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Talphera, Inc. - ACRX STOCK NEWS

Welcome to our dedicated page for Talphera news (Ticker: ACRX), a resource for investors and traders seeking the latest updates and insights on Talphera stock.

Talphera, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on innovative therapies for medically supervised settings, provides centralized access to its latest developments through this news hub. Investors and healthcare professionals will find timely updates on regulatory progress, clinical research, and strategic initiatives related to Talphera's pipeline.

This resource aggregates essential information about Niyad™, the company's Breakthrough Device-designated anticoagulant for dialysis circuits, along with updates on pre-filled syringe collaborations with Aguettant. Content spans FDA communications, partnership announcements, financial developments, and scientific presentations.

Key areas of coverage include Niyad's NEPHRO CRRT Study progress toward PMA submission, updates on Fedsyra™ and PFS-02 development, and analysis of strategic moves like the DSUVIA® divestment. All content maintains strict compliance with financial disclosure standards while providing actionable insights for stakeholders.

Bookmark this page for streamlined tracking of Talphera's progress in developing first-in-class treatments for critical care settings. Verify information directly through SEC filings and official company communications for investment decisions.

Rhea-AI Summary
AcelRx Pharmaceuticals, Inc. changes its name to Talphera, Inc. with a focus on developing and commercializing innovative therapies for medically supervised settings. The company's lead product candidate, Niyad, has been granted FDA Breakthrough Designation and is expected to have a Premarket Approval (PMA) submission to the FDA in the second half of 2024. Talphera will commence trading on the Nasdaq Global Market under the ticker symbol 'TLPH' effective January 10, 2024.
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AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) published a study on U.S. physician anticoagulation use during continuous renal replacement therapy (CRRT) in patients with acute kidney injury. The study reveals increased CRRT machine use, with heparin being used in 43% of patients, citrate in 28%, and no anticoagulation in 29%. Concerns with heparin include systemic bleeding and thrombocytopenia, while citrate usage is hindered by hypocalcemia and safety issues. The study highlights the need for a new regional anticoagulant for patients intolerant to heparin, potentially improving the quality of CRRT for these patients.
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AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) achieved FDA Investigational Device Exemption (IDE) approval for Niyad™ in the third quarter. The company plans to start its Niyad registrational study this quarter and expects topline data by mid-2024. They also have cash and investments of $13.4 million as of September 30, 2023, with a new financing round providing up to $26.3 million. A Key Opinion Leader panel discussion on Niyad is planned for December 6th.
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AcelRx Pharmaceuticals, Inc. (ACRX) to host virtual KOL panel discussion on Niyad anticoagulant for dialysis circuits. Discussion includes recent market research and NEPHRO CRRT study. Register for the webcast event on December 6, 2023 at 11:00 a.m. ET.
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AcelRx Pharmaceuticals will release its third quarter 2023 financial results on November 8th and host a webcast and conference call to discuss the results and provide a business update.
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AcelRx Pharmaceuticals receives FDA approval for pivotal study of Niyad™, the first regional anticoagulant for extracorporeal circuit in the US
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AcelRx Pharmaceuticals CEO to present at H.C. Wainwright Investment Conference
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AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) reported its Q2 2023 financial results and corporate update. The company closed a capital raise in July, led by new healthcare investors, providing access to up to $26.3 million. AcelRx awaits an FDA response to Emergency Use Authorization of Niyad submitted in April, with a registrational study set to initiate in Q4 2023. The company fully repaid senior debt with Oxford in Q2 2023.
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AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) will release its second quarter 2023 financial results after market close on August 10, 2023. The company will host a live webcast and conference call at 4:30 p.m. EDT/1:30 p.m. PDT to discuss the results and provide a business update.
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Talphera, Inc.

Nasdaq:ACRX

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