Earnings summaries and quarterly performance for Lexeo Therapeutics.
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Board of directors at Lexeo Therapeutics.
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Recent press releases and 8-K filings for LXEO.
Lexeo Provides Clinical and Financial Update at Stifel 2025 Healthcare Conference
LXEO
New Projects/Investments
Guidance Update
- Lexeo's Friedreich's ataxia (FA) program demonstrated an 18% average improvement in left ventricular mass index (LVMI) and a 1.5-2 point improvement in neurologic scales in Phase I/II data. The company has aligned with the FDA on an accelerated approval path, including the potential to pool existing data with a future pivotal study.
- The arrhythmogenic cardiomyopathy (PKP2) program, targeting a 60,000-patient market in the U.S., completed Phase I/II enrollment, with high-dose data expected in January. Early data from cohort one showed a patient achieving 70% of normal PKP2 expression and a response in PVCs.
- Both clinical programs exhibit a compelling safety profile, with no treatment-related serious adverse events at the highest FA dose and no liver injury-related SAEs for PKP2, despite a high dose of 6e13 vector genomes per kilogram.
- Lexeo reported a strong financial position with $122 million in cash and marketable securities at the end of Q3 and an additional $154 million raised in October, extending its cash runway into 2028.
Nov 12, 2025, 4:20 PM
Lexeo Therapeutics Provides Updates on Friedreich's Ataxia and PKP2 Arrhythmogenic Cardiomyopathy Programs
LXEO
New Projects/Investments
Guidance Update
- Lexeo Therapeutics (LXEO), a cardiac genetic medicines company, is advancing two clinical-stage programs.
- Its most advanced program for Friedreich's ataxia (FA) received breakthrough therapy designation in July 2025 and is slated to enter a pivotal study in 2026. The FDA is open to pooling data from the Phase 1/2 study with the pivotal study, potentially accelerating the BLA pathway.
- The company's PKP2 arrhythmogenic cardiomyopathy program completed Phase 1/2 enrollment and is expected to present data in early January 2026 for the first set of patients at the higher dose. This program has demonstrated a favorable safety profile, with only one possibly treatment-related serious adverse event.
Nov 10, 2025, 2:30 PM
Lexeo Therapeutics provides clinical development update at Guggenheim Conference
LXEO
New Projects/Investments
Guidance Update
- Lexeo Therapeutics is focused on cardiac genetic medicines, with two primary clinical-stage programs targeting Friedreich's ataxia (FA) and PKP2 Arrhythmogenic Cardiomyopathy.
- The FA program received breakthrough therapy designation in July 2025 and is expected to enter a pivotal study in 2026; FDA alignment allows for pooling Phase 1/2 study data, potentially accelerating the BLA pathway.
- Clinical data for the FA program has shown significant improvements, with patients achieving a 28-30% reduction in Left Ventricular Mass Index (LVMI), surpassing the 10% efficacy threshold agreed upon with the FDA.
- For the PKP2 Arrhythmogenic Cardiomyopathy program, which has completed Phase 1/2 enrollment, data will be presented in early January 2026, including efficacy data from five high-dose patients with over six months of follow-up.
- The PKP2 program has demonstrated a favorable safety profile, with only one possibly treatment-related serious adverse event (sustained ventricular tachycardia) in a patient with a prior history, and no typical gene therapy-related SAEs observed.
Nov 10, 2025, 2:30 PM
Lexeo Therapeutics Provides Updates on Clinical Programs and FDA Alignment
LXEO
New Projects/Investments
Guidance Update
- Lexeo Therapeutics, a cardiac genetic medicines company, is advancing its Friedreich's ataxia (FA) program towards a pivotal study in 2026, following breakthrough therapy designation in July. The FDA has indicated openness to pooling Phase 1/2 data with the pivotal study, which could lead to a smaller study and earlier efficacy evaluation, with a 10% clinically meaningful threshold improvement in left ventricular mass.
- For its PKP2 arrhythmogenic cardiomyopathy program, Lexeo completed Phase 1/2 enrollment and will present data in early January (2026). This readout will include five high-dose patients with over six months of treatment follow-up and safety data from all 10 patients.
- The company has successfully transitioned its manufacturing process for the FA pivotal study, receiving FDA approval to begin dosing patients after demonstrating comparability. Lexeo sees a significant commercial opportunity for its FA therapy, potentially addressing 70% of FA patients with cardiac involvement.
Nov 10, 2025, 2:30 PM
Lexeo Therapeutics Reports Q3 2025 Financial Results and Operational Highlights
LXEO
Earnings
New Projects/Investments
Guidance Update
- Lexeo Therapeutics, Inc. reported a net loss of $20.3 million or $0.33 per share for the three months ended September 30, 2025, compared to a net loss of $29.5 million or $0.89 per share for the same period in 2024.
- As of September 30, 2025, cash, cash equivalents, and investments in marketable securities were $122.8 million. The company completed a $154 million equity financing in October 2025, which, combined with Q3-25 end cash, is expected to fund operations into 2028.
- For its LX2006 program in Friedreich Ataxia, the FDA is open to pooling data from ongoing Phase I/II studies with data from a pivotal trial for a Biologics License Application and approved the analytical comparability report for manufacturing processes in November 2025. Interim clinical data showed an 18% mean improvement in left ventricular mass index (LVMI) at 6 months and 23% at 12 months in participants with abnormal baseline LVMI.
- Enrollment is complete for the LX2020 HEROIC-PKP2 Phase I/II trial with ten participants dosed, and a substantive data update is anticipated in January.
Nov 5, 2025, 12:38 PM
Lexeo Therapeutics Announces Pricing of Public Offering and Concurrent Private Placement
LXEO
- Lexeo Therapeutics, Inc. priced its underwritten public offering and concurrent private placement for estimated gross proceeds of approximately $135 million.
- The public offering includes 15,625,015 shares of common stock at an offering price of $8.00 per share, with underwriters having a 30-day option to purchase up to an additional 2,343,750 shares.
- In the concurrent private placement, Lexeo agreed to sell pre-funded warrants to purchase 1,250,000 shares of common stock to Balyasny Asset Management at $7.9999 per pre-funded warrant.
- As of September 30, 2025, the company estimates it had $122.8 million in cash, cash equivalents, and investments, though this preliminary financial information is subject to change.
Oct 17, 2025, 9:26 PM
Lexeo Therapeutics Details Progress in Friedreich's Ataxia and Arrhythmogenic Cardiomyopathy Programs
LXEO
New Projects/Investments
Guidance Update
- Lexeo Therapeutics, a cardiac genetic medicines company, is progressing its AAV gene therapy programs for Friedreich's ataxia (FA) and arrhythmogenic cardiomyopathy (PKP2).
- The FA program has achieved an expedited path to accelerated approval from the FDA, following clinical data showing significant improvements in cardiovascular disease and neurologic function.
- In Phase 1 studies for FA, patients with elevated left ventricular mass index (LVMI) demonstrated reductions of 20-25% at six months, with all six patients normalizing their LVMI. The pivotal study is powered for a 10% LVMI reduction.
- The PKP2 program is expected to complete Phase 1/2 enrollment this year, with an FDA discussion planned for 2026 after data from seven high-dose patients is mature.
Oct 14, 2025, 11:00 AM
Lexeo Therapeutics Updates on Clinical Pipeline and Financial Outlook
LXEO
New Projects/Investments
Guidance Update
- Lexeo Therapeutics is advancing LX2020 for PKP2-ACM, a potential best-in-class treatment that demonstrated a 67% reduction in PVCs from baseline in one participant at 6 months post-treatment, with a program update expected in 2H 2025.
- The company's LX2006 program for FA Cardiomyopathy targets a disease where cardiac complications are responsible for up to 80% of deaths, with a regulatory update anticipated in Early 2026 and the initiation of a registrational study in 1H 2026.
- Lexeo utilizes an AAVrh10 delivery platform which has shown 1.5x to 2.0x greater biodistribution in the heart compared to AAV9 in preclinical models, potentially allowing for lower doses in cardiac gene therapy.
- As of June 30, 2025, Lexeo Therapeutics reported approximately $153 million in cash and marketable securities, providing a projected financial runway into 2028.
Oct 7, 2025, 1:00 PM
Lexeo Therapeutics Updates on LX2006 Regulatory Path and Clinical Data
LXEO
New Projects/Investments
Guidance Update
- Lexeo Therapeutics received positive regulatory feedback from the FDA for LX2006, indicating openness to a Biologics License Application (BLA) submission that pools Phase 1-2 clinical data with data from the upcoming pivotal study, and agreement to evaluate the co-primary endpoint of Left Ventricular Mass Index (LVMI) at an earlier time point to potentially shorten the pivotal study.
- Interim clinical data for LX2006 showed a 23% mean improvement in LVMI at 12 months for participants with abnormal baseline LVMI, exceeding the FDA's 10% threshold, and demonstrated clinically meaningful improvements in the modified Friedreich ataxia rating scale (MFARS).
- LX2006 maintained a generally well-tolerated safety profile across all dose cohorts, with minimal adverse events, and the company plans to initiate the pivotal study in H1 2026.
Oct 7, 2025, 12:00 PM
Lexeo Therapeutics Announces Progress in FDA Discussions and Positive Interim Clinical Data for LX2006
LXEO
New Projects/Investments
- Lexeo Therapeutics announced progress in FDA discussions for an Accelerated Approval Pathway for LX2006 in Friedreich ataxia (FA) Cardiomyopathy.
- The FDA is open to a Biologics License Application (BLA) submission that includes pooling clinical data from ongoing Phase I/II studies with new data from a planned pivotal study, provided enhanced manufacturing comparability data and an additional nonclinical requirement are met.
- Interim clinical data for LX2006 show sustained or deepening improvements in cardiac and neurologic measures of FA, with participants having abnormal Left Ventricular Mass Index (LVMI) at baseline achieving a mean reduction of 18% at 6 months and 23% at 12 months, exceeding the 10% FDA-aligned threshold.
- The drug has been generally well-tolerated across 17 participants dosed to date, with no clinically significant complement activation and minimal, transient liver function test (LFT) elevations.
- Lexeo plans to initiate the pivotal study in the first half of 2026, with continued discussions on the protocol and comparability expected into early 2026.
Oct 7, 2025, 12:00 PM
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