Applied Dna Scie Stock Price, News & Analysis

Applied DNA Sciences (NASDAQ: APDN) announced the U.S. FDA has granted a re-issued Emergency Use Authorization (EUA) for its Linea™ COVID-19 Assay Kit, expanding its use for serial screening of asymptomatic individuals. This update allows testing without a prescription and enables individual result reporting. With CLIA certification for its Applied DNA Clinical Labs subsidiary, the company aims to support safer reopening strategies for schools and workplaces. The Assay Kit can now process thousands of samples daily, enhancing its market reach and testing capabilities.

Applied DNA Sciences (NASDAQ: APDN) announced that its subsidiary, Applied DNA Clinical Labs (ADCL), received CLIA certification for COVID-19 testing from the New York State Department of Health. This certification enables ADCL to conduct high-throughput diagnostic testing, enhancing its capacity to serve regional healthcare providers and boosting its safeCircle service's economics. The company aims to leverage this certification to broaden its COVID-19 testing and future diagnostic opportunities, with rapid turnaround times for results.

Applied DNA Sciences, Inc. (NASDAQ: APDN) plans to report its fiscal 2021 Q2 financial results on May 13, 2021, after market close. Management will discuss these results during a conference call at 4:30 p.m. ET. The LinearDNA platform, the company's proprietary PCR-based manufacturing system, is being commercialized for applications in diagnostics and drug development, including COVID-19 testing. The company will provide a telephonic replay of the call and will archive the webcast for up to one year.

Applied DNA Sciences (NASDAQ: APDN) announced significant results from a recent clinical trial of its LinearDNA vaccine candidate. The booster injection, administered 30 days post-prime vaccination, resulted in a more than 5-fold increase in SARS-CoV-2 neutralizing antibody levels among felines, surpassing previous predictions. The company plans to initiate a clinical trial for minks to tackle COVID-19 transmission risks. CEO Dr. James A. Hayward emphasized the promising implications of these results for both animal and human applications.

Applied DNA Sciences (NASDAQ: APDN) has secured a new firm fixed-price indefinite delivery contract valued at up to $1.04 million with the Defense Logistics Agency’s Product Test Center in Columbus, Ohio. This contract aims to support the DLA's counterfeit mitigation efforts by providing unique DNA marking services and quality control testing. This collaboration builds on their long-standing partnership since 2014, ensuring the integrity of products in critical sectors.

Applied DNA Sciences (NASDAQ: APDN) announced an amendment to its Master Services Agreement, doubling its maximum value for COVID-19 Assay Kits. The agreement ensures continued access for a customer’s surveillance testing program, with a purchase order for 16,000 tests supporting in-person graduation ceremonies in May 2021. CEO Dr. James A. Hayward emphasized the importance of proactive monitoring amid increasing vaccination rates and new virus variants. The Linea™ COVID-19 Assay Kit is FDA EUA authorized for specific respiratory specimens, aiding in the detection of SARS-CoV-2.

Applied DNA Sciences (NASDAQ: APDN) reported preliminary fiscal Q2 2021 revenues between $2.5 million and $2.7 million, a significant increase from $1.6 million in Q1 2021 and $552,000 in Q2 2020, driven by demand for its safeCircle™ COVID-19 testing program and Linea™ Assay Kit. The company also announced the full forgiveness of an $847,000 PPP loan, leaving it debt-free. The results are preliminary and await full financial disclosure in mid-May 2021.

Applied DNA Sciences (NASDAQ: APDN) announced positive preliminary results from a Phase I clinical trial of its LinearDNA™ COVID-19 vaccine candidate for domestic felines. Conducted in February, the trial showed that the vaccine was well-tolerated, producing high levels of SARS-CoV-2 neutralizing antibodies in all 11 participating cats. The company intends to extend the study until September 2021 to assess the durability of the immune response. Following these results, plans for Phase II trials are anticipated, focusing on vaccinated cats’ resistance to infection.

Applied DNA Sciences, Inc. (NASDAQ: APDN) announced an interview with CEO Dr. James A. Hayward on BBC’s Business Daily, focusing on traceability in cotton. The Company’s CertainT® platform authenticates materials in complex supply chains, having secured approximately 300 million pounds of North American cotton. CertainT ensures product integrity by marking cotton fibers with a unique identifier to combat illicit blending, including forced labor. The Company also commercializes its LinearDNA™ platform for diagnostics and drug development, alongside applications in supply chain security.