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On Tuesday, Rodman & Renshaw initiated coverage on shares of biopharmaceutical company Talphera (NASDAQ: TLPH) with a Buy rating and a price target of $4.00. The firm's analysts highlighted Talphera's focus on the acute care sector, particularly within medically supervised settings such as hospitals.
Talphera is currently conducting a single registrational study on its lead product, Niyad (nafamostat), which has received Breakthrough Therapy designation. The analysts expressed confidence in the potential success of the study, citing "substantial historical evidence" of nafamostat's use in Japan and South Korea. InvestingPro data shows the company maintains a healthy current ratio of 4.4, with more cash than debt on its balance sheet, though it's currently burning through cash reserves.
The company has not yet announced a specific date for releasing data from the ongoing NEPHRO CRRT (Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) study. Nevertheless, Talphera has recently submitted a prior approval supplement that seeks to reduce the number of patients in the study and implement two additional protocol changes to accelerate enrollment.
Rodman & Renshaw's analysts believe that updates on enrollment and data readouts are expected to contribute to Talphera's stock performance throughout 2025. They also predict that subsequent approval and market uptake of Niyad could drive longer-term outperformance of TLPH shares.
In other recent news, clinical-stage biotech company Talphera, Inc. has been granted a review by the U.S. Food and Drug Administration (FDA) for a Prior Approval Supplement (PAS) to amend its NEPHRO CRRT clinical study. The review aims to reduce the number of patients required for the study, which evaluates Niyad™, an anticoagulant for patients undergoing continuous renal replacement therapy. The company hopes that these changes will expedite patient enrollment and support the completion of the trial by year-end.
Talphera has also been facing challenges in meeting Nasdaq’s minimum bid price and equity requirements. The company has been given 180 days to address these deficiencies, which includes falling short of Nasdaq's $10 million stockholders' equity threshold. In response, Talphera has extended its securities purchase agreement deadline with Nantahala Management, LLC until mid-2025, with certain conditions to be met.
Additionally, Talphera has initiated the NEPHRO CRRT study across 14 U.S. clinical sites and secured shareholder approval for amendments to its executive compensation plans. These recent developments are part of the company's ongoing efforts to meet Nasdaq's standards and complete its clinical trials efficiently.
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