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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) reported third-quarter results for 2020, with revenues of approximately $4.3 million, a 27% decline year-over-year due to the COVID-19 pandemic. Selling expenses rose to $5.8 million, while research & development expenses decreased to $1.7 million. Cash at quarter-end was $12.4 million, boosted by a recent equity offering. Key milestones include the FDA's decision on ZIMHI by November 15, 2020 and USWM aiming for more growth with SYMJEPI following a transition from Sandoz.
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) will host an investor conference call on November 9, 2020, at 2:00 PM PT to discuss its third quarter financial results and business updates. The results will be publicly available after 1:00 PM PT on the same day. Dr. Dennis J. Carlo, President and CEO, will lead the call, which will include a discussion on recent developments and future milestones. The company is focused on biologics for allergies, opioid overdose, and respiratory diseases, with its naloxone candidate ZIMHI under FDA review, targeting a decision by November 15, 2020.
Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) announced plans for an underwritten public offering of its common stock, with a potential additional 15% share purchase option for underwriters. The offering is subject to market conditions and is managed by Raymond James & Associates. Funds will be utilized for general corporate purposes, including research, development, and potential acquisitions. The public offering will be registered under a previously filed shelf registration statement with the SEC.
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) held a reconvened 2020 annual meeting where stockholders approved an amendment to increase authorized shares from 100 million to 200 million. The proposal for a reverse stock split was not approved due to insufficient votes. CEO Dr. Dennis J. Carlo expressed satisfaction with the stockholder participation and optimism for the anticipated approval and launch of ZIMHI, a naloxone injection product candidate for opioid overdose, pending FDA review.
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) has announced the adjournment of its 2020 Annual Meeting of Stockholders to September 3, 2020, to allow more time for proxy solicitation on two key proposals: increasing the number of authorized shares and a potential reverse stock split. The meeting will be virtual, accessible to stockholders with a control number. Prior to adjournment, some director nominees were elected, and other proposals were voted on. Adamis focuses on developing products for various therapeutic areas, including allergy and opioid overdose treatment.
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported second-quarter financial results, indicating year-to-date revenues of approximately $8.6 million, down 20% from 2019. The company is optimistic about new agreements with US WorldMeds for its SYMJEPI and ZIMHI products, aiming for FDA approval by November 15, 2020. Despite ongoing pandemic challenges impacting operations, Adamis has acquired rights to develop Tempol, a potential COVID-19 treatment. The company also reported a 19% revenue decrease from its drug outsourcing facility due to reduced medical procedures and patient visits.
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) has received positive feedback from the FDA regarding its Pre-IND filing for Tempol, a potential treatment for COVID-19. The FDA's comments enable Adamis to formally submit an IND application and seek government funding for clinical trials and manufacturing. CEO Dr. Dennis Carlo emphasized Tempol's promising capabilities to prevent disease progression by counteracting the cytokine storm associated with COVID-19. The company is also developing products for various acute respiratory diseases, including ZIMHI, which is under FDA review.
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) announced that US WorldMeds (USWM) has begun promoting its SYMJEPI® (epinephrine) Injection products as of July 1, 2020. This follows the termination agreement with Sandoz Inc. and a new exclusive distribution agreement with USWM. USWM plans to implement a robust marketing strategy targeting allergists and primary care physicians to enhance sales of SYMJEPI. Additionally, a transition services agreement is in place to ensure a smooth transfer of commercial rights and minimize disruption for patients and customers.
Adamis Pharmaceuticals (NASDAQ: ADMP) announced a licensing agreement to commercialize Tempol, an investigational drug for COVID-19 and other respiratory diseases. The agreement allows for worldwide use of Tempol and requires a $250,000 payment and 1,000,000 shares of convertible preferred stock to Matrix Biomed. Preliminary studies show Tempol's potential in reducing inflammation, oxidative stress, and clotting issues in COVID-19 patients. Adamis plans to expedite clinical trials and intends to seek funding for further development of Tempol.
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported a 5% decline in Q1 2020 revenues of approximately $4.7 million, attributed to the pandemic's impact on demand. The company has resubmitted its NDA for ZIMHI to the FDA and signed a commercialization collaboration with US WorldMeds for both ZIMHI and SYMJEPI products. The first quarter saw a reduction in SG&A expenses to $6.1 million from $8 million, while R&D expenses also decreased by 7.3% to $2 million. Cash and equivalents stood at $10.5 million post a $6.2 million funding round earlier in February.
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