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20:03 EDT KemPharm announces strategic acquisition of Arimoclomol from Orphazyme - KemPharm (KMPH) announced a definitive agreement with Orphazyme (ORPH) to acquire arimoclomol, an orally-delivered, first-in-class heat shock protein amplifier being developed as a treatment for Niemann-Pick disease type C. NPC is a rare progressive neurodegenerative disease that impacts children, adolescents, and adults, and is characterized by an inability of the body to transport cholesterol and lipids inside of cells, which leads to the abnormal accumulation of these substances within various tissues of the body, including the brain. Arimoclomol is currently being made available to NPC patients in the U.S., France and Germany under Orphazyme's Early Access Programs. Under the terms of the agreement, KemPharm will purchase substantially all of the assets and operations of Orphazyme, including arimoclomol, for a cash payment of $12.8 million. The company expects to finance the cash payment with a revolving line of credit secured by KemPharm's balance sheet. KemPharm intends to retain the majority of Orphazyme's current employees. In addition, KemPharm has agreed to assume an estimated reserve liability equal to approximately $5.2 million, which is an estimated future rebate due to the French regulatory authorities based on the revenue generated from the EAP in France. For the year ending December 31, 2022, the EAP is expected to generate at least $12 million in revenue based upon enrollment in France as of March 2022. The EAP is expected to remain in place until arimoclomol becomes commercially available in each of the current EAP markets. The transaction is expected to close on or before June 1, 2022, subject to customary closing conditions and approval by Orphazyme's creditors and the Danish bankruptcy court.

16:44 EDT AstraZeneca presents full results from MANDALA Phase III trial - Full results from the positive MANDALA Phase III trial showed that PT027 at two different strengths of budesonide, an inhaled corticosteroid, used as an as-needed rescue medicine, demonstrated a statistically significant reduction in the risk of a severe exacerbation versus albuterol rescue in patients with moderate to severe asthma. PT027 is a potential first-in-class inhaled, fixed-dose combination rescue medication containing albuterol, a short-acting beta2-agonist, and budesonide in the U.S. It is being developed by AstraZeneca and Avillion. Compared with albuterol rescue, PT027 at the 180mcg albuterol/160mcg budesonide dose reduced the risk of a severe exacerbation by 27% in adults and adolescents.1,2 In the trial, patients were randomized to receive PT027 or albuterol rescue, on top of their usually prescribed maintenance ICS, with or without additional controller medicines. In secondary endpoints, PT027 demonstrated a 33% reduction in mean annualized total systemic corticosteroid exposure and a 24% reduction in annualized severe exacerbation rate. A numerically higher odds of patients experiencing an improvement in symptom control and quality of life was also observed after 24 weeks of treatment with PT027 compared to albuterol rescue. Adverse events were similar across the treatment groups in the trial and consistent with the known safety profiles of the individual components, with the most common AEs including nasopharyngitis and headache.1 In the MANDALA trial, PT027 at a lower budesonide dose, also demonstrated a statistically significant reduction of 17% in the risk of severe exacerbation versus albuterol rescue, when used as an as-needed rescue medicine in adults, adolescents, and children aged 4-11 years. The results were published in the New England Journal of Medicine and will be presented at the American Thoracic Society 2022 International Conference.1,2,4 Also being presented at the ATS International Conference this week are the positive DENALI Phase III trial results. In this trial, PT027 demonstrated a statistically significant improvement in lung function measured by forced expiratory volume in one second, compared to the individual components albuterol and budesonide, and compared to placebo in patients with mild to moderate asthma aged 12 years or older. Onset of action and duration of effect were similar for PT027 and albuterol. The safety and tolerability of PT027 in DENALI was consistent with the known profiles of the components.

10:31 EDT USW announces tentative agreement with Arconic on four-year contract - The United Steelworkers said that the union has reached a tentative agreement on a new, four-year master contract with Arconic (ARNC) covering roughly 3,400 workers in Davenport, Iowa; Alcoa, Tenn.; Lafayette, Ind.; and Massena, N.Y. The union has reached a tentative agreement on a new, four-year master contract with Arconic.USW District 11 Director Emil Ramirez, who chaired the negotiations, said the tentative agreement features substantial wage and benefit improvements for all Arconic employees. "For their outstanding work throughout the pandemic and beyond, USW members have earned and deserve a fair agreement," Ramirez said. "The unity and solidarity of our membership across all of the Arconic locations enabled us to negotiate improved security for our earnings, benefits and jobs in this contract." The USW said that the proposed new contract increases wages by 20 percent over its term, maintains the current health care coverage with no premium increases, improves pensions and includes the addition of Martin Luther King Jr. Day as a holiday. Members of the USW committee will now return to their locals to discuss the terms of the proposed agreement with workers with the unanimous recommendation that it be ratified.

10:26 EDT Calliditas Therapeutics launches online patient platform - Calliditas Therapeutics announced the launch of IgAN Connect, a new online platform to provide resources to people living with IgA nephropathy, or IgAN, a chronic autoimmune disease. IgANConnect.com provides individuals who have just been diagnosed with IgA nephropathy, those who have been living with the disease for many years, and caregivers the tools to help understand and manage IgA nephropathy. The complimentary IgAN Connect Facebook page provides an environment where individuals living with the disease are encouraged to explore educational and motivational resources alongside other members of the community, the company said.