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Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) is a renowned specialty biopharmaceutical company committed to developing and commercializing therapeutic solutions in critical areas such as opioid overdose, allergies, respiratory diseases, and inflammatory conditions. The company operates in two primary divisions: specialty pharmaceuticals and biotechnology.
In the specialty pharmaceutical division, Adamis has a promising pipeline that includes four pivotal products: the Epinephrine Injection Pre-Filled Syringe (PFS) for emergency treatment of anaphylaxis, APC-1000 and APC-5000 (dry powder inhalers) for asthma and COPD, and APC-3000, a Hydrofluoroalkane (HFA) inhaled nasal steroid for treating allergic rhinitis. Their strategy aims to offer cost-effective therapeutic alternatives for large market needs, ensuring affordability and accessibility. The company follows the 505(b)(2) regulatory pathway to streamline development and reduce time to market.
In the biotechnology division, Adamis focuses on innovative treatments for diseases with considerable unmet needs. This division's portfolio includes four developmental products, such as TeloB-Vax, which holds promise for treating cancer and infectious diseases. Following its recent merger with DMK Pharmaceuticals, Adamis is now advancing DPI-125, a clinical-stage therapeutic aimed at treating opioid use disorder, a significant public health crisis that requires urgent intervention.
Adamis has received FDA approval for two critical products: ZIMHI® (naloxone) Injection for opioid overdose and SYMJEPI® (epinephrine) Injection for acute allergic reactions, including anaphylaxis. These products are designed to provide rapid, life-saving interventions in emergency situations.
Financially, Adamis is navigating challenges, including maintaining Nasdaq listing compliance and achieving financial stability. Recent measures include a reverse stock split to meet Nasdaq requirements and securing additional funding through public offerings.
Adamis is actively involved in partnerships and collaborations to further its mission. The company recently participated in the White House Roundtable on Opioid Reversal Product Manufacturers and received a grant from the NIH to develop treatment for alcohol use disorder. These initiatives underline Adamis' commitment to addressing public health crises through innovative therapeutic solutions.
The management team, led by CEO Ebrahim Versi, MD, PhD, is focused on expanding the company's product portfolio and improving financial health. The recent merger with DMK Pharmaceuticals is a strategic move to enhance their capabilities in developing neuro-based treatments and leveraging DMK's extensive library of small molecule neuropeptide analogues.
Adamis Pharmaceuticals remains dedicated to making a significant impact in the biopharmaceutical landscape by developing and commercializing treatments that address critical health challenges, ensuring better outcomes for patients worldwide.
Adamis Pharmaceuticals (Nasdaq: ADMP) has submitted a Fast Track Application to the FDA for Tempol, an oral antiviral treatment for COVID-19 currently undergoing a Phase 2/3 trial. Tempol is recognized for its antiviral, anti-inflammatory, and antioxidant properties. Given the surge in COVID-19 cases, the company aims to address unmet medical needs in treatment. Notably, recent studies indicate Tempol's effectiveness against inflammatory cytokines, enhancing its potential value in COVID-19 management.
Adamis Pharmaceuticals (NASDAQ: ADMP) announced new data supporting its ZIMHI™ product's dosage of naloxone hydrochloride. The findings suggest that ZIMHI's 5 mg dose is effective in resuscitating patients from high concentration fentanyl overdoses. This supports the FDA-approved ZIMHI as a critical tool in addressing rising opioid overdose deaths, now the leading cause of death for individuals under 50. The company collaborated with Rosa & Co. LLC on a study published in PLOS ONE, reinforcing the necessity of higher naloxone doses for effective treatment.
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) has announced that it has regained compliance with NASDAQ Marketplace Rule 5250(c)(1). This follows the filing of its Quarterly Reports on Form 10-Q for the periods ended March 31, June 30, and September 30, 2021. As a result, the matter with NASDAQ is now closed. Adamis focuses on developing specialty products for allergy, opioid overdose, and respiratory diseases, with its approved SYMJEPI and ZIMHI injection products for emergency treatments.
Adamis Pharmaceuticals (NASDAQ: ADMP) reported financial results for the nine months ending September 30, 2021. Revenue increased to approximately $3.4 million from $2.1 million, driven by US WorldMeds' marketing of SYMJEPI. The FDA approved ZIMHI for opioid overdose, with a commercial launch expected in Q1 2022. The company has initiated a Phase 2/3 clinical trial for Tempol as a COVID-19 treatment. Selling, general, and administrative expenses rose to $13.2 million, while research and development expenses climbed to $9.1 million. Cash reserves stand at $28.7 million.
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) will host an investor conference call on November 22, 2021, at 2 p.m. PT to discuss its financial and operational results for the first nine months of 2021.
The company will release its financial results after 1 p.m. PT on the same day and will also file quarterly reports on Form 10-Q for the quarters ended March 31, June 30, and September 30, 2021. A live audio webcast will be available for investors.
Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) announced FDA approval for ZIMHI™, a high-dose naloxone injection (5 mg/0.5 mL), designed to treat opioid overdoses. This product aims to combat the rising opioid crisis, which has led to approximately 96,779 deaths in the U.S. over a year. The increased dosage provides a competitive edge over existing products, potentially enabling faster and more effective rescues. Commercial launch is planned for Q1 2022 in partnership with US WorldMeds, which will utilize its established infrastructure to address the urgent need for effective opioid overdose treatments.
Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) announced the appointment of Meera J. Desai, Ph.D., as a new director, effective October 1, 2021, replacing Roshawn Blunt. Dr. Desai brings substantial expertise in drug development and international licensing, expected to enhance corporate strategy and product pipeline refinement. She has a background with notable firms including AcelRx Pharmaceuticals and Novartis. Adamis focuses on developing products for various therapeutic areas, including allergy and opioid overdose, with its naloxone product currently under FDA review.
Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) commenced patient dosing in its Phase 2/3 clinical trial for Tempol, an oral antiviral for COVID-19, targeting 248 participants. The trial aims to evaluate Tempol's efficacy in hospitalized patients against a placebo. Preclinical studies indicated Tempol's antiviral and anti-inflammatory properties. The trial is timely amid rising COVID-19 cases, particularly with the delta variant. The NIH has recognized Tempol as a potential home treatment, emphasizing its ability to mitigate severe disease outcomes.
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) announced the appointment of David C. Benedicto as the new Chief Financial Officer, succeeding Robert O. Hopkins, who leaves after 14 years. Benedicto has been with the company for nearly seven years and holds extensive experience in finance within the biopharmaceutical sector. Additionally, Adamis received a notification from Nasdaq regarding non-compliance due to delayed filings of its Quarterly Reports, with a plan to regain compliance submitted to Nasdaq.
Adamis Pharmaceuticals has announced a study on Tempol, an investigational antioxidant, which demonstrates in-vitro anti-cytokine activity in COVID-19 patients. The publication in Clinical Immunology states that Tempol reduces harmful cytokines, suggesting its potential as a treatment for COVID-19. The NIH has recognized Tempol for its antiviral activity and plans for a clinical trial to evaluate its efficacy as a home treatment. The FDA has authorized this study, aiming to alleviate the strain on healthcare systems caused by COVID-19.
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