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 announced a podium presentation on its product DSUVIA at The Aesthetic Society's annual meeting in San Diego, occurring from April 20-24, 2022. Dr. Hisham Seify will present data on DSUVIA's efficacy and safety for outpatient plastic surgeries. DSUVIA, a sublingual sufentanil tablet, is designed for acute pain management in medically supervised settings. The product aims to minimize opioid use while ensuring effective pain relief. This presentation may enhance awareness and support for DSUVIA's application in cosmetic procedures.
AcelRx Pharmaceuticals has published a study demonstrating the effectiveness of its sufentanil sublingual tablet (SST) 30 mcg for managing pain during radiofrequency microneedling procedures. The study indicated that 96% of patients completed the treatment with SST, compared to only 45% for topical anesthetic alone (p < 0.001). Patient satisfaction and comfort were significantly higher with SST, with only 6% reporting restlessness versus 51% for the control. The results suggest that SST enhances patient experience without severe side effects, potentially positioning DSUVIA as a standard in cosmetic procedures.
AcelRx Pharmaceuticals (NASDAQ: ACRX) announced the publication of study results comparing the efficacy of nafamostat with regional citrate anticoagulation in pediatric continuous renal replacement therapy (CRRT). The study showed that nafamostat, used widely in Korea and Japan, matched citrate's efficacy while exhibiting lower toxicity and costs. Key findings included no incidents of citrate toxicity with nafamostat, which was three times more cost-effective than citrate. AcelRx aims to develop nafamostat for CRRT, hoping to mitigate citrate's risks and simplify administration.
AcelRx Pharmaceuticals (Nasdaq: ACRX) reported its financial results for Q4 and full year 2021, highlighting strategic expansion through new acquisitions, including pre-filled syringe candidates. The company achieved 813 formulary approvals for DSUVIA and noted a 63% increase in unit sales for early Q1 2022 compared to Q4 2021. Despite a net loss of $7.9 million for Q4 2021, down from $8.9 million in Q4 2020, AcelRx aims to submit two NDAs in 2022, with projected R&D and SG&A expenses around $9-10 million quarterly.
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) will release its fourth quarter financial results on March 10, 2022, after market close. The management will conduct a live webcast and conference call at 4:30 PM ET to discuss the results and company updates. Investors can access the webcast via the company's website, where the replay will be available for 90 days. AcelRx focuses on developing innovative therapies, including DSUVIA® for acute pain management and other product candidates such as Zalviso® and Niyad™.
AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) announced the publication of a study demonstrating the effectiveness of its sufentanil sublingual tablet (SST) in pain management during awake plastic surgery. Conducted by Dr. Hisham Seify, the study involved 31 patients and reported rapid recovery times averaging 15 minutes with minimal side effects, including no additional analgesics required during procedures. The findings highlight SST's potential for improving patient experience in medically supervised settings. Ongoing research aims to further evaluate its usage in larger cohorts.
AcelRx Pharmaceuticals (NASDAQ: ACRX) has announced the publication of a review article on the sufentanil sublingual tablet (DSUVIA) in Current Pain and Headache Reports. Authored by Dr. Sarang Koushik, the article highlights the challenges faced by patients with chronic pain regarding IV access during procedures. The review emphasizes DSUVIA's non-invasive administration, high bioavailability, and effectiveness in minimizing over-sedation while allowing real-time patient feedback. The discussion includes the advantages of DSUVIA in the context of COVID-19 and current drug shortages, promoting it as a valuable analgesic option for pain management.
AcelRx Pharmaceuticals (NASDAQ: ACRX) announced the publication of an editorial by Dr. Scott Sigman in the Journal of Orthopaedic Experience and Innovation, discussing the use of the sufentanil sublingual tablet (DSUVIA) in joint replacement surgery. Dr. Sigman's editorial emphasizes the potential of DSUVIA to reduce opioid usage and hospital stays, reporting a 30% decrease in opioid consumption and length of stay for patients treated with DSUVIA. The company aims to position DSUVIA as an important tool for opioid stewardship in surgical settings.
AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) has finalized its acquisition of Lowell Therapeutics, Inc. for approximately $3.5 million in cash and 9,009,538 shares of AcelRx common stock. The deal includes $26 million in contingent consideration linked to regulatory and sales milestones. Key product Niyad, an investigational anticoagulant with Breakthrough Designation from the FDA, is anticipated to generate peak sales of $200 million annually. The acquisition aims to enhance AcelRx's portfolio in medically supervised settings, particularly for dialysis patients.
AcelRx Pharmaceuticals announced the publication of real-world data indicating that sublingual sufentanil (DSUVIA) significantly reduces both hospital length of stay and opioid utilization in patients undergoing total hip and knee replacements. The study, involving 110 patients, revealed that those treated with DSUVIA had approximately 30% less opioid use and were discharged 30% sooner compared to those receiving standard IV opioids. These findings underscore the potential of DSUVIA in enhancing patient outcomes in surgical settings.
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