Radius Health to Get Third Day-180 List of Outstanding Issues

Radius Health, Inc. RDUS announced that the Committee for Medicinal Products for Human Use (CHMP) will provide a third Day-180 List of Outstanding Issues in its regulatory review of abaloparatide-SC.

The CHMP informed the company that it will refer the marketing authorisation application (MAA) to a scientific advisory group for additional advice as part of its ongoing risk-benefit assessment.

Hence, the CHMP expects to issue an opinion on the same during the first half of 2018.

In July 2017, the CHMP issued a second Day-180 List of Outstanding Issues and requested additional data analyses related to the safety and efficacy of abaloparatide-SC for their ongoing regulatory review.

The delay in approval in Europe is disappointing given the potential market.

 

Radius Health’s share price has decreased 21.8% in the year so far compared with the industry’s gain of 7.4%.

We note that Tymlos (abaloparatide) was approved by the FDA in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

Although the osteoporosis market in the United Sates has great potential as approximately 1.4 million postmenopausal women experience an osteoporotic fractur each year, Tymlos is expected to face significant competition from Eli Lilly & Co's LLY Forteo and Amgen Inc's AMGN Prolia.

Moreover, the approved label carries a boxed warning of osteosarcoma (a malignant bone tumor).

Meanwhile, Radius Health is also developing abaloparatide-TD for as a short wear-time transdermal patch. In December 2015, the company initiated a human replicative clinical evaluation to compare the optimized abaloparatide-TD patch with its subcutaneous formulation. The company posted positive results from the trial in September 2016.

The company is currently focused on completing the manufacturing, scale up, and other required activities needed to initiate a pivotal study to evaluate bioequivalence to abaloparatide-SC. The transdermal patch program has the potential to allow physicians who treat osteoporosis, but rarely use injectable drugs, to expand their practices to include the use of anabolic therapy.

Zacks Rank & Key Pick

Radius Health currently carries a Zacks Rank #3 (Hold).

A better-ranked stock in the healthcare sector is Corcept Therapeutics Inc. CORT which currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks (Strong Buy) here.

Corcept’s earnings per share estimates have increased from 78 cents to 88 cents for 2018 over the last 60 days. The company delivered a positive earnings surprise in two of the trailing four quarters with an average beat of 14.32%. The company’s stock is up 124.5% so far this year.

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