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. (Nasdaq: ACRX), a specialty pharmaceutical company focused on innovative therapies for medically supervised settings, provides centralized access to its latest developments through this news hub. Investors and healthcare professionals will find timely updates on regulatory progress, clinical research, and strategic initiatives related to Talphera's pipeline.
This resource aggregates essential information about Niyad™, the company's Breakthrough Device-designated anticoagulant for dialysis circuits, along with updates on pre-filled syringe collaborations with Aguettant. Content spans FDA communications, partnership announcements, financial developments, and scientific presentations.
Key areas of coverage include Niyad's NEPHRO CRRT Study progress toward PMA submission, updates on Fedsyra™ and PFS-02 development, and analysis of strategic moves like the DSUVIA® divestment. All content maintains strict compliance with financial disclosure standards while providing actionable insights for stakeholders.
Bookmark this page for streamlined tracking of Talphera's progress in developing first-in-class treatments for critical care settings. Verify information directly through SEC filings and official company communications for investment decisions.
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) has successfully closed the divestment of its product DSUVIA to Alora Pharmaceuticals, receiving approximately $2.7 million. The agreement includes an initial payment of $1.1 million, a 15% royalty on commercial sales, a 75% royalty on sales to the Department of Defense, and potential milestones of up to $116.5 million. Following this transaction, AcelRx has fully repaid its senior loan with Oxford Finance, achieving a debt-free status. The company is now focusing on advancing its late-stage product candidates, Niyad™ and Fedsyra™, expected to contribute long-term value.
AcelRx Pharmaceuticals (Nasdaq: ACRX) announced the planned divestment of DSUVIA to Alora Pharmaceuticals, with the transaction expected to close on April 3, 2023. This agreement allows AcelRx to earn a 15% royalty on DSUVIA sales, 75% on Department of Defense sales, and up to $116.5 million in sales-based milestones. The company is focusing on its late-stage assets, particularly the Niyad™ program, which has received FDA Breakthrough designation. AcelRx plans to submit an Emergency Use Authorization and a New Drug Application for Fedsyra by the end of Q2 2023. As of December 31, 2022, AcelRx reported $20.8 million in cash and short-term investments.
AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) announced it will release its full year and fourth quarter financial results for 2022 after the market closes on March 30, 2023. Following the announcement, management will host a live webcast and conference call at 4:30 p.m. EDT. AcelRx specializes in innovative therapies for medically supervised settings and has one approved product, DSUVIA, for acute pain management. The company is also advancing multiple candidates, including Niyad™, which is set for Emergency Use Authorization submission during Q2 2023, and two pre-filled syringes scheduled for NDA filing by the same deadline.
AcelRx Pharmaceuticals announced the divestment of its FDA-approved drug DSUVIA to Alora Pharmaceuticals. This agreement grants AcelRx a 15% royalty on commercial sales and 75% royalties on Department of Defense (DoD) sales, along with potential milestone payments of up to $116.5 million. This strategic move allows AcelRx to focus on its late-stage development assets, particularly the Niyad program, which has received breakthrough designation from the FDA. Near-term milestones, including Emergency Use Authorization submission for Niyad, are expected by the end of Q2 2023.
AcelRx Pharmaceuticals (ACRX) announced a peer-reviewed publication detailing the use of DSUVIA (sufentanil sublingual tablet) in rhinology procedures. Conducted at Ear, Nose and Throat Consultants in Las Vegas, the study assessed 77 patients and demonstrated effective perioperative pain management. Patients reported comfort during procedures, with no significant vital sign issues, and fewer oral opioids needed post-surgery. The publication reinforces the potential for DSUVIA to enhance patient satisfaction and streamline pain management in office settings, expanding its application from traditional surgical settings.
AcelRx Pharmaceuticals announced a registered direct offering generating approximately $7.5 million by selling 748,744 shares of common stock and warrants. The shares and accompanying warrants are priced at $2.22625 each, while pre-funded warrants are priced at $2.22615. The pre-funded warrants, immediately exercisable post-closing at $0.0001 per share, allow for further capital generation upon exercise. The offering closes on December 29, 2022, pending customary conditions. Cantor is the sole placement agent.
AcelRx Pharmaceuticals announced a recent study demonstrating the benefits of sufentanil sublingual tablets (SSTs) for managing postoperative pain in knee replacement patients. The retrospective analysis, published in the Journal of Clinical Medicine, involved 71 patients, revealing that those treated with SSTs experienced significantly lower pain scores, required fewer rescue doses, and had shorter hospital stays compared to those receiving traditional femoral nerve block. The study indicates the potential of SSTs in improving patient outcomes and aligns with the recent European launch of DZUVEO.
