COPENHAGEN, Denmark, July 11, 2025 - Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, has finalized its agreement with the European Investment Bank (EIB) to convert debt into equity. EIB will convert €3.5 million of its €7 million loan to Evaxion into equity via a purchase of ordinary Evaxion warrants at a price of $4.87, corresponding to a premium of 89% to the share price by market close yesterday. The agreement immediatel ...

Median Overall Survival (OS) of 13.9 months in triple negative breast cancer (TNBC) exceeds Trodelvy (11.8 months) and doubles control (6.9 months)OS of 17.3 months in HR+ metastatic breast cancer surpasses Trodelvy (14.4 months) and control (11.2 months)No treatment related discontinuations reported PHILADELPHIA and VANCOUVER, British Columbia, July 11, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology ...

Core Insights - BriaCell Therapeutics Corp. announced updated Phase 2 survival data for its lead immunotherapy candidate, Bria-IMT, in combination with an immune checkpoint inhibitor, showing a significant survival advantage in heavily pretreated metastatic breast cancer patients [1][2]. Survival Data Analysis - The Bria-IMT regimen demonstrated a median overall survival (OS) of 13.9 months in triple-negative breast cancer (TNBC) patients, surpassing Trodelvy's 11.8 months and single-agent chemotherapy's 6.9 months [3][4]. - In hormone receptor-positive (HR+) metastatic breast cancer, the median OS for Bria-IMT was 17.3 months, exceeding Trodelvy's 14.4 months and single-agent chemotherapy's 11.2 months [3][4]. - The study included 54 heavily pretreated metastatic breast cancer patients, with a median of six prior therapies, and no treatment-related discontinuations were reported [6]. Comparison with Established Treatments - Bria-IMT's performance outperformed established benchmarks like Trodelvy in both TNBC and HR+ patient subtypes, indicating its potential clinical impact [2][5]. - The median OS for Bria-IMT in TNBC patients is higher than that reported in the treatment arm of the ASCENT study for TNBC patients, and it is twice that reported in the physician's choice arm [5]. Future Outlook - The company is looking forward to validating these findings in its ongoing pivotal Phase 3 study, which has overall survival as its primary endpoint [2].

Glenmark's licensing pact with AbbVie for its blood cancer drug is boosting optimism over Indian biotechnology stocks, with some brokerages calling it the largest such deal in the country https://t.co/1EsAZFtUVB ...

Company Overview and Financial Performance - Vericel is a leader in advanced therapies in sports medicine and burn care, combining innovations in biology with medical technologies[5] - The company has a strong financial profile with ~$162 million in cash and investments[9] - Vericel achieved GAAP Net Income positive in 2024[9] - The company is driving high revenue growth and targets high-70% gross margin and high-30% adjusted EBITDA in the mid-term[17] - The company experienced 20% top-line growth in 2024 and expects continued high revenue growth in 2025 and beyond[18] Market Opportunity and Product Expansion - The total addressable market (TAM) opportunity is expanding to over $5 billion in the years ahead[10] - The core TAM is ~$4 billion, with an expanded TAM of ~$5 billion[11, 12] - MACI Arthro, launched in Q3 2024, targets the largest segment of the current MACI addressable market[9] - MACI Ankle study is anticipated to initiate in 2025, potentially increasing the total MACI addressable market to $4 billion[9, 53] - NexoBrid, launched in the U S in Q4 2023, significantly expands the total addressable market in burn care[9]

INCA033989 Clinical Trial Results and Safety - INCA033989 demonstrated a favorable safety profile in ET patients, with only 1 out of 49 patients discontinuing therapy due to treatment-emergent adverse events [101, 135] - INCA033989 led to rapid and sustained normalization of platelet counts in previously treated ET patients [105, 135] - Hematologic responses were achieved early and sustained, with 86% of patients receiving ≥400 mg achieving a response [113, 115] - A reduction in peripheral blood mutCALR VAF was observed in 89% (34/38) of evaluable patients, correlating with hematologic responses [119, 120, 135] - Biomarker analysis supports a reduction in mutCALR stem/progenitor cells and megakaryocytes in patients achieving a hematologic response [121, 127, 135] INCA033989 Mechanism and Preclinical Data - INCA033989 is a high-affinity mutant CALR selective monoclonal antibody that selectively inhibits constitutive JAK/STAT signaling induced by mutCALR [94] - INCA033989 directly inhibits mutCALR+ CD34+ HSPCs and megakaryocytes, without affecting non-mutated, healthy cells [94] - In a mutCALR conditional knock-in mouse model of established MPN, INCA033989 treatment led to platelet normalization, reversal of anemia, and elimination of megakaryocyte hyperplasia in the bone marrow [90, 94] Essential Thrombocythemia (ET) and Unmet Needs - CALR mutations account for 25% of Essential Thrombocythemia cases [19] - Current ET treatments aim to reduce disease-associated risks but do not impact the natural history [26] - There is an unmet need for disease-modifying therapies in ET [25, 43] Future Development Plans - A registrational trial in ET is planned to be initiated by early 2026 [137]

Anito-cel Product Profile and Clinical Data - Anito-cel, a BCMA-directed CAR T-cell therapy, utilizes a novel D-Domain binder, potentially offering a best-in-class efficacy profile, differentiated safety, and rapid manufacturing[7, 8, 9, 15] - Phase 1 data showed a median Progression-Free Survival (PFS) of 30.2 months[17] - In the iMMagine-1 pivotal trial, the Overall Response Rate (ORR) was 97%, with a stringent Complete Response/Complete Response (sCR/CR) rate of 68%[92] - iMMagine-1 demonstrated a 6-month PFS rate of 91.9% and a 12-month PFS rate of 79.3%[98] - iMMagine-1 showed a favorable safety profile, with 85% of patients experiencing < Grade 1 Cytokine Release Syndrome (CRS) and 92% experiencing no Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS)[17, 108, 118] Market Opportunity and Commercial Strategy - The Multiple Myeloma (MM) CAR T market is projected to reach approximately $12 billion in the 2L+ setting[7, 19, 21, 55, 61] - Arcellx anticipates a high gross margin of ≥70% at launch for anito-cel, with profitability achievable before reaching $1 billion in anito-cel sales[51, 55] - Post-approval, 90% of US Healthcare Professionals (HCPs) are motivated to prescribe anito-cel[30] - Anito-cel is expected to launch with a large Authorized Treatment Center (ATC) network, projected to be 160+ ATCs, leveraging Kite's infrastructure[17, 33, 62] - Payer coverage for anito-cel is projected to be >80% of US lives within 30 days and >90% within 90 days post-launch[45]

Core Viewpoint - Rosen Law Firm is reminding investors who purchased securities of Sarepta Therapeutics, Inc. during the specified class period of the upcoming lead plaintiff deadline on August 25, 2025 [1] Group 1: Class Action Details - Investors who purchased Sarepta securities between June 22, 2023, and June 24, 2025, may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2] - A class action lawsuit has already been filed, and those wishing to serve as lead plaintiff must act by August 25, 2025 [3] - Investors can join the class action by visiting the provided link or contacting the law firm directly for more information [6] Group 2: Law Firm Credentials - Rosen Law Firm emphasizes the importance of selecting qualified counsel with a successful track record in securities class actions, highlighting their own achievements in this area [4] - The firm has recovered hundreds of millions of dollars for investors, including over $438 million in 2019 alone [4] - Rosen Law Firm has been recognized for its performance in securities class action settlements, being ranked No. 1 in 2017 and consistently in the top 4 since 2013 [4] Group 3: Case Specifics - The lawsuit alleges that Sarepta made false and misleading statements regarding the safety and efficacy of its gene therapy, ELEVIDYS, which is intended for treating Duchenne muscular dystrophy [5] - Key issues raised include significant safety risks associated with ELEVIDYS, failure to detect severe side effects in trials, and the potential for regulatory scrutiny due to adverse events [5] - The lawsuit claims that these misrepresentations led to investor damages when the true information became public [5]

Core Viewpoint - The Gross Law Firm has issued a notice to shareholders of PepGen Inc. regarding a class action lawsuit due to alleged misleading statements about the company's lead product candidate, PGN-EDO51, and its clinical study [1][3]. Group 1: Allegations - The complaint alleges that during the class period from March 7, 2024, to March 3, 2025, PepGen's statements regarding PGN-EDO51 were materially false and misleading [3]. - Specific allegations include that PGN-EDO51 was less effective and safe than claimed, and that the phase two CONNECT2 study was dangerous or deficient for FDA approval [3]. - As a result of these issues, it is claimed that PepGen was likely to halt the CONNECT2 study, and the clinical, regulatory, and commercial prospects of PGN-EDO51 were overstated [3]. Group 2: Class Action Details - Shareholders are encouraged to register for the class action by the deadline of August 8, 2025, to potentially become lead plaintiffs [4]. - Once registered, shareholders will receive updates through a portfolio monitoring software regarding the case's status [4]. - There is no cost or obligation for shareholders to participate in this case [4]. Group 3: Law Firm Background - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting investors' rights against deceit and fraud [5]. - The firm aims to ensure companies adhere to responsible business practices and seeks recovery for investors who suffered losses due to misleading statements [5].

Core Viewpoint - The Gross Law Firm has issued a notice to shareholders of Sarepta Therapeutics, Inc. regarding a class action lawsuit related to misleading statements about the safety and efficacy of its gene therapy product, ELEVIDYS [1][3]. Summary by Relevant Sections Allegations - The complaint alleges that during the class period from June 22, 2023, to June 24, 2025, Sarepta Therapeutics made materially false and misleading statements regarding ELEVIDYS, a gene therapy for Duchenne muscular dystrophy. Specific allegations include: - Significant safety risks associated with ELEVIDYS were not disclosed [3]. - Trial protocols failed to identify severe side effects [3]. - Adverse events from ELEVIDYS treatment could lead to halting recruitment and dosing in trials, attracting regulatory scrutiny [3]. - The misleading statements resulted in a lack of reasonable basis for the company's positive outlook on the therapy [3]. Class Action Details - Shareholders who purchased shares of SRPT during the specified class period are encouraged to register for the class action. The deadline for seeking lead plaintiff status is August 25, 2025 [4]. - Participants will be enrolled in a portfolio monitoring system to receive updates on the case [4]. Law Firm Background - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting investors' rights against deceit and fraud. The firm aims to ensure companies engage in responsible business practices [5].