Stock Monitor: Cesca Therapeutics Post Earnings Reporting
LONDON, UK / ACCESSWIRE / April 18, 2018 / Active-Investors.com has just released a free research report on AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) ("AcelRx").If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=ACRX as the Company's latest news hit the wire. On April 16, 2018, the specialty pharmaceutical Company, which is focused on the development and commercialization of innovative therapies for the treatment of acute pain, declared the successful completion of the human factor study to validate the effectiveness of the revised DSUVIA directions for use (DFU). Register today and get access to over 1,000 Free Research Reports by joining our site below:
Active-Investors.com is currently working on the research report for Cesca Therapeutics Inc. (NASDAQ: KOOL), which also belongs to the Healthcare sector as the Company AcelRx Pharma. Do not miss out and become a member today for free to access this upcoming report at:
Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, AcelRx Pharma most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:
This news went well with the investors as AcelRx's shares were up 9% premarket on the day of announcement.
DSUVIA (sufentanil sublingual tablet, 30 mcg) is AcelRx's investigational product candidate, indicated for the management of moderate-to-severe acute pain in a variety of medically supervised settings, such as in emergency medicine, outpatient or ambulatory surgery, non-surgical patients experiencing pain in the hospital, or post-operative patients, after short-stay surgery, who do not require more long-term analgesia. DSUVIA consists of 30-mcg sufentanil in very small sublingually absorbed tablets, which are delivered through a disposable, pre-filled, single-dose applicator (SDA).
FDA Recommendations for Resubmission of DSUVIA NDA
AcelRx submitted a New Drug Application (NDA) for DSUVIA to the US Food and Drug Administration (FDA) on December 13, 2016. On October 12, 2017, the Company received a Complete Response Letter (CRL) from the FDA with recommendations for resubmission. The suggested changes intended to ensure the safe and proper administration of DSUVIA to patients by healthcare professionals in medically supervised settings. It included the following two points:
- Collect additional data in 50 patients with postoperative pain adequate to evaluate the safety of DSUVIA at the maximum dosage in the proposed label; and
- Modify the DFU to mitigate the risk of misplaced tablets and validate the effectiveness of these changes in a human factors study.
Subsequently, the Company shared its official January 2018 Type A meeting minutes with the FDA on March 08, 2018.
- For the first recommendation, AcelRx proposed to reduce the maximum dose in the label to not exceed 12 tablets within a 24-hour period. The existing data from the higher dosing patients in DSUVIA and Zalviso clinical trials should be sufficient to evaluate the safety of DSUVIA at this reduced maximum available daily dose. The FDA found the proposed revision reasonable to support safety at maximal dosing in the DSUVIA NDA resubmission.
- For the second recommendation, AcelRx submitted an updated DFU and a revised protocol for the human factors (HF) study, which is meant to validate the effectiveness of the revised DSUVIA DFU. The FDA reviewed and provided its comments on the updated DFU and HF study protocol.
DSUVIA NDA to be Resubmitted in Q2 FY18
AcelRx stated that the completion of the HF study was the final step needed for the preparation of DSUVIA NDA. The Company intends to resubmit a new NDA in the second quarter of 2018. In the NDA resubmission, AcelRx will provide results from HF study along with the additional DSUVIA and Zalviso data analysis for validating the reduced maximum daily dosage. The approval of DSUVIA would satisfy a large unmet need within healthcare settings and provide healthcare providers and patients with non-invasive pain management options for moderate-to-severe acute pain within medically supervised settings.
Stock Performance Snapshot
April 17, 2018 - At Tuesday's closing bell, AcelRx Pharma's stock ended the trading session flat at $2.40.
Volume traded for the day: 458.59 thousand shares, which was above the 3-month average volume of 438.28 thousand shares.
Stock performance in the last month – up 15.66%; previous three-month period – up 15.66%; past six-month period – up 12.94%; and year-to-date - up 18.52%
After yesterday's close, AcelRx Pharma's market cap was at $121.03 million.
The stock is part of the Healthcare sector, categorized under the Medical Appliances & Equipment industry. This sector was up 0.9% at the end of the session.
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