FDA Nod For BMY’s Sprycel, ARNA To Report Data In Q1, MYL Delists From TASE

Today’s Daily Dose brings you news about Arena’s progress in phase II study of Etrasimod in ulcerative colitis; expanded FDA approval of Bristol-Myers’ leukemia drug Sprycel; voluntarily delisting of Mylan’s ordinary shares from the Tel Aviv Stock Exchange and Vanda’s disappointment over Fanaptum’s failure to win the CHMP’s backing.

Read on…

Arena Pharmaceuticals Inc.’s (ARNA) phase II study of Etrasimod in ulcerative colitis has completed full enrollment of 157 patients.

The 12-week study will evaluate efficacy endpoints like improvement in the Mayo clinical score (3-component, total), response, remission and mucosal healing versus placebo, and dose response. The data from this study are expected in the first quarter of 2018.

ARNA closed Friday’s trading at $26.75, up 1.75%.

The FDA has expanded approval of Bristol-Myers Squibb Co.’s (BMY) leukemia drug Sprycel to include the treatment of children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).

This approval for Sprycel in pediatric patients with Ph+ CML in chronic phase was granted under priority review, and the indication received orphan drug designation from the FDA.

Sprycel had global sales of $1.48 billion in the first nine months of 2017, up 11% over the comparable year-ago period.

BMY closed Friday’s trading at $60.86, down 1.82%.

A majority of CombiMatrix Corp.’s (CBMX) stockholders have voted to approve the previously announced merger agreement with Invitae Corp. (NVTA).

CombiMatrix entered into a definitive merger agreement with Invitae in July of this year to be acquired in an all-stock merger for approximately $33 million of combined consideration, based on a fixed price per share of Invitae’s common stock of $9.49 and subject to certain adjustments.

The merger is expected to be completed in the fourth quarter of 2017, subject to additional closing conditions. CombiMatrix would become a wholly owned subsidiary of Invitae upon closing of the proposed merger.

NVTA closed Friday’s trading at $8.62, down 4.22%.

Dual-listed Mylan N.V. (MYL) is voluntarily delisting its ordinary shares from trading on the Tel Aviv Stock Exchange (TASE). The delisting from the TASE will become effective in three months, on February 12, 2018.

Mylan listed on the TASE in November 2015, in connection with its attempt to acquire Perrigo plc (PRGO). At that time, it committed to maintaining the listing for at least one year.

Although its bid to acquire Perrigo failed, Mylan has…

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