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) will present an overview followed by a fireside chat with Dr. Pamela Palmer on March 24, 2021, at the Benzinga Biotech Small Cap Conference. The presentation starts at 9:25 AM EST and the chat at 11:35 AM EST. Interested participants can register online. A replay will be available for 90 days in the investor relations section of AcelRx's website. The company focuses on developing innovative therapies for medically supervised settings, with one approved product in the U.S. and one investigational product.
AcelRx Pharmaceuticals (Nasdaq: ACRX) reported its financial results for Q4 and FY 2020, revealing net revenues of $5.4 million for the year. The company faced challenges due to COVID-19 but expects a rebound in formulary approvals for DSUVIA in H2 2021. Key milestones include a $30 million contract with the U.S. Army and ongoing studies demonstrating the efficacy of DSUVIA. The net loss for Q4 2020 was $8.9 million, improving from $14.4 million in Q4 2019. AcelRx aims for 615 cumulative formulary approvals by year-end 2021.
AcelRx Pharmaceuticals announced it will release its fourth quarter financial results after market close on March 15, 2021. A conference call and webcast will be held at 4:30 p.m. ET to discuss these results. Investors can join the call by dialing specific numbers based on their location. AcelRx focuses on innovative therapies for pain management, with one approved product in the U.S., DSUVIA, and another in development, Zalviso. More details can be found on their website.
AcelRx Pharmaceuticals (Nasdaq: ACRX) has entered into an agreement with Newport Plastic and Reconstructive Surgery Associates to conduct an investigator-initiated study on the use of DSUVIA (sufentanil sublingual tablet 30 mcg) in same-day plastic surgery procedures. The study, led by Dr. Hisham Seify, will evaluate the safety and efficacy of DSUVIA in various surgical settings, analyzing data from 70 patients. This initiative aims to provide valuable insights into DSUVIA's use as a non-invasive pain management alternative in plastic surgery, which is increasingly adopting this treatment.
AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) has announced the pricing of a public offering of 14.5 million shares of common stock, expected to raise approximately $27.5 million in gross proceeds. The offering is set to close on or about January 22, 2021, subject to customary conditions. AcelRx has granted its underwriter a 30-day option to purchase an additional 2.2 million shares. The funds will be used for working capital, commercialization efforts, and R&D expenses. Cantor Fitzgerald & Co. acts as the sole book-running manager for this offering.
AcelRx Pharmaceuticals (NASDAQ: ACRX) announced an underwritten public offering of common stock on January 19, 2021, with all shares sold by the company. Cantor Fitzgerald & Co. serves as the sole book-running manager, and the underwriter has a 30-day option to purchase an additional 15% of the offered shares. Funds from the offering will be allocated for working capital, commercialization, and R&D expenses, as well as debt payments. This offering is part of a previously filed shelf registration statement with the SEC, effective since July 8, 2020.
AcelRx Pharmaceuticals (Nasdaq: ACRX) announced an investigator-initiated study at University Hospitals Cleveland Medical Center to evaluate the use of DSUVIA in cardiac surgery recovery. The study will assess outcomes like ventilation time, hospital stay, and opioid dosage in patients following enhanced recovery protocols. Dr. Daniel Asher will lead the study. DSUVIA, approved by the FDA in November 2018, aims to provide effective pain management while minimizing opioid use and adverse effects. This study reflects AcelRx's commitment to advancing innovative therapies in postoperative care.
AcelRx Pharmaceuticals (NASDAQ: ACRX) reported preliminary unaudited financial results for FY 2020, with revenues approximating $5.4 million and a cash balance of $42.9 million as of December 31. Key highlights included the approval of DSUVIA by the DoD, expected to generate $30 million in orders over three years, and various ongoing studies assessing DSUVIA's efficacy in reducing opioid use. The company achieved 348 formulary approvals despite COVID-19 challenges. CEO Vince Angotti expressed confidence in future data supporting DSUVIA's market position.
AcelRx Pharmaceuticals (NASDAQ: ACRX) announced a publication in the Journal of Universal Surgery detailing clinical data on its product DSUVIA for acute perioperative pain management. The study involved 298 patients and found that DSUVIA significantly reduced intraoperative IV opioid use by 66% and postoperative opioid requirements by over 50%. Additionally, recovery times in the PACU were shorter, averaging 14 minutes less for those using DSUVIA. The findings suggest economic benefits for hospitals and reinforce DSUVIA's efficacy as a pain management solution.
AcelRx Pharmaceuticals has announced a registered direct offering of 8,333,333 shares of common stock at $1.20 per share, potentially raising $10 million in gross proceeds. The transaction is expected to close by December 11, 2020, pending customary closing conditions. This offering is conducted under a previously filed shelf registration statement with the SEC, effective since July 8, 2020. AcelRx is focused on developing innovative therapies for healthcare settings, with one approved product in the U.S. and additional products in Europe.
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