FDA to review Talphera's request to amend NEPHRO study

SAN MATEO, Calif. - Talphera, Inc. (NASDAQ:TLPH), a clinical-stage biotech company with a market capitalization of $9.8 million, has reached an agreement with the U.S. Food and Drug Administration (FDA) to review a Prior Approval Supplement (PAS) aimed at reducing the number of patients required for its NEPHRO CRRT clinical study. According to InvestingPro analysis, the company maintains a solid liquidity position with a current ratio of 4.42, though it faces challenges with rapid cash utilization. This request, which will be submitted within the next week, follows a series of discussions with the FDA that also resulted in the approval of two additional protocol changes intended to expedite patient enrollment.

The NEPHRO CRRT study is evaluating the efficacy of Niyad™, a lyophilized formulation of nafamostat, as an anticoagulant for patients undergoing continuous renal replacement therapy (CRRT). Talphera anticipates that these modifications to the study protocol will support the completion of the trial by the end of the year. While the company holds more cash than debt on its balance sheet, InvestingPro data reveals it's quickly burning through cash reserves, making efficient trial completion crucial for its financial outlook.

Dr. Shakil Aslam, Talphera's Chief Medical (TASE:PMCN) Officer, stated that the company's recent meeting with the FDA was positive and that the agency's willingness to consider a PAS underscores the importance of nafamostat for patients on CRRT. Nafamostat has been granted Breakthrough Device Designation by the FDA, which reflects its potential to provide more effective treatment for life-threatening or irreversibly debilitating diseases or conditions.

The NEPHRO Study is a double-blinded trial, with a goal to enroll 166 adult patients at up to 14 U.S. hospital intensive care units. The primary endpoint is to compare the mean post-filter activated clotting time using Niyad versus placebo over the first 24 hours. Secondary endpoints include filter lifespan, number of filter changes, number of transfusions, and dialysis efficacy.

The FDA's review of the PAS is expected to be completed within 30 days of submission. As per standard regulatory procedure, the FDA must approve the PAS before Talphera can formally implement the proposed changes to the study protocol. The stock, which has declined nearly 10% in the past week, currently appears undervalued according to InvestingPro Fair Value metrics. Subscribers can access 10+ additional ProTips and comprehensive financial analysis to better understand Talphera's investment potential. The information in this article is based on a press release statement from Talphera, Inc.

In other recent news, Talphera, Inc., a pharmaceutical company, has been grappling with Nasdaq delisting threats due to non-compliance with the minimum bid price requirement and an equity shortfall. The company's stockholders' equity was reported at $9,641,000, falling short of Nasdaq's $10 million threshold, and the common stock did not meet the minimum $1.00 per share bid price over a period of 30 consecutive business days. In response, Talphera has been given 180 days to address these deficiencies.

In other developments, Talphera has extended its securities purchase agreement deadline with Nantahala Management, LLC. The amendment provides the company until mid-2025 to meet certain conditions, including the potential waiving of obligations for the purchasers to buy additional shares of common stock or pre-funded warrants if successful equity financing is carried out.

Additionally, the company initiated the NEPHRO CRRT study, a critical trial for the anticoagulant Nafamostat, across 14 U.S. clinical sites. Talphera also secured shareholder approval for amendments to its executive compensation plans. These recent developments are part of the company's ongoing operations and efforts to meet Nasdaq's standards.

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