Core Insights - Radiopharm Theranostics has completed the preclinical data package for RAD 402, an anti-Kallikrein Related Peptidase 3 (KLK3) monoclonal antibody radiotherapeutic, and is preparing to initiate a Phase 1 clinical trial for prostate cancer in the second half of 2025 [1][2][3] Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for high unmet medical needs, listed on ASX (RAD) and NASDAQ (RADX) [5] - The company has a diverse pipeline that includes one Phase 2 and three Phase 1 trials targeting various solid tumors, including lung, breast, and brain cancers [5] Partnership and Development - A supply agreement has been signed with Cyclotek to radiolabel RAD 402 with Terbium-161 (Tb), which is crucial for the upcoming Phase 1 clinical trial [1][3] - Cyclotek, a leading radiopharmaceutical manufacturer in Australia and New Zealand, will produce and provide doses of Tb-labeled RAD 402 [6][4] Therapeutic Focus - RAD 402 is designed to target KLK3, which is highly expressed in prostate tissue, potentially leading to improved therapeutic efficacy due to the unique properties of Tb compared to other radionuclides [2][4] - The partnership aims to enhance patient outcomes by improving the accessibility of radiopharmaceuticals [7][8]

Company Overview - SELLAS Life Sciences Group, Inc. is a late-stage clinical biopharmaceutical company focused on developing novel therapies for various cancer indications [5] - The lead product candidate, GPS, targets the WT1 protein and has potential applications in both hematologic malignancies and solid tumors [5] - The company is also developing SLS009 (tambiciclib), a differentiated small molecule CDK9 inhibitor with reduced toxicity and increased potency compared to existing CDK9 inhibitors [5] Index Inclusion - SELLAS will be added to the Russell 3000 and Russell 2000 Indexes, effective after the U.S. market close on June 27, 2025, as part of the 2025 Russell indexes annual reconstitution [1] - Membership in these indexes lasts for one year and results in automatic inclusion in appropriate growth and value style indexes, enhancing visibility with institutional investors [3] Strategic Importance - The inclusion in the Russell indexes is seen as a significant corporate milestone, reflecting the company's progress in advancing its pipeline and building long-term shareholder value [4] - The company is approaching the readout of full topline Phase 2 data of SLS009 in acute myeloid leukemia (AML) and the final analysis of the Phase 3 pivotal REGAL trial of GPS in AML [4]

NEW YORK and MELBOURNE, Australia, June 24, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”), a clinical-stage biopharmaceutical company advancing combination drug therapies for high-impact indications, announces the appointment of Douglas B. Kirsch, M.D., FAAN, FAASM to its IHL-42X Obstructive Sleep Apnea (OSA) Clinical Advisory Board. “We are honored to welcome Dr. Kirsch to the IHL-42X Clinical Advisory Board,” stated Dr. Lou Barbato, Incannex Chief Medical O ...

Core Insights - ZEVASKYN™ (prademagene zamikeracel) is the first FDA-approved autologous cell-based gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB) [1][2][9] - The pivotal Phase 3 VIITAL study demonstrated significant wound healing and pain reduction after a single treatment, with 81% of treated wounds showing at least 50% healing compared to 16% in control wounds [5][13] - The publication of the VIITAL study results in The Lancet marks a significant milestone for Abeona Therapeutics as it prepares for the U.S. launch of ZEVASKYN [3][4] Company Overview - Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases, with ZEVASKYN being a key product in its portfolio [15] - The company operates a fully integrated cGMP cell and gene therapy manufacturing facility in Cleveland, Ohio, which is responsible for the commercial production of ZEVASKYN [15] Study Details - The VIITAL study was an intra-patient randomized, open-label, controlled Phase 3 trial involving 11 patients with RDEB, assessing 43 pairs of large chronic wounds [3][4] - The study's co-primary endpoints of wound healing and pain reduction were successfully met, with significant statistical differences observed [5][13] Clinical Results - At week 24, 65% of treated wounds achieved 75% or more healing compared to 7% of control wounds, indicating a substantial improvement in treatment efficacy [13] - Mean change in wound pain was -3.1 in treated wounds versus -0.9 in control wounds, demonstrating a significant reduction in pain levels [13] Safety Profile - No serious ZEVASKYN-related adverse events were reported, consistent with previous clinical experiences, and no cases of squamous cell carcinoma were observed in treated wounds [13][14]

Core Insights - Atea Pharmaceuticals has initiated the global Phase 3 C-FORWARD trial for the combination regimen of bemnifosbuvir and ruzasvir to treat hepatitis C virus (HCV) [1][2] - The regimen is designed to be a potential best-in-class treatment with a short duration of 8 to 12 weeks and low risk for drug-drug interactions [1][3] - HCV remains a significant global health issue, with approximately 50 million people infected worldwide, including 2.4 to 4 million in the US [2][9] Group 1: Trial Details - The C-FORWARD trial is the second Phase 3 trial, complementing the C-BEYOND trial currently enrolling patients in the US and Canada [1][5] - Each Phase 3 trial aims to enroll around 880 treatment-naïve patients, comparing the fixed-dose combination of bemnifosbuvir and ruzasvir to sofosbuvir and velpatasvir [5] - The primary endpoint for both trials is achieving HCV RNA below the lower limit of quantitation (LLOQ) at 24 weeks, indicating sustained virologic response (SVR12) [6] Group 2: Efficacy and Safety - Results from a Phase 2 study showed a robust 98% SVR12 rate in the treatment-adherent population and 95% in the efficacy evaluable population [7] - Additional Phase 1 studies indicated a low risk of drug-drug interactions and safety in patients co-infected with HIV [8] - Bemnifosbuvir has demonstrated significantly higher potency compared to sofosbuvir, with a 10-fold increase in activity against various HCV genotypes [11] Group 3: Market Context - The evolving patient population for HCV treatment includes many individuals with co-morbidities and complex medical histories, necessitating more accessible treatment options [3] - The current landscape shows a rising burden of untreated HCV, particularly in Europe, mirroring trends in North America [3] - Atea's regimen is positioned to address these challenges by combining high efficacy, short treatment duration, and minimal drug interaction risks [3]

Core Insights - Nuvalent, Inc. announced positive pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, in TKI pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) from the global ARROS-1 Phase 1/2 clinical trial [1][2] Group 1: Clinical Trial Progress - The company completed a pre-New Drug Application (NDA) meeting with the FDA and plans to initiate a rolling NDA submission in July 2025, targeting completion in the third quarter of 2025 [2][4] - Zidesamtinib demonstrated an overall response rate (ORR) of 44% in 117 TKI pre-treated patients, with a durability of response of 78% at 12 months and 62% at 18 months [4][10] - In a subset of 55 patients treated with one prior ROS1 TKI, the ORR was 51% with a durability of response of 93% at both the 12- and 18-month landmarks [4][12] Group 2: Efficacy and Safety - Zidesamtinib showed intracranial responses and activity against tumors with a ROS1 G2032R resistance mutation, with a well-tolerated safety profile [4][17] - The most frequent treatment-emergent adverse events (TEAEs) included peripheral edema (36%), constipation (17%), and fatigue (16%) [18][20] - Dose reductions due to TEAEs occurred in 10% of patients, and only 2% discontinued treatment due to TEAEs [20] Group 3: Future Development - The company is advancing clinical startup activities for the ALKAZAR Phase 3 trial, which will evaluate neladalkib, a novel ALK-selective inhibitor, against alectinib in TKI-naïve ALK-positive NSCLC patients [5][27] - Zidesamtinib has received breakthrough therapy designation for ROS1-positive metastatic NSCLC and orphan drug designation for ROS1-positive NSCLC [25][28] - The ongoing ARROS-1 trial is designed to evaluate zidesamtinib in both TKI-naïve and TKI pre-treated patients with advanced ROS1-positive NSCLC [26][30]

Core Insights - Liquidia Corporation has received an additional $50 million under its financing agreement with Healthcare Royalty following a legal victory against United Therapeutics Corporation, allowing for the commercial sale of YUTREPIA™ [1][2] - The funding will accelerate the launch of YUTREPIA, advance Liquidia's clinical pipeline, and support future manufacturing operations [2] - Liquidia has now received a total of $175 million of the $200 million available under the financing agreement, with an additional $25 million contingent on achieving net sales of YUTREPIA exceeding $100 million by June 30, 2026 [2] Company Overview - Liquidia Corporation is focused on developing innovative therapies for rare cardiopulmonary diseases, particularly pulmonary hypertension [8] - The company utilizes its proprietary PRINT® technology to create drug formulations, including YUTREPIA, which is approved for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) [8] - Liquidia is also developing L606, a sustained-release formulation of treprostinil, and markets generic Treprostinil Injection for PAH treatment [8] Product Information - YUTREPIA is an inhaled dry-powder formulation of treprostinil designed for ease of use and enhanced lung deposition [5] - The product is currently undergoing clinical trials, including the ASCENT trial, to evaluate its safety and tolerability in patients with PH-ILD [5] - YUTREPIA was previously known as LIQ861 during its investigational studies [5] Market Context - Pulmonary arterial hypertension (PAH) affects an estimated 45,000 patients in the U.S., with no current cure, making symptom management and quality of life improvement critical [3] - Pulmonary hypertension associated with interstitial lung disease (PH-ILD) has a prevalence of over 60,000 patients in the U.S., with many cases underdiagnosed [4]

Core Viewpoint - Nuvalent, Inc. is set to discuss pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, in a conference call on June 24, 2025, focusing on its application in advanced ROS1-positive non-small cell lung cancer patients [1] Group 1: Company Overview - Nuvalent, Inc. is a clinical-stage biopharmaceutical company dedicated to developing targeted therapies for cancer, specifically aimed at overcoming limitations of existing treatments for kinase targets [5] - The company is advancing a robust pipeline that includes investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, along with multiple discovery-stage research programs [5] Group 2: Zidesamtinib and Clinical Trials - Zidesamtinib is designed to be a brain-penetrant ROS1-selective inhibitor, addressing resistance seen with current ROS1 inhibitors and targeting tumors with treatment-emergent ROS1 mutations [3] - The ARROS-1 trial is a first-in-human Phase 1/2 clinical trial evaluating zidesamtinib in patients with advanced ROS1-positive non-small cell lung cancer and other solid tumors, focusing on safety, tolerability, and preliminary anti-tumor activity [4] - Zidesamtinib has received breakthrough therapy designation for ROS1-positive metastatic non-small cell lung cancer patients previously treated with two or more ROS1 tyrosine kinase inhibitors, as well as orphan drug designation for ROS1-positive NSCLC [3]

Phase 1 clinical study of TERN-601 demonstrated differentiated profile in 28-day study; topline data were presented in September 2024 Phase 2 FALCON clinical trial of TERN-601 completed enrollment; 12-week data expected in 4Q 2025 FOSTER CITY, Calif., June 23, 2025 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and ...

Core Viewpoint - Candel Therapeutics has appointed Charles Schoch as the permanent Chief Financial Officer after his successful tenure as interim CFO, demonstrating strong financial leadership and guiding the company through significant operational and financial milestones [1][2]. Company Leadership - Charles Schoch has been with Candel since November 2021, serving in various financial roles, including VP of Finance and Corporate Controller, before becoming interim CFO in January 2024 [2][3]. - Under Schoch's leadership, the company raised approximately $86 million following positive phase 3 clinical trial results for CAN-2409 in localized prostate cancer [2]. Financial Management - Schoch has established strong investment banking relationships and has effectively managed capital during a complex market environment, supporting Candel's strategic priorities [2][4]. - The finance function under Schoch oversees financial close processes, internal controls, SEC reporting, financial planning, procurement, payroll, and treasury operations [2]. Clinical Development - Candel is focused on developing multimodal biological immunotherapies, with CAN-2409 as the lead product candidate from its adenovirus platform [5]. - The company has completed successful phase 2a clinical trials for CAN-2409 in non-small cell lung cancer and pancreatic ductal adenocarcinoma, and a pivotal phase 3 trial in localized prostate cancer [6][7]. Regulatory Designations - CAN-2409 has received Fast Track Designation from the FDA for multiple cancer treatments and has also been granted Regenerative Medicine Advanced Therapy Designation for localized prostate cancer [6][7]. - The company is preparing for a Biologics License Application submission for CAN-2409 in localized prostate cancer [2]. Future Outlook - Schoch expressed optimism about Candel's financial foundation and disciplined capital allocation, focusing on sustainable growth and advancing the clinical pipeline [4].