Welcome to our dedicated page for Adamis Pharmaceuticals Corporation news (Ticker: ADMP), a resource for investors and traders seeking the latest updates and insights on Adamis Pharmaceuticals Corporation stock.
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 that a patent application for its ZIMHI™ high-dose naloxone injection has been approved by the U.S. Patent and Trademark Office. This patent covers a composition with a dose equal to or greater than five milligrams for injection use, aimed at addressing the opioid overdose crisis, which has seen record fatalities, especially amid the COVID-19 pandemic. The company believes this patent enhances its existing intellectual property for ZIMHI, which is under FDA review.
Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) has announced the pricing of a public offering of 40,540,540 shares of common stock at $1.11 per share, expected to raise approximately $45 million before expenses. The offering is set to close on February 2, 2021, with underwriters granted an option to purchase an additional 6,081,081 shares. Proceeds will support general corporate purposes, including R&D, capital expenditures, and potential acquisitions. The offering is registered under an existing shelf registration statement with the SEC.
Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) has announced plans for an underwritten public offering of its common stock, with expectations to allow underwriters a 30-day option to purchase an additional 15%. The offering is contingent on market conditions and details regarding its size and terms remain uncertain. Proceeds from this offering will be utilized for general corporate purposes, potentially including research and development, clinical trials, and working capital. Raymond James & Associates, Inc. will act as the sole book-running manager.
Adamis Pharmaceuticals (NASDAQ: ADMP) partnered with Stanford University to study Tempol's effects on immune cells from COVID-19 patients. Preliminary findings indicate that Tempol reduces cytokine levels from activated cells, potentially aiding in the treatment of COVID-19. Tempol has shown significant anti-inflammatory and antioxidant properties in previous studies, which may mitigate acute respiratory distress syndrome symptoms. The company plans to submit final data for peer review and seeks funding for further clinical studies. The recent exercise of warrants has provided additional capital to support these efforts.
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) announced a non-binding letter of intent for the sale of its subsidiary, US Compounding Inc. (USC). The proposed transaction could generate gross consideration between $10-20 million, subject to various conditions and negotiations. The deal may include cash, a promissory note, and performance-based payments. Completion depends on regulatory approvals, buyer licensing, and other customary conditions, with no guarantees on final terms or closure timing. This move aligns with Adamis' strategic focus on its core pharmaceutical operations.
Ovarian cancer poses serious challenges globally, with over 240,000 diagnoses annually. BioVaxys Technology Corp. has initiated a clinical program for BVX-0918A, aiming to address unmet needs in Stage III and IV ovarian cancer. The company plans to seek compassionate use approval in the EU and will submit a clinical trial application later this year. Additionally, they completed a preclinical program for the SARS-CoV-2 vaccine candidate BVX-0320 with promising results. Ongoing clinical trials and advancements in immunotherapy are pivotal in shaping the future of cancer treatment.
Adamis Pharmaceuticals (NASDAQ: ADMP) announced that its SYMJEPI® (epinephrine) Injection products are now part of the Walgreens Prescription Savings Club, offered at a competitive price of $99.99 for a two-pack. This price is the lowest available for epinephrine products in the market. The SYMJEPI products, available in 0.3mg and 0.15mg dosages, are essential for treating acute allergic reactions. CEO Dr. Dennis J. Carlo expressed enthusiasm over the partnership, highlighting the company's commitment to making SYMJEPI the most affordable epinephrine product available.
Adamis Pharmaceuticals (NASDAQ: ADMP) announced the submission of an Investigational New Drug (IND) application to the FDA for Tempol, aimed at treating COVID-19. This follows a Pre-IND meeting where the FDA provided recommendations on the application. Tempol is known for its anti-inflammatory and antioxidant properties, showing promise in reducing lung inflammation and preventing platelet aggregation. With over 23 million COVID-19 cases in the US, the company emphasizes the urgent need for new treatments as variants may evade current vaccines.
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) announced its response plan to a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) regarding ZIMHI™, a high-dose naloxone injection for opioid overdose. The CRL, received on November 13, noted deficiencies that must be addressed before approval. Adamis aims to resolve these issues and will submit its responses by year-end, subsequently requesting a Type A meeting with the FDA. The increased opioid overdoses and recent market gaps position ZIMHI as a potential life-saving product.
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) announced that it received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) regarding ZIMHI™, a high-dose naloxone injection for opioid overdose treatment. The CRL indicates that the NDA is not approvable in its current form due to Chemistry, Manufacturing, and Controls (CMC) issues. Importantly, the FDA did not raise concerns about previously noted testing issues. Adamis plans to address the CRL's concerns and will request a Type A meeting with the FDA to discuss next steps.
FAQ
What is the market cap of Adamis Pharmaceuticals Corporation (ADMP)?
What are the main therapeutic areas Adamis Pharmaceuticals Corporation focuses on?
What products are in Adamis Pharmaceuticals' pipeline?
What recent merger has Adamis Pharmaceuticals completed?
What are Adamis' FDA-approved products?
What steps has Adamis taken to maintain its Nasdaq listing?
Who is the CEO of Adamis Pharmaceuticals?
What was the outcome of Adamis' participation in the White House Roundtable?
What financial strategies has Adamis employed recently?
What is the objective of Adamis' grant from the NIH?
How does Adamis plan to enhance its product portfolio?
