0.7600 -0.01 (-0.91%)
After hours: 7:19PM EST
|Bid||0.7600 x 1000|
|Ask||0.7690 x 1400|
|Day's Range||0.7022 - 0.7887|
|52 Week Range||0.4800 - 3.2900|
|Beta (5Y Monthly)||1.62|
|PE Ratio (TTM)||N/A|
|Earnings Date||Mar 12, 2020 - Mar 16, 2020|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||1.00|
We are still in an overall bull market and many stocks that smart money investors were piling into surged through the end of November. Among them, Facebook and Microsoft ranked among the top 3 picks and these stocks gained 54% and 51% respectively. Hedge funds' top 3 stock picks returned 41.7% this year and beat […]
On November 22, 2019, the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its NDA for Adamis’ ZIMHI™ high-dose naloxone injection product for the treatment of opioid overdose. The company has provided responses to the comments included in the CRL and submitted these answers to the FDA this week. With the responses, the company requested a Type A meeting with the agency and is currently waiting for the FDA to respond to this request.
Some investors might love biotech stocks for their lottery ticket-like returns when a company wins the FDA's blessing. A lottery ticket, however, costs only a buck or two, while getting a biotech company wrong can hurt a lot more than that. Case in point: Adamis Pharmaceuticals (ADMP) stock lost half of its value this week after getting the red light from the FDA.The FDA issued a complete response letter (CRL) to the company advising it that the new drug application for Zimhi, a high-dose naloxone injection used for the treatment of opioid overdose, would not be approved as a treatment for opioid overdose. The FDA raised questions about chemistry, manufacturing and controls (CMC), and provided recommendations required for resubmission.Naloxone is an opioid antagonist and works by stopping or reversing an opioid’s effects. The market for such a drug, unfortunately, is growing larger as drug overdoes are now the main cause of death for Americans under 50.As is the norm when receiving a CRL, the drug developer promises to work with the FDA to address any issues raised. Dr. Dennis J. Carlo, President and CEO of Adamis, said, “We believe the comments and recommendations stated in the CRL are manageable and plan to fully cooperate with the FDA. We remain committed to this product and our mission to provide physicians and patients access to a higher dose of naloxone. We will take the Agency’s suggestion and request a meeting as soon as reasonably possible to discuss our plan to resubmit the NDA.”Maxim analyst Jason McCarthy commented, “The company's plan is to expand on the CMC testing that has already been provided to the FDA to satisfy the CRL items. We are awaiting further clarity. In addition, given the company's cash balance of $12.1M and current burn rate, Adamis is likely going to need to raise capital and likely at a 'distressed' valuation.”As a result, McCarthy downgrades the stock from "buy" to "hold", as he "await[s] clarity on the path forward for the company." (To watch McCarthy's track record, click here)With that in mind, the question investors are asking is whether Adamis has bottomed out. With 1 Buy and 2 Holds, the beleaguered biotech currently ranked as a Moderate Buy. The average price target is a rounded $1.00, implying handsome upside potential of 72% for the risk tolerant investor. (See Adamis’s price targets and analyst ratings on TipRanks).To find good ideas for biotech stocks trading at fair value or better, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.
Shares of Adamis Pharmceuticals Corp. fell 52% in trading on Monday after the Food and Drug Administration rejected its application for Zimhi, a naloxone product aimed at treating opioid overdose. The company said the regulator's complete response letter (CRL) questioned chemistry, manufacturing and controls, and not the experimental treatment's safety or efficacy. "The comments and recommendations stated in the CRL are manageable," Adamis president and CEO Dennis Carol said in a news release. The company plans to resubmit its application once those issues have been addressed. Adamis shares have fallen 73% year-to-date. The S&P 500 is up nearly 25%.
Adamis Pharmaceuticals Corp said on Monday the U.S. Food and Drug Administration declined to approve its opioid overdose treatment, raising questions around its chemistry, manufacturing and controls (CMC). In a letter to the company, the FDA questioned the treatment's manufacturing process, but not its safety or effectiveness, Adamis said. The drug Zimhi is a naloxone pre-filled single dose syringe used for emergency treatment of known or suspected opioid overdose.
The CRL stated that the FDA determined it cannot approve the NDA in its present form and provided recommendations needed for resubmission. A CRL is issued by the FDA's Center for Drug Evaluation and Research when it has completed its review of a file and questions remain that preclude the approval of the NDA in its current form. The questions raised by the FDA related generally to Chemistry, Manufacturing and Controls (CMC).
The article compares the pharmacokinetics of two community naloxone formulations (2mg intramuscular (IM) and NARCAN® 4mg intranasal (IN)) to Adamis’ investigational drug ZIMHI (5mg IM) in healthy subjects. Overall, the systemic levels of naloxone associated with the 2mg IM and 4mg IN were similar. Naloxone is an opioid antagonist used to treat narcotic overdoses.
Adamis (ADMP) delivered earnings and revenue surprises of -83.33% and -9.88%, respectively, for the quarter ended September 2019. Do the numbers hold clues to what lies ahead for the stock?
Adamis Pharmaceuticals Corporation (ADMP) today announced financial results for the third quarter ended September 30, 2019 and provided a business update. Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, “Since the full launch in July, Sandoz has implemented several initiatives that we expect will increase sales of SYMJEPITM. “While we are eager for sales of SYMJEPI to grow, we are also looking forward to a final decision by the FDA on ZIMHITM, our naloxone injection product candidate.
Investors need to pay close attention to Adamis Pharmaceuticals (ADMP) stock based on the movements in the options market lately.
SAN DIEGO, Calif., Nov. 06, 2019 -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”) announced today that it will host an investor conference call on Tuesday,.
Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech stocks hitting 52-week highs on Nov. 4) Agile Therapeutics Inc (NASDAQ: AGRX )(follow-on rally ...
Adamis Pharmaceuticals Corporation (ADMP) (“Adamis”) today announced that as of the close of business today, Adamis has not received any notice of action from the U.S. Food and Drug Administration (“FDA”) on the company’s New Drug Application relating to its ZIMHI™ high-dose naloxone injection product for the treatment of opioid overdose. As Adamis has previously stated, in connection with its acceptance for review of the NDA the FDA previously provided a PDUFA target agency action date of October 31, 2019.
Adamis (ADMP) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
A look at the shareholders of Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) can tell us which group is most...
Adamis Pharmaceuticals Corporation (ADMP) (“Adamis”) announced today the presentation of data pertaining to its investigational high dose naloxone product (ZIMHI) at the Institute of Human Virology (IHV) meeting (http://www.ihv.org/ihvmeeting/Program/) in a session on “Opioid Intersection”. Other participants at the meeting included Dr. Robert Gallo, Co-Founder and Director, Institute of Human Virology, Dr. Nora Volkow, Director, National Institute of Drug Abuse, National Institutes of Health, and Admiral Brett Giroir, MD, Assistant Secretary for Health, US Department of Health and Human Services. Naloxone is an opioid antagonist that competes opioids off their receptors in the brain.
Adamis Pharmaceuticals Corporation (ADMP) announced today that it has entered into an exclusive distribution and commercialization agreement with Emerge Health Pty (“Emerge”) to register and commercialize Adamis’ SYMJEPI® (epinephrine) Injection products in Australia and New Zealand.
Adamis Pharmaceuticals Corporation (ADMP) announced today that Dr. Ronald Moss, Chief Medical Officer, will be presenting data on October 4, 2019, pertaining to the company’s investigational high dose naloxone product candidate (ZIMHI) at the Institute of Human Virology (IHV) meeting (http://www.ihv.org/ihvmeeting/Program/) in a session on “Opioid Intersection”. Other participants at the meeting will be public health experts including Dr. Robert Gallo, Co-Founder and Director, Institute of Human Virology, Dr. Robert Redfield, Director of the Centers for Disease Control and Prevention (CDC), and Dr. Nora Volkow, Director, National Institute of Drug Abuse, National Institutes of Health. Naloxone is an opioid antagonist that competes opioids off their receptors in the brain.
If you own shares in Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) then it's worth thinking about how it...
In June, the Company amended the New Drug Application (NDA) for ZIMHI to remove any reference to EVZIO® and withdrew the Paragraph IV certification relating to that product. On August 8, the Company announced it was conducting additional PK studies comparing ZIMHI and a relevant comparator. The data for the PK study has been recorded and is complete. The data base will be forwarded to the FDA this month. As previously announced, the PDUFA date remains October 31, 2019.
Adamis Pharmaceuticals Corporation (ADMP) today provided a progress report and marketing update on the U.S. launch of SYMJEPITM (epinephrine) 0.3 mg and 0.15 mg Injections. During this back-to-school season, there is a heightened awareness of the shortage for epinephrine auto injectors. Adamis, in collaboration with Sandoz, Inc., hopes to alleviate some of the demand with their recently launched both doses of SYMJEPI into the hospital and retail market.
SAN DIEGO, Aug. 26, 2019 -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced the appointment of Howard C. Birndorf and Roshawn Blunt to its Board of Directors..
Ulcers are common in the majority of horses that are subject to stress and can affect horses at any age. Examples of horses under stress include racehorses, endurance horses, dressage horses, hunters, jumpers, 3-day eventers and any type of rodeo horse. In general, horses that are in active training tend to have a prevalence of ulcers in the range of 90 to 95%. Historically, ulcers have been known to negatively affect feeding habits and performance on the track.