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Adamis Pharmaceuticals Resubmits ZIMHI New Drug Application to FDA
5/18/2020
Adamis Pharmaceuticals Corporation (NASDAQ: 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 201
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Adamis Pharmaceuticals Schedules First Quarter 2020 Earnings Conference Call and Business Update
5/15/2020
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”) announced today that it will host an investor conference call on Monday, May 18, 2020 at 2:00 pm Pacific Time to discuss its financial and operating results for the first quarter of 2020 as well as provide an update on business developments and activities. The company’s press release concerning its first quarter 2020 financial results will be available after 1:00 p.m. Pacific Time on Ma
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Adamis Pharmaceuticals Provides Update on SYMJEPI Products and Announces Distribution and Commercialization Agreement for SYMJEPI and ZIMHI Products
5/11/2020
Adamis Pharmaceuticals Corporation (NASDAQ: 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.
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Adamis Pharmaceuticals Announces Publication Demonstrating PET Scan Results of Higher Dose Naloxone in Monkeys
4/23/2020
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”) announced publication in the peer reviewed journal Molecules, “The Effects of Intramuscular Naloxone Dose on Mu Receptor Displacement of Carfentanil in Rhesus Monkeys” ( https://www.mdpi.com/1420-3049/25/6/1360 ). 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
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Adamis Pharmaceuticals Announces Production of Additional Drugs by its US Compounding Subsidiary to Aid in the COVID-19 Pandemic
4/21/2020
Adamis Pharmaceuticals Corporation (NASDAQ: 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.
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Adamis Pharmaceuticals Announces Receipt of Loan Proceeds Under Paycheck Protection Program
4/15/2020
Adamis Pharmaceuticals Corporation (NASDAQ: 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 P
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Adamis Pharmaceuticals Announces Production of Products by its Subsidiary US Compounding to Aid in the COVID-19 Pandemic
4/1/2020
Adamis Pharmaceuticals Corporation (NASDAQ: 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 facilit
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Adamis Pharmaceuticals Announces 2019 Financial Results and Business Update
3/30/2020
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced financial results for the year ended December 31, 2019 and provided a business update.
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Adamis Pharmaceuticals Announces Pricing of $6.7 Million Registered Direct Offering
2/21/2020
SAN DIEGO, Feb. 21, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis” or the “Company”) today announced it has entered into a securities purchase agreement with certain accredited institutional investors to purchase approximately $6.7 million of its common stock in a registered direct offering and warrants to purchase shares of common stock in a concurrent private placement. The combined purchase price for one share of common stock and 0.75 warrants will be
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Adamis Pharmaceuticals Provides Update Regarding ZIMHI
2/19/2020
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”) today provided an update on the ZIMHI™ New Drug Application (NDA) resubmission process.
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Adamis Pharmaceuticals Provides an Update on ZIMHI
12/19/2019
Adamis Pharmaceuticals Corporation provided an update on the ZIMHI™ New Drug Application resubmission process.
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Adamis Pharmaceuticals Receives a Complete Response Letter from the FDA Regarding ZIMHI
11/25/2019
Adamis Pharmaceuticals Corporation today announced that after the close of U.S. markets on November 22nd, it received a Complete Response Letter from the U.S. Food and Drug Administration regarding its New Drug Application for Adamis’ ZIMHI™ high-dose naloxone injection product for the treatment of opioid overdose.
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Adamis Pharmaceuticals Announces Publication of Comparative Pharmacokinetics of Community Use Naloxone Formulations
11/18/2019
The authors concluded that “These results support the notion that higher doses of naloxone result in greater bioavailability, which may be required for reversal due to the more potent synthetic opioids such as fentanyl.”
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Adamis Pharmaceuticals Announces Third Quarter 2019 Financial Results and Business Update
11/12/2019
A new website was launched in the third quarter that provides patients and physicians with product information, instructions for use and provides links to order demonstrator devices and to have SYMJEPI shipped to patients’ homes through PillPack, an Amazon company.
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Adamis Pharmaceuticals Provides Regulatory Update for Its Higher Dose Naloxone Pre-Filled Syringe
11/4/2019
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.
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We round out the month of October and start the month of November with four PDUFA dates on the U.S. Food and Drug Administration’s calendar. Here’s a look.