Talphera Reaches 17 Patient Enrollment Milestone in NEPHRO CRRT Pivotal Trial
Trial Enrollment Update: The NEPHRO CRRT pivotal trial has reached approximately 25% enrollment with 17 patients enrolled, aided by new clinical sites.
Study Timeline: Talphera, Inc. expects to complete the study by the end of 2025, maintaining confidence due to the increased recruitment rate and additional sites starting soon.
Study Design: The NEPHRO CRRT Study is a double-blinded trial involving 70 adult patients undergoing renal replacement therapy, focusing on evaluating the efficacy of Niyad versus placebo.
Product Information: Niyad, a formulation of nafamostat, is being studied as an anticoagulant and has received Breakthrough Device Designation from the FDA, indicating its potential significance in medical treatment.
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Talphera Announces Third Quarter 2025 Financial Results and Provides Corporate Update
Financing Update: Talphera, Inc. closed a $17 million first tranche financing led by CorMedix, Inc., with expectations of sufficient capital through a potential PMA approval of their product Niyad in late 2026.
Clinical Study Progress: Five out of nine target clinical sites for the NEPHRO study are activated, with completion expected in the first half of 2026, and positive enrollment momentum reported.
Financial Performance: For Q3 2025, Talphera reported a net loss of $4.4 million, slightly higher than the previous year, with cash and investments totaling $21.3 million as of September 30, 2025.
Future Guidance: The company anticipates cash operating expenses for 2025 to be between $14 million and $15 million, a reduction from previous estimates, as they continue to advance the NEPHRO CRRT registration trial.
Talphera to Host Third Quarter Financial Results and Corporate Update Call and Webcast on Wednesday, November 12, 2025
Financial Results Announcement: Talphera, Inc. will release its third quarter 2025 financial results on November 12, 2025, followed by a live webcast and conference call at 4:30 p.m. ET to discuss the results and business updates.
Webcast and Conference Call Details: The webcast can be accessed through Talphera's website, and a replay will be available for 90 days. Investors can join the conference call using specific dial-in numbers and a conference ID.
Company Overview: Talphera, Inc. is a specialty pharmaceutical company focused on developing innovative therapies for medically supervised settings, with its lead product candidate, Niyad™, currently under investigation as an anticoagulant.
Regulatory Status: Niyad™ has received Breakthrough Device Designation from the FDA, highlighting its potential significance in medical applications.
Post-Market Jump: Turn Therapeutics Soars 134% Following Nasdaq Debut; Biotech Stocks Rise
Surge in Biotech Stocks: U.S.-listed biotech and healthcare stocks experienced significant after-hours gains, with Turn Therapeutics Inc. leading the way, surging 134.29% after its Nasdaq debut.
Momentum and Anticipation: Other companies like Talphera Inc. and Ionis Pharmaceuticals Inc. also saw notable increases, driven by momentum and upcoming presentations, indicating a strong interest in the biotech sector.
Nebius Group Shares Surge Nearly 50%; Check Out 20 Stocks Making Moves in Premarket Trading
Nebius Group's Contract with Microsoft: Nebius Group N.V. shares surged 49.6% in pre-market trading after announcing a $19.4 billion, five-year GPU infrastructure contract with Microsoft for its new data center in Vineland, New Jersey.
Pre-Market Stock Movements: Several stocks experienced significant pre-market trading changes, with Big Tree Cloud Holdings rising 625.1% and Santech Holdings increasing 533.3%, while NFT Limited and Taitron Components saw declines of 32.2% and 28.8%, respectively.
Talphera Unveils $29 Million Private Placement Driven by CorMedix and Institutional Investors
Private Placement Agreement: Talphera, Inc. has entered into securities purchase agreements for a private placement of common stock and pre-funded warrants, potentially raising up to $29 million, with $17 million from the first closing and $12 million contingent on study results.
Funding and Strategic Support: The funding will support Talphera through the potential approval of Niyad PMA, with CEO Vince Angotti highlighting confidence from CorMedix and institutional investors, as well as accelerated enrollment in the NEPHRO CRRT study.
Talphera Raises Up to $29 Million Through Private Placement Led by CorMedix
Private Placement Details: Talphera, Inc. has entered into agreements for a private placement that could raise up to $29 million, with $17 million expected from the first closing on September 10, 2025, and an additional $12 million contingent on study results and stock price conditions.
Strategic Investment and Future Plans: CEO Vince Angotti highlighted the funding as a means to support Talphera's programs, including Niyad, which aims to be the first FDA-approved regional anticoagulant for CRRT, while also noting CorMedix's investment as a validation of Niyad's potential.
Talphera Announces Third Quarter 2025 Financial Results and Provides Corporate Update
Financing Update: Talphera, Inc. closed a $17 million first tranche financing led by CorMedix, Inc., with expectations of sufficient capital through a potential PMA approval of their product Niyad in late 2026.
Clinical Study Progress: Five out of nine target clinical sites for the NEPHRO study are activated, with completion expected in the first half of 2026, and positive enrollment momentum reported.
Financial Performance: For Q3 2025, Talphera reported a net loss of $4.4 million, slightly higher than the previous year, with cash and investments totaling $21.3 million as of September 30, 2025.
Future Guidance: The company anticipates cash operating expenses for 2025 to be between $14 million and $15 million, a reduction from previous estimates, as they continue to advance the NEPHRO CRRT registration trial.
Talphera to Host Third Quarter Financial Results and Corporate Update Call and Webcast on Wednesday, November 12, 2025
Financial Results Announcement: Talphera, Inc. will release its third quarter 2025 financial results on November 12, 2025, followed by a live webcast and conference call at 4:30 p.m. ET to discuss the results and business updates.
Webcast and Conference Call Details: The webcast can be accessed through Talphera's website, and a replay will be available for 90 days. Investors can join the conference call using specific dial-in numbers and a conference ID.
Company Overview: Talphera, Inc. is a specialty pharmaceutical company focused on developing innovative therapies for medically supervised settings, with its lead product candidate, Niyad™, currently under investigation as an anticoagulant.
Regulatory Status: Niyad™ has received Breakthrough Device Designation from the FDA, highlighting its potential significance in medical applications.
Post-Market Jump: Turn Therapeutics Soars 134% Following Nasdaq Debut; Biotech Stocks Rise
Surge in Biotech Stocks: U.S.-listed biotech and healthcare stocks experienced significant after-hours gains, with Turn Therapeutics Inc. leading the way, surging 134.29% after its Nasdaq debut.
Momentum and Anticipation: Other companies like Talphera Inc. and Ionis Pharmaceuticals Inc. also saw notable increases, driven by momentum and upcoming presentations, indicating a strong interest in the biotech sector.
Nebius Group Shares Surge Nearly 50%; Check Out 20 Stocks Making Moves in Premarket Trading
Nebius Group's Contract with Microsoft: Nebius Group N.V. shares surged 49.6% in pre-market trading after announcing a $19.4 billion, five-year GPU infrastructure contract with Microsoft for its new data center in Vineland, New Jersey.
Pre-Market Stock Movements: Several stocks experienced significant pre-market trading changes, with Big Tree Cloud Holdings rising 625.1% and Santech Holdings increasing 533.3%, while NFT Limited and Taitron Components saw declines of 32.2% and 28.8%, respectively.
Talphera Unveils $29 Million Private Placement Driven by CorMedix and Institutional Investors
Private Placement Agreement: Talphera, Inc. has entered into securities purchase agreements for a private placement of common stock and pre-funded warrants, potentially raising up to $29 million, with $17 million from the first closing and $12 million contingent on study results.
Funding and Strategic Support: The funding will support Talphera through the potential approval of Niyad PMA, with CEO Vince Angotti highlighting confidence from CorMedix and institutional investors, as well as accelerated enrollment in the NEPHRO CRRT study.
Talphera Raises Up to $29 Million Through Private Placement Led by CorMedix
Private Placement Details: Talphera, Inc. has entered into agreements for a private placement that could raise up to $29 million, with $17 million expected from the first closing on September 10, 2025, and an additional $12 million contingent on study results and stock price conditions.
Strategic Investment and Future Plans: CEO Vince Angotti highlighted the funding as a means to support Talphera's programs, including Niyad, which aims to be the first FDA-approved regional anticoagulant for CRRT, while also noting CorMedix's investment as a validation of Niyad's potential.
