Core Viewpoint - A class action securities lawsuit has been filed against Sarepta Therapeutics, Inc. due to alleged securities fraud affecting investors between June 22, 2023, and June 24, 2025 [1] Group 1: Lawsuit Details - The lawsuit claims that Sarepta made false statements regarding the safety of its gene therapy ELEVIDYS for Duchenne, which posed significant risks to patients [2] - It is alleged that the trial protocols for ELEVIDYS failed to identify severe side effects, leading to potential regulatory scrutiny and risks regarding the therapy's approvals [2] - The defendants are accused of materially misleading investors and lacking a reasonable basis for their positive statements about ELEVIDYS [2] Group 2: Next Steps for Investors - Investors who suffered losses during the specified timeframe have until August 25, 2025, to request appointment as lead plaintiff, although participation in any recovery does not require this [3] - Class members may be entitled to compensation without any out-of-pocket costs or fees [3] Group 3: Firm Background - Levi & Korsinsky has a history of securing hundreds of millions of dollars for shareholders and is recognized as one of the top securities litigation firms in the United States [4]

4D-150 Clinical Activity and Tolerability - 4D-150 demonstrates robust and durable clinical activity across all studied populations, including recently diagnosed patients with wet AMD[7] - 4D-150 exhibits a tolerability profile comparable to approved anti-VEGF agents[8] 4D-150 Injection-Free Rates in Wet AMD - In the severe wet AMD population, 44% of patients were injection-free through 52 weeks, with 48% requiring >1 injection and 8% requiring 1 injection, resulting in an 83% treatment burden reduction[13] - In the broad wet AMD population (including recently diagnosed), 70% of patients were injection-free through 52 weeks, with 20% requiring >1 injection and 10% requiring 1 injection, resulting in an 89% treatment burden reduction[16] - In the recently diagnosed wet AMD population, 87% of patients were injection-free through 52 weeks, with 13% requiring 1 injection, resulting in a 98% treatment burden reduction[19] 4D-150 Intraocular Inflammation (IOI) Profile - 4D-150 development is enabled by a favorable IOI profile, with IOI rates of 2-3%[22] 4FRONT Phase 3 Program Design - The 4FRONT Phase 3 program in treatment-naïve wet AMD is designed to maximize the probabilities of clinical, regulatory, and commercial success[10, 24, 35] - The 4FRONT-1 Phase 3 study's primary endpoint is BCVA noninferiority of 4D-150 3E10 vg/eye to Aflibercept 2mg Q8 weeks[33]

Comparison with multiple landmark first-line metastatic pancreatic ductal adenocarcinoma studies substantiates strong two-year survival benefit of 21.9% vs. 9.2% historical benchmarkConsistent survival benefit compared to standard-of-care chemotherapy in randomized studies in the large HR+/HER2- metastatic breast cancer indicationData from over 1,100 patients across tumor types reveals a favorable, well-understood safety profileSAN DIEGO and CALGARY, AB, July 8, 2025 /PRNewswire/ -- Oncolytics Biotech® Inc. ...

--Nasdaq compliance follows reverse stock split previously announced on June 17, 2025LOS ALTOS, Calif., July 08, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced it has regained compliance with the Nasdaq Stock Market (“Nasdaq”) continued listing standard for minimum share price under Rule 5550(a)(2) of the Nasdaq Listing Qualifications. This updat ...

NEW YORK, July 08, 2025 (GLOBE NEWSWIRE) -- via InvestorWire — Calidi Biotherapeutics Inc. (NYSE American: CLDI) today announces its placement in an editorial published by NetworkNewsWire ("NNW"), one of 70+ brands within the Dynamic Brand Portfolio@IBN (InvestorBrandNetwork), a specialized communications platform with a focus on financial news and content distribution for private and public companies and the investment community. To view the full publication, “Precision Genetic Medicine Platform Could Disr ...

Core Insights - Fifty 1 Labs, Inc. (FITY) aims to achieve a $50 million valuation and lead the $320.6 billion functional medicine market, with a projected CAGR of 10.9% [1] - The company plans to uplist to the OTCQB by Q1 2026 and eventually to the NASDAQ Capital Market, demonstrating a commitment to growth and shareholder value [1][3] Group 1: Company Strategy - FITY's Game Plan focuses on AI-driven drug repurposing and functional medicine, targeting high-growth areas within the $5.68 trillion biotech market, which has a CAGR of 13.8% [2] - The company is investing a minimum of $1,000,000 in R&D through its subsidiary, Fifty1 AI Labs LLC, to develop an AI platform that integrates various data sources for drug repurposing [2][6] - Strategic acquisitions are planned, including targeting a biotech startup valued between $5 million and $10 million to enhance R&D capabilities [3] Group 2: Leadership and Commitment - The leadership team combines expertise in science, operations, and strategic planning, with key figures including CEO Paul Arora and Nobel laureate James Orbinski [4][5] - Officers and directors are deferring their salaries for two years until the $50 million valuation is achieved, alongside a personal investment of $350,000 to support R&D and expansion [6] - The company is committed to transparency with shareholders, planning a virtual conference in Q3 2025 and regular updates on progress [3] Group 3: Market Position and Innovation - FITY is leveraging AI to deliver personalized solutions for chronic diseases, positioning itself within the $320.6 billion functional medicine market [7] - The company plans to establish R&D hubs in Vancouver to enhance its market presence and operational capabilities [7] - The personalized medicine sector is projected to reach $900 billion by 2030, indicating significant growth potential for FITY [5]

Premier research journal article provides validation for BiomX’s phage therapy platform, showcasing first-in-human Phase 1b/2a trial results for antibiotic-resistant P. aeruginosa infectionsNew, updated data demonstrates a further bacteria reduction of 2.7 log₁₀ (approximately 500-fold) compared to placebo, with no emergent resistance and preservation of a healthy microbiomeBiomX is advancing its Phase 2b trial of BX004 with topline results expected Q1 2026 NESS ZIONA, Israel, July 08, 2025 (GLOBE NEWSWIRE) ...

Electronic Catalog listing approval makes Symvess available to healthcare professionals at U.S. Department of Defense and U.S. Department of Veterans Affairs facilitiesDURHAM, N.C., July 08, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced today that Symvess has been awarded Electronic Catalog (ECAT) listing approval from the U.S. Defense Logistics Agency. EC ...

Core Insights - BriaCell Therapeutics Corp. has reported updated survival data from its ongoing Phase 2 clinical study of Bria-IMT in patients with metastatic breast cancer, indicating a robust survival signal and well-tolerated profile for the treatment [1][4]. Patient Survival Data - The Phase 2 study included 54 heavily pre-treated metastatic breast cancer patients, with a median of 6 prior treatment lines [7]. - The most recent cohort of 25 patients achieved a one-year survival rate of 52%, with 11 patients remaining alive, including one at 38.3 months and another at 30.3 months [6][7]. - Survival rates in this cohort exceed current standard of care therapies for similar patient populations [6]. Expert Commentary - Experts have highlighted the potential of Bria-IMT to improve survival and tolerability for late-stage patients, especially those who have progressed despite treatment with checkpoint inhibitors and antibody-drug conjugates [4][6]. - The ongoing investigation in a Phase 3 randomized clinical trial aims to further assess the efficacy of Bria-IMT in combination with checkpoint inhibitors [4]. Comparative Analysis - Bria-IMT plus checkpoint inhibitors showed a 52% one-year survival rate compared to approximately 38-40% for other studies with fewer prior treatment lines [5][6]. - The study indicates that Bria-IMT may provide significant benefits for patients who have failed multiple lines of therapy, including those treated with ENHERTU and TRODELVY [6][7]. Company Overview - BriaCell is a clinical-stage biotechnology company focused on developing novel immunotherapies aimed at transforming cancer care [8].

Core Viewpoint - Medicus Pharma Ltd. has submitted a request for a Type C meeting with the FDA to discuss the fast-tracking of its clinical development program for treating Basal Cell Carcinoma (BCC) using Dissolvable Doxorubicin-containing Microneedle Arrays (D-MNA) [1][2] Group 1: Clinical Development Program - The Type C meeting aims to align on the clinical pathway and seek FDA feedback on the D-MNA product development [2] - The clinical study SKNJCT-003 is a randomized, double-blind, placebo-controlled trial enrolling up to 60 subjects with BCC, evaluating two dose levels of D-MNA against a placebo [2][5] - The high-dose of 200μg D-MNA is the maximum dose used in the previous Phase 1 safety study, which was completed in March 2021 [3][5] Group 2: Study Design and Objectives - The company seeks FDA agreement on several key topics, including the appropriateness of selected doses, primary endpoints, patient population definitions, study design, and safety assessments for future studies [4] - The Phase 1 study (SKNJCT-001) met its primary objective of safety and tolerability, with no serious adverse events reported and six participants achieving complete responses [5][10] Group 3: Ongoing and Future Studies - The Phase 2 clinical study (SKNJCT-003) is currently underway at nine clinical sites in the U.S., with an interim analysis showing over 60% clinical clearance [6] - The number of participants in SKNJCT-003 has been increased to 90, and the company is expanding clinical trial sites to Europe [6] - A separate clinical study (SKNJCT-004) is being conducted in the UAE, aiming to randomize 36 patients across four sites [7] Group 4: Strategic Acquisitions - In June 2025, the company announced a definitive agreement to acquire Antev Limited, a UK-based biotech company developing Teverelix for advanced prostate cancer [8][11]