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- Thinly traded nano cap XTL Biopharmaceuticals (XTLB) is up 10% out of the blocks this morning in response to its announcement that has received encouraging written guidance from the FDA ahead of its IND filing for lead product candidate, hCDR1, for the treatment of lupus erythematosus (SLE).
- The agency suggests that the primary efficacy endpoint be based on a measure of lupus disease activity called the BILAG index, which was the secondary endpoint in a prior Phase 2 study of hCDR1. It also recommends the study be run as a Phase 2 and includes guidance regarding the appropriate patient population and the number of subjects needed to prove safety.
- According to the company, the trial design, based on the FDA's feedback, increases its likelihood of success since it will be substantially the same as the prior Phase 2 study which showed efficacy in the 0.5 mg dose as measured by the BILAG index.
- SLE, a chronic autoimmune disorder, affects more than 5M people worldwide. There has been only one drug approved by the FDA in the past 50 years to treat the disease [Glaxo's (GSK +0.4%) Benlysta (belimumab)]. Two drugs in late-stage development failed to achieve their primary efficacy endpoints, demonstrating the challenging nature of SLE.
Dec. 1, 2015, 9:10 AM
- XTL Biopharmaceuticals (XTLB) Q3 results: Revenues: $0; R&D Expense: $0.1M (+150.0%); SG&A: $0.3M (-19.9%); Operating Loss: ($0.4M) (-7.9%); Net Loss: ($0.4M) (-0.9%); Loss Per Sharee: $0.00; Quick Assets: $4.3M (+48.3%).
- No guidance given.
Dec. 1, 2015, 9:00 AM
- XTL Biopharmaceuticals (NASDAQ:XTLB): Q3 EPS of $0.00.
Oct. 13, 2015, 1:06 PM
- XTL Biopharmaceuticals (XTLB) and Yeda Research and Development Company amend their January 2014 agreement to extend an additional five months to XTL to achieve key development milestones for hCDR1 for the treatment of systemic lupus erythematosus (SLE), an autoimmune disorder. The milestones include the delivery to Yeda of a full protocol for a clinical trial and raising $5M ($4M has already been raised). The goal for the start of the clinical trial is January 2017.
- Only one product, Glaxo's (GSK) Benlysta (belimumab), has been approved for the treatment of SLE in the past 50 years.
- XTL's candidate, hCDR1, is a targeted peptide that modulates the immune system by prompting the generation of regulatory T cells which initiates a beneficial cascade of events involving T and B cells as well as other immune system-related molecules. This rebalances the immune system and lessens SLE-related symptoms.
Sep. 1, 2015, 9:25 AM
- XTL Biopharmaceuticals (XTLB) Q2 results: Revenues: $0; R&D Expense: $0.07M (+133.3%); SG&A: $0.4M (+10.8%); Operating Loss: ($0.5M) (-25.0%); Net Loss: ($0.4M) (-13.2%); Loss Per Share: $0.00; Quick Assets: $4.8M (+77.8%).
- No guidance given.
Sep. 1, 2015, 9:14 AM
- XTL Biopharmaceuticals (NASDAQ:XTLB): Q2 EPS of $0.00 in-line.
May 15, 2015, 12:05 PM
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May 8, 2015, 9:16 AM| May 8, 2015, 9:16 AM | 4 Comments
Feb. 25, 2015, 12:48 PM
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Dec. 1, 2014, 8:21 AM
XTL Biopharmaceuticals Ltd engages in the acquisition and development of proprietary products and late-stage pharmaceutical products for the treatment of unmet clinical needs. It has three product candidates in clinical development: the hCDR1 peptide for the treatment of Systemic Lupus... More
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