NASDAQ:RLYB

Rallybio Reports First Quarter 2024 Financial Results and Provides Business Updates

Retrieved on: 
Thursday, May 9, 2024
Professional Services, Health, Finance, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Birth, Administration, DSM-IV codes, Corporation, Pregnancy, Risk, Safety, Pharmacokinetics, Publication, Iron overload, Johnson & Johnson, Gestational age, Data, Research and development, Patient, Marker beacon, Caregiver, Workforce, G&A, Pharmaceutical industry

Rallybio is on track to initiate a Phase 2 trial in pregnant women at higher risk for HPA-1a alloimmunization and FNAIT in the second half of 2024.

Key Points: 
  • Rallybio is on track to initiate a Phase 2 trial in pregnant women at higher risk for HPA-1a alloimmunization and FNAIT in the second half of 2024.
  • Rallybio expects to provide an update on this analysis and future development plans for RLYB116 in the second half of 2024.
  • Net Loss and Net Loss Per Common Share: Rallybio reported a net loss of $19.0 million, or $0.47 per common share, for the first quarter of 2024.
  • This compares to a net loss of $17.3 million, or $0.43 per common share, for the first quarter of 2023.

Rallybio to Present at the 2024 Citizens JMP Life Sciences Conference

Retrieved on: 
Tuesday, May 7, 2024
Professional Services, Health, Finance, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Citizenship, Patient, Corporation, Conference, Webcast

Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company committed to identifying and accelerating the development of life-transforming therapies for patients with severe and rare diseases, today announced that Steve Uden, M.D., Chief Executive Officer of Rallybio, will participate in a fireside chat at the Citizens JMP Life Sciences Conference on Tuesday, May 14, 2024 at 11:30 a.m.

Key Points: 
  • Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company committed to identifying and accelerating the development of life-transforming therapies for patients with severe and rare diseases, today announced that Steve Uden, M.D., Chief Executive Officer of Rallybio, will participate in a fireside chat at the Citizens JMP Life Sciences Conference on Tuesday, May 14, 2024 at 11:30 a.m.
  • ET in New York, NY.
  • A live webcast of the fireside chat will be accessible through the Events and Presentations section of Rallybio’s website at www.rallybio.com .
  • An archived replay of the webcast will be available for 30 days following the presentation.

FNAIT Systematic Literature Review and Meta-Analysis Presented at the Academy of Managed Care Pharmacy 2024 Annual Meeting

Retrieved on: 
Wednesday, April 17, 2024
Professional Services, Health, Finance, Clinical Trials, General Health, Biotechnology, Corporation, Meta-analysis, Pregnancy, Risk, Woman, Poster, Annual Reviews (publisher), Research, Development, Knowledge, Data, Patient, AMCP, Annual general meeting, Dietary supplement

These rates are consistent with Rallybio’s current estimate of annual at-risk pregnancies and translate to tens of thousands of fetuses and newborns at risk each year for the potentially devastating consequences of FNAIT.

Key Points: 
  • These rates are consistent with Rallybio’s current estimate of annual at-risk pregnancies and translate to tens of thousands of fetuses and newborns at risk each year for the potentially devastating consequences of FNAIT.
  • Rallybio is on track to initiate a Phase 2 dose confirmation study for RLYB212 in pregnant women in the second half of 2024.
  • The poster, titled “Fetal and Neonatal Alloimmune Thrombocytopenia: A Systematic Literature Review and Meta-analysis of Adverse Pregnancy-Related Outcomes to Support the Development of a Novel Prophylactic Therapeutic,” was presented by Andrea V. Margulis of RTI Health Solutions.
  • The meta-analysis is based on 12 observational cohort studies from Europe, Canada, and Egypt published from 1985 through 2018.

Rallybio Announces Collaboration to Advance Therapeutic Solutions for Pregnant Individuals at Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Retrieved on: 
Wednesday, April 10, 2024
Research, Finance, Clinical Trials, Health Technology, Professional Services, Biotechnology, General Health, Health, Science, Other Science, Corporation, Risk, Johnson & Johnson, Neonatal Fc receptor, Data, Patient, Pharmaceutical industry

Rallybio is on track to initiate a Phase 2 dose confirmation study for RLYB212 in pregnant individuals at higher risk of alloimmunization and FNAIT in the second half of 2024.

Key Points: 
  • Rallybio is on track to initiate a Phase 2 dose confirmation study for RLYB212 in pregnant individuals at higher risk of alloimmunization and FNAIT in the second half of 2024.
  • Johnson & Johnson is conducting a Phase 3 study of nipocalimab, an investigational monoclonal antibody targeting FcRn, in pregnant individuals who are already alloimmunized.
  • “Our complementary approaches, if successful, would ensure that pregnant individuals at risk of developing FNAIT have a potential treatment option – regardless of their alloimmunization status.
  • Pregnant individuals who are already alloimmunized are not eligible for inclusion in Rallybio’s natural history study, nor for potential preventative treatment with Rallybio’s investigational therapeutic, RLYB212.

Rallybio Announces FNAIT Systematic Literature Review to be Presented at the AMCP 2024 Annual Meeting

Retrieved on: 
Monday, April 1, 2024
Professional Services, Health, Finance, Clinical Trials, General Health, Biotechnology, AMCP, Development, Risk, Patient, Corporation, CDT, Annual Reviews (publisher), Meta-analysis, Annual general meeting

Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company committed to identifying and accelerating the development of life-transforming therapies for patients with severe and rare diseases, today announced that data from a systematic literature review assessing the frequency of fetal and neonatal alloimmune thrombocytopenia (FNAIT) risk among pregnant mothers will be presented at the Academy of Managed Care Pharmacy (AMCP) 2024 Annual Meeting in New Orleans from April 15th to 18th.

Key Points: 
  • Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company committed to identifying and accelerating the development of life-transforming therapies for patients with severe and rare diseases, today announced that data from a systematic literature review assessing the frequency of fetal and neonatal alloimmune thrombocytopenia (FNAIT) risk among pregnant mothers will be presented at the Academy of Managed Care Pharmacy (AMCP) 2024 Annual Meeting in New Orleans from April 15th to 18th.
  • Rallybio is developing RLYB212, a novel human monoclonal anti-HPA-1a antibody designed to prevent alloimmunization in at-risk pregnant mothers, thereby eliminating the risk of FNAIT and its potentially devastating consequences in fetuses and newborns.
  • Details of the poster presentation are as follows:
    Title: Fetal and Neonatal Alloimmune Thrombocytopenia: A Systematic Literature Review and Meta-analysis of Adverse Pregnancy-Related Outcomes to Support the Development of a Novel Prophylactic Therapeutic
    Poster Session Date and Time: April 17, 2024, 1:00 - 2:30 p.m. CDT (2:00 - 3:30 p.m. EDT)
    Additional information about the AMCP 2024 Annual Meeting is available at: https://amcpannual.org/

Rallybio Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, March 12, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Pregnancy, Administration, Risk, C5, Patient, Corporation, Acquisition, EMA, European Medicines Agency, Woman, Injection site reaction, Research and development, Clinical trial, Workforce, Pharmacokinetics, Safety, Antiphospholipid syndrome, Data, Pharmaceutical industry

The workforce reduction included 19 roles and will be substantially complete by the end of the first quarter of 2024.

Key Points: 
  • The workforce reduction included 19 roles and will be substantially complete by the end of the first quarter of 2024.
  • In November 2023, Rallybio announced preliminary data from the completed multiple dose cohort of the Phase 1 safety and pharmacokinetics (PK) study for RLYB212.
  • Research & Development (R&D) Expenses: R&D expenses were $15.9 million for the fourth quarter of 2023, compared to $10.8 million for the same period in 2022.
  • General & Administrative (G&A) Expenses: G&A expenses were $5.2 million for the fourth quarter of 2023, compared to $6.3 million for the same period in 2022.

Rallybio to Present at the TD Cowen 44th Annual Health Care Conference

Retrieved on: 
Monday, February 26, 2024
Biotechnology, Pharmaceutical, Health, EST, Corporation, Webcast, Patient, Conference

Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company committed to identifying and accelerating the development of life-transforming therapies for patients with severe and rare diseases, today announced that Steve Uden, M.D., Chief Executive Officer of Rallybio, will participate in a panel discussion, “Orphan Bone & Neuromuscular Diseases,” at the TD Cowen 44th Annual Health Care Conference on Monday, March 4, 2024 at 9:10 a.m. EST in Boston, MA.

Key Points: 
  • Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company committed to identifying and accelerating the development of life-transforming therapies for patients with severe and rare diseases, today announced that Steve Uden, M.D., Chief Executive Officer of Rallybio, will participate in a panel discussion, “Orphan Bone & Neuromuscular Diseases,” at the TD Cowen 44th Annual Health Care Conference on Monday, March 4, 2024 at 9:10 a.m. EST in Boston, MA.
  • A live webcast of the panel discussion will be accessible through the Events and Presentations section of Rallybio’s website at www.rallybio.com .
  • A replay of the webcast will be available for 30 days following each presentation.

Rallybio Announces Portfolio Prioritization and Provides Corporate Update

Retrieved on: 
Tuesday, February 6, 2024
Cardiology, Biotechnology, Technology, Health, Pharmaceutical, Neurology, Health Technology, Research, Artificial Intelligence, Science, Clinical Trials, Mother, Antiphospholipid syndrome, Caregiver, Patient, EMA, Workforce, Data, Risk, Pregnancy, European Medicines Agency, Corporation, Pharmaceutical industry

Rallybio Corporation (Nasdaq: RLYB) today announced the prioritization of its portfolio and a 45% workforce reduction to focus resources on its Phase 2-ready clinical stage programs, RLYB212 and RLYB116.

Key Points: 
  • Rallybio Corporation (Nasdaq: RLYB) today announced the prioritization of its portfolio and a 45% workforce reduction to focus resources on its Phase 2-ready clinical stage programs, RLYB212 and RLYB116.
  • “Following a thorough review of our business, we have made the decision to prioritize our portfolio.
  • Rallybio expects to provide an update on screening numbers in its full-year earnings release in March 2024.
  • Rallybio continues to expect to complete this manufacturing work and provide an update on the development plan for RLYB116 in the second half of 2024.

Rallybio Highlights Portfolio Advances and Outlines Expected Milestones in 2024

Retrieved on: 
Thursday, January 4, 2024
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Rallybio expects to initiate its Phase 2 dose confirmation study for RLYB212 in the second half of 2024.

Key Points: 
  • Rallybio expects to initiate its Phase 2 dose confirmation study for RLYB212 in the second half of 2024.
  • Rallybio expects to complete this manufacturing work and provide an update on the development plan for RLYB116 in the second half of 2024.
  • Rallybio and EyePoint expect to provide an update on this collaboration in the first half of 2024.
  • Rallybio and Exscientia plan to provide an update on the progress of the program in the second half of 2024.

Rallybio Announces Preliminary Phase 1 Multiple Ascending Dose Data for RLYB116, an Innovative Subcutaneously Injected Inhibitor of Complement Component 5

Retrieved on: 
Wednesday, December 20, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, GMG, ISR, Aes, Half-life, Incidence, Injection site reaction, Pharmacokinetics, PD, History, Hepatitis, Antiphospholipid syndrome, Corporation, C5, Investment, Webcast, Patient, Safety, Pharmaceutical industry

Rallybio Corporation (Nasdaq: RLYB) today announced preliminary Phase 1 multiple ascending dose (MAD) data for RLYB116, an innovative, long-acting, low volume subcutaneously injected inhibitor of complement component 5 (C5), in development for patients with complement-mediated diseases.

Key Points: 
  • Rallybio Corporation (Nasdaq: RLYB) today announced preliminary Phase 1 multiple ascending dose (MAD) data for RLYB116, an innovative, long-acting, low volume subcutaneously injected inhibitor of complement component 5 (C5), in development for patients with complement-mediated diseases.
  • The Phase 1 MAD study for RLYB116 evaluated the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous RLYB116 in healthy participants with multiple dose administration.
  • The reduction in free C5 at 24 hours after the first dose of 100 mg was greater than 99%.
  • “The preliminary results from this Phase 1 multiple ascending dose study of RLYB116 support continued development in patients with gMG,” said Eric Watsky, M.D., RLYB116 Program Lead for Rallybio.