Trump says envoy Witkoff had productive meeting with Putin
CARMEL, Ind. - MBX Biosciences, Inc. (NASDAQ:MBX), a clinical-stage biopharmaceutical company with a market capitalization of $347 million, has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for MBX 4291, a long-acting GLP-1/GIP receptor co-agonist prodrug designed for the treatment of obesity. According to InvestingPro data, the company maintains a strong liquidity position with its current ratio of 23.3x, indicating robust short-term financial stability.
The company plans to initiate a Phase 1 clinical trial evaluating MBX 4291 in healthy overweight volunteers in the third quarter of 2025, pending FDA clearance of the application.
MBX 4291 is being developed as a once-monthly injectable treatment for obesity using the company’s proprietary PEP platform technology. According to the company’s press release, the drug candidate demonstrated similar activity profile and body weight loss as tirzepatide in preclinical studies.
"MBX 4291 is designed to be a potential best-in-class, once-monthly injectable for the treatment of obesity," said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. While the company’s stock has experienced a 46% decline over the past six months, analysts remain optimistic, with consensus price targets ranging from $30 to $44 per share. InvestingPro analysis indicates the stock is currently undervalued, with additional insights available through the comprehensive Pro Research Report.
The company claims preclinical studies showed extended duration of action compared to tirzepatide, which supports the potential for monthly administration rather than weekly dosing.
MBX Biosciences is also advancing multiple early-stage obesity drug candidates using its proprietary platform.
The clinical-stage biopharmaceutical company focuses on developing precision peptide therapies for endocrine and metabolic disorders. Its pipeline includes canvuparatide (MBX 2109) in Phase 2 development for chronic hypoparathyroidism and imapextide (MBX 1416) in Phase 1 development for post-bariatric hypoglycemia. While the company holds more cash than debt on its balance sheet, InvestingPro data shows it is currently burning through cash with a negative free cash flow of $67 million in the last twelve months. For deeper insights into MBX’s financial health and growth prospects, investors can access the detailed Pro Research Report, available exclusively to InvestingPro subscribers.
In other recent news, MBX Biosciences is approaching a significant milestone with the upcoming release of data from its Phase 2b AVAIL clinical trial for canvuparatide, a parathyroid hormone replacement for hypoparathyroidism. Stifel has reiterated its Buy rating and $40 price target, highlighting the potential of canvuparatide to become a more convenient alternative to daily treatments. Meanwhile, JMP Securities maintains a Market Outperform rating and a $38 price target, anticipating a competitive positioning for canvuparatide based on its unique weekly dosing regimen. MBX has also announced changes to its board of directors, with Carl L. Gordon departing and new directors Tiba Aynechi and P. Kent Hawryluk elected for three-year terms. The company secured stockholder approval for Ernst & Young LLP as its independent accounting firm. Additionally, MBX is advancing other clinical programs, including trials for MBX-1416 and MBX-4291, aimed at treating post-bariatric hypoglycemia and obesity, respectively. Citizens JMP has initiated coverage with a Market Outperform rating and a $38 price target, citing MBX’s innovative Precision Endocrine Peptide platform. The company’s financial position appears strong, with $240.8 million in cash and equivalents, supporting its operations into mid-2027.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.