Adamis Pharmaceuticals Corporation (ADMP) (“Adamis”) announced today the publication of an article entitled “An open-label, randomized, single-dose, two-period, two-treatment crossover bioavailability study comparing 5 mg/0.5 ml of intramuscular naloxone hydrochloride to 2 mg/0.4 ml intramuscular naloxone hydrochloride autoinjector in healthy subjects“ in the peer reviewed publication “The Journal of Opioid Management.” The article compares the pharmacokinetics of the current intramuscular (IM) doses of naloxone (2 mg dose, Evzio, Kaleo Inc) to Adamis’ investigational drug ZIMHI (5 mg dose) in healthy subjects.
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.
Adamis Pharmaceuticals Corp said on Monday its opioid overdose treatment was rejected by the U.S. Food and Drug Administration. In a letter to the company, the FDA raised questions about the treatment's chemistry and manufacturing but not about its safety or effectiveness, Adamis said.
Adamis Pharmaceuticals Corporation (ADMP) today announced that it has received loan proceeds of $3,191,700 (“PPP Loan”) under the Paycheck Protection Program (“PPP”). The PPP, established as part of the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”), provides for loans to qualifying businesses for amounts up to 2.5 times the average monthly payroll expenses of the qualifying business, calculated as provided under the PPP. The PPP provides a mechanism for forgiveness of up to the full amount borrowed after eight weeks as long as the borrower uses the loan proceeds during the eight-week period after the loan origination for eligible purposes, including payroll costs, certain benefits costs, rent and utilities costs or other permitted purposes, and maintains its payroll levels, subject to certain other requirements and limitations.
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.
Adamis Pharmaceuticals Corporation (ADMP) today announced that its wholly owned drug outsourcing facility, US Compounding Inc. (USC), has shifted part of its production to provide medical-grade hand sanitizers to hospitals and health care workers to assist in the ongoing fight against COVID-19. USC began manufacturing sanitizers after the Food and Drug Administration (FDA) issued guidance enabling FDA-registered outsourcing facilities, such as USC, to formulate certain alcohol-based hand sanitizer products for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.
Q1 2020 Adamis Pharmaceuticals Corp Earnings Call
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Earlier this month, the company announced that it had entered into an agreement with Sandoz Inc. providing for the mutually agreed return to Adamis of the marketing, promotion, and distribution rights to the company’s SYMJEPI ® (epinephrine) Injection 0.3mg, SYMJEPI® (epinephrine) Injection 0.15mg products currently marketed and available in the United States, and the termination of the commercialization agreement between Adamis and Sandoz, following a transition period, supported by a transition services agreement that is currently being negotiated. Adamis also simultaneously entered into an exclusive distribution and commercialization agreement with US WorldMeds, LLC (USWM) for the United States commercial rights for the SYMJEPI products as well as the Company’s ZIMHI™ (naloxone HCI Injection, USP) 5mg/0.5mL product candidate.
The combined purchase price for one share of common stock and 0.75 warrants will be $0.58. Under the terms of the purchase agreement, Adamis has agreed to sell 11,600,000 shares of its common stock. In a concurrent private placement, Adamis has agreed to issue warrants to purchase up to an aggregate of 8,700,000 shares of common stock.
Adamis Pharmaceuticals Corporation (ADMP) today announced it is reacquiring from Sandoz Inc. the rights to its SYMJEPI ® (epinephrine) Injection 0.3mg, SYMJEPI® (epinephrine) Injection 0.15mg products currently marketed and available in the United States. Adamis has simultaneously entered into an exclusive distribution and commercialization agreement with US WorldMeds, LLC for the United States commercial rights for the SYMJEPI products, as well as its ZIMHI™ (naloxone HCI Injection, USP) 5mg/0.5mL product candidate.
Naloxone is an opioid antagonist that binds the opioid receptors in the brain (mu receptors) and displaces opioid-bound drugs thereby reversing toxicity and resuscitating an overdose victim. In this study, monkeys received doses of carfentanil, a synthetic opioid 10,000 times stronger than morphine and 100 times more potent than fentanyl, followed by different doses of naloxone. The monkeys were then examined using PET (Positron Emission Tomography) imaging of the brain to observe the number of brain receptors bound with naloxone.
Q1 2020 Adamis Pharmaceuticals Corp Earnings Call
On November 22, 2019, Adamis received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its NDA for its ZIMHI high-dose naloxone injection product for the treatment of opioid overdose. On December 22, 2019, the company announced that it had provided responses to the comments raised in the CRL and had also requested a Type A meeting. The FDA scheduled the meeting for the second week of February.
Adamis Pharmaceuticals Corporation (ADMP) today announced the resubmission of the Company’s New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for its ZIMHI™ (naloxone HCI Injection, USP) 5mg/0.5mL product candidate for the treatment of opioid overdose. The resubmission follows the company’s meeting with the agency in February and is intended to address the issues raised by the FDA in the agency’s November 2019 Complete Response Letter (“CRL”). Adamis previously announced that it entered into an exclusive distribution and commercialization agreement with US WorldMeds, LLC (“USWM”) for commercial rights for the ZIMHI product candidate.
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.
Adamis recently reported their Q1 earnings with a miss on EPS and revenue. The COVID-19 pandemic has had a significant impact on the company's US Compounding sa
Adamis Pharmaceuticals Corporation (ADMP) today announced that its wholly owned drug outsourcing facility, US Compounding Inc. (USC), has increased its product mix to provide additional drugs to assist in the ongoing fight against COVID-19. Due to this pandemic, the U.S. Food and Drug Administration (FDA) has allowed outsourcing facilities to compound certain medications that are in short supply, but not listed on FDA’s Drug Shortage List. USC has begun manufacturing a variety of these pharmaceutical products, many of which may be used to treat acutely ill COVID-19 patients.
Adamis (ADMP) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank 1 (Strong Buy).
SAN DIEGO, May 18, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced financial results for the first quarter...
SAN DIEGO, May 15, 2020 -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”) announced today that it will host an investor conference call on Monday, May 18,.
On October 1, 2019, the company announced it had entered into an exclusive distribution and commercialization agreement with Emerge Health to seek registration and commercialize SYMJEPI in both Australia and New Zealand. On November 22, 2019, the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the company’s New Drug Application (NDA) relating to its ZIMHI high-dose naloxone injection product for the treatment of opioid overdose.
Q3 2019 Adamis Pharmaceuticals Corp Earnings Call
Biotech stocks had another up week, with the American Society of Gene & Stem Cell Therapy virtual conference presentations and the ASCO abstracts made available online Thursday calling the shots. Earnings news flow continued to taper.Biopharma companies worki…