AcelRx Pharmaceuticals, Inc. (ACRX)
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DESCRIPTION
AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company, focuses on the development and commercialization of therapies for the treatment of acute pain. Its lead product candidate is DSUVIA and DZUVEO, a 30 mcg sufentanil sublingual tablet for the treatment of moderate-to-severe acute pain. The company develops ZALVISO, a pre-programmed and patient-controlled analgesia system that allows hospital patients with moderate-to-severe acute pain to self-dose with sufentanil sublingual tablets to manage their pain; ARX-02, which is in Phase 2 clinical trial for the treatment of cancer breakthrough pain in opioid-tolerant patients; and 4ARX-03 for mild sedation and pain relief during painful procedures. Its product candidates also include Niyad, a regional anticoagulant for the extracorporeal circuit; and LTX-608, a nafamostat formulation for direct IV infusion being explored as an investigational product for antiviral treatment of COVID, acute respiratory distress syndrome, disseminated intravascular coagulation, and acute pancreatitis. The company was formerly known as SuRx, Inc. and changed its name to AcelRx Pharmaceuticals, Inc. in August 2006. AcelRx Pharmaceuticals, Inc. was incorporated in 2005 and is based in Hayward, California.
NEWS

AcelRx Announces Rebranding With Name Change to Talphera, Inc.
prnewswire.com
2024-01-09 09:05:00Name 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").

AcelRx Pharmaceuticals Announces Publication of Study Evaluating Anticoagulation Practices for Continuous Renal Replacement Therapy in the United States
prnewswire.com
2023-12-12 08:30:00Use 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 medically supervised settings, today announced the publication of a quantitative market research study evaluating current U.S. physician anticoagulation use during continuous renal replacement therapy (CRRT) in patients with acute kidney injury in the intensive care unit.

AcelRx Pharmaceuticals, Inc. (ACRX) Q3 2023 Earnings Call Transcript
seekingalpha.com
2023-11-09 00:27:10AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX ) Q3 2023 Earnings Conference Call November 8, 2023 4:30 PM ET Company Participants Raffi Asadorian - CFO Vince Angotti - CEO Pam Palmer - Chief Medical Officer and Co-Founder Conference Call Participants Thomas Yip - H.C. Wainwright & Co. James Molloy - Alliance Global Partners Operator Welcome to the AcelRx third quarter 2023 financial results conference call.

AcelRx Reports Third Quarter 2023 Financial Results and Provides Corporate Update
prnewswire.com
2023-11-08 16:05:00Niyad™ 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 discussion on Niyad planned for December 6 th Webcast and conference call to be held today at 4:30 p.m. ET SAN MATEO, Calif.

AcelRx to Host Third Quarter 2023 Financial Results Call and Webcast on November 8, 2023
prnewswire.com
2023-10-26 16:30:00HAYWARD, 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 4:30 p.m.

AcelRx Receives IDE Approval for Niyad and Advances to a Single Registration Study
prnewswire.com
2023-10-03 08:30:00Investigational 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 approved by the FDA SAN MATEO, Calif. , Oct. 3, 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 is advancing Niyad™ (a lyophilized formulation of nafamostat) into a registrational study following the recent approval of an Investigational Device Exemption (IDE) submission to the United States Food and Drug Administration (FDA).

AcelRx Pharmaceuticals to Participate in the H.C. Wainwright Annual Investment Conference
prnewswire.com
2023-09-06 08:30:00SAN 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.

What Makes AcelRx Pharmaceuticals (ACRX) a New Buy Stock
zacks.com
2023-08-22 18:47:40AcelRx Pharmaceuticals (ACRX) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

AcelRx Pharmaceuticals, Inc. (ACRX) Q2 2023 Earnings Call Transcript
seekingalpha.com
2023-08-10 20:16:06AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX ) Q2 2023 Earnings Conference Call August 10, 2023 4:30 PM ET Company Participants Raffi Asadorian – Chief Financial Officer Vince Angotti – Chief Executive Officer Pam Palmer – Founder and Chief Medical Officer Conference Call Participants Thomas Yip – H.C. Wainwright Laura Suriel – Alliance Global Operator Welcome to the AcelRx Second Quarter 2023 Financial Results Conference Call.

AcelRx Pharmaceuticals (ACRX) Reports Q2 Loss, Tops Revenue Estimates
zacks.com
2023-08-10 19:01:50AcelRx Pharmaceuticals (ACRX) came out with a quarterly loss of $0.41 per share versus the Zacks Consensus Estimate of a loss of $0.53. This compares to loss of $1.20 per share a year ago.

AcelRx Reports Second Quarter 2023 Financial Results and Provides Corporate Update
prnewswire.com
2023-08-10 16:05:00Capital 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 with Oxford fully repaid in Q2 2023 Webcast and conference call to be held today at 4:30 p.m. EDT SAN MATEO, Calif.

AcelRx to Host Second Quarter 2023 Financial Results Call and Webcast on August 10, 2023
prnewswire.com
2023-07-27 16:05:00HAYWARD, 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 4:30 p.m.

AcelRx Pharmaceuticals Announces Closing of Previously Announced Private Placement Priced At-The-Market Under Nasdaq Rules
prnewswire.com
2023-07-21 08:00:00Transformative 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 of innovative therapies for use in medically supervised settings, today announced the closing of its previously announced private placement of common stock, pre-funded warrants and common warrants for aggregate gross proceeds to the Company of $10 million, before deducting the placement agent's fees and other offering expenses payable by the Company, with an additional potential $16.3 million upon the exercise of the common warrants, which include an acceleration feature should the Company achieve certain performance milestones.

AcelRx Pharmaceuticals Announces $10 Million Private Placement of Securities Priced At-The-Market Under Nasdaq Rules
prnewswire.com
2023-07-18 08:00:00Upon 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 for use in medically supervised settings, today announced that it has entered into a definitive agreement for the purchase and sale of an aggregate of 5,340,591 shares of common stock, at a purchase price of $1.36 per share of common stock, and pre-funded warrants to purchase 2,012,356 shares of common stock at a purchase price of $1.359 per pre-funded warrant (the "Pre-Funded Warrants").

AcelRx Pharmaceuticals (ACRX) Reports Break-Even Earnings for Q1
zacks.com
2023-05-10 19:45:22AcelRx Pharmaceuticals (ACRX) reported break-even quarterly earnings per share versus the Zacks Consensus Estimate of a loss of $0.80. This compares to loss of $1.20 per share a year ago.

AcelRx Pharmaceuticals Reports First Quarter 2023 Financial Results and Provides Corporate Update
prnewswire.com
2023-05-10 16:05:00Request 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.
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AcelRx Announces Rebranding With Name Change to Talphera, Inc.
prnewswire.com
2024-01-09 09:05:00Name 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").

AcelRx Pharmaceuticals Announces Publication of Study Evaluating Anticoagulation Practices for Continuous Renal Replacement Therapy in the United States
prnewswire.com
2023-12-12 08:30:00Use 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 medically supervised settings, today announced the publication of a quantitative market research study evaluating current U.S. physician anticoagulation use during continuous renal replacement therapy (CRRT) in patients with acute kidney injury in the intensive care unit.

AcelRx Pharmaceuticals, Inc. (ACRX) Q3 2023 Earnings Call Transcript
seekingalpha.com
2023-11-09 00:27:10AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX ) Q3 2023 Earnings Conference Call November 8, 2023 4:30 PM ET Company Participants Raffi Asadorian - CFO Vince Angotti - CEO Pam Palmer - Chief Medical Officer and Co-Founder Conference Call Participants Thomas Yip - H.C. Wainwright & Co. James Molloy - Alliance Global Partners Operator Welcome to the AcelRx third quarter 2023 financial results conference call.

AcelRx Reports Third Quarter 2023 Financial Results and Provides Corporate Update
prnewswire.com
2023-11-08 16:05:00Niyad™ 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 discussion on Niyad planned for December 6 th Webcast and conference call to be held today at 4:30 p.m. ET SAN MATEO, Calif.

AcelRx to Host Third Quarter 2023 Financial Results Call and Webcast on November 8, 2023
prnewswire.com
2023-10-26 16:30:00HAYWARD, 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 4:30 p.m.

AcelRx Receives IDE Approval for Niyad and Advances to a Single Registration Study
prnewswire.com
2023-10-03 08:30:00Investigational 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 approved by the FDA SAN MATEO, Calif. , Oct. 3, 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 is advancing Niyad™ (a lyophilized formulation of nafamostat) into a registrational study following the recent approval of an Investigational Device Exemption (IDE) submission to the United States Food and Drug Administration (FDA).

AcelRx Pharmaceuticals to Participate in the H.C. Wainwright Annual Investment Conference
prnewswire.com
2023-09-06 08:30:00SAN 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.

What Makes AcelRx Pharmaceuticals (ACRX) a New Buy Stock
zacks.com
2023-08-22 18:47:40AcelRx Pharmaceuticals (ACRX) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

AcelRx Pharmaceuticals, Inc. (ACRX) Q2 2023 Earnings Call Transcript
seekingalpha.com
2023-08-10 20:16:06AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX ) Q2 2023 Earnings Conference Call August 10, 2023 4:30 PM ET Company Participants Raffi Asadorian – Chief Financial Officer Vince Angotti – Chief Executive Officer Pam Palmer – Founder and Chief Medical Officer Conference Call Participants Thomas Yip – H.C. Wainwright Laura Suriel – Alliance Global Operator Welcome to the AcelRx Second Quarter 2023 Financial Results Conference Call.

AcelRx Pharmaceuticals (ACRX) Reports Q2 Loss, Tops Revenue Estimates
zacks.com
2023-08-10 19:01:50AcelRx Pharmaceuticals (ACRX) came out with a quarterly loss of $0.41 per share versus the Zacks Consensus Estimate of a loss of $0.53. This compares to loss of $1.20 per share a year ago.

AcelRx Reports Second Quarter 2023 Financial Results and Provides Corporate Update
prnewswire.com
2023-08-10 16:05:00Capital 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 with Oxford fully repaid in Q2 2023 Webcast and conference call to be held today at 4:30 p.m. EDT SAN MATEO, Calif.

AcelRx to Host Second Quarter 2023 Financial Results Call and Webcast on August 10, 2023
prnewswire.com
2023-07-27 16:05:00HAYWARD, 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 4:30 p.m.

AcelRx Pharmaceuticals Announces Closing of Previously Announced Private Placement Priced At-The-Market Under Nasdaq Rules
prnewswire.com
2023-07-21 08:00:00Transformative 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 of innovative therapies for use in medically supervised settings, today announced the closing of its previously announced private placement of common stock, pre-funded warrants and common warrants for aggregate gross proceeds to the Company of $10 million, before deducting the placement agent's fees and other offering expenses payable by the Company, with an additional potential $16.3 million upon the exercise of the common warrants, which include an acceleration feature should the Company achieve certain performance milestones.

AcelRx Pharmaceuticals Announces $10 Million Private Placement of Securities Priced At-The-Market Under Nasdaq Rules
prnewswire.com
2023-07-18 08:00:00Upon 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 for use in medically supervised settings, today announced that it has entered into a definitive agreement for the purchase and sale of an aggregate of 5,340,591 shares of common stock, at a purchase price of $1.36 per share of common stock, and pre-funded warrants to purchase 2,012,356 shares of common stock at a purchase price of $1.359 per pre-funded warrant (the "Pre-Funded Warrants").

AcelRx Pharmaceuticals (ACRX) Reports Break-Even Earnings for Q1
zacks.com
2023-05-10 19:45:22AcelRx Pharmaceuticals (ACRX) reported break-even quarterly earnings per share versus the Zacks Consensus Estimate of a loss of $0.80. This compares to loss of $1.20 per share a year ago.

AcelRx Pharmaceuticals Reports First Quarter 2023 Financial Results and Provides Corporate Update
prnewswire.com
2023-05-10 16:05:00Request 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.