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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 significant updates regarding its product pipeline. The company has resubmitted its NDA for ZIMHI, a naloxone injection for opioid overdose, to the FDA and is awaiting a response. Additionally, Adamis is preparing to begin patient enrollment for a Phase 2/3 trial of Tempol, aimed at treating COVID-19. The company's epinephrine product, SYMJEPI, has seen a 90% increase in unit sales since transitioning commercial partners.
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) announced it received a notification from NASDAQ for failing to file its 10-Q for Q1 2021. As a result, the company is not compliant with NASDAQ Rule 5250(c)(1), which mandates timely filings. Adamis has 60 days to submit a plan to regain compliance, with the possibility of a 180-day extension if accepted. If the plan is rejected, Adamis can appeal to the NASDAQ Hearings Panel. This notice has no immediate impact on the listing of ADMP's stock.
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) has postponed its investor conference call originally set for May 17, 2021, due to a delay in filing its Quarterly Report (Form 10-Q) for Q1 2021. The company filed a Form 12b-25 with the SEC to extend the filing deadline by five days, as allowed under Rule 12b-25 of the Securities Exchange Act of 1934. A new date for the conference call will be announced soon. Adamis focuses on developing biopharmaceutical products for various therapeutic areas, including allergy and respiratory diseases.
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) has resubmitted its New Drug Application (NDA) for ZIMHI™, a high-dose naloxone injection intended for opioid overdose treatment, to the FDA. This follows feedback from a Type A meeting held in April. The CEO, Dr. Dennis J. Carlo, expressed confidence that the new submission addresses previous concerns raised in a November 2020 Complete Response Letter. ZIMHI aims to provide an effective alternative in the market for naloxone products, potentially saving lives during the ongoing opioid crisis.
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) will host an investor conference call on May 17, 2021, at 2 p.m. PT to discuss its Q1 2021 financial results and provide a business update. The press release with these results will be available after 1 p.m. PT on the same day. During the call, Dennis J. Carlo, Ph.D., along with the management team, will cover recent developments, quarterly events, and future goals. A live audio webcast will be accessible, with a replay offered post-event.
Adamis Pharmaceuticals (NASDAQ: ADMP) announced its financial results for the year ended December 31, 2020, reporting total revenues of $16.5 million, down from $22.1 million in 2019. The company plans to advance its pipeline, including resubmitting the NDA for ZIMHI and initiating a Phase 2/3 trial for Tempol in COVID-19 patients by Q2 2021. A recent public offering raised approximately $48.6 million, providing financial support for operations. Adamis expects transformative growth in 2021, driven by product launches and partnerships.
Adamis Pharmaceuticals (NASDAQ: ADMP) announced an investor conference call on April 15, 2021, at 2 p.m. PT to discuss its fourth-quarter and full-year 2020 financial results. The press release with these results will be available post 1 p.m. PT on the same day. The call will provide insights into the company's recent developments and future goals. Dennis J. Carlo, President and CEO, will lead the discussion, and a live audio webcast will be accessible.
Adamis Pharmaceuticals (NASDAQ: ADMP) provided an update regarding its New Drug Application (NDA) for ZIMHI™, a high-dose naloxone injection for opioid overdose treatment. Following a Type A meeting with the FDA, Adamis plans to resubmit the NDA within 45 days, pending no delays. The FDA indicated a commitment to expedite the review as the opioid crisis escalates. CEO Dr. Dennis J. Carlo highlighted the urgency, noting a significant rise in overdose deaths, emphasizing ZIMHI's potential to save lives.
Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) announced significant findings from studies at the University of Texas Medical Branch, revealing that Tempol, a novel antioxidant, effectively reduces lung inflammation in COVID-19 challenged hamsters. This marks the first data confirming Tempol's anti-inflammatory properties in this context. The company plans to submit findings for peer review and is preparing for a Phase 2/3 clinical trial to evaluate Tempol's safety and efficacy in early COVID-19 patients. The trial aims to assess how Tempol affects inflammation markers and hospitalization rates.
Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) received FDA clearance to commence a clinical trial for Tempol as a treatment for COVID-19. The study, titled "A Phase 2/3, Adaptive, Randomized, Double-Blind, Placebo-Controlled Study," aims to evaluate Tempol's safety and effectiveness in reducing hospitalization rates among early COVID-19 patients. Tempol has shown potential benefits such as reducing pro-inflammatory cytokines and platelet aggregation. The CEO underscores the urgency for new COVID-19 therapies as virus mutations pose risks to current treatments.
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