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Scilex Holding Company has signed a licensing agreement with ROMEG Therapeutics to exclusively market Gloperba, an FDA-approved oral medication for treating gout flares in the U.S. Gout affects approximately 8.7 million people nationwide, and the treatment market is expected to reach $8.3 billion by 2025, with a 16% annual growth rate. Gloperba, a liquid form of colchicine, addresses unmet medical needs, particularly for patients with difficulty swallowing pills. Scilex aims to leverage its extensive distribution network and sales experience to enhance market access for Gloperba.
Sorrento Therapeutics (Nasdaq: SRNE) has initiated a Phase I clinical study for STI-1558, an oral SARS-CoV-2 main protease inhibitor designed for standalone COVID-19 treatment without ritonavir. The drug demonstrated an IC50 value of 2.7 nM and shows potent antiviral activity against all COVID-19 variants, including Omicron. Preclinical studies indicated effective protection in mice against viral replication and associated lung pathology. STI-1558's oral bioavailability is up to 85%, supporting its potential as a best-in-class antiviral treatment.
Scilex Holding Company, a subsidiary of Sorrento Therapeutics (SRNE), has pre-emptively paid off $41.4 million of its senior secured notes on June 3, 2022. This payoff aligns with a plan to potentially repurchase the remaining amount before September 30, 2022, with $28 million forgiven by note holders. Scilex's executives emphasized that this move enhances their balance sheet and reduces uncertainty. Furthermore, they are advancing plans for a merger with Vickers Vantage Corp. I, aiming to boost capital and focus on commercialization efforts, including the SP-102 (SEMDEXA™) Phase 3 clinical trial.
Scilex Holding Company, a subsidiary of Sorrento Therapeutics (Nasdaq: SRNE), announced ZTlido is now covered by managed health care plans, increasing access for approximately 190 million lives in the U.S. This coverage expansion follows the addition of 5.5 million patients from a national pharmacy benefit manager. Scilex is working to increase coverage to 250-260 million lives by year-end. Additionally, a business combination agreement with Vickers Vantage Corp. I aims to elevate Scilex’s market presence, with the transaction expected to close by Q3 2022, pending shareholder approval.
Sorrento Therapeutics (SRNE) announced a strategic collaboration with Caris Life Sciences and the Prostate Cancer Clinical Trial Consortium (PCCTC) to enhance treatment decisions for advanced prostate cancer patients. This partnership aims to analyze patient samples from the Phase 2 Maverick trial, focusing on the mechanisms of disease response and resistance.
By leveraging Caris' advanced molecular profiling technologies, the collaboration intends to create a comprehensive molecular blueprint that may improve clinical outcomes in this patient population.
Sichuan Kelun-Biotech and Levena Biopharma, a subsidiary of Sorrento Therapeutics (Nasdaq: SRNE), will present updated A166 data at the 2022 ASCO meeting in Chicago from June 3-7. A166 is a novel HER2 antibody-drug conjugate targeting HER2-positive breast cancer. The presentation reports a best overall response rate (ORR) of 73.9% in the 4.8 mg/kg cohort and a median progression-free survival of 12.3 months. This Phase 1 trial included 58 patients and highlighted one complete response lasting over 7 months.
Scilex Holding Company, a subsidiary of Sorrento Therapeutics (Nasdaq: SRNE), has initiated a Phase 2 clinical trial for SP-103, a 5.4% lidocaine topical system targeting moderate to severe acute lower back pain (LBP). The study will enroll 80 patients and is expected to complete in one year, potentially paving the way for a Phase 3 trial. SP-103 seeks to overcome limitations of existing therapies, including opioids, with a total addressable market of approximately $10 billion by 2026. The trial's progression signals a critical step in developing effective non-opioid pain management solutions.
Sorrento Therapeutics (Nasdaq: SRNE) announced the appointment of Tammy Reilly, a former Roche Laboratories executive, to its board of directors. With over 30 years of experience in life sciences and pharmaceuticals, Reilly will bring expertise in therapeutics, diagnostics, and consumer merchandising. Chairman Henry Ji emphasized the significance of Reilly's experience during a pivotal time for Sorrento, as it advances late-stage clinical programs and commercializes diagnostics globally. Reilly expressed enthusiasm in contributing to the company’s mission to innovate in cancer and virology treatments.
Sorrento Therapeutics (Nasdaq: SRNE) announces that its license partner, China Oncology Focus Limited (COF), has completed enrollment of 498 patients for a Phase III trial of Socazolimab, an anti-PD-L1 monoclonal antibody, in the treatment of extensive-stage small-cell lung cancer (ES-SCLC). This multicenter trial, approved by the NMPA in March 2021, will assess the efficacy of Socazolimab combined with chemotherapy. An interim analysis is expected in April 2023.
Sorrento Therapeutics has received FDA clearance for Abivertinib (Fujovee™) to commence the Phase 2 MAVERICK study targeting metastatic castrate resistant prostate cancer (mCRPC). This trial will enroll up to 100 patients with the HSD3β1(1245C) allele and aims to evaluate the efficacy of Abivertinib with abiraterone, focusing on 6-month radiographic progression-free survival. The mCRPC market is projected to grow from $2.7 billion in 2021 to $4.56 billion by 2031, with U.S. market share increasing from 67% to 68%.
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