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BOCA RATON, FLORIDA - INmune Bio , Inc. (NASDAQ: NASDAQ:INMB), a clinical-stage biotechnology company with a market capitalization of $212.74 million, announced today its plans to submit regulatory filings for CORDStrom, a therapy for the treatment of recessive dystrophic epidermolysis bullosa (RDEB) in pediatric patients. According to InvestingPro data, the company maintains a strong financial position with more cash than debt on its balance sheet, providing runway for its development programs. The decision follows a positive outcome of a Type C meeting with the U.S. Food and Drug Administration (FDA) and is supported by data from the MissionEB clinical trial.
RDEB is a rare genetic disease that manifests in early childhood, causing the skin to be extremely fragile and prone to painful blistering. Current treatments are limited to topical applications targeting active lesions, presenting a significant unmet need for systemic therapy.
The MissionEB study, conducted in the UK, was a double-blind, placebo-controlled, cross-over trial involving 30 pediatric patients. Results demonstrated that CORDStrom was well tolerated, with no serious adverse events reported. Notably, the treatment led to a sustained reduction in itch severity by over 27% at 6 months in children with severe RDEB. It also showed broader improvements in skin integrity and reduced pain in patients with intermediate disease severity.
Based on these findings, INmune Bio is preparing to submit a Biologics License Application (BLA) in the US and Marketing Authorization Applications (MAAs) in the UK and EU. The company received exclusive commercial rights to the clinical data from the Great Ormond Street Hospital (GOSH) NHS Foundation Trust, which will support a 12-month open-label study at GOSH for all MissionEB study patients.
The FDA has granted CORDStrom Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD), providing various incentives, including potential eligibility for a priority review voucher and seven years of market exclusivity post-approval. While the stock has shown remarkable momentum with a 105% year-to-date return, InvestingPro analysis indicates the company faces near-term challenges with analysts anticipating a sales decline in the current year. Get access to 12 more exclusive ProTips and comprehensive analysis through InvestingPro’s detailed research reports.
INmune Bio’s Chief Scientific Officer, Dr. Mark Lowdell, expressed optimism about the results and regulatory support, emphasizing the potential of CORDStrom as a systemic therapy for RDEB and other inflammatory diseases.
The company also announced upcoming reporting on top-line data from its MINDFuL study for Alzheimer’s treatment and additional data from its CaRe PC study for prostate cancer throughout 2025.
This news is based on a press release statement and reflects the company’s current position and plans for CORDStrom’s regulatory submissions and clinical development.
In other recent news, INmune Bio Inc. continues to make significant strides in its clinical and corporate developments. The biotech firm recently advanced its Phase II segment of the clinical trial for metastatic castration-resistant prostate cancer (mCRPC) at the West Los Angeles Veterans Administration (VA) Hospital, marking a key milestone in the study of its novel NK cell targeted therapy, INKmune.
Simultaneously, research firms BTIG and Rodman & Renshaw have maintained a positive outlook on INmune Bio’s prospects. BTIG reiterated its Buy rating and $21.00 price target, emphasizing the potential of INKmune therapy for mCRPC. Meanwhile, Rodman & Renshaw initiated coverage with a Buy rating and set a price target of $23.00, primarily based on the potential future cash flows from INmune Bio’s fosgonimeton program.
In the realm of corporate governance, INmune Bio extended its Rights Agreement to December 30, 2025, as revealed in a recent SEC filing. This extension aims to protect shareholder interests and govern the company’s rights issuance. Concurrently, the company’s Compensation Committee approved new stock option grants for several officers and non-employee directors, aligning their interests with those of shareholders.
These recent developments underscore INmune Bio’s ongoing efforts in clinical advancements and corporate governance, as it continues to explore novel therapeutic avenues in the field of immunology.
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