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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 Corporation (NASDAQ: ADMP) announced the successful enrollment of 248 subjects in its Phase 2/3 clinical trial evaluating Tempol for COVID-19 treatment. The Data Safety Monitoring Board (DSMB) will review interim data from about 200 subjects this month. CEO David J. Marguglio emphasized the significance of this milestone, as it marks the first efficacy evaluation by the DSMB. If significant efficacy is observed, the trial may conclude early. Positive results could lead to an FDA submission for Emergency Use Authorization.
Adamis Pharmaceuticals Corporation convened its 2022 Annual Meeting of Stockholders, addressing various proposals. A significant proposal for a reverse stock split was adjourned until September 8, 2022, allowing further stockholder participation. Approximately 60% of common and 100% of preferred shares were represented. Other votes included the election of director nominees and the rejection of the 2020 Equity Incentive Plan amendment. The Board emphasizes the importance of maintaining a Nasdaq listing and will clarify intentions regarding the reverse stock split in the coming days.
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported its Q2 2022 financial results, showing revenues of approximately $1.2 million, down from $2.6 million in 2021, primarily due to a recall of SYMJEPI. Cash and cash equivalents stood at $8.9 million. The company is focused on the ongoing Phase 2/3 trial for Tempol, with the potential for Emergency Use Authorization if significant efficacy is shown. Meanwhile, ZIMHI has been positively received in the market. Management will hold a conference call for further updates.
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) updated its U.S. Phase 2/3 clinical trial, examining Tempol's safety and efficacy as a COVID-19 treatment. The Data Safety Monitoring Board (DSMB) will meet in late September to assess interim data. Previous DSMB meetings in March and June suggested continuing the trial without modifications. The trial involves over 200 patients and aims to evaluate the sustained resolution of COVID-19 symptoms among others. Positive outcomes could lead to FDA discussions for further development.
On July 21, 2022, Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) announced key leadership changes aimed at enhancing shareholder value. CEO David J. Marguglio outlined initiatives to improve cash flow from existing products and expand the company’s pipeline, including ongoing clinical trials for a COVID-19 treatment. The company seeks shareholder support for its proposals at the Annual Meeting on August 12, 2022, which include electing new directors, a potential reverse stock split to comply with Nasdaq listing standards, and amending the Equity Incentive Plan to attract talent.
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) announced that the Data Safety Monitoring Board (DSMB) has reviewed the interim clinical and safety data for its Phase 2/3 clinical trial of Tempol for treating COVID-19 and has recommended that the study proceed as planned. The DSMB's assessment indicates a favorable evaluation of the trial data. CEO David J. Marguglio emphasized the importance of completing the trial amid ongoing public health challenges with COVID-19. Previous studies showed Tempol's significant anti-cytokine activity and inflammation reduction in animal models.
Adamis Pharmaceuticals Corporation announced the appointment of Vickie Reed as a new director on May 26, 2022. With a robust background in healthcare financial leadership, Ms. Reed aims to enhance the company's corporate strategies. Her experience includes roles at Mirati Therapeutics and Zogenix, alongside serving on the board of Evoke Pharma. The Board's Chairman expressed confidence in her ability to create long-term stockholder value. Adamis specializes in biopharmaceuticals, focusing on products for allergy, opioid overdose, and respiratory diseases.
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) has announced a leadership transition, appointing David J. Marguglio, Co-Founder and Chief Business Officer, as President and CEO, effective immediately. This follows the retirement of Dennis J. Carlo, Ph.D., from his roles as CEO and Board Director. Marguglio aims to enhance the company's product pipeline and leverage collaborations for long-term growth, building on the recent success of their FDA-approved products, SYMJEPI and ZIMHI.
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported financial results for Q1 2022, with revenues of approximately $1.2 million, down from $1.4 million in Q1 2021, primarily due to a manufacturing hold on SYMJEPI. The company reported net loss from discontinued operations at about $165,000, a decrease from $1.5 million year-over-year. Cash and equivalents stood at $17.8 million. ZIMHI was commercially launched in late March, and the clinical trial for Tempol for COVID-19 continues, with positive interim evaluations from the Data Safety Monitoring Board.
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) will host a conference call on May 16, 2022, at 2 p.m. PT to discuss its Q1 2022 financial results and offer a business update. The press release detailing these results will be available around 1 p.m. PT on the same day. CEO Dennis J. Carlo will lead the call, which is open to the public. A live audio webcast will also be accessible, with a replay available afterward. Adamis specializes in products for allergy, opioid overdose, and respiratory issues, including FDA-approved SYMJEPI® and ZIMHI™ therapies.
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