IN8bio Updated Positive Results from Phase 1 Trial of INB-100 in Leukemia

 

• 100% of acute myeloid leukemia (AML) patients across both original and expansion cohorts remain in complete remission (CR), with a median follow-up of 20.1 months

• AML patients treated demonstrated one-year progression-free survival (PFS) and overall survival (OS), exceeding real-world control groups

• Patients treated with INB-100 demonstrating prolonged and durable remissions supported by gamma-delta T cell persistence beyond one year
  

• Company to host conference call at 8:30am EST today. Use this link to participate or access the listen-only version of the webcast here

IN8bio will host a conference call and webcast today, Tuesday, February 11, 2025, at 8:30 am ET. The webcast can be accessed by clicking this link and can also be accessed on the Events & Presentations page of the Company’s website. To participate in the live call, please register using this link. It is recommended that participants register at least 5 minutes in advance of the call. Once registered, participants will be informed of the dial-in number and will be provided a unique PIN.

For more information about the study – including detailed findings, conclusions and next steps – please visit the Company’s poster being presented at the American Society of Transplantation and Cellular Therapy conference: https://investors.in8bio.com/news-events/events-presentations.

https://www.globenewswire.com/news-release/2025/02/11/3024098/0/en/IN8bio-Reports-Updated-Positive-Results-from-Phase-1-Trial-of-INB-100-in-Leukemia-Patients.html

Travere to Submit sNDA for FILSPARI® (sparsentan) in FSGS Kidney Disorder

 Company completed Type C meeting with FDA, aligning on its plan to submit an sNDA; submission expected around end of 1Q25

If approved, FILSPARI could be the first and only approved medicine indicated for FSGS, a rare kidney disorder and leading cause of kidney failure

sNDA submission to be based on results from Phase 3 DUPLEX and Phase 2 DUET studies of FILSPARI in FSGS

Company to host conference call and webcast today at 8:30 a.m. ET

Travere Therapeutics will host a conference call and webcast to discuss these updates today, Tuesday, February 11, 2025, at 8:30 a.m. ET. To participate in the conference call, dial +1 (800) 549-8228 (U.S.) or +1 (646) 564-2877 (International), conference ID 05607.

The webcast can be accessed on the Investor page of Travere’s website at ir.travere.com/events-presentations. Following a live webcast, archived version of the call will be available for 30 days on the Company’s website.

https://www.globenewswire.com/news-release/2025/02/11/3024045/0/en/Travere-Therapeutics-to-Submit-sNDA-for-FILSPARI-sparsentan-in-FSGS.html

Firefly Neuroscience Accepted into NVIDIA Connect Program

 Collaboration to provide Firefly with the technical resources to help further unleash the power of its FDA-cleared BNA™ platform

         For the first time, Firefly also unveils a new strategic initiative to build the world’s first foundation model of the human brain using its BNA™ technology

https://www.globenewswire.com/news-release/2025/02/11/3024072/0/en/Firefly-Neuroscience-Accepted-into-NVIDIA-Connect-Program.html

'Ocean Biomed Breakthrough Findings in EGFR-Mutant Lung Cancer, Plans FDA Alignment'

 Poised to Enter Booming Bispecific Antibody Market Amid Growing Pharma Interest

Ocean Biomedical (NASDAQ: OCEA) today announced newly published research findings demonstrating the ability of its proprietary cancer immunotherapy candidates to favorably interact with tyrosine kinase inhibitors (TKI), such as osimertinib that are used to treat non-small cell lung cancer (NSCLC). Specifically, they demonstrate that Ocean’s immunotherapy candidates provide synergy with the TKI therapies (gefitinib and osimertinib) to suppress tumor growth and progression. In addition, the paper’s findings demonstrate that its proprietary cancer immunotherapy candidates have a remarkable ability to restore treatment sensitivity following development of osimertinib resistance. This breakthrough offers a potential paradigm shift in the treatment of Epidermal Growth Factor Receptor (EGFR)-mutant NSCLC and could expand treatment options for patients whose tumors are no longer responding to tyrosine kinase inhibitors.

Ocean Biomedical is initiating preclinical studies to advance its immunotherapy program and will engage with the FDA this year to align on a regulatory pathway for first-in-human trials.

https://www.globenewswire.com/news-release/2025/02/10/3023373/0/en/Ocean-Biomedical-Announces-Breakthrough-Findings-in-EGFR-Mutant-Lung-Cancer-and-Plans-for-FDA-Alignment-on-Next-Stage-Development.html

Regeneron Linvoseltamab BLA Accepted for Relapsed/Refractory Multiple Myeloma

 Acceptance follows resolution of third-party fill/finish manufacturing issues

FDA decision expected by July 10, 2025

https://www.globenewswire.com/news-release/2025/02/11/3024043/0/en/Linvoseltamab-BLA-Accepted-for-FDA-Review-for-the-Treatment-of-Relapsed-Refractory-Multiple-Myeloma.html

Humana's Q4 Earnings: 13% Revenue Growth, 2025 Profit Outlook Falls Below Street View

 On Tuesday, Humana Inc. (NYSE:HUM) posted a fourth-quarter adjusted EPS loss of $(2.16), down from $(0.11) a year ago, in line with the consensus and including incremental investments in Stars.

The company reported revenues of $29.19 billion, up 13.5% year-over-year from $25.73 billion, beating the consensus of $28.84 billion, primarily driven by higher per-member Medicare premiums and Medicare Advantage and state-based contracts membership growth, offset by a decline in stand-alone PDP membership, and a decline in membership in the group commercial medical business as a result of the company’s decision to exit the business.

Humana ended the fourth quarter with 16.35 million in total medical membership, compared to 16.86 million a year ago. Individual Medicare Advantage membership reached 5.66 million, up from 5.67 million a year ago.

Humana says the insurance segment adjusted benefit ratio of 91.9%, which includes a 20-basis point increase related to incremental Star Ratings investments, was consistent with expectations.

Guidance: Humana expects 2025 GAAP sales of $126 billion-$128 billion versus the consensus of $119.41 billion.

Sales guidance includes Insurance segment sales of $121 billion—$123 billion and CenterWell segment sales of $20.5 billion—$21.5 billion.

The insurer expects individual Medicare Advantage annual membership decline of approximately 550,000, or approximately 10%, from 2024, inclusive of the company’s decision to exit certain unprofitable plans and counties, with group Medicare Advantage to remain relatively flat and Medicare stand-alone PDP growth of approximately 200,000.

Humana reaffirms the 2025 adjusted EPS outlook of $16.25 versus the consensus of $16.71.

For 2025, Humana expects its insurance segment’s benefit ratio guidance of approximately 90.1-90.5%.

In prepared remarks, Humana said, “Our 2025 MA pricing strategy was focused on resetting pricing and membership to more accurately reflect the funding and medical cost trend environment, improving underlying margins.”

https://finance.yahoo.com/news/insurance-giant-humanas-q4-earnings-132020270.html

Biohaven Acceptance, Priority Review for Treatment of Spinocerebellar Ataxia

 

• Spinocerebellar Ataxia (SCA) is a rare, genetic, life-threatening neurodegenerative disease with no available treatment.
• Troriluzole demonstrated a 50-70% slowing of SCA disease progression on the primary and secondary outcome measures at the 3-year endpoint in a real-world evidence (RWE) study.
• Troriluzole has a well-established safety profile and if approved, would be the first and only FDA-approved treatment for SCA; subject to receipt of FDA approval, Biohaven is prepared to commercialize troriluzole for SCA in the US in 2025.

https://www.prnewswire.com/news-releases/biohaven-announces-fda-acceptance-and-priority-review-of-troriluzole-new-drug-application-for-the-treatment-of-spinocerebellar-ataxia-302373056.html