Welcome to our dedicated page for Emmaus Life Scie news (Ticker: EMMA), a resource for investors and traders seeking the latest updates and insights on Emmaus Life Scie stock.
Emmaus Life Sciences develops, markets, and sells biopharmaceutical therapies focused on sickle cell disease, led by Endari® (prescription-grade L-glutamine oral powder). News about EMMA commonly covers financial results, Endari commercialization, FDA labeling activity, competition from generic L-glutamine, and sales trends across the U.S. and international markets.
Company updates also address market access and distribution strategy for Endari, including activity in the Middle East and North Africa region and Saudi Arabia. Emmaus reports operating expenses, liquidity, and other financial items alongside product safety and indication information for Endari, which is approved to reduce acute complications of sickle cell disease in adult and pediatric patients five years of age and older.
Emmaus Life Sciences (OTCQX: EMMA) reported Q3 2021 net revenues of $5.8 million, up 3% year-over-year but down 6% from Q2 2021. For the nine months ending September 30, 2021, revenues increased 4% to $17.6 million. Operating loss for Q3 2021 was $31,000, compared to $8,000 in Q3 2020, with a net loss of $3.2 million. The company expanded access to its sickle cell treatment, Endari, through a partnership with UpScript and entered an agreement with Asembia for provider support. Emmaus also submitted a marketing application for Endari in the UAE and secured a license for Kainos' IRAK4 inhibitor.
Emmaus Life Sciences (OTCQX: EMMA) announced a partnership with UpScript IP Holdings to enhance access to its sickle cell disease treatment, Endari®, through telehealth services. This initiative aims to allow patients to receive physician consultations and prescriptions from home, thereby reducing exposure to infections. Endari®, approved in July 2017, is designed for patients aged five and older to alleviate acute complications of sickle cell disease. The telehealth services are set to launch in the coming months, promising improved patient convenience and healthcare accessibility.
Emmaus Life Sciences (OTCQX: EMMA) announced a partnership with Asembia to enhance patient and provider support services for Endari®, its L-glutamine oral powder treatment for sickle cell disease. Asembia will streamline insurance authorization, benefits investigation, and co-pay assistance, aiming to improve access for patients. This collaboration is expected to boost the efficiency of delivery for Endari to individuals suffering from sickle cell disease. Emmaus continues to focus on innovative treatments while supporting the approximately 100,000 individuals in the U.S. living with this condition.
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.