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Biotech Daily Dose

Wave Life Sciences Posts Wider FY25 Loss, Highlights Progress Across RNA Pipeline

By RTTNews Staff Writer   ✉   | Published:   | Follow Us On Google News

Wave Life Sciences Ltd. (WVE) has reported fourth-quarter and full-year 2025 results and outlined continued progress across its RNA-based therapeutic pipeline, including RNA editing, RNAi and antisense programs in metabolic, liver, neuromuscular and CNS diseases.

For the fourth quarter of 2025, the company incurred a net loss of $53.2 million compared with net income of $29.3 million in the same quarter of 2024.

For the full year 2025, the company's net loss widened to $204.4 million, widening from a net loss of $97.0 million in 2024.

The company's pipeline includes WVE-007, WVE-006, WVE-N531, which is advancing toward an NDA based on monthly dosing data, and WVE-003 in early-stage development.

-- WVE-007 is under a Phase 1 clinical trial in healthy individuals with overweight or obesity and an average BMI of 32.1 kg/m², dubbed INLIGHT.

Interim results from the ongoing Phase 1, single-ascending dose portion of the INLIGHT trial were reported last December. According to the trial results, a single 240 mg dose of WVE-007 demonstrated improved body composition with fat loss similar to GLP-1 at three months, with muscle preservation.

The company expects to report six-month follow-up data from the 240 mg single-dose cohort and three-month follow-up data from the 400 mg single-dose cohort of the INLIGHT trial this quarter.

The INLIGHT program includes a Phase 1 study in healthy individuals, while the planned Phase 2a trial will evaluate WVE-007 in people with higher BMI and obesity-related comorbidities.

A Phase 2a multidose portion of INLIGHT evaluating WVE-007 as monotherapy in individuals with higher BMI and comorbidities is expected to be initiated in the first half of 2026.

-- WVE-006 is under a phase 1b/2a study in alpha-1 antitrypsin deficiency (AATD), a genetic condition that can affect both lungs and liver. The study, dubbed RestorAATion-2, is now fully enrolled through the 600 mg dose group. Earlier results showed that WVE-006 helped the body produce more of the AAT protein, which is the main goal of treatment.

The company plans to share new data from the 400 mg multidose group in the first quarter of 2026, followed by additional updates from the 600 mg group later in the year.

Wave is also in discussion with regulators about whether the program could qualify for an accelerated approval pathway, with feedback expected by mid-2026.

--WVE-008 is an RNA-editing candidate aimed at a common genetic form of liver disease linked to the PNPLA3 I148M mutation. The company is preparing to file for regulatory clearance to begin clinical testing in 2026.

--Wave continues to progress WVE-N531 for Duchenne muscular dystrophy. The company remains on track to submit a New Drug Application in 2026, seeking accelerated approval based on monthly dosing data.

The company's partnership with GSK continues to expand. In January 2026, GSK selected a fourth program to move forward. The collaboration allows GSK to advance up to eight programs using Wave's RNA platform.

If all the programs progress, Wave could receive up to $2.8 billion in milestone payments, along with royalties on future sales. The company expects to continue receiving milestone payments through 2026 and beyond.

Wave ended 2025 with $602.1 million in cash and cash equivalents, supported by financing activities and milestone payments from GSK. The company expects this cash to fund operations into the third quarter of 2028.

WVE closed Wednesday's session at $14.54, up 3.71%. The stock is currently trading at $14.36, down 1.20%

For comments and feedback contact: editorial@rttnews.com

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