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Wave Life Sciences Ltd. (Nasdaq: WVE) is a clinical-stage biotechnology company harnessing its groundbreaking synthetic chemistry platform to create stereopure nucleic acid therapeutics. Focused on rare genetic diseases, Wave's pipeline addresses conditions such as alpha-1 antitrypsin deficiency, obesity, Duchenne muscular dystrophy (DMD), and Huntington's disease. Wave's proprietary PRISMTM platform integrates various RNA modalities, including RNA editing, antisense, exon-skipping, and RNA interference, enabling scientific breakthroughs that address both rare and common disorders.
Recently, Wave has made significant progress with its Phase 2 FORWARD-53 trial for DMD, showing promising results with WVE-N531. This trial, which began dosing in December 2023, aims to evaluate dystrophin protein generation in boys amenable to exon 53 skipping, with critical data expected in 2024. The company also anticipates delivering first-of-its-kind RNA editing proof-of-mechanism data in 2024 for its WVE-006 program, targeting alpha-1 antitrypsin deficiency.
Financially, Wave is well-capitalized, with substantial cash inflows and strategic partnerships, including a notable collaboration with GSK. This partnership has led to significant milestone payments and the initiation of development programs utilizing Wave's advanced GalNAc-siRNA format.
Wave Life Sciences is at the forefront of RNA medicine, driven by a commitment to transform human health and provide life-changing treatments for devastating diseases.
Wave Life Sciences (Nasdaq: WVE) has announced a proposed public offering of $175 million in ordinary shares and pre-funded warrants. The biotechnology company, focused on RNA medicines, intends to grant underwriters a 30-day option to purchase additional ordinary shares up to 15% of the total offering. J.P. Morgan and Leerink Partners are acting as joint book-running managers, with Truist Securities and Mizuho as book-runners.
The offering is subject to market conditions and will be made through a prospectus and related supplement. A preliminary prospectus supplement and accompanying base prospectus will be filed with the SEC and available on their website. The final terms will be disclosed in a final prospectus supplement.
Wave Life Sciences announced positive interim data from the FORWARD-53 clinical trial evaluating WVE-N531 in boys with Duchenne Muscular Dystrophy (DMD) amenable to exon 53 skipping. Key findings include:
- Mean muscle content-adjusted dystrophin expression of 9.0% and unadjusted dystrophin of 5.5%
- Meaningful improvement in serum biomarkers for muscle health
- Skeletal muscle concentrations of ~41,000 ng/g with 61-day tissue half-life
- WVE-N531 was safe and well-tolerated with only mild treatment-related adverse events
The company expects feedback on a pathway to accelerated approval and complete 48-week data in Q1 2025. Wave Life Sciences is advancing a broader DMD pipeline targeting up to 40% of boys with DMD.
Wave Life Sciences (Nasdaq: WVE) has received FDA Rare Pediatric Disease Designation for WVE-N531, a treatment for Duchenne muscular dystrophy (DMD) patients amenable to exon 53 skipping. The company expects to deliver data from the potentially registrational FORWARD-53 trial, including dystrophin protein expression, in Q3 2024.
In a previous Part A study, WVE-N531 achieved 53% exon skipping and muscle tissue concentrations 20-30 times higher than those reported by technologies using muscle delivery conjugates. The treatment also demonstrated distribution to myogenic stem cells, a unique feature among exon skipping therapies. Preclinical data showed potential for cardiac and respiratory benefits.
Wave Life Sciences (Nasdaq: WVE) reported Q2 2024 financial results and provided a business update. Key highlights include:
1. Successful clinical translation of RNA medicines platform in HD patients with WVE-003, showing statistically significant mHTT reductions up to 46%.
2. Dystrophin data expected in Q3 2024 from FORWARD-53 trial of WVE-N531 for DMD.
3. Dosing initiated in RestorAATion-2 trial of WVE-006 for AATD; proof-of-mechanism data expected in Q4 2024.
4. New preclinical data on WVE-007 for obesity expected at R&D Day in Fall 2024.
5. Q2 2024 revenue: $19.7 million; net loss: $32.9 million.
6. Cash position: $154.0 million as of June 30, 2024, expected to fund operations into Q4 2025.
Wave Life Sciences (Nasdaq: WVE), a clinical-stage biotechnology company focusing on RNA medicines, has announced its upcoming second quarter 2024 financial results release. The company will host a live webcast and conference call on Thursday, August 8, 2024, at 8:30 a.m. ET to discuss the results and provide business updates.
Investors and interested parties can access the webcast through the 'Investor Events' section of the company's website. Analysts wishing to participate in the Q&A session can join via a provided audio conferencing link. An archived version of the webcast will be available on the company's website following the live event.
Wave Life Sciences announced positive results from their Phase 1b/2a SELECT-HD trial for WVE-003, a therapeutic for Huntington's disease (HD). The trial showed a statistically significant 46% reduction in mutant huntingtin (mHTT) protein in the cerebrospinal fluid compared to placebo, while preserving wild-type huntingtin (wtHTT) protein. The drug was generally safe and well-tolerated. These results validate Wave's RNA medicines platform and support potential accelerated approval discussions with regulators. Wave plans to continue developing WVE-003 and other therapies targeting HD and other conditions, with anticipated data releases in 2024 and 2025.
Wave Life Sciences announced upcoming presentations at two significant conferences in June 2024. At the Obesity & Weight Loss Drug Development Summit, they will discuss their INHBE program, targeting fat burning and muscle preservation. At the RNA Editing Summit, they will present their RNA editing capabilities for mRNA correction, highlighting their WVE-006 program for Alpha-1 antitrypsin deficiency. The company aims to demonstrate the potential of their RNA medicines in treating both rare and common diseases.
Wave Life Sciences, a clinical-stage biotech company, will present at the 2024 Jefferies Global Healthcare Conference. The event is scheduled for June 6, 2024, at 7:30 a.m. ET, and will feature a presentation by Paul Bolno, the CEO. A live webcast will be accessible through the Investor Relations page on the company's website, with a replay available for a time. This event provides insight into the company's progress in RNA medicines aimed at transforming human health.
Wave Life Sciences reported its first quarter 2024 financial results and provided updates on its innovative RNA medicines pipeline and collaborations. The company remains on track for key data sets, including proof-of-mechanism data in AATD patients, INHBE program for obesity, GSK collaboration programs, allele-selective HD program, and registrational FORWARD-53 trial in DMD. Wave has cash and cash equivalents of $181 million and additional $12 million earned under GSK collaboration. The company is well-positioned for future growth and leadership in RNA medicines.
Wave Life Sciences announced the appointment of Dr. Erik Ingelsson as Chief Scientific Officer. Dr. Ingelsson will drive Wave's therapeutic portfolio strategy by leveraging genetics and genomics capabilities to advance RNA medicines. His experience in genetic insights and drug discovery will shape Wave's transformative RNA medicines, including the INHBE program for obesity.
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