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, a specialty pharmaceutical company, will present an overview of its business at the LD Micro Main Event on December 14 at 1:40 p.m. ET. A live webcast will be available for those interested in the updates. AcelRx specializes in innovative therapies for medically supervised environments, offering products like DSUVIA® for acute pain management. The company's pipeline includes Zalviso®, designed for patient-controlled analgesia, which is not yet approved in the U.S. For more details, visit www.acelrx.com.
AcelRx Pharmaceuticals (NASDAQ: ACRX) has partnered with the National Rural Health Association (NRHA) to enhance the marketing of its product, DSUVIA® (sufentanil sublingual tablet, 30 mcg). This initiative aims to address healthcare challenges in rural areas, especially during the pandemic. DSUVIA is designed for acute pain management in medically supervised settings, providing rapid analgesia without the complications of IV administration. The partnership emphasizes opioid stewardship and better patient care in rural hospitals.
AcelRx Pharmaceuticals (NASDAQ: ACRX) announced the publication of a commentary in Practical Pain Management discussing the benefits of DSUVIA for acute pain management. The commentary, authored by three pharmacy thought-leaders, highlights a study indicating that preoperative DSUVIA administration led to faster discharge from the post-anesthesia care unit and reduced opioid use by over 50%. DSUVIA is designed for use in medically supervised settings and has FDA approval since November 2018. The company is actively seeking European marketing partners for its product.
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) has announced its participation in the Credit Suisse 29th Annual Virtual Healthcare Conference, scheduled for November 9-12, 2020. Management will present a business overview on November 10, at 2 pm ET. Investors will have opportunities for one-on-one meetings. A live webcast will be available on AcelRx's website, with a replay archived for 90 days. AcelRx specializes in innovative therapies for medically supervised settings, with approved products DSUVIA® in the U.S. and DZUVEO™ in Europe, along with the Zalviso® system under development.
AcelRx Pharmaceuticals reported its Q3 2020 financial results, showcasing notable progress following the approval of DSUVIA. The company generated $1.4 million in net revenues, significantly up from $0.3 million in Q2 2020. AcelRx reduced its combined R&D and SG&A expenses to $8.6 million compared to $12.0 million in Q3 2019. Noteworthy achievements include a collaboration with Zimmer Biomet, DSUVIA's addition to the Department of Defense formulary, and a $3.6 million contract from the U.S. Army. The net loss for Q3 2020 was $8.9 million.
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) will release its third quarter financial results on November 5, 2020, after market close. A live webcast and conference call will take place at 4:30 p.m. ET to discuss these results and provide business updates. The conference call can be accessed by dialing specific numbers for domestic, Canadian, and international callers. AcelRx specializes in developing innovative therapies for medically supervised settings and has one FDA-approved product, DSUVIA®, and another candidate, Zalviso®, currently in development.
AcelRx Pharmaceuticals (Nasdaq: ACRX) will host a virtual Key Opinion Leader (KOL) event on the perioperative use of DSUVIA on October 7, 2020, at 12 PM ET. The event will feature presentations by Dr. Christian Tvetenstrand and Dr. Koth Cassavaugh, discussing studies on DSUVIA's effectiveness in reducing opioid use post-surgery. DSUVIA, approved by the FDA in November 2018, is a sublingual sufentanil tablet designed for acute pain management in medically supervised settings. The event can be accessed through the company's website.
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) has secured a contract of up to $3.6 million from the U.S. Army for its product DSUVIA. This contract aims to support a study for developing clinical practice guidelines. Orders may be fulfilled over four years, with an initial purchase expected within the year. AcelRx anticipates additional orders for troop deployments following DSUVIA’s approval for the Joint Deployment Formulary. DSUVIA is indicated for managing severe acute pain in medically supervised settings, highlighting its unique sublingual delivery and pharmacokinetic profile.
AcelRx Pharmaceuticals announced the addition of DSUVIA to the U.S. Department of Defense's Joint Deployment Formulary, enhancing military access to the drug. This milestone underscores the significance of DSUVIA in managing acute pain and reflects growing momentum for its use, supported by new data indicating improved recovery times in surgical settings. DSUVIA, approved by the FDA in November 2018, is designed for non-invasive administration, offering advantages over intravenous alternatives. AcelRx continues discussions for European marketing partnerships for its products.
AcelRx Pharmaceuticals (Nasdaq: ACRX), a specialty pharmaceutical company, will present at two upcoming conferences: the H.C. Wainwright & Co. 22nd Annual Global Investment Conference on September 14, 2020 and the Cantor Fitzgerald Virtual Global Healthcare Conference on September 16, 2020. The management will provide business updates and participate in one-on-one investor meetings. A live webcast can be accessed via the company’s website. Replays will be available for 90 days after the events.
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