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. (formerly AcelRx Pharmaceuticals, Inc., Nasdaq: ACRX) is a specialty pharmaceutical company dedicated to developing and commercializing innovative therapies for use in medically supervised settings. Talphera's primary focus is on advancing patient care through its lead product candidate, Niyad™, a lyophilized formulation of nafamostat designed as an anticoagulant for the extracorporeal circuit. Niyad has received Breakthrough Device Designation from the FDA and is currently under study through an Investigational Device Exemption (IDE). If approved, Niyad would become the first regional anticoagulant approved for use in dialysis circuits in the U.S.
In addition to Niyad, Talphera is developing two pre-filled syringes in collaboration with Aguettant: Fedsyra™, a pre-filled ephedrine syringe, and PFS-02, a pre-filled phenylephrine syringe. The company’s rebranding reflects its broader mission to support healthcare providers with products that enhance patient care in medically supervised settings.
Recent Milestones:
- Completion of the divestment of DSUVIA® to Alora Pharmaceuticals, with up to $116.5 million in sales-based milestones and a 75% royalty on sales to the Department of Defense.
- Submission of an Emergency Use Authorization (EUA) for Niyad to the FDA in April 2023.
- IDE approval from the FDA to initiate the NEPHRO CRRT Study evaluating Niyad in renal replacement therapy, with anticipated topline data in mid-2024.
- Successful capital raise led by healthcare investors including Nantahala Capital Management, securing up to $26.3 million in funding, with $10 million immediately available.
Talphera remains committed to achieving its regulatory and development milestones, advancing the NEPHRO study, and supporting healthcare providers with innovative and effective treatments.
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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FAQ
What is the market cap of Talphera (ACRX)?
The market cap of Talphera (ACRX) is approximately 14.6M.
What is Talphera, Inc.?
Talphera, Inc. (formerly AcelRx Pharmaceuticals, Inc.) is a specialty pharmaceutical company focused on developing and commercializing innovative therapies for use in medically supervised settings.
What is Niyad™?
Niyad™ is a lyophilized formulation of nafamostat, designed as an anticoagulant for the extracorporeal circuit. It has received Breakthrough Device Designation from the FDA.
What recent milestones has Talphera achieved?
Recent milestones include the divestment of DSUVIA® to Alora Pharmaceuticals, submission of an EUA for Niyad, IDE approval for the NEPHRO CRRT Study, and a successful capital raise securing up to $26.3 million in funding.
What are Talphera’s plans for Niyad?
Talphera plans to initiate the NEPHRO CRRT Study for Niyad in Q4 2023, with topline data expected mid-2024. A PMA submission is planned for the second half of 2024.
What is the significance of the FDA’s Breakthrough Device Designation for Niyad?
The Breakthrough Device Designation expedites the development and review process for Niyad, recognizing its potential to provide significant advantages over existing treatment options.
What other products is Talphera developing?
In addition to Niyad, Talphera is developing two pre-filled syringes: Fedsyra™, a pre-filled ephedrine syringe, and PFS-02, a pre-filled phenylephrine syringe.
How has the company rebranded itself?
The company has rebranded from AcelRx Pharmaceuticals to Talphera, Inc. to reflect its broader mission of developing innovative therapies for various medically supervised settings beyond acute pain.
What prompted the name change to Talphera?
The name change to Talphera, derived from 'Talisman', was chosen to signify a new era and mission focusing on advancements in patient care in medically supervised settings.
When will Talphera start trading under its new ticker symbol?
Talphera will begin trading on the Nasdaq Global Market under the ticker symbol 'TLPH' effective January 10, 2024.
What is the financial status of Talphera?
As of September 30, 2023, Talphera has $13.4 million in cash and investments. The company recently secured up to $26.3 million in additional funding from a private placement.
Talphera, Inc.
Nasdaq:ACRX
ACRX Rankings
ACRX Stock Data
14.58M
12.03M
2.64%
38.89%
3%
Drug Manufacturers - Specialty & Generic
Healthcare
United States
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