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 reported a successful initial development batch of its Niyad product and plans for Emergency Use Authorization in early 2023. DSUVIA sales reached $0.5 million in Q3 2022, marking a 217% increase year-over-year. The company holds $20.9 million in cash and short-term investments as of September 30, 2022. Despite a decline in total net revenues due to a prior year upfront payment, AcelRx reduced overall expenses to $6.6 million. The net loss per share was $0.94, down from $1.40 in Q3 2021. Future product submissions and commercial planning are in progress.
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) will release its third quarter financial results on November 14, 2022, post-market. A conference call and webcast will follow at 4:30 p.m. EDT to discuss the results and business updates. Investors can access the webcast via the company's website. AcelRx specializes in innovative therapies for medically supervised settings, with approved products like DSUVIA® for acute pain management and investigational products under development.
AcelRx Pharmaceuticals (Nasdaq: ACRX) reported positive findings from a study presented at Plastic Surgery The Meeting 2022, demonstrating the benefits of DSUVIA (sufentanil sublingual tablets) in 324 complex plastic surgery procedures. The study indicated that DSUVIA enables surgeries without general anesthesia, significantly reducing discharge times and cognitive impairments. Complications were minimal, with no significant vital sign instability. Surgeons noted that patients preferred avoiding general anesthesia's costs and risks, supporting DSUVIA as a viable alternative.
AcelRx Pharmaceuticals has announced the launch of DZUVEO® (sufentanil sublingual tablet, 30 mcg) across Europe through its commercial partner Laboratorie Aguettant. This marks the first time DZUVEO is available outside the U.S., where it is known as DSUVIA®. The product offers a non-invasive option for acute pain management, designed to reduce dosing errors and improve recovery times compared to intravenous opioids. The launch covers key European markets, with Spain, Portugal, and Italy expected to commence commercialization in the first half of 2023.
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) announced the results of a study conducted at Brigham and Women's Hospital, demonstrating that patients treated with its sufentanil sublingual tablet (SST) post-major spine surgery reported significantly lower pain scores compared to those receiving intravenous opioids. The 190-patient trial revealed SST patients averaged a pain score of 3.2 vs. 5.7 and 5.0 for two IV opioid control groups (p<0.001). The findings, presented at the ANESTHESIOLOGY 2022 meeting, suggest SST's potential as an effective analgesic alternative in post-operative care.
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) announced a 1-for-20 reverse stock split effective October 25, 2022, at 5:01 p.m. ET. This action is aimed at regaining compliance with Nasdaq's minimum bid price of $1.00. Following the split, the number of outstanding shares will decrease from approximately 147 million to about 7.4 million. AcelRx's stock will trade on a split-adjusted basis starting October 26, 2022. The reverse split will not change stockholders' percentage interests, although fractional shares will be converted to cash. Stockholders can reach out to their brokers or Computershare for queries.
AcelRx Pharmaceuticals presented at the ANESTHESIOLOGY 2022 meeting about the potential of DSUVIA® for battlefield analgesia. The abstract emphasizes the advantages of the sufentanil sublingual tablet (SST) for rapid pain relief, citing its benefits over traditional opioid options like morphine and fentanyl. Aimed at the Department of Defense, the SST is noted for its quick onset, minimal side effects, and low risk of addiction, marking a significant evolution in military pain management protocols. CEO Vince Angotti reiterated the importance of DSUVIA as a safer alternative for soldiers in acute trauma situations.
AcelRx Pharmaceuticals, based in Hayward, Calif., has announced that CEO Vince Angotti will present at the H.C. Wainwright Annual Investment Conference from September 12-14, 2022, in New York. The presentation will include a live component and one-on-one meetings. Investors can access the live broadcast on September 12 at 12:00 PM EDT via a provided webcast link. After the event, the recorded presentation will be available on AcelRx's website for 90 days. AcelRx focuses on innovative therapies, including the opioid DSUVIA, for acute pain management in medically supervised settings.
AcelRx Pharmaceuticals (ACRX) announced an abstract on DSUVIA's benefits for battlefield analgesia accepted at the ANESTHESIOLOGY 2022 annual meeting. The abstract emphasizes DSUVIA's advantages over traditional morphine, including a high therapeutic index and rapid onset of action. The company aims to collaborate with the Department of Defense to enhance DSUVIA's use among military personnel. This focus aligns with efforts to improve pain management protocols in trauma settings, addressing the limitations associated with morphine, thereby positioning DSUVIA as a safer alternative for soldiers.
AcelRx Pharmaceuticals reported Q2 2022 net revenues of $0.6 million, marking a 133% increase year-over-year in commercial sales for DSUVIA. The company anticipates achieving $9 million in annual savings from a realigned cost structure initiated in June 2022, alongside an $84.1 million gain from extinguishing debt. AcelRx is on track for an EU launch of DZUVEO and pursuing Emergency Use Authorization for Niyad™ in 2023. The cash balance was $27.9 million as of June 30, 2022, and the company continues to reduce headcount to manage expenses.
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