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Corcept Plans Korlym Label Expansion, Pipeline in Progress


We issued an updated report on Corcept Therapeutics Inc. CORT on Mar 7.

Over the year, Corcept’s shares have returned 62.2% compared with the industry’s gain of 2.5%.

Korlym is Corcept’s lead drug and the company is planning to commercialize it by deploying medical liaisons and sales representatives. Korlym enjoys orphan drug designation in the United States for Cushing’s syndrome. The drug also enjoys orphan status in Europe for the treatment of endogenous Cushing’s syndrome.

Corcept is currently working on developing Korlym for additional indications. It is conducting a phase I/II safety and efficacy study on Korlym in combination with Halaven for the treatment of TNBC. The preliminary efficacy data from the study were encouraging. We expect a successful label expansion of Korlym to boost the top line significantly, as the market holds huge potential, given that more than 40,000 women in the United States being diagnosed with the disease every year.

Corcept is evaluating CORT125134 in phase II for the treatment of Cushing's syndrome. The United States and other regulatory authorities have given CORT125134 its generic name relacorilant. During the fourth quarter of 2017, the company announced positive interim data from the phase II study. The study showed that patients with hyperglycemia demonstrated improved glucose tolerance as measured by the oral glucose tolerance test. Levels of osteocalcin — a marker of bone formation — also improved.

Results for both these measures grew as the dose of relacorilant increased, with the highest dose reaching statistical significance compared to the baseline. The company is continuing testing of higher doses with results expected in the second quarter of 2018. The phase III study is expected to commence in the second quarter of 2018.

The company is advancing its selective cortisol modulator, CORT125281 as a treatment for patients of metastatic castration-resistant prostate cancer. In September 2017, the company began a phase I study in healthy subjects and by the end of 2017 it plans to start enrolling patients in a dose ranging trial that combines CORT125281 with Xtandi.

Selective cortisol modulator CORT118335 is in phase I study and results are expected in second quarter 2018. The company expects to begin phase II trials for both indications by the end of 2018.

The successful development of its pipeline candidates will further boost the company’s portfolio and drive sales.

Zacks Rank & Stocks to Consider

Corcept carries a Zacks Rank #3 (Hold).

A few better-ranked stocks from the same space are Regeneron REGN, Ligand Pharmaceuticals LGND and Enanta Pharma ENTA. While Regeneron and Ligand sport a Zacks Rank #1 (Strong Buy), Enanta Pharma carries a Zacks Rank #2 (Buy), each. You can see the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings per share estimates have moved up from $17.13 to $18.65 and from $20.37 to $21.56 for 2018 and 2019, respectively in the last 30 days. The company pulled off a positive earnings surprise in three of the last four quarters, with an average beat of 9.15%.

Ligand’s earnings per share estimates have moved up $3.54 to $4.15 from $4.75 to $5.75 for 2018 and 2019 respectively over the last 30 days. The company delivered positive earnings surprises in three of the trailing four quarters, with an average beat of 24.88%. The company’s shares have rallied 57.2% over a year.

Enanta Pharma delivered a positive earnings surprise in three of the last four quarters, with an average beat of 373.1%. The company’s shares surged 181.2% over a year

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