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XLRN Soars, FDA Approves Triple Combo Pill For Type 2 Diabetes, MGEN On Watch

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Today's Daily Dose brings you news about Acceleron Pharma's pulmonary arterial hypertension trial data; FDA approval of Lilly's combination tablet containing three type 2 diabetes medicines in one pill; Merck's DIFICID tablets and oral suspension securing the regulatory nod in the U.S. and miRagen's near-term catalyst.

Read on…

Shares of Acceleron Pharma Inc. (XLRN) were up over 60% in extended trading on Monday, following positive results from a phase II trial of Sotatercept in patients with pulmonary arterial hypertension.

The phase II trial, dubbed PULSAR, achieved its primary endpoint of a statistically significant reduction in pulmonary vascular resistance.

The trial also achieved statistically significant improvements in the key secondary endpoint of six-minute walk distance (6MWD) and other secondary endpoints, including amino-terminal brain natriuretic propeptide (NT-proBNP), and World Health Organization (WHO) functional class.

XLRN closed Monday's trading at $52.87, up 1.58%. In after-hours, the stock was up 64.57% at $87.01.

The FDA has approved Boehringer Ingelheim and Eli Lilly and Co.'s (LLY) Trijardy XR to lower blood sugar in adults with type 2 diabetes, along with diet and exercise.

Trijardy XR provides three type 2 diabetes medicines in one pill, including Jardiance (empagliflozin), Tradjenta (linagliptin) and metformin hydrochloride extended-release. This combination tablet is the first single-pill option with three complementary mechanisms of action to help manage blood glucose in adults with type 2 diabetes.

According to the companies, Trijardy XR will be available in four different dosages, including: 5 mg empagliflozin/2.5 mg linagliptin/1000 mg metformin HCl extended-release; 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin HCl extended-release; 12.5 mg empagliflozin/2.5 mg linagliptin/1000 mg metformin HCl extended-release; and 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin HCl extended-release.

Jeff Emmick, Vice president, Product Development, Lilly, said, "We developed Trijardy XR because many people with type 2 diabetes need help managing this complex condition without adding more pills to their treatment plan. We look forward to making this new option available soon."

LLY closed Monday's trading at $138.31, down 0.55%.

The FDA has approved Merck's (MRK) New Drug Application for DIFICID for oral suspension, and a supplemental New Drug Application for DIFICID tablets for the treatment of Clostridioides (formerly Clostridium) difficile-associated diarrhea (CDAD) in children aged six months and older.

Dificid, a macrolide antibacterial drug, is already available in a tablet formulation for adults (18 years of age or older) for treatment of Clostridium difficile-associated diarrhea.

Clostridioides (formerly Clostridium) difficile, also known as C. difficile or C. diff, is one of the most common causes of healthcare-associated infections in U.S. hospitals.

MRK closed Monday's trading at $86.10, up 0.14%.

Shares of miRagen Therapeutics Inc. (MGEN) jumped more than 50% on Monday as the Company gears up to present new efficacy and safety data from its Phase 1 trial of cobomarsen in adult T-cell leukemia/lymphoma (ATLL) at the 12th Annual T-Cell Lymphoma Forum on Friday, January 31, 2020.

Cobomarsen is also being studied in a global phase II trial in patients with mycosis fungoides (MF), the most common type of cutaneous T-cell lymphoma, dubbed SOLAR. The primary endpoint data from this study is expected in the second half of 2021.

MRG-110 a phase II-ready investigational drug for the treatment for chronic ischemic disorders and Remlarsen a potential treatment in the prevention or reduction of keloid scarring, which is under phase II trial are the other compounds in the Company's pipeline.

MGEN closed Monday's trading at $1.46, up 50.52%. In after-hours, the stock was up 9.59% to $1.60.

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