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About Aileron Therapeutics Inc.
Aileron Therapeutics Inc. (NASDAQ: ALRN) is a clinical-stage biopharmaceutical company dedicated to advancing a novel pipeline of first-in-class medicines that address significant unmet medical needs in orphan pulmonary, fibrotic, and oncology indications. With a strong foundation in peptide therapeutics, Aileron is at the forefront of developing innovative therapies designed to improve patient outcomes in challenging and underserved medical conditions.
Core Product Pipeline
LTI-03: Aileron's lead product candidate, LTI-03, is a synthetic peptide with a dual mechanism of action targeting alveolar epithelial cell survival and inhibition of profibrotic signaling. Currently in clinical development, LTI-03 has shown promise in treating idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease. The therapy's unique approach aims to not only slow disease progression but potentially restore healthy lung function.
LTI-01: Another key asset in Aileron's pipeline, LTI-01, is a proenzyme developed for loculated pleural effusions. Having completed Phase 1b and Phase 2a clinical trials, LTI-01 has received Orphan Drug Designation in both the U.S. and EU, as well as Fast Track Designation in the U.S., underscoring its potential to address critical unmet needs in this condition.
ALRN-6924: Previously a lead oncology candidate, ALRN-6924 is a clinical-stage therapy that reactivates the tumor-suppressing protein p53 by targeting MDMX and MDM2. This innovative approach has positioned ALRN-6924 as the first and only clinical-stage drug targeting MDMX, with potential applications in rare cancers like retinoblastoma.
Market Position and Competitive Edge
Aileron Therapeutics operates in the highly specialized fields of peptide-based therapeutics and orphan disease indications. By focusing on first-in-class therapies, the company differentiates itself from competitors through its innovative mechanisms of action and targeted approach to high-need patient populations. Its strategic focus on orphan diseases, supported by Orphan Drug and Fast Track designations, positions it to capitalize on regulatory incentives and market exclusivity.
Industry Significance
As a pioneer in peptide therapeutics, Aileron Therapeutics is contributing to the advancement of treatments for complex diseases with limited existing options. Its commitment to addressing unmet medical needs in IPF, fibrosis, and oncology aligns with broader industry trends emphasizing innovation in rare and life-threatening diseases. With a robust clinical pipeline and a focus on leveraging cutting-edge science, Aileron is poised to make a meaningful impact on patient care and the biopharmaceutical landscape.
Aileron Therapeutics announced its rebranding to Rein Therapeutics, reflecting its focus on developing therapies for orphan pulmonary and fibrosis indications. The company's stock will trade under the new symbol RNTX starting January 13, 2025.
The company reported positive topline data from Cohort 2 of its Phase 1b trial for LTI-03 in November 2024, showing statistical significance in four biomarkers and dose dependence in five markers for idiopathic pulmonary fibrosis (IPF) treatment. The high-dose LTI-03 (5 mg BID) demonstrated a favorable safety profile.
In 2024, Brian Windsor was appointed CEO, and the company raised $17.7 million through a stock offering. For 2025, Rein plans to initiate a Phase 2 trial for LTI-03 in IPF treatment. The company also has LTI-01, a Phase 2b-ready asset for loculated pleural effusions, which has received Orphan Drug and Fast Track Designations.
Aileron Therapeutics (NASDAQ: ALRN) reported Q3 2024 financial results and highlights. The company announced positive data from Cohort 2 of its Phase 1b trial for LTI-03 in IPF patients, showing dose-dependent effects in five biomarkers. The combined data from Cohorts 1 and 2 achieved statistical significance in four biomarkers. Cash position was $17.7 million as of September 30, 2024, expected to fund operations into June 2025. Q3 net loss was $5.8 million ($0.27 per share), with R&D expenses at $3.7 million and G&A expenses at $2.3 million.
Aileron Therapeutics (NASDAQ: ALRN) announced positive topline data from Cohort 2 of its Phase 1b trial for LTI-03 in Idiopathic Pulmonary Fibrosis (IPF). The high-dose treatment (5 mg BID) showed positive trends in seven out of eight biomarkers, with four biomarkers achieving statistical significance in the combined Cohort 1 and 2 data. Surfactant protein D, an indicator of epithelial cell health, decreased by 5% after 14 days of treatment. The drug demonstrated dose-dependent effects in five biomarkers and was well-tolerated with no safety concerns. The company is now planning a Phase 2 clinical trial.
Aileron Therapeutics (NASDAQ: ALRN) and Advancium Health Network have entered into an exclusive option agreement for ALRN-6924, targeting retinoblastoma, a rare pediatric eye cancer. Advancium paid a non-refundable fee for the option to acquire ALRN-6924, with potential additional payments upon exercise. The drug selectively targets MDM2 and MDMX proteins to activate p53-mediated tumor suppression in cancer cells. Retinoblastoma affects approximately 300 cases in the US and 9,000 worldwide annually, primarily in children. ALRN-6924 has shown promising results in preclinical models, demonstrating anti-proliferative activity in RB cell lines and compatibility with intraocular injection.
Aileron Therapeutics (NASDAQ: ALRN) is presenting data from its Phase 1b clinical trial of LTI-03 for Idiopathic Pulmonary Fibrosis (IPF) at the 22nd International Colloquium on Lung and Airway Fibrosis. The trial's Cohort 1, evaluating low-dose LTI-03 (2.5 mg BID), showed positive trends in seven out of eight biomarkers, with three showing statistically significant improvements in collagen synthesis, inflammation, and fibrogenesis.
The company has also completed enrollment for Cohort 2, testing high-dose LTI-03 (5 mg BID), with topline data expected soon. Pre-clinical data using precision cut lung slices (PCLS) further supports LTI-03's potential effectiveness in IPF treatment. The ongoing Phase 1b trial aims to evaluate the safety and tolerability of LTI-03 in IPF patients over 14 days of treatment.
Aileron Therapeutics (NASDAQ: ALRN) has completed enrollment in Cohort 2 of its ongoing Phase 1b clinical trial evaluating LTI-03 in Idiopathic Pulmonary Fibrosis (IPF). The trial, which enrolled a total of 24 patients, aims to assess the safety and tolerability of LTI-03 in IPF patients after 14 days of treatment. Cohort 2 will evaluate a high-dose of LTI-03 (5 mg BID).
Previously announced results from Cohort 1, which evaluated a low-dose of LTI-03 (2.5 mg BID), showed positive trends in seven out of eight biomarkers. This suggests a potential therapeutic effect, with evidence of reduced expression among multiple profibrotic proteins produced by basal-like cells and fibroblasts that contribute to IPF progression. Three biomarkers showed statistically significant data, reinforcing LTI-03's potential to improve lung function and reverse IPF progression.
Aileron Therapeutics (NASDAQ: ALRN), a biopharmaceutical company focused on orphan pulmonary and fibrosis indications, has announced its participation in the 8th Annual IPF Summit in Boston, MA. Brian Windsor, Ph.D., President and CEO of Aileron, will present on August 21, 2024, at 2:45 PM ET.
The presentation, titled 'Biomarker Strategies in the Clinical Development of LTI-03 in IPF', will be part of the session on Emerging Biology & Early Translation. This session aims to enhance the predictive power of preclinical modeling and improve the transition from bench to bedside for next-generation therapeutics.
The IPF Summit is the largest drug development initiative for the pulmonary fibrosis community, bringing together key stakeholders from the biopharmaceutical industry, clinical practice, and academic research globally.
Aileron Therapeutics (NASDAQ: ALRN) reported Q2 2024 financial results and business highlights. Key points include:
1. Positive data from Cohort 1 of Phase 1b trial for LTI-03 in idiopathic pulmonary fibrosis (IPF), with positive trends in 7 of 8 biomarkers.
2. Completed a $18.2 million registered direct offering in May 2024.
3. Q2 2024 R&D expenses increased to $3.7 million from $0.2 million in Q2 2023.
4. G&A expenses rose to $5.3 million from $1.9 million year-over-year.
5. Net loss for Q2 2024 was $8.9 million ($0.45 per share).
6. Cash position as of June 30, 2024: $21.9 million, expected to fund operations into H2 2025.
7. Topline results from Cohort 2 (high-dose LTI-03) expected in Q3 2024.
Aileron Therapeutics (NASDAQ: ALRN), a biopharmaceutical company focused on developing first-in-class medicines for orphan pulmonary and fibrosis indications, has announced its participation in the Canaccord Genuity 44th Annual Growth Conference. The company's President and CEO, Brian Windsor, Ph.D., is scheduled to present on Tuesday, August 13, 2024, at 4:00 p.m. EDT in Boston, MA.
Investors and interested parties can access a live webcast of the presentation through Aileron's investor relations website. The webcast replay will remain available for 90 days following the event, providing an opportunity for those unable to attend the live presentation to catch up on Aileron's latest developments and future plans.
Aileron Therapeutics (NASDAQ: ALRN), a biopharmaceutical company focusing on orphan pulmonary and fibrosis indications, announced that it will be included in the Russell Microcap® Index. This inclusion will take effect on July 1, 2024, following the annual reconstitution of Russell U.S. Indexes, which ranks the 4,000 largest U.S. stocks by market capitalization. Membership in the Russell Microcap® Index means automatic inclusion in applicable growth and value style indexes, and will last for one year.
Aileron's inclusion is attributed to the clinical progress of its lead asset, LTI-03, for idiopathic pulmonary fibrosis, with positive data from a Phase 1b trial. Russell indexes are benchmarks for about $10.5 trillion in assets and are widely used by investment managers and institutional investors.
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