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.
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) announced that an abstract titled "Experience in Complex Outpatient Plastic Surgery Procedures Using Sufentanil Sublingual Tablets" has been accepted for podium presentation at Plastic Surgery: The Meeting 2022 from October 27-30, 2022, in Boston, MA. The presentation will occur in-person with no virtual option. AcelRx focuses on innovative therapies for medically supervised settings, with its product DSUVIA® (sufentanil sublingual tablet) approved for acute pain management in certified healthcare settings.
AcelRx Pharmaceuticals (Nasdaq: ACRX) announced the acceptance of an abstract titled "The Impact of Sublingual Sufentanil on Postoperative Pain Control in Patients Undergoing Spine Surgery" for e-Abstract presentation at the ANESTHESIOLOGY 2022 annual meeting from October 21-25, 2022, in New Orleans, LA. This presentation will be available to registrants virtually and during the event. AcelRx aims to enhance its profile in pain management with its product, DSUVIA, an innovative sublingual opioid analgesic, providing rapid pain relief in medically supervised settings.
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) will release its second quarter financial results on August 11, 2022, after market close. A live webcast and conference call will follow at 4:30 p.m. EDT to discuss the results and business updates. Investors can access the webcast through the company's website, with a replay available for 90 days. AcelRx focuses on innovative therapies, including its approved product, DSUVIA®, and several product candidates aimed at managing severe pain and other medical conditions.
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) announced that CEO Vince Angotti will present at the H.C. Wainwright Global Investment Conference from May 23-26, 2022, in Miami, FL. Angotti's presentation is scheduled for May 24 at 3:30 PM EDT, available through a live webcast. The recorded session will be accessible for 90 days on AcelRx's website. AcelRx focuses on developing innovative therapies for medically supervised settings, with its approved product, DSUVIA, managing acute pain in clinical environments.
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) announced modifications to the FDA's DSUVIA Risk Evaluation and Mitigation Strategies (REMS) requirements. The FDA has eliminated the 6-month healthcare setting audit and reduced annual audits to a maximum of 400 sites that received DSUVIA shipments in the last six months. This change reflects AcelRx's compliance and safety record, which includes no accidental exposures. DSUVIA is a sublingual opioid analgesic approved for severe acute pain in medically supervised settings.
AcelRx Pharmaceuticals (ACRX) reported its Q1 2022 financial results, highlighting a net loss of $8.7 million, or $0.06 per share. The company achieved 64% sales growth of DSUVIA compared to the previous quarter, with unit sales reaching 10,530. AcelRx recently acquired Lowell Therapeutics, enhancing its late-stage pipeline with Niyad™, which targets anticoagulation and has Breakthrough Device Designation from the FDA. A cost restructuring is expected to save $9 million annually, while cash reserves stand at $39.3 million as of March 31, 2022.
AcelRx Pharmaceuticals (NASDAQ: ACRX) announced findings from an investigator-initiated trial demonstrating that the sufentanil sublingual tablet (SST) significantly reduced opioid intake in patients undergoing plastic surgery. The study revealed that SST patients required over five-fold less opioids post-surgery compared to those receiving standard IV opioids. Conducted on 61 patients, results indicated 16.4% of SST patients needed rescue opioids in recovery, compared to 90.6% in the control group. The findings support the clinical benefits of SST, including reduced nausea and comparable discharge times.
AcelRx Pharmaceuticals (Nasdaq: ACRX) will release its Q1 2022 financial results before the market opens on May 16, 2022. A live webcast and conference call hosted by management will begin at 8:30 a.m. ET to discuss the financial results and provide business updates. The webcast can be accessed via their website. AcelRx specializes in innovative therapies for medically supervised settings, with products including DSUVIA and several investigational candidates.
AcelRx Pharmaceuticals (NASDAQ: ACRX) announced a Key Opinion Leader webinar on May 4, 2022, at 1:00 PM EDT. The event will focus on the company's late-stage product candidate, Niyad™, a regional dialysis anticoagulant that has received FDA Breakthrough Device Designation. Niyad, already approved in Japan and Korea, aims to prevent clotting in dialysis machines. Experts Stuart Goldstein, MD, and Lakhmir Chawla, MD, will discuss the unmet medical need for such treatments in the U.S.
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) announced results from a podium presentation at The Aesthetic Meeting 2022, highlighting the efficacy of DSUVIA® (sufentanil sublingual tablet) in minimally invasive plastic surgery. The study involved 124 patients, showing that control patients required over five times more IV morphine than those treated with DSUVIA. The recovery time for SST-treated patients was significantly shorter, and adverse effects were minimal, indicating DSUVIA's potential to enhance postoperative pain management.
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