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Avidity Biosciences to Present Data from EXPLORE44® Clinical Development Program of Del-Zota in DMD44 at 30th Annual Congress of the World Muscle Society

Avidity Biosciences to Present Data from EXPLORE44® Clinical Development Program of Del-Zota in DMD44 at 30th Annual Congress of the World Muscle Society

✨ Onyx Summary Avidity Biosciences will present new one-year data on delpacibart zotadirsen (del-zota) for Duchenne muscular dystrophy (DMD44) at the 30th Annual World Muscle Society Congress, showing reversal of disease progression and improvements across functional measures from its EXPLORE44® and EXPLORE44-OLE™ trials. The presentations, featuring leading clinicians, reinforce del-zota’s

Phathom Pharmaceuticals Appoints Sanjeev Narula as Chief Financial and Business Officer

Phathom Pharmaceuticals Appoints Sanjeev Narula as Chief Financial and Business Officer

✨ Onyx Summary Phathom Pharmaceuticals appointed Sanjeev Narula as Chief Financial and Business Officer, bringing over two decades of financial leadership experience from Intra-Cellular Therapies, Viatris, and Pfizer. His appointment strengthens Phathom’s executive team as the company advances commercialization of its GI franchise, VOQUEZNA, and pursues its strategy toward profitability

MassBio 2025 Patient Advocacy Summit: Purpose, In Spite of Pressure

MassBio 2025 Patient Advocacy Summit: Purpose, In Spite of Pressure

✨ Onyx Summary MassBio will host the 2025 Patient Advocacy Summit on November 6 at the MassBioHub, themed “Purpose, In Spite of Pressure,” highlighting how patients and advocates drive progress across the healthcare and drug development landscape. The event will feature a keynote by Yelak Biru and Fatima Scipione on the

Perspective Therapeutics Announces First Patient Dosed with PSV359 in the Second Cohort of a Phase 1/2a Study in Patients with FAP-α Positive Solid Tumors

Perspective Therapeutics Announces First Patient Dosed with PSV359 in the Second Cohort of a Phase 1/2a Study in Patients with FAP-α Positive Solid Tumors

✨ Onyx Summary Perspective Therapeutics announced that the first patient has been treated in the second cohort of its Phase 1/2a trial evaluating [212Pb]PSV359, a targeted alpha radiopharmaceutical for solid tumors expressing FAP-α. The study advances dose escalation to 5.0 mCi following favorable safety review at lower doses,

Ocugen to Present at Industry and Investor Conferences in October 2025

Ocugen to Present at Industry and Investor Conferences in October 2025

✨ Onyx Summary Ocugen will present at the 2025 Cell & Gene Meeting on the Mesa (Oct. 6, Phoenix), Chardan’s 9th Annual Genetic Medicines Conference (Oct. 21, New York), and the 2025 Maxim Growth Summit (Oct. 22, New York) to outline progress toward its goal of three BLAs in the

enGene Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

enGene Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

✨ Onyx Summary enGene Holdings granted inducement equity awards to four new employees, including Chief Medical Officer Hussein Sweiti, M.D., MSc, with options to purchase a total of 657,950 common shares at an exercise price of $6.83 per share. The grants, made under Nasdaq Listing Rule 5635(c)

enGene Appoints Hussein Sweiti, M.D., MSc, as Chief Medical Officer

enGene Appoints Hussein Sweiti, M.D., MSc, as Chief Medical Officer

✨ Onyx Summary enGene Holdings appointed Hussein Sweiti, M.D., MSc, as Chief Medical Officer, effective September 29, 2025. Dr. Sweiti, formerly Global Medical Head of Oncology Clinical Development at Johnson & Johnson, joins enGene as it transitions detalimogene voraplasmid toward regulatory filing and potential commercialization in high-risk, BCG-unresponsive non-muscle invasive

Saama Introduces Modular and Adaptive AI Agents For Clinical Innovation

Saama Introduces Modular and Adaptive AI Agents For Clinical Innovation

✨ Onyx Summary Saama announced the launch of modular Clinical AI Agents built on its Agentic AI platform, enabling sponsors to drive efficiency and innovation across the clinical development lifecycle through partial autonomy and human-in-the-loop oversight. The purpose-built system addresses integration and compliance failures seen in generalist AI models, offering adaptable,

Kyverna Therapeutics Highlights Potential of KYV-101 in Multiple Sclerosis with Data from Phase 1 Investigator-Initiated Trials to be Presented at ECTRIMS

Kyverna Therapeutics Highlights Potential of KYV-101 in Multiple Sclerosis with Data from Phase 1 Investigator-Initiated Trials to be Presented at ECTRIMS

✨ Onyx Summary Kyverna Therapeutics reported updated Phase 1 data from investigator-initiated trials of its CD19 CAR T-cell therapy, KYV-101, in progressive multiple sclerosis, showing favorable safety, CNS penetration, and early signs of disease stabilization or improvement. The data, presented by Stanford and UCSF at the 2025 ECTRIMS Congress, reinforce KYV-101’

Advanced Clinical Announces Leadership Transition

Advanced Clinical Announces Leadership Transition

✨ Onyx Summary Advanced Clinical announced that CEO Julie Ross has departed to pursue a new opportunity, with Founder and Owner Leo Sheridan assuming the role of Chief Executive Officer. Supported by a seasoned leadership team, the transition underscores the company’s continued focus on global growth, operational excellence, and delivering

Lexicon Pharmaceuticals Announces Update on Submission of Additional Data to U.S. FDA Supporting the Benefit-Risk Profile of Zynquista® in Type 1 Diabetes

Lexicon Pharmaceuticals Announces Update on Submission of Additional Data to U.S. FDA Supporting the Benefit-Risk Profile of Zynquista® in Type 1 Diabetes

✨ Onyx Summary Lexicon Pharmaceuticals announced that the FDA will require additional time to review newly submitted clinical data supporting the potential resubmission of its New Drug Application for Zynquista® (sotagliflozin) as an adjunct therapy for adults with type 1 diabetes, with feedback now expected in Q4 2025. The update follows

Pilavapadin Provides Meaningful Pain Reduction in Adults with Diabetic Peripheral Neuropathic Pain (DPNP) in Data Presented at the European Association for the Study of Diabetes (EASD) and NEUROdiab Annual Meetings

Pilavapadin Provides Meaningful Pain Reduction in Adults with Diabetic Peripheral Neuropathic Pain (DPNP) in Data Presented at the European Association for the Study of Diabetes (EASD) and NEUROdiab Annual Meetings

✨ Onyx Summary Lexicon Pharmaceuticals presented new Phase 2b PROGRESS study data for its investigational AAK1 inhibitor, pilavapadin, at the NEUROdiab and EASD 2025 meetings, showing that the 10 mg once-daily dose achieved a statistically and clinically meaningful reduction in diabetic peripheral neuropathic pain while maintaining strong tolerability. The findings strengthen

Piramal Pharma Solutions Augments Formulation Capabilities with the Addition of New Korsch XM-12 Bilayer Tablet Press at its Morpeth, UK Facility

Piramal Pharma Solutions Augments Formulation Capabilities with the Addition of New Korsch XM-12 Bilayer Tablet Press at its Morpeth, UK Facility

✨ Onyx Summary Piramal Pharma Solutions announced the acquisition of a Korsch XM-12 bilayer tablet press for its Morpeth, UK facility, enhancing its capabilities in oral solid and hormonal drug product development and manufacturing. The investment strengthens precision, flexibility, and containment in tablet production, supporting Piramal’s commitment to advanced drug

SpyGlass Pharma Appoints Anand Sundaram as Head of Commercial

SpyGlass Pharma Appoints Anand Sundaram as Head of Commercial

✨ Onyx Summary SpyGlass Pharma appointed Anand Sundaram as Vice President, Head of Commercial, to lead launch strategy and build its commercial organization ahead of two planned Phase III trials for its sustained drug delivery platform. Sundaram brings extensive ophthalmic commercialization experience from Opthea, Iveric Bio, Novartis, and Genentech, strengthening SpyGlass’