being offered pursuant to the public offering are being offered at a public offering price of $1.30 per share. All of the shares are being offered by Lexicon. The gross proceeds from the public offering are expected to be $41.6 ...
POXEL SA: The Commercial Court of Lyon Approves the Recovery Plan and Brings an End to the Judicial Reorganisation Proceedings
Businesswire· 2026-01-30 06:57
Core Viewpoint - POXEL SA has successfully exited judicial reorganisation proceedings, with the recovery plan ratified by the Commercial Court of Lyon, allowing the company to focus on its commercial development and settle its liabilities [1][2][3]. Recovery Plan Key Elements - The recovery plan includes business development, cost structure optimisation, and settlement of outstanding liabilities [4]. - The company aims to establish new partnerships for the commercialisation of Imeglimin in Asia, particularly in China, and promote PXL770 for ADPKD while leveraging the value of PXL065 in HCM [6]. Financial Structure Strengthening - Measures include a €5 million equity line over five years from IRIS, new bond borrowings of €3.75 million from IPF, and a capital increase with maintenance of shareholders' preferred subscription rights [5][6]. - The company plans to convert part of the IPF debt into shares and settle other creditors according to an agreed repayment schedule [6]. Company Overview - POXEL is a clinical stage biopharmaceutical company focused on innovative treatments for chronic serious diseases with metabolic pathophysiology, including MASH and rare disorders [8]. - The company’s product pipeline includes PXL065, PXL770, and Imeglimin, with Imeglimin already marketed in Japan through a partnership with Sumitomo Pharma [8].
Idorsia to present long-term lucerastat data and kidney biopsy results at WORLDSymposium
Globenewswire· 2026-01-30 06:00
Core Insights - Idorsia Ltd announces the presentation of long-term results from the lucerastat treatment at the 22nd Annual WORLDSymposium™, highlighting its potential as a first-in-class oral substrate reduction therapy for Fabry disease [1][7] Study Overview - The MODIFY study was a multicenter, double-blind, randomized, placebo-controlled trial involving 118 patients to assess the efficacy and safety of lucerastat as an oral monotherapy for Fabry disease [3] - The study did not meet its primary endpoint of reducing neuropathic pain but showed significant reductions in plasma and urinary Gb3 levels compared to placebo, sustained over time in the open-label extension [4][14] Long-term Efficacy - An interim analysis of the open-label extension revealed a notable reduction in the rate of eGFR decline among patients treated with lucerastat, suggesting a potential disease-modifying effect [5] - Patients with impaired renal function at baseline experienced a marked attenuation of kidney function loss, indicating lucerastat's promise in long-term organ protection [5][14] Kidney Biopsy Sub-study - A kidney biopsy sub-study evaluated Gb3 accumulation in key kidney cell types in male patients with classic Fabry disease who received lucerastat for at least two years, providing insights into its impact on renal disease biology [2] Patient Population and Disease Background - Fabry disease is a rare, X-linked lysosomal storage disorder caused by mutations in the GLA gene, leading to the accumulation of Gb3 and progressive damage across multiple organ systems [6][8] - Recent studies suggest a higher prevalence of Fabry disease than previously estimated, with over 21,000 diagnosed patients expected across the US, EU5, and Japan by 2034 [9] Current Treatment Landscape - Current treatment options for Fabry disease include enzyme replacement therapies and oral chaperone therapy, which have limitations, highlighting the unmet need for a well-tolerated, oral, disease-modifying therapy [10][11]
Starton Holdings(STA) - Prospectus(update)
2026-01-29 23:55
As filed with the Securities and Exchange Commission on January 29, 2026. Registration No. 333-292059 ________________________________________________ AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ________________________________________________ STARTON HOLDINGS, INC. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Exact name of registrant as specified in its charter) DELAWARE (Jurisdiction of incorporation or organization) _____________________ ...