RLYB

– RLYB116 Confirmatory PK/PD Study Data Expected in 4Q 2025 – – Generated $20 Million from Sale of Interest in REV102 – – Cash Runway Extended through 2027 – NEW HAVEN, Conn., November 06, 2025--(BUSINESS WIRE)--Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today reported financial results for the third quarter ended September 30, 2025, and provided an update on recent company developments. "In the third quarter, we continued to execute with discipline and focus, advancing our lead program, RLYB116, and achieving a key clinical milestone with the completion of dosing in Cohort 1 in our confirmatory PK/PD Phase 1 study," said Stephen Uden, M.D., Chief Executive Officer of Rallybio. "In parallel, we strengthened our balance sheet with non-dilutive capital received from the sale of our interest in REV102. With the second cohort of the RLYB116 study progressing, we remain on track to report data in the fourth quarter of 2025 and are increasingly confident in RLYB116's potential to be an effective therapeutic. Our internal and external market assessments further validate the importance of advancing this program, as we plan for the next stage in development and in RLYB116’s potential to address serious unmet needs in complement-mediated diseases." Recent Business Highlights and Upcoming Milestones: Corporate Updates In the third quarter of 2025, Rallybio generated a total of $20 million pursuant to its agreement with Recursion Pharmaceuticals for the sale of its interest in REV102, an investigational ENPP1 inhibitor in development for the treatment of hypophosphatasia (HPP). The total included $7.5 million from an upfront payment and $12.5 million related to the initiation of additional preclinical studies. RLYB116 Program In September 2025, Rallybio completed dosing of Cohort 1 in the RLYB116 Phase 1 confirmatory pharmacokinetic/pharmacodynamic (PK/PD) clinical trial, which is planned for development in two hematologic conditions with significant unmet need: immune platelet transfusion refractoriness (PTR) and refractory antiphospholipid syndrome (APS).The Phase 1 study is designed to demonstrate complete and sustained complement inhibition as well as favorable tolerability. Data from Cohort 1 support the advancement of RLYB116...

Explore Rallybio's Fair Values from the Community and select yours Net loss: US$19.1m (loss narrowed by 46% from 1H 2024). US$0.43 loss per share (improved from US$0.83 loss in 1H 2024). Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. All figures shown in the chart above are for the trailing 12 month (TTM) period Looking ahead, revenue is forecast to grow 78% p.a. on average during the next 2 years, compared to a 19% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's share price is broadly unchanged from a week ago. We should say that we've discovered 4 warning signs for Rallybio (2 don't sit too well with us!) that you should be aware of before investing here. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

– Data Readouts from Cohort 1 and Cohort 2 of RLYB116 Confirmatory PK/PD Study on Track for 3Q and 4Q 2025, Respectively – – Sold Interest in REV102 to Recursion Pharmaceuticals for Up to $25 Million, including an Upfront Equity Payment of $7.5 Million – – Cash Runway into Mid-2027 – NEW HAVEN, Conn., August 07, 2025--(BUSINESS WIRE)--Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today reported financial results for the second quarter ended June 30, 2025, and provided an update on recent company developments. "The second quarter marked a pivotal step forward as we advanced our lead program, RLYB116, into a confirmatory PK/PD study, which is an important milestone that reflects the strength of our science and the dedication of our team. Meanwhile, the strategic divestiture of a preclinical asset underscores our commitment to disciplined portfolio management, enabling us to sharpen our focus and strengthen the balance sheet as we continue to develop transformative therapies for patients and build long-term value for shareholders," said Stephen Uden, M.D., Chief Executive Officer of Rallybio. "With the RLYB116 confirmatory PK/PD study underway, we continue to look forward to the release of topline data from Cohort 1 and Cohort 2, expected in the third and fourth quarter of 2025, respectively." Recent Business Highlights and Upcoming Milestones: Corporate Updates In July 2025, Rallybio announced that it entered into a definitive agreement to sell its interest in REV102, an ENPP1 inhibitor in preclinical development for the treatment of patients with hypophosphatasia (HPP), to its joint venture partner Recursion Pharmaceuticals (Recursion) for up to $25.0 million, including an upfront equity payment of $7.5 million and near-term milestones. The upfront payment extends Rallybio’s cash runway into the middle of 2027. In addition to the upfront payment, Rallybio is eligible to receive a contingent equity payment of $12.5 million upon the initiation of additional preclinical studies, and a $5.0 million cash milestone payment in connection with the initiation of dosing in a Phase 1 clinical study, as defined in the agreement. Rallybio is also eligible to receive low single-digit royalties on all future net sales by Recursion of produ...

Company shares partnership and clinical updates including $7 million Sanofi milestone and more information on patient populations for REC-1245 (RBM39) and REC-617 (CDK7) SALT LAKE CITY, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Recursion (Nasdaq: RXRX) a leading clinical stage TechBio company decoding biology to radically improve lives, today reported business updates and financial results for its second quarter ended June 30, 2025. Recursion will host a (L)earnings Call on August 5, 2025 at 8:00 am ET / 6:00 am MT / 1:00 pm BST from Recursion’s X (formerly Twitter), LinkedIn, and YouTube accounts giving analysts, investors, and the public the opportunity to ask questions of the company by submitting questions here: https://forms.gle/tZx2fkcmm7BDk9cJ8. "The power of our platform not only allows us to discover and develop potential new medicines, but also gives us insights on patient populations to target that would be challenging using traditional methods,” said Chris Gibson, Co-Founder and CEO of Recursion. “In discovery, we’re deploying advanced models like Boltz-2 to rapidly design ligands for high-value targets. State of the art platform capabilities helped us drive our fourth partnered discovery milestone with Sanofi this quarter, reflecting tangible momentum across our joint pipeline. We are leveraging these and other improvements to the Recursion OS to not only accelerate and improve our funnel of new programs, but also execution of later stage programs in our pipeline like RBM39 and CDK7.” Summary of Business Highlights Portfolio - Internal and Partnered Programs “REC-1245, our potential first-in-class RBM39 degrader, was identified using phenomap-derived insight, and mimics CDK12 loss to induce replication stress and suppress DDR pathways without CDK12 related toxicities. Early data show strong activity in tumors characterized by replication stress and DNA repair vulnerabilities. Our DAHLIA trial is now enrolling select tumor types to identify responsive populations. For REC-617, our CDK7 inhibitor, we leveraged multi-omic and real world patient data and causal AI modeling to select platinum-resistant ovarian cancer as the first combination cohort,” said Najat Khan, PhD, Chief R&D Officer and Chief Commercial Officer of Recursion. Internal Pipeline Updates: REC-1245 (RBM39): Recursion provided updates on the biomarker strategy and patient population current...

– On Track to Initiate Dosing in RLYB116 Confirmatory PK/PD Study in 2Q 2025, with Multiple Data Readouts Anticipated in 2H 2025 – – $54.5 Million in Cash, Cash Equivalents, and Marketable Securities as of March 31, 2025 Provides Runway into 1H 2027 – NEW HAVEN, Conn., May 08, 2025--(BUSINESS WIRE)--Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today reported first quarter financial results for the period ended March 31, 2025, and provided an update on recent company developments. "We are focused on advancing RLYB116 into a confirmatory pharmacokinetic/pharmacodynamic study this quarter, and believe that data from this study will demonstrate RLYB116’s potential to be a best-in-class therapeutic for patients with complement-driven diseases," said Stephen Uden, M.D., Chief Executive Officer of Rallybio. "Leveraging our team’s deep expertise in the complement field, we are well-positioned to maximize RLYB116’s transformative potential across multiple billion-dollar market opportunities. Additionally, we believe significant value resides within our preclinical pipeline, which includes REV102 and RLYB332. By advancing our innovative pipeline, we are committed to creating exceptional value for our shareholders while delivering life-changing therapies to patients who need them most." Recent Business Highlights and Upcoming Milestones: RLYB116 Program Rallybio is on track to initiate dosing in the RLYB116 confirmatory clinical pharmacokinetic/pharmacodynamic (PK/PD) study in the second quarter of 2025. Results from Cohort 1 (150 mg once weekly) and Cohort 2 (225 mg once weekly) are anticipated in the third and fourth quarter of 2025, respectively. Data from this study are expected to demonstrate complete and sustained complement inhibition with improved tolerability of RLYB116. REV102 Program Investigational new drug application (IND)-enabling studies are underway for REV102, an ENPP1 inhibitor for the treatment of patients with hypophosphatasia (HPP), which is being developed through a joint venture with Recursion Pharmaceuticals. These studies are expected to support the initiation of a Phase 1 study in the second half of 2026. Presentation of data evaluating REV102 in a preclinical model of later-onset HPP is expected in the sec...

— Key Data Readouts from Sentinel Participant in RLYB212 Phase 2 Clinical Trial Expected in 2Q 2025 and 3Q 2025 — — Initiation of RLYB116 Confirmatory PK/PD Study Expected in 2Q 2025, with Data Anticipated in 2H 2025 — — $65.5 Million in Cash, Cash Equivalents, and Marketable Securities as of December 31, 2024 Provides Runway into 2H 2026 — NEW HAVEN, Conn., March 13, 2025--(BUSINESS WIRE)--Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today reported financial results for the fourth quarter and full year ended December 31, 2024, and provided an update on recent company developments. "We are pleased with our strong execution in 2024, and look forward to reporting on our planned milestones in 2025," said Stephen Uden, M.D., Chief Executive Officer of Rallybio. "Dosing in our RLYB212 Phase 2 trial is underway, our differentiated C5 inhibitor, RLYB116, is on track to enter a confirmatory pharmacokinetic/pharmacodynamic study in the second quarter, and our potentially best-in-class ENPP1 inhibitor for patients with hypophosphatasia, REV102, is advancing toward Phase 1 in 2026. Through exceptional execution of these programs and continued financial discipline, we are laser focused on driving value for Rallybio in 2025 and positioning the Company for sustained growth and success in the future." Recent Business Highlights and Upcoming Milestones: RLYB212 Program In February 2025, Rallybio announced that the sentinel participant was dosed in the Phase 2 trial investigating RLYB212 in pregnant women at higher risk for HPA-1a alloimmunization and fetal and neonatal alloimmune thrombocytopenia (FNAIT). Pharmacokinetic (PK) and safety data from the second trimester are expected in the second quarter of 2025, with PK and safety data at the time of delivery expected in the third quarter of 2025. The Company received regulatory approval to begin the Phase 2 trial in October 2024 and initiated screening in November 2024. More than 14,300 pregnant women were screened in Rallybio’s FNAIT natural history study as of January 31, 2025, at which time screening was concluded at sites in the United States and Canada. Natural history data will continue to be collected in a sub-study of the Phase 2 trial, where participants at higher risk for HPA-1a...