FDA approves drugs for adults with type 2 diabetes

Merck announces FDA approval for STEGLATRO, STEGLUJAN 

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FDA approves drug for Type 2 diabetes

Merck (MRK) and Pfizer (PFE) announced that the U.S. Food and Drug Administration has approved STEGLATROTM tablets, an oral sodium-glucose cotransporter 2 inhibitor, and the fixed-dose combination STEGLUJAN tablets.

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FDA approves drug for Type 2 diabetes

STEGLATRO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

STEGLUJAN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and sitagliptin is appropriate.

STEGLATRO and STEGLUJAN are not recommended in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

STEGLUJAN has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using STEGLUJAN.

STEGLATRO and STEGLUJAN are contraindicated in patients with severe renal impairment, end-stage renal disease or on dialysis, or with a history of a serious hypersensitivity reaction to ertugliflozin.

STEGLUJAN is also contraindicated in patients with a history of a serious hypersensitivity reaction to sitagliptin.

These FDA approvals are supported by seven Phase 3 studies of approximately 4,800 patients.

STEGLATRO was studied as monotherapy and in combination with metformin and/or sitagliptin, as well as with insulin and a sulfonylurea, in adults with type 2 diabetes and moderate renal impairment.


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Ignyta sold for $1.7 billion

Roche to acquire Ignyta for $27 per share in cash

Ignyta sold for $1.7B. Stockwinners.com
Ignyta sold for $1.7B

Roche (RHHBY) and Ignyta (RXDX) announced they have entered into a definitive merger agreement for Roche to fully acquire Ignyta at a price of $27.00 per share in an all-cash transaction.

This corresponds to a total transaction value of $1.7B on a fully diluted basis.

This price represents a premium of 74% to Ignyta’s closing price on December 21 and a premium of 71% and 89% to Ignyta’s 30-day and 90-day volume weighted average share price on December 21, respectively.

The merger agreement has been unanimously approved by the boards of Ignyta and Roche.

Under the terms of the merger agreement, Roche will promptly commence a tender offer, to acquire all outstanding shares of Ignyta common stock, and Ignyta will file a recommendation statement containing the unanimous recommendation of the Ignyta board that Ignyta’s shareholders tender their shares to Roche.

Ignyta will continue its operations in San Diego and be responsible for the ongoing pivotal study of #entrectinib to ensure this important medicine reaches patients without delay.

Under the terms of the merger agreement, Roche will promptly commence a tender offer to acquire all of the outstanding shares of Ignyta’s common stock at a price of $27.00 per share in cash.

The closing of the tender offer will be subject to a majority of Ignyta’s outstanding shares being tendered in the tender offer.

Following completion of the tender offer, Roche will acquire all remaining shares at the same price of $27.00 per share through a second step merger.

The closing of the transaction is expected to take place in the first half of 2018.

RXDX closed at $15.55. RHHBY closed at $31.06.


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