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BioMarin Withdraws Application for Kyndrisa: Stock Falls 2.5%


Jun. 2 2016, Updated 12:53 p.m. ET

BioMarin stock falls

As of June 1, 2016, BioMarin Pharmaceutical (BMRN) was the most underperforming stock among the large-cap stocks of the SPDR S&P Biotech ETF (XBI). BMRN fell 2.5% and underperformed the SPDR S&P 500 ETF (SPY). The fall came after BioMarin withdrew its Market Authorization Application for Kyndrisa in Europe.

In a press release, BioMarin announced that “it has withdrawn its Kyndrisa (drisapersen) Marketing Authorization Application ([or] MAA) from the European Medicines Agency ([or] EMA) following discussions at the May 2016 Committee for Medicinal Products for Human Use ([or] CHMP) meeting. Those discussions clearly indicated that the CHMP intended to issue a negative opinion. Kyndrisa is an experimental drug for the treatment of Duchenne muscular dystrophy ([or] DMD) amenable to exon 51 skipping.”

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Based on discussions at the CHMP meeting and the FDA’s (U.S. Food and Drug Administration’s) Complete Response Letter in January, BioMarin intends to discontinue clinical and regulatory development of Kyndrisa. It will discontinue development of three other first-generation follow-on products—BMN 044, BMN 045, and BMN 053.

These drugs are currently in Phase 2 studies for distinct forms of Duchenne muscular dystrophy. Even with this outcome for Kyndrisa in Europe, BioMarin still expects to achieve non-GAAP (generally accepted accounting principles) break-even or better in 2017.

On June 1, BioMarin Pharmaceutical stock closed at $87.40 and was trading above its 20-day moving average price of $85.10. The stock has fallen 16.6% on a year-to-date basis. BioMarin has a book value of $14.12 per share. At its current price, the stock is trading at a price-to-book value of ~6.2x. Analysts’ consensus 12-month target price estimate for BioMarin is $113.20. Eighteen analysts are recommending a “buy,” and two analysts are recommending a “hold” for the stock. No analysts have recommended a “sell.” BioMarin has a weight of 1.8% in XBI’s portfolio.

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XBI’s large-cap outperformers

Baxalta (BXLT) and Alexion Pharmaceuticals (ALXN) were the outperformers among XBI’s large-caps, with returns of 2.1% and 1.2%, respectively. Baxalta has been on an upward trend ever since its shareholders approved the merger with Shire (SHPG). Baxalta closed at $46.20 and was trading above its 20-day moving average price of $43.40 on June 1. The stock has risen 18.4% on a year-to-date basis. It has a weight of 2.1% in XBI.

Alexion Pharmaceuticals rose after receiving orphan drug designation from the European Commission for ALXN1210 for the treatment of paroxysmal nocturnal hemoglobinuria (or PNH). Alexion closed at $152.70 and was trading above its 20-day moving average. However, the stock has fallen 20% on a year-to-date basis. Alexion Pharmaceuticals carries a weight of 1.9% in XBI.

Next, let’s take a look at Intercept and its upcoming presentations at investor conferences.


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