The U.S. Food and Drug Administration (FDA) agreed to reduce the number of patients in the NEPHRO CRRT study from 166 to 70 Talphera expects the registrational NEPHRO CRRT study to be completed by the end of 2025 Cash and investments at December 31, 2024 of $8.9 million , together with the private placement financing recently announced of up to $14.8 million , expected to provide capital through target completion of the... Read More

The U.S. Food and Drug Administration (FDA) agreed to reduce the number of patients in the NEPHRO CRRT study from 166 to 70 patients, of which 6 patients are already enrolled Talphera believes the NEPHRO CRRT study should be completed by the end of 2025 Existing investors, Nantahala Capital and Rosalind Advisors led the capital commitment priced at-the-market as defined by Nasdaq rules $4.925 million in gross proceeds at... Read More

SAN MATEO, Calif. , March 26, 2025 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH), ("Talphera"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that it will release fourth quarter and full-year 2024 financial results after market close on Monday, March 31, 2025 , then host a live webcast and conference call... Read More

Submission of a Prior Approval Supplement for a reduction in the number of patients in the NEPHRO CRRT study is expected within the coming week The FDA agreed to two additional protocol changes expected to accelerate enrollment in the NEPHRO CRRT study SAN MATEO, Calif. , Jan. 14, 2025 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH), ("Talphera"), a specialty pharmaceutical company focused on the development and... Read More

Five sites actively screening with multiple patients having completed the study; two additional institutions expected to begin screening in the fourth quarter totaling seven active sites Cash and investments at September 30, 2024 of $11.1 million Conference call and webcast to be held Wednesday, November 13, 2024 at 4:30 pm ET SAN MATEO, Calif. , Nov. 13, 2024 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH), ("Talphera"), a... Read More

SAN MATEO, Calif. , Nov. 6, 2024 /PRNewswire/ -- Talphera, Inc . (Nasdaq: TLPH), ("Talphera"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that it will release third quarter 2024 financial results after market close on Wednesday, November 13, 2024 , then host a live webcast and conference call at 4:30... Read More

SAN MATEO, Calif. , Oct. 8, 2024 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH), ("Talphera"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that management will participate in a fireside chat at the 2024 Maxim Healthcare Virtual Summit and will be available for 1x1 meetings with registered investors. The... Read More

SAN MATEO, Calif. , Sept. 5, 2024 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH), ("Talphera"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that management will participate in the H.C. Wainwright 26 th Annual Global Investment Conference and will be taking 1x1 meetings. The conference is being held on... Read More

The safety and effectiveness of nafamostat is being assessed in the NEPHRO CRRT registrational trial in 166 patients at up to 14 clinical sites Primary endpoint in the NEPHRO CRRT study is measured over the first 24 hours, with patients completing the study after 72 hours Dr. Stuart Goldstein , a world-renowned nephrologist, is the first physician to enroll a patient in the NEPHRO CRRT study SAN MATEO, Calif. , Aug. 19, 2024... Read More

NEPHRO CRRT study patient screening has initiated at multiple clinical sites The safety and effectiveness of nafamostat is being assessed in the NEPHRO CRRT registrational study in 166 patients at up to 14 clinical sites Cash and investments at June 30, 2024 of $14.0 million Conference call and webcast to be held Wednesday, August 14, 2024 at 4:30 pm ET SAN MATEO, Calif. , Aug. 14, 2024 /PRNewswire/ -- Talphera, Inc.... Read More

SAN MATEO, Calif. , Aug. 5, 2024 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH), ("Talphera"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that it will release second quarter 2024 financial results after market close on Wednesday, August 14, 2024 , then host a live webcast and conference call at 4:30 p.m.... Read More

SAN MATEO, Calif. , May 20, 2024 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH), ("Talphera"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that the Board of Directors of Talphera has granted inducement awards consisting of a non-statutory time-based stock option to purchase 185,000 shares of common stock... Read More

SAN MATEO, Calif. , May 16, 2024 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH), ("Talphera"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that management will participate in a fireside chat at the A.G.P. Virtual Healthcare conference May 21, 2024 at 10:40 a.m. ET . Presentation Information Presentation... Read More

First patients at multiple sites are expected to be enrolled in the NEPHRO CRRT registrational study in Q2 2024 Dr. Shakil Aslam , an expert in renal diseases, including acute kidney injury, joins Talphera as Chief Development Officer Cash and investments at March 31, 2024 of $18.6 million Conference call and webcast to be held Tuesday, May 14, 2024 at 4:30 pm ET SAN MATEO, Calif. , May 14, 2024 /PRNewswire/ -- Talphera,... Read More

SAN MATEO, Calif. , May 2, 2024 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH), ("Talphera"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that it will release first quarter 2024 financial results after market close on Tuesday, May 14, 2024 , then host a live webcast and conference call at 4:30 p.m. Eastern... Read More

Company rebranding and corporate transformation to Talphera completed in Q1 2024 First patient enrollment in the NEPHRO CRRT registrational study expected in Q1 2024 with a projected PMA submission by the end of 2024 Cash and investments at December 31, 2023 of $9.4 million together with the royalty and equity financings completed in January 2024 expected to provide cash runway to a potential Niyad™ approval in Q2 2025... Read More

SAN MATEO, Calif. , March 1, 2024 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH), (Talphera), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced as part of its commitment to operating with best practices in corporate governance, its Board of Directors has decided to reduce the size of the Board from ten to seven... Read More

SAN MATEO, Calif. , Feb. 26, 2024 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH), ("Talphera"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that it will release fourth quarter and full-year 2023 financial results after market close on Wednesday, March 6, 2024 , then host a live webcast and conference call... Read More

The total committed funding is expected to provide sufficient capital to fund Talphera through a potential FDA approval of Niyad™, targeted for the first half of 2025 $16 million of total equity committed with $6 million upfront and $10 million upon the announcement of positive NEPHRO registration trial data Existing investors, Nantahala Capital and Rosalind Advisors, committed the total equity capital priced at-the-market... Read More

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... Read More

Use of CRRT increased during COVID and remained at these higher utilization levels Study results demonstrate challenges physicians have with heparin and citrate, the two currently available CRRT anticoagulants SAN MATEO, Calif. , Dec. 12, 2023 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in... Read More

Niyad™ Investigational Device Exemption (IDE) approval by the FDA achieved in third quarter Company plans to begin its Niyad registrational study this quarter with topline data expected mid-2024 Cash and investments of $13.4 million as of September 30, 2023 Financing closed in July led by new healthcare investors providing up to $26.3 million , of which $10 million was made immediately available Key Opinion Leader panel... Read More

Two KOLs will discuss recent quantitative market research on the use of anticoagulants in the dialysis circuit Discussion will also focus on the Niyad study protocol for upcoming NEPHRO Study Register to attend the webcast event on December 6, 2023 at 11:00 a.m. ET SAN MATEO, Calif. , Nov. 7, 2023 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the... Read More

HAYWARD, Calif. , Oct. 26, 2023 /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 that it will release third quarter 2023 financial results after market close on Wednesday, November 8, 2023 , then host a live webcast and conference call at... Read More

Investigational Device Exemption (IDE) approval by the U.S. Food and Drug Administration (FDA) allows AcelRx to begin pivotal study of Niyad™ Single registration study with pre-agreed upon endpoints planned to initiate in Q4 2023 with topline data expected mid-2024; clinical site readiness is currently underway Niyad would be the first and only approved regional anticoagulant in the U.S. for the extracorporeal circuit, if... Read More

SAN MATEO, Calif. , Sept. 6, 2023 /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 that Chief Executive Officer, Vince Angotti will present in-person and be available for one-on-one meetings throughout the H.C. Wainwright 25 th Annual... Read More

Capital raise closed in July, led by new healthcare investors; provides access to up to $26.3 million in capital, with $10 million immediately available AcelRx awaits response to Emergency Use Authorization (EUA) of Niyad™ submitted to the FDA in April; registrational study set to initiate in Q4 2023 Proforma $17 .4 million in cash as of June 30, 2023, including gross proceeds from financing closed in July 2023 Senior debt... Read More

HAYWARD, Calif. , July 27, 2023 /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 that it will release second quarter 2023 financial results after market close on Thursday, August 10, 2023 , then host a live webcast and conference call at... Read More

Transformative capital raise, led by new investors including Nantahala Capital Management The private placement provides access to up to $26.3 million of gross proceeds upon the exercise of the milestone-affected warrants HAYWARD, Calif. , July 21, 2023 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), ("AcelRx" or the "Company"), a specialty pharmaceutical company focused on the development and commercialization... Read More

Upon the achievement of certain milestones accelerating the warrants' expiration date, AcelRx may receive an additional $16.3 million of gross proceeds if the common warrants are exercised in full HAYWARD, Calif. , July 18, 2023 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), ("AcelRx" or the "Company"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies... Read More

Request for Emergency Use Authorization of Niyad™ submitted to the FDA in April Divestment of DSUVIA® to Alora Pharmaceuticals closed April 3, 2023 $13.4 million in cash as of March 31, 2023 Webcast and conference call to be held today at 4:30 p.m. EDT HAYWARD, Calif. , May 10, 2023 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and... Read More

HAYWARD, Calif. , April 27, 2023 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that it will release first quarter financial results for 2023 after the market close on Wednesday, May 10, 2023. Thereafter, AcelRx management will host a live webcast... Read More

In connection with closing, AcelRx received approximately $2.7 million from Alora Pharmaceuticals and Aguettant AcelRx announces full repayment of its senior loan with Oxford Finance HAYWARD, Calif. , April 5, 2023 /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... Read More

Divestment of DSUVIA® to Alora Pharmaceuticals expected to close the week of April 3, 2023 AcelRx advancing its proprietary Niyad™ nafamastat program with FDA Breakthrough designation in line with a strategic focus on late-stage assets Near-term corporate milestones expected by the end of Q2 2023 include Niyad Emergency Use Authorization submission and the filing of a New Drug Application for Fedsyra™, the first of two... Read More

HAYWARD, Calif. , March 21, 2023 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that it will release full year and fourth quarter financial results for 2022 after the market close on Thursday, March 30, 2023. Thereafter, AcelRx management will host... Read More

Agreement with Alora Pharmaceuticals provides AcelRx with 15% royalties on commercial sales, 75% royalties on Department of Defense (DoD) sales, up to $116.5 million in potential sales-based milestone payments, and a strong commercial partner experienced with commercialization in hospital settings Divestment allows AcelRx to prioritize resources on its late stage development assets, led by Niyad™, the lead nafamostat program... Read More

Study is the first to report on the use of DSUVIA® in the rapidly growing field of rhinology where otolaryngologists are performing painful nasal and sinus procedures in the office which were historically conducted only in ambulatory surgery centers or hospitals HAYWARD, Calif. , March 1, 2023 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development... Read More

HAYWARD, Calif. , Dec. 27, 2022 /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 it has entered into an agreement with a life sciences-focused investment fund for the sale of 748,744 shares of its common stock, pre-funded warrants... Read More

Patients reported lower pain scores, required fewer rescue doses and had a shorter hospital stay than patients receiving continuous femoral nerve block This study of patients following knee replacement surgery adds to a growing database supporting the benefits of using sufentanil sublingual tablets for surgical pain management HAYWARD, Calif. , Dec. 8, 2022 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX),... Read More