Latest news with #Uden
Business Wire
08-07-2025
- Business
- Business Wire
Rallybio Sells Interest in REV102 Program to Recursion Pharmaceuticals
NEW HAVEN, Conn.--(BUSINESS WIRE)--Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today announced that it has 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 joint venture partner Recursion Pharmaceuticals for up to $25 million, including an upfront equity payment of $7.5 million and near term milestones. With the upfront payment, Rallybio expects its cash runway to extend into mid-2027. The REV102 program originated from a joint venture between Rallybio and Recursion focused on the discovery and development of novel, orally available small molecule inhibitors of ENPP1 for the treatment of patients with HPP. The lead candidate from the joint venture, REV102, entered into IND-enabling studies in early 2025. 'The Rallybio team has long been committed to targeting ENPP1 to address a significant unmet need in patients with HPP. By combining Rallybio's expertise in HPP preclinical and translational research with Recursion's integrated AI/experimental platform, we transformed this concept into the first potential oral disease-modifying treatment for HPP,' said Stephen Uden, M.D., Chief Executive Officer of Rallybio. 'We look forward to the advancement of REV102 through key milestones and, ultimately, to the delivery of this important treatment to patients in need.' Dr. Uden added, 'For Rallybio, divesting this preclinical asset enables us to extend our cash runway while sharpening our focus on strategically advancing our pipeline in ways that leverage our drug development expertise. We eagerly anticipate the release of topline data from our ongoing RLYB116 confirmatory PK/PD study this year.' Under the terms of the agreement, Rallybio is eligible to receive certain payments, including $7.5 million in upfront equity, a contingent equity payment of $12.5 million upon the initiation of additional preclinical studies, and a $5 million 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. In addition, Rallybio may be eligible to receive certain payments in the event of Recursion's sale of the REV102 program. 'We extend our sincere thanks to Rallybio for their invaluable partnership in advancing this program to its current stage,' said David Hallett, Chief Scientific Officer of Recursion. 'Having full ownership of this important program allows Recursion to accelerate the development of the first potential oral disease-modifying treatment to HPP patients, who currently face significant challenges with limited access to existing therapies.' About Rallybio Rallybio (NASDAQ: RLYB) is a clinical-stage biotechnology company with a mission to develop and commercialize life-transforming therapies for patients with severe and rare diseases. Rallybio has built a pipeline of promising product candidates aimed at addressing diseases with unmet medical need in areas of complement dysregulation and hematology. The Company's lead program, RLYB116, is a differentiated C5 inhibitor with the potential to treat diseases of complement dysregulation, with an initial focus on immune platelet transfusion refractoriness (PTR) and refractory antiphospholipid syndrome (APS). Rallybio's pipeline also includes RLYB332, a preclinical long-acting matriptase-2 antibody for the treatment of diseases of iron overload. Rallybio is headquartered in New Haven, Connecticut. For more information, please visit and follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements that are based on our management's beliefs and assumptions and currently available information. All statements, other than statements of historical facts contained in this press release are forward-looking statements. In some cases, forward-looking statements can be identified by terms such as 'may,' 'will,' 'should,' 'expect,' 'plan,' 'anticipate,' 'could,' 'intend,' 'target,' 'project,' 'contemplate,' 'believe,' 'estimate,' 'predict,' 'potential' or 'continue' or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements concerning the extension of Rallybio's runway, whether REV102 will advance to anticipated milestones, and whether the contingent consideration will be received. The forward-looking statements in this press release are only predictions and are based largely on management's current expectations and projections about future events and financial trends that management believes may affect Rallybio's business, financial condition and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, our ability to successfully conduct the RLYB116 PK/PD confirmatory study, and complete such study and obtain results on our expected timelines, or at all, whether our cash resources will be sufficient to fund our operating expenses and capital expenditure requirements and whether we will be successful raising additional capital, our ability to enter into strategic partnerships or other arrangements, competition from other biotechnology and pharmaceutical companies, and those risks and uncertainties described in Rallybio's filings with the U.S. Securities and Exchange Commission (SEC), including the Quarterly Report on Form 10-Q for the period ended March 31, 2025, and subsequent filings with the SEC. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we are not obligated to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise.
Yahoo
08-07-2025
- Business
- Yahoo
Rallybio Sells Interest in REV102 Program to Recursion Pharmaceuticals
– Company Eligible to Receive Up to $25 Million, Including an Upfront Equity Payment of $7.5 Million – – Extends Rallybio Cash Runway to Mid-2027 – NEW HAVEN, Conn., July 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 announced that it has 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 joint venture partner Recursion Pharmaceuticals for up to $25 million, including an upfront equity payment of $7.5 million and near term milestones. With the upfront payment, Rallybio expects its cash runway to extend into mid-2027. The REV102 program originated from a joint venture between Rallybio and Recursion focused on the discovery and development of novel, orally available small molecule inhibitors of ENPP1 for the treatment of patients with HPP. The lead candidate from the joint venture, REV102, entered into IND-enabling studies in early 2025. "The Rallybio team has long been committed to targeting ENPP1 to address a significant unmet need in patients with HPP. By combining Rallybio's expertise in HPP preclinical and translational research with Recursion's integrated AI/experimental platform, we transformed this concept into the first potential oral disease-modifying treatment for HPP," said Stephen Uden, M.D., Chief Executive Officer of Rallybio. "We look forward to the advancement of REV102 through key milestones and, ultimately, to the delivery of this important treatment to patients in need." Dr. Uden added, "For Rallybio, divesting this preclinical asset enables us to extend our cash runway while sharpening our focus on strategically advancing our pipeline in ways that leverage our drug development expertise. We eagerly anticipate the release of topline data from our ongoing RLYB116 confirmatory PK/PD study this year." Under the terms of the agreement, Rallybio is eligible to receive certain payments, including $7.5 million in upfront equity, a contingent equity payment of $12.5 million upon the initiation of additional preclinical studies, and a $5 million 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. In addition, Rallybio may be eligible to receive certain payments in the event of Recursion's sale of the REV102 program. "We extend our sincere thanks to Rallybio for their invaluable partnership in advancing this program to its current stage," said David Hallett, Chief Scientific Officer of Recursion. "Having full ownership of this important program allows Recursion to accelerate the development of the first potential oral disease-modifying treatment to HPP patients, who currently face significant challenges with limited access to existing therapies." About Rallybio Rallybio (NASDAQ: RLYB) is a clinical-stage biotechnology company with a mission to develop and commercialize life-transforming therapies for patients with severe and rare diseases. Rallybio has built a pipeline of promising product candidates aimed at addressing diseases with unmet medical need in areas of complement dysregulation and hematology. The Company's lead program, RLYB116, is a differentiated C5 inhibitor with the potential to treat diseases of complement dysregulation, with an initial focus on immune platelet transfusion refractoriness (PTR) and refractory antiphospholipid syndrome (APS). Rallybio's pipeline also includes RLYB332, a preclinical long-acting matriptase-2 antibody for the treatment of diseases of iron overload. Rallybio is headquartered in New Haven, Connecticut. For more information, please visit and follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements that are based on our management's beliefs and assumptions and currently available information. All statements, other than statements of historical facts contained in this press release are forward-looking statements. In some cases, forward-looking statements can be identified by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements concerning the extension of Rallybio's runway, whether REV102 will advance to anticipated milestones, and whether the contingent consideration will be received. The forward-looking statements in this press release are only predictions and are based largely on management's current expectations and projections about future events and financial trends that management believes may affect Rallybio's business, financial condition and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, our ability to successfully conduct the RLYB116 PK/PD confirmatory study, and complete such study and obtain results on our expected timelines, or at all, whether our cash resources will be sufficient to fund our operating expenses and capital expenditure requirements and whether we will be successful raising additional capital, our ability to enter into strategic partnerships or other arrangements, competition from other biotechnology and pharmaceutical companies, and those risks and uncertainties described in Rallybio's filings with the U.S. Securities and Exchange Commission (SEC), including the Quarterly Report on Form 10-Q for the period ended March 31, 2025, and subsequent filings with the SEC. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we are not obligated to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise. View source version on Contacts Investor ContactsSamantha TracyRallybio Corporation(475) 47-RALLY (Ext. 282)investors@ Kevin LuiPrecision AQ(212) Media Contactmedia@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
08-04-2025
- Business
- Yahoo
Rallybio to Discontinue Development of RLYB212 for Prevention of FNAIT
– RLYB212 Phase 2 PK Results Did Not Achieve Target Concentrations, Including Minimum Target Concentration Required for Efficacy – – RLYB116 Confirmatory PK/PD Study to Initiate in 2Q 2025, with Data in 2H 2025 – NEW HAVEN, Conn., April 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 announced the discontinuation of the RLYB212 program for the prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT). The Company's decision to discontinue RLYB212 development was based on pharmacokinetic (PK) data from the Phase 2 clinical trial demonstrating the inability of the RLYB212 dose regimen to achieve predicted target concentrations, as well as the minimum target concentration required for efficacy. Rallybio remains focused on advancing RLYB116, a once-weekly low volume C5 inhibitor for the treatment of complement-driven diseases, as well as its emerging preclinical programs. "We are disappointed by the PK results of the RLYB212 Phase 2 trial," said Stephen Uden, M.D., Chief Executive Officer of Rallybio. "Given that the results significantly deviated from the predicted range and the absence of empiric data to further inform dose adjustment, the risk/benefit no longer supports continued dosing, and we will discontinue RLYB212 development. We are grateful to the participants, investigators, and study staff for their partnership and dedication to this program." Dr. Uden continued, "Rallybio remains steadfast in our mission to develop transformative therapies. We are focused on creating shareholder value by advancing our portfolio of potentially best-in-class assets for patients with rare diseases, which includes RLYB116 and REV102, an ENPP1 inhibitor for patients with hypophosphatasia, as well as RLYB332, a long-acting matriptase-2 antibody for diseases of iron overload." RLYB212 Phase 2 Trial The single-arm Phase 2 dose confirmation trial was designed to assess the PK and safety of RLYB212 in pregnant women at higher risk for HPA-1a alloimmunization and FNAIT. Secondary objectives included the assessment of pregnancy and neonatal/infant outcomes, and the occurrence of emergent HPA-1a alloimmunization. Second trimester PK results from the sentinel participant demonstrated an inability of RLYB212 to achieve predicted target concentrations of 6 ng/mL to 10 ng/mL, as well as the minimum target concentration required for efficacy of 3 ng/mL, with values near or below the assay's lower limit of quantitation. Dose adjustment is not deemed feasible given that PK levels are meaningfully outside the predicted range and the absence of empiric data to inform an adjustment. It is hypothesized that HPA-1a antigen expression on the placenta may be impacting plasma concentrations of RLYB212. No further enrollment in the trial is planned and all screening of participants has been stopped. The Company will continue safety follow-up of the sentinel participant as specified in the clinical trial protocol. Promising Rare Disease Pipeline to Deliver Data in 2H 2025 RLYB116 Program Rallybio remains on track to initiate dosing in the RLYB116 confirmatory clinical pharmacokinetic/ pharmacodynamic (PK/PD) study in the second quarter of 2025, with data readouts from Cohorts 1 and 2 expected in the third and fourth quarter of 2025, respectively. The study is expected to demonstrate complete and sustained complement inhibition with improved tolerability of RLYB116. RLYB116 is a novel antibody mimetic fusion protein designed to inhibit C5 and to provide a once-weekly, small volume, subcutaneously injected therapy to meet patient demand for a convenient, self-administered at-home solution. RLYB116 has the potential to address significant unmet need for patients across a number of complement mediated diseases, including paroxysmal nocturnal hemoglobinuria (PNH), antiphospholipid syndrome (APS), and generalized myasthenia gravis (gMG), which together represent a commercial opportunity of more than $6 billion. Importantly, this strategic focus on complement-mediated diseases presents a unique opportunity for Rallybio to utilize its team's deep domain experience in successfully designing, developing, and delivering complement inhibitors for patients with rare diseases. Preclinical Programs REV102, an ENPP1 inhibitor for the treatment of patients with HPP under development through a joint venture with Recursion Pharmaceuticals, entered investigational new drug application (IND)-enabling studies in the first quarter of 2025 to support the initiation of a Phase 1 study in 2026. Data evaluating REV102 in a preclinical model of later-onset HPP is expected in the second half of 2025. Rallybio's portfolio also includes RLYB332, a long-acting, monoclonal anti-matriptase-2 antibody that has the potential to be a best-in-class treatment for diseases of iron overload. Preclinical data has demonstrated superior impact on PD parameters relative to comparator molecules, including on serum iron, unsaturated iron binding capacity (UIBC), and transferrin saturation (TSAT). The Company is preparing plans for future development of RLYB332. About RallybioRallybio (NASDAQ: RLYB) is a clinical-stage biotechnology company with a mission to develop and commercialize life-transforming therapies for patients with severe and rare diseases. Rallybio has built a pipeline of promising product candidates aimed at addressing diseases with unmet medical need in areas of complement dysregulation, hematology, and metabolic disorders. The Company's lead program, RLYB116, is a differentiated C5 inhibitor with the potential to treat diseases of complement dysregulation. Rallybio also has two programs in preclinical development, including REV102, an ENPP1 inhibitor for the treatment of patients with hypophosphatasia (HPP), and RLYB332, a long-acting matriptase-2 antibody for the treatment of diseases of iron overload. Rallybio is headquartered in New Haven, Connecticut. For more information, please visit and follow us on LinkedIn and Twitter. Forward-Looking StatementsThis press release contains forward-looking statements that are based on our management's beliefs and assumptions and currently available information. All statements, other than statements of historical facts contained in this press release are forward-looking statements. In some cases, forward-looking statements can be identified by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements concerning the timing of initiating the RLYB116 confirmatory PK/PD study and the date when data is available, including data for Cohorts 1 and 2, whether the PK/PD confirmatory study will demonstrate improved tolerability and sustained inhibition of terminal complement, whether RLYB116 will be effective in treating a broad range of complement-mediated diseases, the potential commercial opportunity for RLYB116, and the timing of initiation of a REV102 Phase 1 study. The forward-looking statements in this press release are only predictions and are based largely on management's current expectations and projections about future events and financial trends that management believes may affect Rallybio's business, financial condition and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, our ability to successfully initiate and conduct our planned clinical trials, including the RLYB116 PK/PD confirmatory study, and complete such clinical trials and obtain results on our expected timelines, or at all, whether our cash resources will be sufficient to fund our operating expenses and capital expenditure requirements and whether we will be successful raising additional capital, competition from other biotechnology and pharmaceutical companies, and those risks and uncertainties described in Rallybio's filings with the U.S. Securities and Exchange Commission (SEC), including Rallybio's Annual Report on Form 10-K for the period ended December 31, 2024, and subsequent filings with the SEC. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we are not obligated to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise. View source version on Contacts Investor ContactsSamantha TracyRallybio Corporation(475) 47-RALLY (Ext. 282)investors@ Kevin LuiPrecision AQ(212) Media Contactmedia@ Sign in to access your portfolio
BBC News
28-01-2025
- General
- BBC News
Ashes of 300,000 people remain unclaimed, undertakers say
The ashes of up to 300,000 people remain unclaimed at funeral parlours across the UK, according to an industry National Association of Funeral Directors (NAFD) came up with the estimate in response to a consultation by the Law Commission, which is seeking to make broad reforms to the law of burial and cremation in England and Uden, who runs of W. Uden and Sons, said his funeral parlours across south London hold the unclaimed ashes of about 200 people - some dating back to the Law Commission proposes that if a funeral director has not heard from the next of kin for four weeks they should have the right to return the ashes to the crematorium. It said that such legislation should be retrospective to apply to all the ashes the funeral directors have accumulated over the Bradburne, the director of external affairs for the NAFD, said: "There needs to be something put in place going forward so the backlog doesn't build up and the Law Commission's suggestion seems very sensible. "There also then needs to be an additional solution, which is how to address this additional legacy, the legacy ashes if you like."She said solutions could include "mass scatterings" or events to properly handle their dispersal. One of the oldest ashes held at Mr Uden's funeral parlour are those of 68-year-old Elsie Elanor Agnes Emler, who died on 15 April 1965 at Farnborough Hospital in Kent. Apart from the Certificate of Cremation, there are no records of her or any recorded contact with her asked why so many ashes remain uncollected Mr Uden said: "I think the main reason is families don't know what to do with them. "I think they don't have a definite plan, a definite route of what they wish to do with their loved one's cremated remains. "They almost put it in the back of their mind and want to forget about it. And as years pass they feel, well we might as well just leave them with the funeral directors."
