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, focused on innovative therapies, presented data on DSUVIA (sufentanil sublingual tablet) at the California Society of Plastic Surgeons Annual Meeting. The study involving 76 patients demonstrated effective pain management during both short and long surgical procedures, with minimal opioid use post-surgery. 89% of patients were opioid-free after lengthy procedures, and no serious adverse events were reported. DSUVIA aims to improve postoperative pain control while reducing recovery times, highlighting its potential in outpatient settings.
AcelRx Pharmaceuticals (Nasdaq: ACRX) announced a podium presentation on DSUVIA at the California Society of Plastic Surgeons Annual Meeting in Monterey, CA. The presentation, titled 'The Use of Sublingual Sufentanil for Peri-operative Pain Management in an Outpatient and Clinic Setting,' will be given by Dr. Hisham Seify on May 31, 2021. DSUVIA is designed for acute pain management in medically supervised settings, providing rapid analgesia with a non-invasive method. AcelRx is also in discussions for potential European marketing partnerships for its product.
AcelRx Pharmaceuticals (Nasdaq: ACRX) announced an investigator-initiated study at Tampa General Hospital to evaluate DSUVIA for managing acute pain in sickle cell disease patients experiencing vaso-occlusive crisis (VOC). The study will enroll 100 patients receiving DSUVIA while waiting for IV access, comparing their outcomes to a historical control group. Key endpoints include time to analgesia, hospital admission rates, and patient satisfaction. DSUVIA, a rapid-onset sublingual medication, aims to improve pain management for opioid-tolerant patients in emergency settings.
AcelRx Pharmaceuticals (ACRX) reported its Q1 2021 financial results, revealing net revenues of $0.5 million and a net loss of $9.0 million, down from $15.9 million in Q1 2020. Cash reserves stood at $67.3 million. CEO Vince Angotti emphasized progress in the commercialization of DSUVIA, which saw its highest ordering volume in April. The company has engaged in several investigator-initiated studies to build evidence for DSUVIA's effectiveness in pain management, alongside achieving 432 formulary approvals. A response to an FDA warning letter has been submitted, with ongoing discussions for closure.
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) announced a poster presentation at the 46th Annual Regional Anesthesiology and Acute Pain Medicine Meeting, detailing a study on DSUVIA (sufentanil sublingual tablet) for managing acute pain. The study found that patients receiving 30 mcg of SST required 50% less opioids in the post-anesthesia care unit (PACU) and had higher opioid-free percentages (36% vs. 8%). Although PACU pain scores were not significantly different, the improved overall benefit of analgesia scores indicated greater patient satisfaction. Limitations included the lack of comparison to an active control group.
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) will announce its first quarter financial results on May 17, 2021, after market close. A live conference call and webcast will follow at 4:30 p.m. ET, where management will discuss the financials and provide updates on the business. The webcast can be accessed via the company's website, along with a presentation. AcelRx specializes in developing innovative therapies for medically supervised settings, featuring products like DSUVIA® and Zalviso® for pain management.
AcelRx Pharmaceuticals (Nasdaq: ACRX) announced a new investigator-initiated study at The CORE Institute Specialty Hospital, Phoenix, Arizona, assessing DSUVIA (sufentanil sublingual tablet 30 mcg) for pain management in same-day hip or knee replacements. The study aims to evaluate the effectiveness and safety of DSUVIA versus standard care in 100 patients, focusing on length of stay, morphine use, and therapy completion. The initiative may enhance patient discharge outcomes and reduce side effects associated with traditional IV opioids.
AcelRx Pharmaceuticals (Nasdaq: ACRX) announced an investigator-initiated study at Montefiore Medical Center to evaluate the safety and efficacy of DSUVIA (sufentanil sublingual tablet 30 mcg) in patients on buprenorphine therapy undergoing same-day surgical procedures. The study, led by Dr. Naum Shaparin, will assess analgesic effectiveness compared to standard IV opioids across 30 patients. The goal is to determine if DSUVIA can enhance pain management in this challenging patient population.
AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) announced the appointment of Marina Bozilenko to its Board of Directors. With over 30 years of healthcare and investment banking experience, Bozilenko has a proven track record of raising over $30 billion and leading numerous M&A transactions. CEO Vince Angotti expressed optimism about her contributions, especially as AcelRx seeks to enhance its market presence and formulary approvals. Bozilenko aims to leverage her expertise to support the company's growth.
AcelRx Pharmaceuticals (NASDAQ: ACRX) announced the publication of Phase 3 data on DSUVIA in the Journal of Pain Research, showing high satisfaction ratings from both patients and healthcare professionals for acute pain management. The pooled analysis of 283 patients revealed that 61% of healthcare professionals rated pain control in older patients as "excellent". DSUVIA was mentioned to have a well-tolerated safety profile, with 68% of patients experiencing no adverse events. Key adverse events included nausea (22.9%) and headache (5.0%). The findings support DSUVIA’s effectiveness across various demographic subgroups.
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