Rein Therapeutics, Inc. Stock Price, News & Analysis

Rein Therapeutics (NASDAQ: RNTX) announced that the U.S. Food and Drug Administration has lifted the full clinical hold on its Phase 2 RENEW trial of LTI-03 in idiopathic pulmonary fibrosis (IPF) after reviewing Rein’s complete response submission.

The company expects to resume U.S. enrollment in late 2025 or early 2026 across ~20 U.S. sites, complementing ~30 global sites. The study will enroll up to 120 patients, assess safety, tolerability and efficacy with key secondaries including FVC and imaging measures, and plans initial topline data in Q3 2026. Rein stated early data suggest LTI-03 may slow fibrosis and support lung repair.

Rein Therapeutics (NASDAQ: RNTX) announced EMA authorization on Oct 9, 2025 to start its global Phase 2 RENEW trial of LTI-03 for idiopathic pulmonary fibrosis (IPF).

The EMA approval covers study sites in Germany and Poland; the company previously received clearance from the U.K. MHRA. LTI-03 is described as a first-in-class therapy intended to both reduce lung scarring and promote tissue repair. The approvals position Rein to begin multi-region patient enrollment and advance its lead candidate through Phase 2.

Rein Therapeutics (NASDAQ: RNTX) has published new data in iScience demonstrating the potential of its lead drug candidate LTI-03 in treating Idiopathic Pulmonary Fibrosis (IPF). The study, conducted on actual lung tissue from IPF patients, showed that LTI-03 effectively reduced multiple scarring pathways and lowered collagen production without causing cell damage, unlike the current FDA-approved treatment nintedanib.

The research supports Rein's ongoing Phase 2 RENEW trial, which will evaluate LTI-03 in up to 120 IPF patients, with initial data expected in 2026. IPF affects approximately 100,000 people in the U.S. and 70,000 in the U.K., with the global treatment market projected to exceed $11 billion by 2031.

Rein Therapeutics (NASDAQ: RNTX) has received approval from the UK's MHRA to begin its Phase 2 "RENEW" clinical trial for LTI-03, a first-in-class therapy targeting idiopathic pulmonary fibrosis (IPF). The trial will evaluate 120 patients across two dose groups against placebo, with initial data expected in 2026.

LTI-03 is designed to target fibrosis while protecting lung regeneration capability, potentially offering a breakthrough treatment for IPF, a serious lung disease with a median survival of just 3-5 years after diagnosis. The 24-week trial will primarily assess safety and tolerability, with secondary endpoints including lung function and fibrosis progression measures.

Rein Therapeutics (NASDAQ: RNTX) announced upcoming presentations at the IPF Summit 2025 in Boston, MA, from August 19-21, 2025. Chief Scientific Officer Cory Hogaboam will present on the role of lung-resident macrophages in IPF and the potential of Caveolin-scaffolding domain (CSD) peptides in treating the disease.

CEO Brian Windsor will discuss the company's Phase 2 trial of LTI-03, which will enroll up to 120 patients to evaluate safety, tolerability, and lung function outcomes. The trial represents Rein's innovative approach to addressing IPF through a multi-pathway strategy aimed at not just slowing fibrosis but potentially improving patient outcomes.

XtalPi (2228.HK) and DoveTree Medicines have announced a groundbreaking $6 billion strategic collaboration in AI-driven drug discovery. The partnership combines XtalPi's AI and robotics platform with DoveTree's biological expertise to develop novel therapeutics across multiple disease areas.

Under the agreement, DoveTree receives exclusive global rights and will pay XtalPi an upfront payment of $51 million, with $49 million in near-term payments and up to $5.89 billion in milestone payments and tiered royalties. The collaboration will focus on developing first-in-class candidates in oncology, immunology, inflammation, neurology, and metabolic diseases.

DoveTree, founded by renowned drug developer Dr. Gregory Verdine, brings expertise in "drugging the undruggable" targets, while XtalPi contributes its intelligent de novo drug discovery platform spanning multiple modalities including small molecules, biologics, ADCs, and molecular glues.

Rein Therapeutics (NASDAQ: RNTX) has secured up to $21 million in flexible financing through two strategic agreements with Yorkville Advisors Global, LP. The financing package includes a $6 million pre-paid advance agreement with an initial $1 million funded at signing, and a $15 million standby equity purchase agreement (SEPA) available over 36 months.

The funds will support the company's RENEW Phase 2 trial of LTI-03 for idiopathic pulmonary fibrosis (IPF) treatment, pipeline development, and general corporate purposes. The pre-paid advance facility allows draws over 12 months with a 5% discount and stock-based repayment, while the SEPA provides optional stock sales pending SEC registration.

Rein Therapeutics (NASDAQ: RNTX), a biopharmaceutical company focused on developing first-in-class medications for orphan pulmonary and fibrosis conditions, has announced the adjournment of its 2025 Annual Meeting of Stockholders due to lack of quorum. The meeting will reconvene on July 23, 2025, at 9:00 a.m. Eastern Time.

The record date remains May 5, 2025, and stockholders can continue voting until 11:59 p.m. Eastern Time on July 22, 2025. The board strongly recommends voting "FOR" all proposals outlined in the proxy statement filed with the SEC on May 12, 2025. Previously submitted proxies will remain valid unless properly revoked.

Rein Therapeutics (NASDAQ: RNTX) has announced the dosing of its first patient in the RENEW Phase 2 trial of LTI-03, targeting idiopathic pulmonary fibrosis (IPF). The trial will evaluate the safety, tolerability, and efficacy of LTI-03, a novel Caveolin-1-related peptide treatment.

The study is designed as a multi-center, randomized, double-blind, placebo-controlled trial that aims to enroll 120 patients across 50 global sites. Participants must have been diagnosed with IPF within 5 years of screening. The trial's primary endpoint focuses on treatment-emergent adverse events through Week 24, while secondary endpoints measure efficacy through FVC, ppFVC, and HRCT metrics. Rein is collaborating with IQVIA for enrollment, and topline interim data is expected in H1 2026.