FDA Nod For BMY's Sprycel, ARNA To Report Data In Q1, MYL Delists From TASE – Markets Insider

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(RTTNews) – 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 been listed on the TASE for more than two years.

Mylan comprises 8.5% of the total value of stocks and convertible securities on the TASE, reports Israeli newspaper Haaretz.

Mylan’s Chairman of the Board Robert J. Coury noted: “Over the last two years, we have learned that many of our Israeli institutional shareholders actually hold their shares in Mylan on the NASDAQ. Further, Mylan’s holding on the TASE represents less than 3.5% of our total shareholdings and the average trading volume on the TASE is less than 3.5% of our global trading volume. Given these factors and the fact that the TASE’s trading hours and days are different from other markets, our board of directors decided at this time that it would not be in Mylan’s best interests to continue our listing on the TASE. That said, we do appreciate the ties we have forged with the Israeli institutional market.”

Mylan’s shares will continue to be listed on the NASDAQ, and all of its ordinary shares now traded on the TASE may be transferred to the NASDAQ.

MYL closed Friday’s trading at $38.16, up 0.21%.

The initial results from dose-escalation stage of a phase 1/2 study evaluating Nektar Therapeutics’ (NKTR) investigational medicine NKTR-214 plus Bristol-Myers Squibb’s (BMY) blockbuster immunotherapy drug Opdivo underscore the potential benefit of the combination across several tumor types, according to the two companies.

In PIVOT-02, the dose-escalation stage of the study, important response rates across all three tumor types – melanoma, renal cell carcinoma and non-small lung cancer – in both PD-L1 positive and PD-L1 negative patients, were observed. There were no treatment discontinuations due to adverse events or study deaths, noted the companies.

A clinical collaboration to evaluate the potential for the combination of Opdivo and NKTR-214 to show improved and sustained efficacy and tolerability above the current standard of care was signed between Nektar and Bristol-Myers Squibb last September. The costs of the combined therapy trials are being shared equally by the two companies.

NKTR closed Friday’s trading at $32.50, up 2.39%.

Vanda Pharmaceuticals Inc.’s (VNDA) request for approval of Fanaptum for the treatment of schizophrenia in adult patients in the European Union has once gain failed to win positive opinion from the Committee for Medicinal Products for Human Use, or CHMP.

In July 2017, the CHMP recommended refusal of the Fanaptum MAA, following which Vanda requested a re-examination of the initial opinion. However, the re-examination too has not done any good as it has only confirmed the refusal of the Fanaptum Marketing Authorization Application.

The drug is approved in the U.S., Israel and Mexico, under the name Fanapt, for the treatment of schizophrenia in adults.

Fanapt net product sales were $74.3 million for the full year 2016, and $55.84 million in the first nine months of 2017.

VNDA closed Friday’s trading at $13.15, down 0.75%.

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