LIFE Gets A Boost With Kyorin Deal, XERS Up 20% After-Hrs, ITCI On Watch

pharma 061317 06jan20

Today's Daily Dose brings you news about Xeris Pharma's trial results of ready-to-use (RTU) glucagon for the prevention of exercise-induced hypoglycemia; Merck's Keytruda trial results in patients with extensive-stage small-cell lung cancer; collaboration and license agreement between aTyr Pharma and Kyorin Pharmaceutical.

Read on…

Shares of aTyr Pharma Inc. (LIFE) soared more than 40% on Monday after the Company announced a collaboration and license agreement with Kyorin Pharmaceutical Co., Ltd. for the development and commercialization of aTyr's lead clinical candidate, ATYR1923, for interstitial lung diseases, in Japan.

ATYR1923 is currently under a proof-of-concept phase Ib/IIa trial in patients with pulmonary sarcoidosis, a form of interstitial lung disease.

The agreement entitles aTyr to receive an $8 million upfront payment and up to an additional $167 million in the aggregate upon achievement of certain development, regulatory and sales milestones, as well as tiered royalties on net sales in Japan. Kyorin will receive the exclusive right to develop and commercialize ATYR1923 in Japan for interstitial lung diseases.

aTyr will supply the drug product for Japan while Kyorin will be responsible for funding all research, development, regulatory, marketing and commercialization activities in Japan.

LIFE closed Monday's trading at $6.11, up 43.43%.

Intra-Cellular Therapies Inc. (ITCI) has commenced an underwritten public offering of 10 million shares of its common stock.

The Company intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering.

J.P. Morgan Securities LLC, SVB Leerink LLC, and Evercore Group L.L.C. are acting as joint book-running managers for the offering.

The Company received FDA approval for its CAPLYTA (lumateperone) for the treatment of schizophrenia in adults last month. The commercial launch of the drug is expected to be initiated in late Q1 2020.

ITCI closed Monday's trading at $30.62, down 1.76%.

Merck's (MRK) phase III trial investigating its blockbuster drug KEYTRUDA in combination with chemotherapy met one of its dual primary endpoints of progression-free survival in the first-line treatment of patients with extensive-stage small-cell lung cancer (ES-SCLC).

In the study, treatment with KEYTRUDA in combination with chemotherapy (etoposide plus cisplatin or carboplatin) also resulted in a statistically significant improvement in progression-free survival compared to chemotherapy alone at a prior interim analysis. However, at the final analysis of the study, this improvement in overall survival did not meet statistical significance.

Keytruda is approved for the treatment of melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, and endometrial carcinoma.

The drug fetched annual revenues of $7.17 billion for Merck in 2018 and $7.97 billion in the first nine months of 2019.

The Company has also sought FDA approval of Keytruda for the treatment of patients with bacillus Calmette-Guérin-unresponsive, high-risk, nonmuscle-invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy, and a decision is expected in January.

MRK closed Monday's trading at $91.64, up 0.43%.

Shares of Xeris Pharmaceuticals Inc. (XERS) jumped over 20% in extended trading on Monday, following positive topline results from the in-clinic stage of a phase II study of its developmental ready-to-use (RTU) glucagon for the prevention of hypoglycemia during and after moderate-to-high intensity aerobic exercise in adults with Type 1 diabetes mellitus (T1D).

According to the study results, a mini dose of RTU glucagon was adequate to maintain normal blood glucose levels during prolonged, moderate-to-intense aerobic exercise. Episodes of hypoglycemia were observed both during and after the prescribed exercise session. Overall, there were more exercise-induced hypoglycemia (EIH) episodes among subjects who received standard of care (placebo plus 50% insulin pump reduction) than subjects who received RTU glucagon plus 50% insulin pump reduction.

The use of glucose tablets to treat hypoglycemia during and after exercise was less with RTU glucagon when compared to standard of care, noted the Company.

Last October, the Company reported positive results from an in-clinic stage of a phase II study of its developmental ready-to-use (RTU) glucagon in patients who experience postprandial hypoglycemic episodes following bariatric surgery. The data from the second half of the study, which is outside of the controlled in-clinic environment, is expected to be available in the first half of 2020.

XERS closed Monday's trading at $5.79, down 4.61%. In after-hours, the stock was up 22.63% to $7.10.

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