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Arena Pharmaceuticals, Pfizer, Bristol-Myers Squibb, Onyx Mark Key Dates in June


The FDA is scheduled to make a decision on Arena's diet pill. Bristol-Myers and Pfizer hope to get US clearance for the Eliquis blood thinner, a potential blockbuster.

MINYANVILLE ORIGINAL For drug and biotech investors, the big themes for June are medicines for cancer, obesity, and blood clots. The month is shaping up to be a busy and important one for drug approval decisions from the US Food and Drug Administration.

Kicking things off is a major medical meeting focused on cancer research. Later in the month, the FDA will rule on two of the most closely watched new drug approvals of the year, one for weight loss and the other for an improved blood thinning treatment.

Here is a preview of some of the highlights. In the case of approval decisions, dates are subject to change.

June 1-5
Thousands of scientific papers will be presented at the annual meeting of the American Society of Clinical Oncology, or ASCO, in Chicago. Johnson & Johnson's (JNJ) study of its Zytiga prostate cancer drug for patients in the early stages of the disease is among the conference highlights. (See Five Stocks to Watch as Cancer Drug Meeting Opens.)

June 5
Ariad Pharmaceuticals (ARIA) and Merck (MRK) expect to hear a decision from the FDA on possible approval of Taltorvic, a treatment for adults and children with metastatic soft tissue sarcoma. It's unlikely the drug will be approved after advisers to the FDA cast a 13-1 vote advising against recommending the treatment.

June 9
Xenoport (XNPT) and GlaxoSmithKline (GSK) await word from the FDA on approving the drug Horizant for the additional use of treating nerve pain in people with shingles. Horizant was approved last year to treat a condition known as restless legs syndrome. Xenoport's stock fell 7% to $5.49 midday Friday. The shares are still up more than 24% over the past month.

June 20
Onyx Pharmaceuticals (ONXX) faces a panel of FDA advisers who will weigh the merits of approving Kyprolis for multiple myeloma in patients who received other treatments. Ultimately, the company hopes to win approval for a broader group of patients, which would bolster the drug's chance of becoming a big seller. But this is an important date as the company needs to win approval for the initial indication. The FDA is expected to make a decision in July on approval.

Sanofi (SNY) also faces an FDA panel to review the drug semulparin for reducing risk of potentially deadly blood clots in cancer patients.

June 21
Repligen (RGEN) expects to hear from the FDA on its application for SecreFlo, a treatment for patients with pancreatitis. The company has said it expects the FDA to reject the treatment as the agency wants more clinical study data.

June 27
One of the most highly anticipated FDA decisions in the drug/biotech world: Arena Pharmaceuticals (ARNA) awaits word of possible approval of the weight-loss pill Lorcaserin. If approved, it would be the first time in more than a decade that a new diet pill was approved in the US. In May, advisers to the agency recommended the treatment be approved. (See Diet Pill Maker Arena Pharmaceuticals Wins Backing of FDA Advisers.)

June 28
In another closely watched decision, the FDA is scheduled to rule on Pfizer (PFE) and Bristol-Myers Squibb's (BMY) blood thinner Eliquis. Investors expect Eliquis to be a blockbuster product that competes with J&J's Xarelto. (See Johnson & Johnson Setback Is Positive for Pfizer, Bristol-Myers.)

June 29
Japanese drug maker Astellas expects a decision from the FDA on mirabegron for treatment of overactive bladder. An FDA advisory panel voted 7-4 in favor of approval in April.

Twitter: @brettchase

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