Drugs

FDA Lifts Hold on Rein Pulmonary Fibrosis Trial

FDA has lifted a clinical hold against a Rein Therapeutics Phase 2 (RENEW) trial evaluating LTI-03 in patients with idiopathic pulmonary fibrosis, allowing the company to resume enrollment in the U.S. The FDA action follows a review of Rein’s complete response submission, which addressed all outstanding regulatory concerns, according to the company.

“This is a major milestone for us,” Brian Windsor, Rein’s chief executive officer, is quoted in a release as saying. “We believe LTI-03 has the potential to meaningfully shift how IPF is treated by not only slowing fibrosis but also supporting lung repair.”

Rein expects to restart U.S. patient recruitment in late 2025 or early 2026 across roughly 20 sites across the U.S. The U.S. trial will complement the broader RENEW program, which encompasses an additional 30 sites in the United Kingdom, Germany, Poland, and Australia.

The Phase 2 study is designed to evaluate the safety, tolerability, and efficacy of LTI-03 in up to 120 patients with IPF. Key secondary endpoints include changes in lung function as measured by forced vital capacity and imaging-based assessments of fibrosis progression, according to the company. Topline data are anticipated in the third quarter of 2026.

LTI-03 is described as an inhaled peptide therapy derived from Caveolin-1 biology, a regulator of fibrotic signaling. It is designed to both inhibit lung scarring and preserve alveolar progenitor cells critical for tissue repair, the company says. Early data suggest the therapy may offer a dual benefit: slowing fibrosis while promoting lung healing, it adds.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome