Inhibikase: FDA Issues Clinical Hold On IkT-148009 Programs – Quick Facts

US Reports 3327 New Covid Cases

With 3327 new cases of coronavirus infection reporting on Sunday, the total U.S. Covid cases reached 97,455,455.

The total number of people losing their lives due to the disease in the country has risen to 1,070,296, as per Johns Hopkins University’s latest data.

Covid positive cases fell by 2 percent and deaths by 6 percent in the last fortnight, according to the New York Times.

U.S. hospitals reported a 3 percent increase in the number of Covid patients in the last two weeks. The number of I.C.U. admissions due to the worse stage of the viral disease increased by 2 percent.

27,415 people are hospitalized due to Covid. 3,168 of these patients are admitted in intensive care units.

The nation’s current test positivity rate is 8.5 percent.

499 additional deaths were reported globally on Sunday, taking the total number of people who lost their lives due to the pandemic so far to 6,589,641.

New York Community Bancorp Gets Final Regulatory Approval To Complete Flagstar Bancorp Acquisition

New York Community Bancorp, Inc. (NYCB) and Flagstar Bancorp, Inc. (FBC) announced Monday that NYCB has received regulatory approval from the Federal Reserve Board (FRB) to complete its previously announced acquisition of Flagstar.

On October 28, 2022, NYCB and Flagstar announced the receipt of regulatory approval from the Office of the Comptroller of the Currency to convert Flagstar Bank, FSB to a national bank to be known as Flagstar Bank, N.A. and to merge New York Community Bank into Flagstar Bank, N.A.

With the FRB approval, no further regulatory approvals are required to complete the acquisition. The consummation of the acquisition of Flagstar by NYCB is expected to take place on December 1, 2022, subject to the satisfaction of the remaining customary closing conditions.

The Company will continue to be known as New York Community Bancorp, Inc. and trade under the “NYCB” ticker symbol.

The acquisition would create one of the largest regional banks in the country, operating 395 branches across a nine-state franchise, including strong footholds in the Northeast and the Midwest and exposure to high growth markets in the Southwest and West Coast.

Allegion To Acquire Plano Group For Undisclosed Terms

Security solutions provider Allegion plc (ALLE) announced Monday that through one of its subsidiaries, it has signed a definitive agreement to acquire assets of plano group, a software-as-a-service (SaaS) workforce management solution. Terms of the transaction were not disclosed.

Based in Germany, plano has been a long-time service provider and development partner for Allegion’s leading European workforce management brand, Interflex, and its SP-EXPERT software platform.

Following the close of the acquisition, plano will continue to serve advanced workforce management (AWFM) customers as part of the Interflex portfolio.

The transaction is expected to close in the first quarter of 2023, subject to customary closing conditions.

Following the closure, the founder of the plano business, Robert Schüler, will join Interflex, helping ensure a smooth integration and driving progress of the AWFM software business strategy.

Ouster Gains On Merger Agreement With Velodyne, Outlook

Shares of Ouster, Inc. (OUST) are trading more than 5 percent in the pre-market after the company reported a definitive merger agreement with global lidar sensors and solutions provider Velodyne Lidar Inc. (VLDR, VLDRW). Further, the company has reiterated its full-year revenue.

As per the agreement, each Velodyne share will be exchanged for 0.8204 shares of Ouster at closing. The transaction will result in existing Velodyne and Ouster shareholders each owning approximately 50% of the combined company, based on current shares outstanding. The merger transactions are expected to be completed in the first half of 2023. The shares have been on an uptrend since November 3rd.

Looking ahead to the full year 2022, the company reiterated revenue guidance of $40 to $55 million. Wall Street analysts are looking for $46.14 million.

Currently, shares are at $1.29, up 5 percent from the previous close of $1.13 on a volume of 610,674.

Viatris To Acquire Oyster Point And Famy Life Sciences To Create Ophthalmology Franchise

Healthcare company Viatris Inc. (VTRS) announced Monday that it intends to create an ophthalmology franchise by acquiring Oyster Point Pharma and Famy Life Sciences.

Under the terms of a definitive agreement, Viatris has agreed to acquire Oyster Point for $11 per share in cash upfront through a tender offer. In addition, each Oyster Point stockholder will receive one non-tradeable contingent value right, representing up to an additional $2 per share contingent upon Oyster Point’s achieving certain metrics based on full year 2022 performance.

Viatris is targeting to close the acquisition of Oyster Point in the first quarter 2023, subject to customary closing conditions, including receipt of regulatory approval, and tender acceptance of more than 50% of Oyster Point shares.

Concurrently, the Company also expects to acquire Famy Life Sciences, which has a complementary ophthalmology portfolio.

The Company anticipates these acquisitions have the potential to add at least $1 billion in sales by 2028. As a result of the expected strong top-line growth, the Company anticipates it will also add at least $500 million in adjusted EBITDA by 2028.

Together, the two acquisitions have an aggregate purchase price of approximately $700 million to $750 million which Viatris expects to fund with cash on hand.

Inhibikase: FDA Issues Clinical Hold On IkT-148009 Programs – Quick Facts

Inhibikase Therapeutics, Inc. (IKT) announced the FDA has reviewed its Investigational New Drug application for IkT-148009 for the treatment of Multiple Systems Atrophy and has issued a clinical hold on the IkT-148009 201 program in Parkinson’s disease and the use of IkT-148009 in Multiple Systems Atrophy. The FDA will provide an official clinical hold letter to the company within 30 days.

“We have not seen any serious adverse events in the ongoing 201 trial. Given the safety, tolerability and pharmacokinetics data observed in clinical trials with IkT-148009 to date, we are actively working with the FDA to understand the agency’s concerns and to resolve them as soon as possible,” Milton Werner, CEO, said.

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