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ADARx Pharmaceuticals shares soar in Nasdaq debut after upsized IPO

ADARx Pharmaceuticals shares soar in Nasdaq debut after upsized IPO

Sept 25 (Reuters) - Shares of ADARx Pharmaceuticals rose 30% above their initial public offering price on Friday after the late-stage gene therapy developer raised $446.3 million in an upsized US initial public offering. The shares opened at $22.10, above their IPO price of $17.
ReutersReuters
ADARx Pharmaceuticals raises $446.3 million in upsized US IPO

ADARx Pharmaceuticals raises $446.3 million in upsized US IPO

Sept 25 (Reuters) - ADARx Pharmaceuticals said on Thursday it had raised $446.3 million in an upsized US initial public offering, reflecting growing investor appetite for biotech listings.
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AI-Powered Drug Discovery Firms Enveda Biosciences and Basecamp Research Secure Significant Funding Rounds

AI-Powered Drug Discovery Firms Enveda Biosciences and Basecamp Research Secure Significant Funding Rounds

AI-Powered Drug Discovery Firms Enveda Biosciences and Basecamp Research Secure Significant Funding Rounds
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Novotech to Acquire Agilex Biolabs, Expanding Bioanalytical Capabilities in Australia

Novotech to Acquire Agilex Biolabs, Expanding Bioanalytical Capabilities in Australia

Novotech to Acquire Agilex Biolabs, Expanding Bioanalytical Capabilities in Australia
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Scancell Holdings Secures Up to $25 Million in Debt Financing for iSCIB1+ Phase 3 Development

Scancell Holdings Secures Up to $25 Million in Debt Financing for iSCIB1+ Phase 3 Development

Scancell Holdings Secures Up to $25 Million in Debt Financing for iSCIB1+ Phase 3 Development
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Fate Therapeutics Receives $15 Million Grant from California Institute for Regenerative Medicine to Advance Lupus Nephritis Treatment

Fate Therapeutics Receives $15 Million Grant from California Institute for Regenerative Medicine to Advance Lupus Nephritis Treatment

Fate Therapeutics, a clinical-stage biopharmaceutical company, has been awarded a $15.0 million grant by the California Institute for Regenerative Medicine (CIRM) through its CLIN2 program. This funding is designated to support the clinical development of RECLAIM-LN, the company's Phase 2, potentially registrational trial for FT819. FT819 is an off-the-shelf CAR T-cell therapy aimed at treating refractory moderate-to-severe Systemic Lupus Erythematosus (SLE) with Lupus Nephritis (LN). Lupus Nephritis is a severe manifestation of SLE, affecting approximately 150,000 patients in the United States and is a leading cause of morbidity and mortality. The RECLAIM-LN study, which will enroll approximately 53 patients, seeks to evaluate the efficacy and safety of FT819, particularly focusing on the proportion of participants achieving complete renal response at Week 26. The study was developed in collaboration with the FDA under FT819's Regenerative Medicine Advanced Therapy (RMAT) designation.
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US FDA Launches INTERACT Program to Streamline Biologic Product Development

US FDA Launches INTERACT Program to Streamline Biologic Product Development

The U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) has introduced the INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER ProducTs) program. This new initiative aims to facilitate early engagement between potential sponsors and FDA staff, providing advice on critical issues in the initial stages of biologic product development. The program's objective is to accelerate product development by addressing sponsors' questions, removing regulatory roadblocks, and establishing a clearer path for bringing products to patients. According to CBER director Peter Marks, INTERACT meetings will help streamline development by guiding sponsors on preclinical testing requirements, manufacturing aspects for first-in-human trials, initial clinical development strategies, and device or assay design considerations. The INTERACT program will replace the existing pre-pre-investigational new drug (IND) meeting program for all biologic products.
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Amaero Inc. Postpones U.S. IPO Citing Adverse Market Conditions

Amaero Inc. Postpones U.S. IPO Citing Adverse Market Conditions

Amaero Inc. Postpones U.S. IPO Citing Adverse Market Conditions
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NYU Researchers Develop AI Tool for Stable Molecule Identification in Drug Discovery

NYU Researchers Develop AI Tool for Stable Molecule Identification in Drug Discovery

NYU Researchers Develop AI Tool for Stable Molecule Identification in Drug Discovery
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China's Biopharmaceutical Sector Emerges as Global Innovation Leader Amidst Patent Cliff

China's Biopharmaceutical Sector Emerges as Global Innovation Leader Amidst Patent Cliff

China's Biopharmaceutical Sector Emerges as Global Innovation Leader Amidst Patent Cliff
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Viking Therapeutics' VK2735 Shows Promising Weight Loss Maintenance in Clinical Trials

Viking Therapeutics' VK2735 Shows Promising Weight Loss Maintenance in Clinical Trials

Viking Therapeutics announced positive topline results for its injectable GLP-1/GIP dual agonist, VK2735, demonstrating significant weight loss and impressive maintenance of that weight loss in a Phase 1 clinical trial. After 21 weeks, participants receiving 17.5 mg of VK2735 experienced an average body weight reduction of 17.7%. Crucially, the study also evaluated various maintenance dosing options. Following a transition to every-other-week dosing for three months, up to 97% of the weight loss was maintained, compared to 61% for the placebo group. Monthly dosing maintained up to 90% of the weight loss. An exploratory control arm that continued weekly dosing showed a 21.7% weight loss, with Viking suggesting further weight loss could occur with longer-term weekly administration. The safety profile was favorable, with gastrointestinal-related adverse events during the 12-week maintenance period being comparable to placebo, and no moderate or severe nausea reported in the step-down regimens.
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Ionis and Roche Announce Positive Interim Phase 3 Data for Sefaxersen in IgA Nephropathy

Ionis and Roche Announce Positive Interim Phase 3 Data for Sefaxersen in IgA Nephropathy

Ionis and Roche Announce Positive Interim Phase 3 Data for Sefaxersen in IgA Nephropathy