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 announced the appointment of Jill Broadfoot to its Board of Directors. Ms. Broadfoot, currently CFO of aTyr Pharma, brings extensive experience in finance and operations from her previous roles at Emerald Health and GW Pharmaceuticals. CEO Vince Angotti welcomed her at a critical time for AcelRx, emphasizing her value in supporting ongoing corporate development and licensing activities. AcelRx is focused on innovative therapies for medically supervised settings, including its approved product DSUVIA and various product candidates.
AcelRx Pharmaceuticals (NASDAQ: ACRX) announced a registered direct offering of 17,500,000 shares of common stock and warrants, priced at $0.80 per share. The estimated gross proceeds are approximately $14.0 million, pending closing by November 17, 2021, subject to customary conditions. The warrants will become exercisable after six months at an exercise price of $1.00 per share. This offering is conducted under a previously filed shelf registration statement with the SEC, declared effective on July 8, 2020.
AcelRx Pharmaceuticals, Inc. (ACRX) announced a definitive merger agreement to acquire Lowell Therapeutics, Inc. for approximately $32.5 million, with contingent cash and stock considerations. The acquisition targets Lowell's Niyad, a promising anticoagulant for dialysis patients. Although Niyad is not FDA-approved yet, it holds Breakthrough Device Designation. Financially, AcelRx reported Q3 2021 revenues of $1.9 million and a net loss of $8.4 million. The merger aims to enhance AcelRx's portfolio and address unmet medical needs in anticoagulation.
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) will release its third quarter financial results on November 15, 2021, before the market opens. A live webcast and conference call will occur at 8:00 a.m. Eastern Time to discuss these results and company updates. Investors can access the event on the company's website and participate via conference call using various dialing options. AcelRx specializes in innovative therapies for medically supervised settings, with approved products like DSUVIA and investigational products like Zalviso.
AcelRx Pharmaceuticals (Nasdaq: ACRX) will provide business updates at two investor conferences in September 2021. The presentations will be at the H.C. Wainwright & Co. 23rd Annual Global Investment Conference on September 13, 2021, at 9:00 AM ET, and the Cantor Fitzgerald Virtual Global Healthcare Conference on September 22, 2021, at 2:00 PM ET. Interested parties can access live and on-demand webcasts through the company's website. AcelRx focuses on developing innovative therapies such as DSUVIA® for acute pain management and Zalviso®, a patient-controlled analgesia system.
AcelRx Pharmaceuticals (Nasdaq: ACRX) announced a presentation at the Miami Cosmetic Surgery event on the efficacy of its sufentanil sublingual tablet (SST) in reducing post-operative recovery time and opioid use for outpatient plastic surgery. Dr. Hisham Seify will present findings on August 27, 2021, showcasing results distinct from previous studies involving general anesthesia. The FDA-approved DSUVIA® (30 mcg) is designed for acute pain management in medically supervised settings, offering a non-invasive alternative to intravenous administration.
AcelRx Pharmaceuticals reported Q2 2021 financial results, highlighting revenue growth attributed to increased sales of DSUVIA as healthcare restrictions eased. The company secured a licensing agreement with Laboratoire Aguettant for DZUVEO in Europe, potentially earning $55 million in milestones. AcelRx supports ongoing investigator-initiated trials to enhance DSUVIA's market presence. Q2 revenues totaled $0.4 million with an $9.9 million net loss. Cash reserves stood at $55.3 million, with reduced R&D and SG&A expenses compared to the prior year.
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) will release its Q2 financial results on August 16, 2021, after market close. A conference call will be held at 4:30 p.m. ET to discuss these results and provide a business update. Investors can access the call via the company’s website. AcelRx focuses on developing therapies for acute pain management, with FDA-approved products including DSUVIA and Zalviso. The company is also advancing products in partnership with Laboratoire Aguettant.
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) announced licensing agreements with Laboratoire Aguettant for the commercialization of DZUVEO in Europe and to obtain rights for two pre-filled syringe products in the U.S. AcelRx can earn up to $55 million and a revenue share of 35% to 45% from Aguettant for DZUVEO. For the U.S. products, sales-based milestones could reach up to $24 million, with a revenue share of 40% to 45%. This strategic collaboration enhances AcelRx's product portfolio while limiting development costs.
AcelRx Pharmaceuticals (Nasdaq: ACRX) announced an agreement with the FDA to finalize corrective actions concerning a warning letter received on February 11, 2021, related to DSUVIA promotional materials. The FDA approved AcelRx's plan to update these materials, including a letter to healthcare professionals and updates on DSUVIA.com for eight months. DSUVIA is a sublingual sufentanil tablet for managing acute pain in medically supervised settings. The company expects to receive a close-out letter from the FDA following compliance with these measures.
