– ARCALYST® (rilonacept) Q4 2025 and full year 2025 net product revenue of $202.1 million and $677.6 million, respectively –– ARCALYST 2026 net product revenue expected to be $900 - $920 million –– KPL-387 Phase 2 recurrent pericarditis data expected in 2H 2026 –– KPL-1161 Phase 1 trial planned to initiate by the end of 2026 –– Cash balance increased by $170.4 million in 2025 to $414.1 million – – Conference call and webcast scheduled for 8:30 am ET today – LONDON, Feb. 24, 2026 (GLOBE NEWSWIRE) -- – Kiniks ...

Core Viewpoint - AtaiBeckley Inc has appointed Michael Faerm as Chief Financial Officer, effective March 9, 2026, to lead the company's financial strategy and operations as it advances its clinical-stage programs, particularly BPL-003 moving toward Phase 3 [1][4]. Group 1: Executive Appointment - Michael Faerm brings over 25 years of experience in life sciences, equity research, and investment banking to his new role as CFO [2]. - Anne Johnson, the current CFO since 2024, will transition to Chief Accounting Officer, ensuring continuity in financial operations [3]. Group 2: Company Strategy and Pipeline - AtaiBeckley focuses on developing rapid-acting, durable mental health treatments, with a pipeline that includes BPL-003 for treatment-resistant depression, VLS-01 for treatment-resistant depression, and EMP-01 for social anxiety disorder [5]. - BPL-003 is currently in Phase 3 planning, while VLS-01 and EMP-01 are in Phase 2 clinical development [5].

, the country's first indigenously developed biosimilar of With this launch, the company reinforces its commitment to advancing Currently, more than 100 million people in India are living with diabetes, making it one of the largest diabetic populations globally. "We are committed to making advanced biologics accessible to patients who need them most. ANYRA is a transformative step for affordable retinal care in India. By delivering a high-quality, indigenously developed Aflibercept 2 mg, we are expanding ...

Core Insights - Ocular Therapeutix has appointed David W. Robinson as Global Chief Commercial Officer, which is expected to enhance the company's strategic positioning for the global launch of AXPAXLI™ for wet age-related macular degeneration and non-proliferative diabetic retinopathy, pending approval [1][2][3] Company Overview - Ocular Therapeutix, Inc. is an integrated biopharmaceutical company focused on redefining the retina experience with its investigational product candidate AXPAXLI™ (OTX-TKI), currently in Phase 3 clinical trials for wet AMD and NPDR [8] - The company also markets DEXTENZA, an FDA-approved corticosteroid for ocular inflammation and pain, and is developing OTX-TIC, a travoprost intracamreal hydrogel for glaucoma [9] Leadership and Experience - David W. Robinson has a strong background in ophthalmology, having previously served as Chief Marketing Officer at Merck and played a key role in the launch of EYLEA at Regeneron, which is recognized as a significant success in the retina market [2][4][5] - Robinson's experience includes strategic launch planning, global market access, and building commercial teams, which will be crucial for Ocular's upcoming product launches [3][5] Product Potential - AXPAXLI is viewed as having global potential, with opportunities to improve patient outcomes and streamline logistics for healthcare providers, while also offering a predictable profile for payors [3] - The product candidate is positioned to address significant unmet needs in retinal diseases, with registrational programs already in progress [3][8]

Core Viewpoint - Innovent Biologics' partner Ollin has reported positive topline results from the Phase 1b JADE clinical study, indicating that OLN324, a next-generation VEGF/Ang2 bispecific antibody, shows superior efficacy compared to faricimab in treating diabetic macular edema (DME) and wet age-related macular degeneration (wAMD) [1][5]. Group 1: Clinical Study Results - OLN324 demonstrated faster and greater retinal drying compared to faricimab, with 4mg treated patients showing mean improvements in retinal drying that were approximately 75% greater at Week 1 and about 50% greater at Week 12 [2][3]. - Nearly 90% of patients treated with OLN324 4mg achieved absence of DME at Week 12, compared to 57% of faricimab patients [2]. - All treatment groups showed equivalent anatomic outcomes in wAMD, with sustained improvements in vision noted across both DME and wAMD treatment groups [3]. Group 2: Clinical Significance - The observed differences in speed and extent of retinal drying with OLN324 versus faricimab are considered clinically significant, potentially leading to broad utility for OLN324 across major retinal diseases [4]. - OLN324 is the first therapy to demonstrate superior anatomic efficacy compared to faricimab in a head-to-head clinical trial, validating its higher potency and dosing [5]. Group 3: Market Potential - OLN324 has the potential to become the new standard of care in the approximately $15 billion global market for retinal therapeutics [5]. - The successful results from the JADE Phase 1b trial position OLN324 favorably for future global Phase 3 studies in both DME and wAMD [5][6]. Group 4: Safety Profile - A favorable safety profile was observed with OLN324, with no cases of intraocular inflammation reported during the study, contrasting with one case in the faricimab group [9].

Core Insights - Intellia Therapeutics announced positive follow-up data from the Phase 1 clinical trial of its investigational product nexiguran ziclumeran (nex-z) for patients with transthyretin (ATTR) amyloidosis with cardiomyopathy, showcasing significant clinical benefits and disease stabilization [1][2][10] Group 1: Clinical Trial Results - The Phase 1 trial demonstrated a consistent and durable reduction in serum TTR levels, with a mean reduction of 87% observed in patients followed for 36 months [3] - At 24 months, 70% of patients showed stability or improvement in NT-proBNP levels, and 85% showed stability or improvement in hs-Troponin T levels, indicating positive outcomes in disease progression [5] - Functional status preservation was noted, with 69% of patients showing stability or improvement in the 6-minute walk test, and 81% of patients stable or improved in their NYHA classification [5] Group 2: Mortality Assessment - A post-hoc mortality assessment indicated an all-cause mortality rate of 3.9 per 100 patient-years for patients treated with nex-z, compared to 12.7 per 100 patient-years in a matched cohort, suggesting a significant reduction in mortality risk [6][7] Group 3: Safety Profile - Nex-z was generally well tolerated, with infusion-related reactions and transaminase elevations being the most common treatment-related adverse events, and liver enzyme elevations did not exceed Grade 2 [8] Group 4: Product Overview - Nex-z is based on CRISPR/Cas9 gene editing technology and aims to be the first one-time treatment for ATTR amyloidosis with cardiomyopathy and/or polyneuropathy, currently under investigation in ongoing Phase 3 trials [10][11]

Core Insights - JW Therapeutics has executed an amendment to its strategic collaboration agreement with Regeneron Pharmaceuticals, marking a significant upgrade in their long-term partnership and initiating a new phase in TCR-T cell therapy and platform innovation [1] Financial Considerations - The aggregate consideration under the amendment will not exceed approximately US$50 million, which includes various milestone payments related to product development and regulatory achievements [2][3] Development and Collaboration Scope - Regeneron will fund certain development activities related to the MAGE-A4 Product, providing an upfront payment and milestone payments upon achieving specific development milestones, thereby enhancing JW Therapeutics' financial position and reducing capital expenditure [3] - The amendment broadens the collaboration to include core technology licensing, granting Regeneron a non-exclusive global license for JW Therapeutics' proprietary Drug Product Process and an option for the Lentiviral Vector Manufacturing Process [4] Ownership and Strategic Objectives - JW Therapeutics retains full ownership and commercial control of its core technologies under the non-exclusive licensing terms, allowing for future partnerships while aligning with its strategic objective to establish long-term platform value in the global cell therapy landscape [5] Leadership Perspective - The Chairman and CEO of JW Therapeutics emphasized that the amendment validates the company's technology capabilities and potential for clinical and commercial innovation in solid tumors, aiming to accelerate the development of cell immunotherapy products [5]

Core Insights - Intellia Therapeutics announced promising long-term follow-up data from the Phase 1 study of investigational gene therapy nexiguran ziclumeran (nex-z) for hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN) [1][2] - The results indicate significant and durable reductions in serum TTR levels, suggesting potential for improved patient outcomes [2][3] Group 1: Clinical Results - A one-time dose of nex-z led to a mean serum TTR reduction of 92% at 24 months and 90% at 36 months among patients [3][4] - Among 18 patients assessed at 24 months, 72% showed clinically meaningful improvements in the modified Neuropathy Impairment Score (mNIS+7) [5] - Secondary endpoints such as modified body mass index (mBMI), Norfolk Quality of Life-Diabetic Neuropathy (QoL-DN), and neurofilament light chain (NfL) also trended towards improvement [5] Group 2: Safety Profile - Nex-z has been generally well tolerated, with mild to moderate infusion-related reactions being the most common adverse events [6] - No new drug-related events were reported during the follow-up period, and previously reported liver enzyme elevations resolved without intervention [6][8] Group 3: Future Developments - The Phase 3 MAGNITUDE-2 trial is progressing rapidly, with patient enrollment expected to complete in the first half of 2026 [7][8] - Intellia anticipates submitting a biologics license application (BLA) for nex-z by 2028 [7][8] - The trial aims to evaluate the efficacy and safety of nex-z in approximately 50 patients with ATTRv-PN [7][9] Group 4: About Nex-z and ATTR Amyloidosis - Nex-z is based on CRISPR/Cas9 technology and aims to inactivate the TTR gene, potentially becoming the first one-time treatment for ATTR amyloidosis [11] - ATTR amyloidosis is a rare and progressive disease affecting an estimated 50,000 people with hereditary forms and between 200,000 to 500,000 with wild-type forms [12]

Core Insights - Intellia Therapeutics is set to present long-term data from its Phase 1 trial of investigational nex-z for hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN) at the 5th International ATTR Amyloidosis Meeting on September 25-26, 2025, in Baveno, Italy, highlighting up to three years of patient follow-up [1] Company Overview - Intellia Therapeutics, Inc. is a clinical-stage gene editing company focused on CRISPR-based therapies, aiming to revolutionize medicine by developing novel treatments for unmet medical needs [5] - The company is leading the development and commercialization of nex-z in collaboration with Regeneron Pharmaceuticals, Inc. [3] Product Information - Nex-z is based on CRISPR/Cas9 technology and aims to be the first one-time treatment for transthyretin (ATTR) amyloidosis by inactivating the TTR gene responsible for producing the TTR protein [3] - Interim Phase 1 clinical data indicates that nex-z administration results in consistent, deep, and long-lasting reductions in TTR levels [3] Disease Context - ATTR amyloidosis is a rare and progressive disease, with hereditary ATTR (ATTRv) caused by mutations in the TTR gene, leading to the production of misfolded TTR proteins that accumulate as amyloid in the body [4] - Approximately 50,000 individuals globally are affected by ATTRv amyloidosis, while the number of those with wild-type ATTR (ATTRwt) amyloidosis ranges between 200,000 and 500,000 [4]

Core Insights - Metagenomi, Inc. has appointed Dr. Laurence Reid to its Board of Directors, bringing 30 years of experience in building biotech companies and shaping business strategies [1][2] - Dr. Reid's expertise is expected to enhance Metagenomi's efforts in advancing its proprietary gene editing technologies and developing curative genetic medicines [2] Company Overview - Metagenomi is a precision gene editing company utilizing artificial intelligence and machine learning to create potentially curative genome editing therapeutics [3] - The company’s gene editing toolbox has analyzed over 7.4 billion proteins, enabling it to target various genetic mutations across the human genome [3] - Metagenomi's lead program focuses on Hemophilia A, aiming to provide lifelong protection from bleeding events and joint damage [3] Leadership Background - Dr. Reid has a strong track record as a biotech executive, having served in leadership roles at several companies, including Decibel Therapeutics and Warp Drive Bio [2] - He is currently the chairperson of Broken String Biosciences and serves on the boards of KalVista Pharmaceuticals and other private biotech firms [2] - Dr. Reid holds a B.A. in natural sciences from Cambridge University and a Ph.D. in biochemistry from King's College, London University [2]