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Shares of Puma Biotechnology Inc (NASDAQ: PBYI) plunged more than 25 percent following plans to modify the summary of product characteristics (SmPC) in its European Marketing Authorization Application (MAA) for its breast cancer drug neratinib.

The company now plans to restrict the intended population to patients initiating neratinib treatment within one year after completion of adjuvant trastuzumab therapy.

Earlier, the proposed indication was for the "extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab based therapy."

Puma submitted its neratinib MAA last summer.

During the regulators meeting, the timeline for Neratinib was discussed. Neratinib will likely be sequenced immediately after adjuvant trastuzumab. Furthermore, more benefits were observed in the subgroup of patients who received neratinib within one year from prior trastuzumab completion.

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In addition, data from the pivotal adjuvant trastuzumab trials suggest that patients are at higher risk of recurrence closer to completion of adjuvant trastuzumab, and the risk of recurrence may decrease over time.

Puma also noted that the Committee for Medicinal Products for Human Use (CHMP) is continuing to review Puma's MAA and has not yet made a final decision to recommend approval of the drug for the updated or any other indication and there is no guarantee when, if ever, the MAA will be approved.

Separately, Puma reported a wider loss for its fourth quarter. On a GAAP basis, Puma reported a net loss applicable to common stock of $72.7 million, or $2.04 per share, versus a net loss of $61.7 million, or $1.90 per share, a year ago.

Excluding items, the loss came in at $1.22 a share versus loss of $1.23 a share, last year. However, the loss was better than consensus loss estimate of $1.92 a share.

On December 31, 2016, Puma had cash and cash equivalents of $194.5 million and marketable securities of $35.0 million.

Shares of Puma closed Wednesdays trading at $38.05. In the pre-market hours Thursday, the stock plunged 26.41 percent to $28.

According to the verified Twitter account of TheStreet's senior columnist Adam Feuerstein, "Hedge funds that own $PBYI are screaming at sell side analysts to defend the stock."

TheStreet also published on its website a possible connection between Puma's movements and those of Roche Holding Ltd. (ADR) (OTC: RHHBY). Feuerstein and Martin Baccardax wrote: "The Roche AG (RHHBY) breast cancer drug Perjeta notched an important win in the closely followed 'Aphinity' clinical trial, promising to add billions of dollars in sales to the Swiss drugmaker's top line. Perjeta's success spells big trouble for Puma Biotechnology (PBYI), which could see its competeing, but still approved, breast cancer drug neratinib without any patients to treat."

At last check in Thursday's pre-market session, shares of Puma were down 26.54 percent at $27.95. ADR shares of Roche were up 5.75 percent at $32.30.

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Puma Biotechnology Shares Plunge On Plans To Modify Neratinib European MAA, Competitor Roche's Perjeta Win - Benzinga

This entry was posted on March 4, 2017 at 6:43 am and is filed under Biotechnology. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |