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Clinical Trial News

Modular Medical Advances Tubeless Pivot Insulin Pump with October FDA Filing and Gamified Training Platform

  • Modular Medical plans to file a special 510(k) application with the FDA in October 2025 for its next-generation tubeless Pivot patch pump targeting "almost-pumpers" with user-friendly design.
  • The company is partnering with Level Ex to develop a gamified training application for the Pivot pump, building on Level Ex's successful Level One diabetes management game endorsed by Breakthrough T1D.
  • Modular Medical is also pursuing European market clearance for its MODD1 insulin pump through BSI Group, targeting Q1 2026 for expected EU regulatory approval.
  • The company is collaborating with Nudge BG to develop an adaptive full closed-loop Automated Insulin Delivery system that eliminates the need for mealtime announcements.

Real-World Study Confirms High-Volume Intravitreal Injections Do Not Increase Glaucoma Risk

Real World Evidence
  • A large retrospective multicenter study of 2,405 eyes found no increased risk of glaucoma or ocular hypertension with high-volume intravitreal agents avacincaptad pegol, pegcetacoplan, and aflibercept 8mg compared to standard 50 µL injections.
  • The study analyzed treatment-naïve patients with neovascular age-related macular degeneration over 18-24 months, showing stable intraocular pressure across all treatment groups with differences within 1 mmHg.
  • These real-world findings corroborate clinical trial data and provide reassurance for clinicians using the three FDA-approved high-volume therapies that entered the market in 2023.

Avidity Biosciences Reports Strong Q2 Results, Advances Three RNA Therapeutics Toward BLA Submissions

Rare Disease
  • Avidity Biosciences reported Q2 revenue of $3.8 million, significantly exceeding consensus estimates of $1.61 million, while advancing three neuromuscular disease programs toward potential BLA submissions.
  • The company maintains a robust financial position with $1.2 billion in cash and marketable securities, sufficient to fund operations through mid-2027.
  • Three RNA therapeutic programs targeting FSHD, DMD44, and DM1 made meaningful advances during Q2, with potential commercialization expected starting in 2026.
  • Research and development expenses increased to $138.1 million, reflecting significant investment in the company's late-stage neuromuscular disease pipeline.

Geron Appoints Harout Semerjian as CEO to Drive RYTELO Expansion and Late-Stage Pipeline

  • Geron Corporation has appointed Harout Semerjian as President and CEO effective August 7, 2025, bringing over 30 years of hematology and oncology experience from leadership roles at Novartis, Ipsen, and GlycoMimetics.
  • The appointment comes as Geron focuses on expanding awareness and access to RYTELO, its first-in-class telomerase inhibitor approved for treating lower-risk myelodysplastic syndromes with transfusion-dependent anemia.
  • Under new leadership, the company aims to advance its late-stage pipeline including completion of the pivotal Phase 3 IMpactMF trial for relapsed/refractory myelofibrosis.
  • Wall Street analysts maintain an "Outperform" consensus with an average price target of $3.39, representing potential upside of 182.41%.

Shilpa Medicare Receives World's First Approval for NorUDCA, Novel NAFLD Treatment

Drug Approval
  • Shilpa Medicare has received historic approval for NorUDCA, marking the first-in-class treatment for non-alcoholic fatty liver disease (NAFLD) in India and making it the first company globally to obtain approval for this indication.
  • NAFLD affects approximately 25% of the world's population (1.2 billion people) and impacts an estimated 188 million individuals in India alone, representing the most prevalent liver condition globally.
  • Clinical results demonstrate NorUDCA's superior efficacy compared to placebo, showing significant improvement in both liver structure and function for NAFLD patients.
  • The company plans to launch NorUDCA tablets in India immediately while advancing global regulatory efforts to bring this vital therapy to patients internationally.

Researchers Develop Wireless Soft Neural Interface with Integrated Micropump for Targeted Brain Drug Delivery

  • Researchers have developed a revolutionary soft neural interface integrated with a tapered peristaltic micropump that enables fully wireless drug delivery directly to brain tissue, addressing limitations of traditional rigid implants and tethered systems.
  • The device features a three-chamber peristaltic pump with asymmetrically tapered microchannels that achieve unidirectional drug flow without mechanical valves, using thermal expansion and contraction of air chambers via Joule heating to drive precise drug release.
  • The flexible polyimide-based system maintains thermal safety within recommended limits for chronically implanted devices and demonstrates stable wireless operation with tunable drug delivery rates controlled via Bluetooth Low Energy communication.
  • Benchtop validation in brain tissue phantoms confirmed directional drug propagation with minimal backflow, while the device's modular design enables adaptation for various therapeutic molecules and integration with digital health platforms.

Janux Therapeutics Receives $10 Million Milestone Payment from Merck as First Patient Dosed in TRACTr Cancer Immunotherapy Trial

  • Janux Therapeutics received a $10 million milestone payment from Merck following the dosing of the first patient in their TRACTr collaboration for cancer immunotherapy development.
  • The milestone validates Janux's modular TRACTr platform technology, which is designed to overcome limitations of traditional T-cell engagers by activating only within the tumor microenvironment.
  • Janux currently has two TRACTr candidates in Phase 1 clinical trials: JANX007 targeting PSMA and JANX008 targeting EGFR, with potential for additional development and commercial milestone payments.
  • Despite the positive development, the company continues to face funding challenges due to accelerating operating losses and the need to manage large cash burn rates.

Cosmo Pharmaceuticals and Takeda Renew Multi-Year Manufacturing Agreement for Ulcerative Colitis Treatment

  • Cosmo Pharmaceuticals N.V. and Takeda have renewed their multi-year manufacturing and supply agreement for Mesalazine MMX 1200 mg, an oral once-daily treatment for ulcerative colitis.
  • The agreement reinforces Cosmo's position as a trusted global manufacturing partner and aligns with the company's Vision 2030 strategy to expand CDMO leadership.
  • Production will continue at Cosmo's advanced 18,000 m² manufacturing facility in Lainate, Italy, which is approved by multiple regulatory authorities worldwide and ISO 13485 certified.

India's First Indigenous CAR-T Therapy Achieves Two-Year Remission Milestone in Aggressive Blood Cancer

CAR-TOncology
  • Seven patients with relapsed or refractory CD19-positive B-cell Non-Hodgkin Lymphoma treated with India's first indigenous CAR-T therapy have achieved over two years of progression-free survival.
  • Immuneel Therapeutics' Varnimcabtagene autoleucel (IMN-003A) demonstrated an 83% overall response rate at Day 90 and 83% complete response rate in the IMAGINE Phase 2 trial.
  • More than 50 patients across leading Indian hospitals have been treated with consistent outcomes and favorable safety profiles, marking a breakthrough in accessible cancer immunotherapy.
  • The therapy represents a significant advancement in making world-class CAR-T treatments available domestically, supported by government backing through BIRAC grants.

FDA Approves Boehringer Ingelheim's HERNEXEOS as First-in-Class HER2 TKI for Rare Lung Cancer Subset

Drug ApprovalPrecision Medicine
  • The FDA granted accelerated approval to HERNEXEOS (zongertinib) in August 2025, marking the first oral therapy specifically targeting HER2 tyrosine kinase domain mutations in non-squamous NSCLC.
  • Clinical data demonstrated a 75% objective response rate in previously untreated patients and 96% disease control rate, with a more manageable safety profile compared to existing treatments.
  • The approval addresses an aggressive cancer subset affecting 2-4% of lung cancer patients and represents a significant advancement in precision oncology for underserved populations.

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