We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Rigel (RIGL) Sinks on Failure of Mid-Stage Study on Lead Drug
Read MoreHide Full Article
Shares of Rigel Pharmaceuticals, Inc. (RIGL - Free Report) crashed 13.6% after the company announced disappointing top-line data from a mid-stage study on lead candidate, fostamatinib, an oral spleen tyrosine kinase (“SYK”) inhibitor.
Rigel’s stock has lost 21.8% in the last six months as against the industry’s gain of 3.2%.
The company was evaluating the candidate in a proof-of-concept phase II study in patients with IgA nephropathy (IgAN), an orphan autoimmune disease of the kidneys.
Patients enrolled in the trial were required to have a diagnosis of IgAN verified by biopsy and proteinuria greater than 500 mg/day. Patients were randomized into one of the three groups: placebo, fostamatinib at 100 mg bid or fostamatinib at 150 mg bid for 24 weeks. The study evaluated the safety and efficacy as measured by change in proteinuria and renal function.
However, the trial did not achieve statistical significance for its primary endpoint, which was mean change in proteinuria comparing fostamatinib dose groups to placebo controls in all patients studied. The mean change in proteinuria (sPCR) was -177, -577, and -158 mg/g for the placebo, 100 mg bid and 150 mg bid dose groups, respectively.
Nevertheless, the initial data showed a greater reduction in proteinuria in fostamatinib-treated patients relative to placebo patients (this finding did not reach statistical significance) in a pre-specified subgroup analysis of patients with greater than 1 gram/day of proteinuria at baseline. Patients with greater than 1 gram/day of proteinuria have an increased risk of disease.
The company also expects to provide further analysis, including histology, data later in the year.
As a result of these data, Rigel will now seek a partner to collaborate for conducting follow-on clinical studies in IgAN for funding. The concerned partner will be responsible for the subsequent commercialization of fostamatinib in an ex-US territory.
Rigel is also evaluating fostamatinib for a number of other indications. While the failure of IgAN study was disappointing for investors, they do have something to look forward to. Rigel’s NDA for fostamatinib in patients with chronic immune thrombocytopenia (“ITP”) is currently under review with an expected action date of Apr 17, 2018. Since the IgAN study failed, Rigel is now pinning hopes on this review. A tentative approval of the study will boost investor sentiment given the market potential. Chronic ITP affects an estimated 65,000 adult patients in the United States. However, it might not be easy for the company to gain market share for this indication given the presence of Novartis’ (NVS - Free Report) Promacta and Amgen’s (AMGN - Free Report) Nplate.
Rigel is also evaluating fostamatinib in a phase II study for autoimmune hemolytic anemia.
Regeneron’s earnings per share estimates have moved up from $18.65 to $18.68 for 2018 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%.
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
Image: Bigstock
Rigel (RIGL) Sinks on Failure of Mid-Stage Study on Lead Drug
Shares of Rigel Pharmaceuticals, Inc. (RIGL - Free Report) crashed 13.6% after the company announced disappointing top-line data from a mid-stage study on lead candidate, fostamatinib, an oral spleen tyrosine kinase (“SYK”) inhibitor.
Rigel’s stock has lost 21.8% in the last six months as against the industry’s gain of 3.2%.
The company was evaluating the candidate in a proof-of-concept phase II study in patients with IgA nephropathy (IgAN), an orphan autoimmune disease of the kidneys.
Patients enrolled in the trial were required to have a diagnosis of IgAN verified by biopsy and proteinuria greater than 500 mg/day. Patients were randomized into one of the three groups: placebo, fostamatinib at 100 mg bid or fostamatinib at 150 mg bid for 24 weeks. The study evaluated the safety and efficacy as measured by change in proteinuria and renal function.
However, the trial did not achieve statistical significance for its primary endpoint, which was mean change in proteinuria comparing fostamatinib dose groups to placebo controls in all patients studied. The mean change in proteinuria (sPCR) was -177, -577, and -158 mg/g for the placebo, 100 mg bid and 150 mg bid dose groups, respectively.
Nevertheless, the initial data showed a greater reduction in proteinuria in fostamatinib-treated patients relative to placebo patients (this finding did not reach statistical significance) in a pre-specified subgroup analysis of patients with greater than 1 gram/day of proteinuria at baseline. Patients with greater than 1 gram/day of proteinuria have an increased risk of disease.
The company also expects to provide further analysis, including histology, data later in the year.
As a result of these data, Rigel will now seek a partner to collaborate for conducting follow-on clinical studies in IgAN for funding. The concerned partner will be responsible for the subsequent commercialization of fostamatinib in an ex-US territory.
Rigel is also evaluating fostamatinib for a number of other indications. While the failure of IgAN study was disappointing for investors, they do have something to look forward to. Rigel’s NDA for fostamatinib in patients with chronic immune thrombocytopenia (“ITP”) is currently under review with an expected action date of Apr 17, 2018. Since the IgAN study failed, Rigel is now pinning hopes on this review. A tentative approval of the study will boost investor sentiment given the market potential. Chronic ITP affects an estimated 65,000 adult patients in the United States. However, it might not be easy for the company to gain market share for this indication given the presence of Novartis’ (NVS - Free Report) Promacta and Amgen’s (AMGN - Free Report) Nplate.
Rigel is also evaluating fostamatinib in a phase II study for autoimmune hemolytic anemia.
Zacks Rank & Key Pick
Rigel currently carries a Zacks Rank #4 (Sell).
A better-ranked stock from the same space is Regeneron Pharmaceuticals (REGN - Free Report) , which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Regeneron’s earnings per share estimates have moved up from $18.65 to $18.68 for 2018 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%.
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
Click for details >>