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Nasdaq Falls Over 100 Points; Bank of America Posts Upbeat Earnings - Bank of America (NYSE:BAC), BriaCell Therapeutics (NASDAQ:BCTX)
Benzinga· 2026-01-14 14:40
Market Overview - U.S. stocks traded lower, with the Nasdaq Composite falling more than 100 points on Wednesday, while the Dow decreased by 0.21% to 49,090.31, the NASDAQ declined 0.67% to 23,551.77, and the S&P 500 dropped 0.47% to 6,931.31 [1] - Energy shares gained by 0.9%, while consumer discretionary stocks dipped by 0.9% [1] Company Earnings - Bank of America Corp reported a net income of $7.6 billion for Q4 fiscal 2025, down from $6.80 billion a year ago, with an EPS of 98 cents, beating the analyst consensus estimate of 96 cents [2] - Revenue increased by 7% year-over-year to $28.532 billion, surpassing the analyst consensus estimate of $27.944 billion [2] Commodity Prices - Oil traded up 1% to $61.73, gold increased by 1% to $4,643.70, silver rose by 5.8% to $91.365, and copper gained 0.5% to $6.0450 [5] Global Market Performance - European shares were mostly higher, with the eurozone's STOXX 600 rising 0.1%, Spain's IBEX 35 Index up 0.4%, London's FTSE 100 gaining 0.3%, Germany's DAX falling 0.5%, and France's CAC 40 rising 0.1% [6] - Asian markets closed mixed, with Japan's Nikkei surging 1.48%, Hong Kong's Hang Seng Index gaining 0.56%, while China's Shanghai Composite fell 0.31% and India's BSE Sensex decreased by 0.29% [7] Stock Movements - High Roller Technologies, Inc. shares surged 322% to $14.65 after announcing a partnership with Crypto.com [8] - Lottery.com Inc shares increased by 87% to $0.96, while Inspire Veterinary Partners Inc shares rose by 99% to $0.046 following an increase in authorized common stock [8] - Briacell Therapeutics Corp shares dropped 53% to $5.11 after pricing a $30 million public offering at $5.59 per unit [8] - Plus Therapeutics Inc shares fell 41% to $0.28 after announcing a $15 million public offering at $0.38 per unit [8] - Hub Cyber Security Ltd shares decreased by 40% to $0.32 after announcing a reverse stock split [8]
Plus Therapeutics Announces Pricing of Upsized $15 Million Public Offering
Globenewswire· 2026-01-14 13:00
Core Viewpoint - Plus Therapeutics, Inc. has announced a public offering of 39,473,684 units at a price of $0.38 per unit, aiming to raise approximately $15 million in gross proceeds for working capital and general corporate purposes [1][2]. Group 1: Offering Details - Each unit consists of one share of common stock and one warrant, with each warrant exercisable at $0.38 per share and expiring five years from issuance [1]. - The underwriter has a 30-day option to purchase up to an additional 5,921,052 shares and/or warrants to cover over-allotments [1]. Group 2: Financial and Regulatory Information - The offering is expected to close on January 15, 2026, subject to customary closing conditions [2]. - A registration statement related to the securities was filed with the SEC on January 9, 2026, and declared effective on January 13, 2026 [3]. Group 3: Company Overview - Plus Therapeutics is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for challenging CNS cancers, with a pipeline that includes programs for leptomeningeal metastases and recurrent glioblastoma [5]. - The company has established a supply chain through strategic partnerships to support the development and potential commercialization of its products [5]. Group 4: Subsidiary Information - CNSide Diagnostics, LLC, a wholly owned subsidiary of Plus Therapeutics, develops proprietary tests like CNSide® to identify tumor cells in the CNS for patients with carcinomas and melanomas [6].
Plus Therapeutics(PSTV) - Prospectus
2026-01-09 21:10
Table of Contents As filed with the Securities and Exchange Commission on January 9, 2026. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form S-1 REGISTRATION STATEMENT Under The Securities Act of 1933 PLUS THERAPEUTICS, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 33-0827593 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number ...
Plus Therapeutics Announces Read Out of Type B Meeting with the FDA with Goal of Accelerating Approval of REYOBIQ™ for Leptomeningeal Metastases
Globenewswire· 2026-01-08 12:30
Core Insights - Plus Therapeutics, Inc. has completed a Type B meeting with the FDA regarding the pivotal trial strategy for REYOBIQ in treating leptomeningeal metastases (LM), leading to constructive discussions on study design [1][3] - The company aims to incorporate FDA feedback into its current dose optimization trial and plans to align on a revised protocol later this year, with the goal of preparing for a pivotal trial [1][3] - REYOBIQ is a novel injectable radiotherapy designed for CNS tumors, with potential advantages over existing therapies, and is currently being evaluated in multiple clinical trials [5][8] FDA Meeting Highlights - The FDA indicated that accelerated approval may be appropriate for the LM indication, but more data is needed to validate circulating tumor cells (CTCs) as a surrogate endpoint [6] - The FDA recommended evaluating endpoints with established clinical benefits, such as overall survival, while considering CTCs as a secondary endpoint [6] - A randomized controlled trial design was discussed, potentially including an intrathecal chemotherapeutic as a comparator [6] About Leptomeningeal Metastases - LM is a rare but severe complication of advanced cancer, occurring in approximately 5% of metastatic cancer patients, with a median survival of 2-6 months [4] - Common sources of LM include breast cancer, lung cancer, and melanoma, highlighting the urgent need for novel therapies [4] About REYOBIQ - REYOBIQ (rhenium Re186 obisbemeda) is formulated to deliver targeted high-dose radiation in CNS tumors, aiming to optimize patient outcomes with reduced off-target risks [5] - The product is being evaluated for recurrent glioblastoma, LM, and pediatric brain cancer in various clinical trials, supported by significant grants from the National Cancer Institute and other organizations [5] Company Overview - Plus Therapeutics is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for challenging CNS cancers, with a pipeline that includes treatments for LM and recurrent glioblastoma [8] - The company has established a supply chain through strategic partnerships to support the development and future commercialization of its products [8]
Plus Therapeutics, Inc. (PSTV) Presents at 2025 San Antonio Breast Cancer Symposium (SABCS) - Slideshow (NASDAQ:PSTV) 2025-12-17
Seeking Alpha· 2025-12-17 23:02
Group 1 - The article does not provide any relevant content regarding the company or industry [1]
Plus Therapeutics Expands CNSide Assay Platform to State of California
Globenewswire· 2025-12-11 12:30
Core Insights - CNSide Diagnostics has received lab licenses to provide its proprietary CNSide CSF Tumor Cell Enumeration test in 48 U.S. states, covering over 90% of the U.S. population [1][2] - The CNSide CSF Assay Platform has demonstrated superior clinical utility over standard care, supported by 9 peer-reviewed publications and the FORESEE clinical trial [2] - More than 11,000 CNSide tests have been performed at over 120 U.S. cancer institutions since 2020, achieving high sensitivity of 92% and specificity of 95%, influencing treatment decisions in 90% of cases [3] Company Overview - CNSide Diagnostics, LLC is a wholly-owned subsidiary of Plus Therapeutics, Inc., focused on developing and commercializing proprietary laboratory-developed tests for identifying tumor cells in patients with CNS cancers [4] - Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company headquartered in Houston, Texas, developing targeted radiotherapeutics for challenging CNS cancers, with a pipeline that includes programs for leptomeningeal metastases and recurrent glioblastoma [5]
Plus Therapeutics Announces Expansion of CNSide Team and Issuance of Inducement Grants
Globenewswire· 2025-12-09 12:30
Core Insights - Plus Therapeutics, Inc. is expanding its team at CNSide Diagnostics, LLC to enhance its capabilities in the CNS cancer diagnostics market, which is valued at over $6 billion in the U.S. [2][7] - The company is making progress towards a national launch and expanding test coverage, with plans for additional agreements with payors beyond existing contracts with UnitedHealthcare and Humana [2][8] Team Expansion - Mr. Prem Gurnani has been appointed as Senior Director of Lab Operations and Systems Implementation, bringing over 16 years of experience in diagnostics and clinical operations [8] - Ms. Elaine Luckey joins as Director of Quality and Regulatory Affairs, with over 20 years of experience in quality and regulatory affairs in laboratory environments [8] Equity Grants - The company granted stock options to Mr. Gurnani and Ms. Luckey, allowing them to purchase up to 33,750 shares each, with an exercise price equal to the closing stock price on December 4, 2025 [4][6] - Each executive also received 11,250 restricted stock units (RSUs), which will vest over three years, with one-third vesting on January 1, 2027 [5][6] Company Overview - Plus Therapeutics is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for challenging CNS cancers, aiming to improve clinical outcomes [8][9] - The company is advancing a pipeline of product candidates, particularly in leptomeningeal metastases and recurrent glioblastoma, supported by strategic partnerships for development and manufacturing [9]
Plus Therapeutics Highlights Three REYOBIQ™ Clinical Data Presentations at 2025 WFNOS/SNO Annual Meeting
Globenewswire· 2025-12-04 12:30
Core Insights - Plus Therapeutics, Inc. presented positive clinical data for REYOBIQ at the WFNOS/SNO Annual Meeting, indicating no dosage limiting toxicity in the ReSPECT-LM trial and promising safety and efficacy in the ReSPECT-GBM trial [1][2][12] - The company aims to improve survival rates for patients with central nervous system (CNS) cancers through its expanding clinical data set and the CNSide diagnostic portfolio [2][12] ReSPECT-LM Trial - The Phase 1 trial for Leptomeningeal Metastases (LM) showed that REYOBIQ was well-tolerated at a maximum dose of 66 mCi, with a recommended Phase 2 dose of 44.1 mCi [7] - Enrollment in Cohort 1 has begun, with three patients treated without dose limiting toxicity [7] ReSPECT-GBM Trial - The Phase 1/2 trial for recurrent Glioblastoma (GBM) has enrolled 24 out of a planned 34 patients, with a recommended Phase 2 dose of 22.3 mCi based on safety profiles [8] - Efficacy data indicated a median overall survival of 17 months for patients receiving ≥100 Gy, compared to 6 months for those receiving <100 Gy, surpassing historical outcomes for bevacizumab monotherapy [14] Safety Profile - Most treatment-related adverse events in both Phase 1 and 2 trials were Grade 1 or 2, with no treatment-related deaths reported [9] - Common adverse events included lymphopenia (7.9%), cognitive disorder (7.0%), and headache (7.0%) [9] Imaging and Efficacy - MRI combined with SPECT imaging biomarkers effectively evaluates overall survival response in recurrent GBM treatment, aiding in personalized patient planning [12][14] - REYOBIQ's efficacy is positively correlated with treatment coverage ratio and progression-free survival, while negatively correlated with tumor volume [14] About REYOBIQ - REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy designed for targeted high-dose radiation in CNS tumors, with potential advantages over currently approved therapies [15] - The drug is being evaluated in multiple clinical trials, including ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC, with funding support from various institutions [15]
Plus Therapeutics to Present ReSPECT Phase 1 Dose Escalation Study Results for Leptomeningeal Metastases at the 2025 San Antonio Breast Cancer Symposium
Globenewswire· 2025-12-01 12:30
Core Insights - Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for central nervous system (CNS) cancers, with an abstract accepted for a poster spotlight presentation at the San Antonio Breast Cancer Symposium [1][2] Group 1: Company Overview - Plus Therapeutics is headquartered in Houston, Texas, and specializes in targeted radiotherapeutics aimed at difficult-to-treat CNS cancers, aiming to enhance clinical outcomes [6][7] - The company is advancing a pipeline of product candidates, particularly in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM) [7] Group 2: Product Information - REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy designed to deliver targeted high-dose radiation to CNS tumors, potentially improving patient outcomes compared to existing therapies [4] - REYOBIQ is currently being evaluated in clinical trials for recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer, with significant funding support from various institutions [4] Group 3: Clinical Context - Leptomeningeal metastases (LM) occur in approximately 5% of patients with metastatic cancer, with a median survival of 2-6 months, indicating a critical need for effective treatment options [3] - The CNSide Diagnostics, LLC, a subsidiary of Plus Therapeutics, develops tests to identify tumor cells that have metastasized to the CNS, enhancing patient management for those with LM [5]
Plus Therapeutics Announces Completion of U.S. FDA Meeting on Future Clinical Development Plans for REYOBIQ™ in Leptomeningeal Metastases
Globenewswire· 2025-11-24 12:30
Core Insights - Plus Therapeutics has completed a Type B meeting with the FDA to discuss clinical development plans for REYOBIQ targeting leptomeningeal metastases [1][2] - The company plans to provide an update on next steps early in 2026 and will implement amendments to the LM trial based on FDA recommendations [2] About Leptomeningeal Metastases (LM) - LM is a severe complication of advanced cancer, occurring in approximately 5% of metastatic cancer patients, with a median survival of 2-6 months [3] - Common sources of LM include breast cancer, lung cancer, and melanoma, highlighting the urgent need for novel therapies [3] About REYOBIQ™ - REYOBIQ is a novel injectable radiotherapy designed for targeted high-dose radiation in CNS tumors, potentially improving patient outcomes compared to existing therapies [4] - It is being evaluated in clinical trials for recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer, with significant funding support from various institutions [4] About CNSide Diagnostic, LLC - CNSide Diagnostics, a subsidiary of Plus Therapeutics, develops proprietary tests to identify tumor cells in the CNS, aiding in the management of patients with leptomeningeal metastases [5] About Plus Therapeutics - Plus Therapeutics is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for CNS cancers, with a pipeline that includes programs for LM and recurrent glioblastoma [6] - The company has established a supply chain through strategic partnerships to support the development and potential commercialization of its products [6]