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AcelRx Announces Year-End 2020 Metrics and Review of 2020 Achievements

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AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced preliminary unaudited financial results and other information in connection with its participation in investor presentations, meetings and events during the week of the 39th Annual J.P. Morgan Healthcare Conference. The Company will post its revised corporate presentation in the investor section of its website.

Key Highlights of 2020

  • DSUVIA® achieved Milestone C approval from the Department of Defense (DoD), a decision that approves DSUVIA for use in all U.S. Army sets, kits and outfits (SKOs). Initial stocking orders have begun for U.S. Army SKOs and are expected to approximate $30 million over the next three years, dependent on troop deployment schedules.

  • In March, AcelRx announced an agreement with Brigham and Women’s Hospital for an investigator-initiated study of DSUVIA led by Richard D. Urman MD, MBA, Associate Professor of Anesthesia and co-director of the Center for Perioperative Research at Brigham and Women’s Hospital and Harvard Medical School. This study is ongoing and is evaluating the perioperative use of DSUVIA in patients undergoing spine surgery compared to their standard intravenous (IV) opioid regimen.

  • In July, AcelRx entered into a distribution agreement with Zimmer Biomet to market DSUVIA within the dental and oral surgery markets in the United States exclusively through Zimmer Biomet’s Dental division. The formal launch is planned in 2021, once Zimmer Biomet receives necessary licenses. The estimated applicable market in dental surgeries is over 7 million annual procedures.

  • In August, AcelRx announced the publication of a study entitled, “Reduced Opioid Use and Reduced Time in the Postanesthesia Care Unit Following Preoperative Administration of Sublingual Sufentanil in an Ambulatory Surgery Setting,” by Christian Tvetenstrand, MD and Michael Wolff, MD, in the Journal of Clinical Anesthesia and Pain Management (Tvetenstrand and Wolff Study). Highlights of the publication included a greater than 50% overall reduction in opioids administered perioperatively and a 34% reduction in postanesthesia care unit (PACU) time in the DSUVIA-treated patients compared to historical controls. See Cautionary Statements section below.

  • In August, AcelRx announced an investigator-initiated study with Cleveland Clinic evaluating the effects of DSUVIA on post-operative recovery from orthopedic surgery. This double-blind study is ongoing and compares DSUVIA to IV fentanyl for patients undergoing knee arthroscopy.

  • In September, AcelRx announced that the U.S. military’s access to DSUVIA was expanded with the addition of DSUVIA to the DoD Joint Deployment Formulary.

  • In September, the U.S. Army awarded AcelRx a contract of up to $3.6 million over four years for the purchase of DSUVIA to support a DoD study to aid the development of clinical practice guidelines.

  • In December, AcelRx announced the publication of clinical data in an article in the Journal of Universal Surgery entitled, “A Medication Use Evaluation of Sufentanil Sublingual Tablet 30 mcg for the Perioperative Management of Surgical Pain,” by lead author Koth Cassavaugh, PharmD, Director of Pharmacy (the Cassavaugh Evaluation), which reported that perioperative dosing of DSUVIA can provide more rapid PACU recovery times compared to standard IV opioid administration. In addition, patients in the control group received 66% higher mean dosing of intraoperative IV opioids compared to patients receiving DSUVIA and postoperative opioid use for the DSUVIA group was less than half of the control IV opioid group, with orthopedic surgery patients having the largest decrease (69%). See Cautionary Statements section below.

  • Achieved 348 formulary approvals through the close of 2020, a significant achievement in a year with COVID-related restrictions and delays.

  • Preliminary unaudited FY 2020 revenues approximated $5.4 million.

  • Preliminary December 31, 2020 cash, cash equivalents and short-term investments balance was $42.9 million.

“I’m pleased with our team’s commercial execution during these challenging times,” said Vince Angotti, AcelRx Chief Executive Officer.  “We expect further real-world data to support the value proposition of DSUVIA as an alternative to IV opioids, and we continue to make solid progress on the four pillars of our revenue plan.  I look forward to providing further updates during our year-end earnings call.”

The information above related to the Company’s expected operating results for the year ended and as of December 31, 2020, including revenue and cash, cash equivalents and short-term investments, is preliminary, has not been audited and is subject to change upon completion of the audit of the Company’s financial statements as of and for the year ended December 31, 2020.

About DSUVIA (sufentanil sublingual tablet), 30 mcg

DSUVIA®, known as DZUVEO™ in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners. This release is intended for investors only. For more information, including important safety information and black box warning for DSUVIA, please visit www.DSUVIA.com.

About AcelRx Pharmaceuticals, Inc.

AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.  AcelRx’s proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. AcelRx has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO™ in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.  For additional information about AcelRx, please visit www.acelrx.com.

Cautionary Statements

Tvetenstrand and Wolff Study
The study compared a prospective group of patients with preoperative dosing of a single sublingual DSUVIA tablet to a historical control group receiving standard intravenous (IV) opioid administration for same-day general surgery procedures. A total of 127 patients were evaluated in the study. Study limitations include that it was an open-label study, the retrospective nature of the control group, and the focus on only general surgery patients. AcelRx did not provide funding for the conduct of the Tvetenstrand and Wolff Study but did fund medical writing support. Dr. Tvetenstrand is a paid consultant of AcelRx.

Cassavaugh Evaluation
The evaluation focused on 140 patients who were dosed with DSUVIA compared to 158 patients who had been dosed with traditional IV opioids during the same time period undergoing the same surgical procedures. Study limitations included that it was a single-center, retrospective study of DSUVIA dosing in a surgical patient population and both inpatient and outpatient surgery data was combined. The study did not control for whether patients were opiate naïve or opiate tolerant in the treatment groups, however, there is no reason for these patients to be present at a substantially higher frequency in either group. AcelRx did not provide funding for the conduct of the evaluation but did fund medical writing support. Dr. Cassavaugh is a paid consultant of AcelRx.

Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related to revenues and cash, cash equivalents and short-term investments AcelRx expects to report for fiscal year 2020, the timing of the procurement of DSUVIA by the military, the timing of the formal launch by Zimmer Biomet, and expectations for further real-world data to support the value proposition of DSUVIA as an alternative to IV opioids. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as “believes,” “expects,” “anticipates,” “may,” “will,” “should,” “seeks,” “approximately,” “intends,” “plans,” “estimates,” or the negative of these words or other comparable terminology. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements. In addition,  such risks and uncertainties may include, but are not limited to, those described in AcelRx’s annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. Except to the extent required by law, AcelRx undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

SOURCE AcelRx Pharmaceuticals, Inc.

Related Links

http://www.acelrx.com

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ROSEN, A TOP RANKED LAW FIRM, Continues to Investigate Securities Claims Against OrthoPediatrics Corp. – KIDS

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Rosen Law Firm, a global investor rights law firm, continues to investigate potential securities claims on behalf of shareholders of OrthoPediatrics Corp. (NASDAQ: KIDS) resulting from allegations that OrthoPediatrics may have issued materially misleading business information to the investing public.

On December 2, 2020, Culper Research published a report entitled “OrthoPediatrics Corp. (KIDS): Even Channel Stuffing Can’t Save This Company[.]” The report alleged that OrthoPediatrics has “engaged in a channel stuffing scheme that has systematically and significantly overstated revenues.” On this news, the Company’s stock price fell $5.40 per share, or 12%, to close at $39.35 per share on December 3, 2020.

Then on December 14, 2020, Culper Research published a second report entitled “OrthoPediatrics Corp. (KIDS): Pleading the Fifth” in which it concluded that the Company “is a structurally broken business which has relied on nefarious tactics to inflate its reported revenues.”

Rosen Law Firm is preparing a securities lawsuit on behalf of OrthoPediatrics shareholders. If you purchased securities of OrthoPediatrics please visit the firm’s website at http://www.rosenlegal.com/cases-register-2015.html to join the securities action. You may also contact Phillip Kim of Rosen Law Firm toll free at 866-767-3653 or via email at pkim@rosenlegal.com or cases@rosenlegal.com.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm or on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm.

Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 3 each year since 2013. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm’s attorneys are ranked and recognized by numerous independent and respected sources. Rosen Law Firm has secured hundreds of millions of dollars for investors.

Attorney Advertising. Prior results do not guarantee a similar outcome.

Contact Information:

Laurence Rosen, Esq.
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686-1060
Toll Free: (866) 767-3653
Fax: (212) 202-3827
lrosen@rosenlegal.com
pkim@rosenlegal.com
cases@rosenlegal.com
www.rosenlegal.com

SOURCE Rosen Law Firm, P.A.

Related Links

www.rosenlegal.com

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University Medical Center Opens Onsite COVID-19 Vaccination Center At Encore At Wynn Las Vegas

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The UMC COVID-19 Vaccination Center will open its doors at Encore at Wynn Las Vegas (NASDAQ: WYNN) on Monday, January 18.

The UMC COVID-19 Vaccination Center will operate Monday – Friday, with the ability to increase hours as the program expands. It is conveniently located in the resort’s convention space near the Encore self-parking garage. Vaccines at the Center are available to residents of Nevada who are eligible under the current State of Nevada vaccination guidelines.

Initially, the UMC COVID-19 Vaccination Center will only offer the vaccine to people 70 and older, healthcare workers, and first responders.

To ensure efficiency, appointments are required by UMC and can be scheduled in advance at www.umcsn.com/COVIDvaccine or by calling (702) 383-2619. Eligible Nevadans may need to book their appointments several weeks in advance.

To determine eligibility for the vaccine under the current state guidelines, please visit https://nvhealthresponse.nv.gov/wp-content/uploads/2021/01/NEVADA-COVID-19-VACCINE-PLAYBOOK-V3-BRIEF_011121.pdf.

This unique partnership was formed to increase distribution of the vaccine throughout the Las Vegas Valley at a convenient location, and to assist in the state’s recovery from the pandemic.

“We offered Encore as a vaccination location to help facilitate vaccine distribution as quickly and efficiently as possible throughout the Las Vegas Valley,” said Matt Maddox, CEO of Wynn Resorts. “Our partnership with UMC began with our extensive onsite employee testing program. Based upon the success of that program with UMC, we look forward to hosting this critical step in our state’s economic and health recovery.”

“The UMC COVID-19 Vaccination Center at Encore will serve as a valuable asset to our community as we work together to protect our most vulnerable populations and eventually bring an end to the COVID-19 pandemic,” said UMC CEO Mason Van Houweling. “UMC’s world-class health care team members look forward to working alongside our trusted partners at Wynn Resorts to build a brighter, healthier future for Southern Nevada.”

The Encore location will replace UMC’s existing COVID-19 vaccination clinic at UMC’s Delta Point Building. All UMC vaccination appointments scheduled on or after January 18 will take place at the Encore location.

The UMC COVID-19 Vaccination Center is equipped to offer hundreds of vaccinations each day. Additional information is available at www.umcsn.com/COVIDvaccine.

About Wynn Resorts COVID-19 Relief Efforts

Wynn Resorts is committed to protecting our employees, working for the health and safety of our guests, and taking care of our communities impacted by COVID-19 with relief efforts that fill financial and supply chain gaps where they matter most. The donation and volunteer strategies follow an extensive financial protection plan implemented by Wynn Resorts CEO Matt Maddox that began with a $250 million investment that ensured all 15,000 Wynn employees in North America received their full wage during the government-mandated shutdown.

To provide relief to first responders and protection to those suffering the financial impact of the crisis, the Company procured and donated more than $3 million worth of financial aid, personal protective equipment, food and prepared meals, and essential cleaning and hygiene supplies to dozens of health care facilities and local nonprofit organizations throughout Las Vegas and Greater Boston. In May 2020, Wynn Las Vegas began providing all employees with direct access to reliable and accurate COVID-19 tests on-site at no cost; and in early 2021 will debut a custom-built state-of-the-art COVID-19 testing lab and mobile health app available to resort guests.

Media Contact:
Michael Weaver
702-770-7501
michael.weaver@wynnresorts.com

Deanna Pettit-Irestone
702-770-2121
deanna.pettit@wynnlasvegas.com

SOURCE Wynn Las Vegas

Related Links

http://www.wynnlasvegas.com

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Caesars Entertainment, Inc. to Report 2020 Fourth Quarter and Full-Year Results on February 25, 2021

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Caesars Entertainment, Inc. (NASDAQ: CZR) will release its financial results for the fourth quarter and full-year 2020 after the market closes on Thursday, February 25, 2021. The company will also host a conference call on February 25, 2021 at 5:00 p.m. Eastern Time2:00 p.m. Pacific Time, to discuss its results and other matters related to the company.

Participants should dial (833) 665-0647, or (914) 987-7309 for international callers, and enter Conference ID 5039038 approximately 10 minutes before the call start time. The call will be accessible on the Investor Relations section of Caesars Entertainment’s website at https://investor.caesars.com.

A recording of the live call will be available on the Investor Relations section of the company’s website for 90 days after the event.

About Caesars Entertainment, Inc.

Caesars Entertainment, Inc. is one of the largest gaming-entertainment companies in the U.S. and one of the world’s most diversified gaming-entertainment providers. Since its beginning in Reno, Nevada, in 1937, Caesars Entertainment has grown through development of new resorts, expansions and acquisitions. Caesars Entertainment’s resorts operate primarily under the Caesars®, Harrah’s®, Horseshoe® and Eldorado® brand names. Caesars Entertainment offers diversified amenities and one-of-a-kind destinations, with a focus on building loyalty and value with its guests through a unique combination of impeccable service, operational excellence and technology leadership. Caesars Entertainment is committed to its employees, suppliers, communities and the environment through its PEOPLE PLANET PLAY framework. For more information, please visit www.caesars.com/corporate.

SOURCE Caesars Entertainment, Inc.

Related Links

http://www.caesars.com

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