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Tuesday, January 09, 2024 9:16:46 AM
Name change to "Talphera" reflects a new era of the Company in partnership with the medical community developing novel solutions for medically supervised settings
Talphera will begin trading on Nasdaq under the trading symbol "TLPH" effective January 10
SAN MATEO, Calif., Jan. 9, 2024 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced the rebranding of the Company, with a name change to Talphera, Inc. ("Talphera"). The rebrand decision was made to reflect the Company's strategy of developing and commercializing products to support advancing care to optimize outcomes in medically supervised settings, moving beyond the original focus on acute pain. The Company's lead nafamostat product candidate, Niyad, is expected to have a Premarket Approval (PMA) submission to the FDA in the second half of 2024.
The name Talphera was derived from "Talisman", meaning a strong leader, and reflects the new "pharmaceutical era" for the Company. The company's new mission at Talphera is to support healthcare providers by developing and commercializing products in medically supervised settings that deliver advances in care to patients. Talphera will commence trading on the Nasdaq Global Market under the ticker symbol "TLPH" effective January 10, 2024.
"We were a company founded on acute pain treatments with the understanding that patient outcomes depend on the quality of the tools available to a patient's medical team. This understanding remains the focal point of our product candidates in development. Rebranding to Talphera represents a new era of the company where we have a broader mission to develop and commercialize innovative therapies for use in medically supervised settings beyond acute pain," said Vince Angotti, Chief Executive Officer of Talphera.
Talphera's lead product candidate, Niyad, has been granted FDA Breakthrough Designation and is currently being studied under an investigational device exemption, or IDE, as an anticoagulant for the extracorporeal circuit. If approved, Niyad would be the first-ever regional anticoagulant approved by the FDA for use in the dialysis circuit.
Talphera expects to initiate the registrational study of Niyad™, the NEPHRO CRRT (Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) Study, shortly. The study has already received central Institutional Review Board (IRB) approval. The study is designed as a prospective, double-blinded trial to be conducted at up to 10 U.S. hospital intensive care units. The study will enroll and evaluate 166 adult patients undergoing renal replacement therapy, who cannot tolerate heparin or are at risk for bleeding. The primary endpoint of the study is mean post-filter activated clotting time using Niyad versus placebo over the first 24 hours. Key secondary endpoints include filter lifespan, number of filter changes over 72 hours, number of transfusions over 72 hours and dialysis efficacy (based on urea concentration) over the first 24 hours.
The first patient is expected to be enrolled for the NEPHRO study in the first quarter of 2024. Since the end of last year, the company has completed all sponsor actions and is awaiting activation from registered sites. A PMA submission for Niyad is expected to be filed with the FDA in the second half of 2024.
About Talphera, Inc.
Talphera, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. Talphera's lead product candidate, Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption, or IDE, as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation status from the FDA. Talphera is also developing two pre-filled syringes in-licensed from its partner Aguettant: Fedsyra™, a pre-filled ephedrine syringe, and PFS-02, a pre-filled phenylephrine syringe. This release is intended for investors only. For additional information about Talphera, please visit www.talphera.com.
About Nafamostat
Nafamostat is a broad spectrum, synthetic serine protease inhibitor with anticoagulant, anti-inflammatory and potential anti-viral activities. Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption, or IDE, as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation Status from the FDA. LTX-608 is a proprietary nafamostat formulation for direct IV infusion that will be investigated and developed as a potential anti-viral for the treatment of COVID, acute respiratory distress syndrome (ARDS), disseminated intravascular coagulation (DIC) and acute pancreatitis.
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Recent TLPH News
- Talphera Announces First Patient Enrolled in the Registrational Trial Evaluating Nafamostat for Anticoagulation of the Extracorporeal Circuit • PR Newswire (US) • 08/19/2024 12:30:00 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 08/14/2024 09:22:34 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/14/2024 08:12:36 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2024 08:10:32 PM
- Talphera Announces Second Quarter 2024 Financial Results and Provides Corporate Update • PR Newswire (US) • 08/14/2024 08:01:00 PM
- Talphera to Host Second Quarter 2024 Financial Results and Corporate Update Call and Webcast on Wednesday, August 14, 2024 • PR Newswire (US) • 08/05/2024 08:05:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/14/2024 09:19:26 PM
- Talphera Announces Inducement Grants under Nasdaq Listing Rule 5635(c)(4) • PR Newswire (US) • 05/20/2024 09:25:00 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 05/20/2024 09:22:15 PM
- Talphera to Participate at A.G.P. Virtual Healthcare Conference • PR Newswire (US) • 05/16/2024 09:45:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/14/2024 09:00:59 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/14/2024 08:15:28 PM
- Talphera Announces First Quarter 2024 Financial Results and Provides Corporate Update • PR Newswire (US) • 05/14/2024 08:05:00 PM
- Talphera to Host First Quarter 2024 Financial Results Call and Webcast on Tuesday, May 14, 2024 • PR Newswire (US) • 05/02/2024 08:15:00 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 03/06/2024 10:00:48 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/06/2024 09:11:29 PM
- Talphera Announces Fourth Quarter 2023 Financial Results and Provides Corporate Update • PR Newswire (US) • 03/06/2024 09:05:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/05/2024 01:55:33 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/05/2024 01:54:23 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/05/2024 01:53:08 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/01/2024 12:35:13 PM
- Talphera Announces Reduction in Size of its Board of Directors from Ten to Seven Members • PR Newswire (US) • 03/01/2024 12:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/28/2024 02:06:44 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/28/2024 02:01:01 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/28/2024 01:58:02 AM
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