Eisai (ESALY) and Biogen (BIIB) announced that the U.S. Food and Drug Administration has accepted the Biologics License Application, or BLA, under the accelerated approval pathway for lecanemab, an investigational anti-amyloid beta protofibril antibody for the treatment of mild cognitive impairment due to Alzheimer's disease and mild AD with confirmed presence of amyloid pathology in the brain. Eisai's application, which was completed in early May 2022, has been granted Priority Review, with a Prescription Drug User Fee Act, or PDUFA, action date of January 6, 2023. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. The Clarity AD Phase 3 clinical study for lecanemab in early AD is ongoing and Eisai completed enrollment in March 2021 with 1,795 patients. The readout of the primary endpoint data of Clarity AD will occur in the Fall of 2022. The FDA has agreed that the results of Clarity AD, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. Eisai utilized the FDA's Accelerated Approval Pathway in an effort to streamline the submission process for the potential traditional approval of lecanemab in order to expedite patients' access to lecanemab. Dependent upon the results of the Clarity AD clinical trial, Eisai will submit for traditional approval of lecanemab to the FDA during Eisai's fiscal year 2022, which ends on March 31, 2023. Haruo Naito, Chief Executive Officer at Eisai, said, "The acceptance of lecanemab's BLA with priority review is an important milestone in serving people living with Alzheimer's disease who have been waiting for new treatment options to address an underlying pathology of Alzheimer's disease. We will continue to actively cooperate with the FDA's review in an effort to bring this new treatment option to people living with Alzheimer's disease and their families as soon as possible."

Lockheed Martin was awarded a $185.92M cost-plus-incentive-fee contract modification to previously awarded contract to exercise an option for engineering design and development. Work is expected to be completed by September 2023. FY22 research, development, test and evaluation funds in the amount of $17.83M and FY22 shipbuilding and conversion funds in the amount of $535,657 will be obligated at the time of award and will not expire at the end of the current fiscal year. The Naval Sea Systems Command is the contracting activity.

In a regulatory filing, Xometry disclosed that its CEO Randolph Altschuler sold 20K shares of common stock on July 1st in a total transaction size of $659.2K.

Vornado Realty Trust announced that it has completed the previously announced sale of the Center Building, an eight-story 498,000 square foot office building located at 33-00 Northern Boulevard in Long Island City, New York, for $172.8M. The financial statement gain, which will be recognized in the second quarter, is estimated to be $15M. The tax gain is estimated to be $74M.

Primoris Services "announced a heavy civil project valued at more than $170 million. The project, secured by the Company's Energy/Renewables Segment, was awarded by the Texas Department of Transportation. The project involves construction of a section of Highway 59 in Polk County, Texas. It is scheduled to commence in the third quarter of 2022 with completion expected in the fourth quarter of 2024."

The agency said in part: "The U.S. Department of Transportation reassigned, with conditions, 16 peak-hour runway timings, previously operated by Southwest Airlines (LUV), at Newark-Liberty International Airport to Spirit Airlines. Today's action secures low-cost service options for Newark customers and improves competition in the Newark market, which was affected when Southwest Airlines discontinued service there.Today's decision provides certainty to carriers that have been operating at Newark using temporary, ad hoc timings made available while other carriers reduced service during the COVID-19 pandemic. Given the Department's concern over the recent airline cancellations, delays, challenges with customer service and other operational disruptions that have hurt travelers, the Department is requiring Spirit (SAVE), as a condition of accepting the timings, to report additional data on disruptions facing their airline customers and its ability to provide them with accommodations...The 16 timings reassigned were originally operated by Southwest Airlines in 2010 when it acquired them as part of a Department of Justice competition remedy to the United-Continental (UAL) merger. The Department received applications from Spirit and JetBlue Airways (JBLU) for all 16 timings, and from Alaska Airlines (ALK) for four of the timings. After reviewing the applications against the decisional criteria announced by the Department, the Department found that Spirit will best be able to provide competition with all 16 timings, consistent with the Department of Justice's original competition remedy, and is most likely to provide the lowest fares to the most consumers." Reference Link

In a regulatory filing, Beyond Air director Robert Carey disclosed the acquisition of 175,000 common shares of the company on June 30 at a price of $6.4474 per share.