Emmaus Life Scie Stock Price, News & Analysis

Emmaus Life Sciences has submitted an application for marketing authorization of Endari® to the U.A.E. Ministry of Health. This marks a significant step for the treatment of sickle cell disease, with a review period expected to last 10-12 months. The company estimates around 600 sickle cell patients reside in the U.A.E. and approximately 225,000 in the MENA region could benefit from Endari. The submission is part of a broader strategy to file similar applications across Gulf Cooperation Council states.

Emmaus Life Sciences, Inc. (OTCQX: EMMA) has secured an exclusive license from Kainos Medicine, Inc. for the IRAK4 inhibitor KM10544, aimed at treating various cancers. This agreement builds upon their existing collaboration, enhancing Emmaus' treatment pipeline. Financial terms remain undisclosed. The company will conduct in-vivo studies followed by Investigational New Drug enabling studies and pursue Orphan Drug Designation for relevant indications. CEO Yutaka Niihara emphasized the significance of this milestone for developing treatments for resilient lymphomas.

Emmaus Life Sciences (OTC: EMMA) reported a 5% increase in net revenues to $11.8 million for the six months ending June 30, 2021, boosted by bulk purchases and recovery from COVID-19 disruptions. Operating expenses rose by 12% to $12.1 million, leading to an operating loss of $1.1 million. Net loss expanded to $5.9 million, compared to $4.0 million in 2020, primarily due to increased expenses. The company is now current with SEC reporting and has applied for stock quotation resumption on the OTCQX tier.

Emmaus Life Sciences (OTC: EMMA) announced that the National Health Regulatory Authority of Bahrain approved a Temporary License for the importation of Endari® on August 12, 2021. This approval allows Endari, a prescription grade L-glutamine oral powder, to be imported for treating sickle cell disease for up to 12 months. With a sickle cell disease incidence of 2.1% in Bahrain and an estimated 225,000 patients in the MENA region, this marks a significant step for Emmaus in addressing unmet medical needs in the area. The company is also applying for marketing authorization in Saudi Arabia and Kuwait.

Emmaus Life Sciences, Inc. (OTC: EMMA) announced a restatement of financial statements for the fiscal year ending December 31, 2020. Investors should disregard previous financial data from the Annual Report filed on May 4, 2021. The amended report shows a net income increase to $1.4 million, up from $1.1 million originally reported, reflecting improved performance in their equity method investment. The company is also working to file overdue quarterly reports to avoid a trading suspension.

Emmaus Life Sciences (OTC: EMMA) reported preliminary sales results for the six months ending June 30, 2021. In Q2 2021, the company shipped 6,880 boxes of its sickle cell disease treatment, Endari, marking a 21% rise from 5,690 boxes in Q1 2021, which was affected by severe weather. However, total sales volume for the first half of 2021 remained unchanged compared to the same period in 2020. Emmaus plans to release complete interim financial results in the upcoming Forms 10-Q.

Emmaus Life Sciences, Inc. (OTC: EMMA) has submitted its Marketing Authorization application for Endari® to the Kuwait Drug and Food Control (KDFC) as of July 15, 2021. This application aims to register Endari®, an oral powder for treating sickle cell disease, which is already FDA-approved for patients aged five and older. The KDFC has agreed to a fast-track review expected to conclude within twelve months. Though only around 500 patients suffer from sickle cell disease in Kuwait, Endari® will be available for early access during the review period, addressing a critical medical need.

Emmaus Life Sciences (OTC: EMMA) announced that it received confirmation from Swissmedic for its Marketing Authorization application for Endari® in Switzerland. This application follows the orphan drug status granted in November 2020. The review typically takes 16 to 18 months, during which Endari® will be available on an early-access basis. Endari® is FDA-approved and indicated for reducing complications of sickle cell disease. Approximately 220 patients are affected by sickle cell disease in Switzerland, with increasing numbers expected.

Emmaus Life Sciences (OTC: EMMA) announced that its Marketing Authorization application for Endari® has been accepted by the Saudi Food and Drug Authority. The review process is expected to take 12 to 18 months. Endari®, a prescription L-glutamine oral powder, treats sickle cell disease, which affects 1.4% of Saudi Arabia's population, equating to approximately 225,000 potential patients in the MENA region. The company will provide early access to Endari® during the approval phase to meet urgent medical needs.