EMA rejects Puma’s neratinib, Shares tumble

Puma says EMA communicates negative trend vote over MAA for neratinib

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EMA rejects Breast Cancer Drug!
Puma Biotechnology (PBYI) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has communicated a negative trend vote after meeting with the company today to discuss the Marketing Authorisation Application for neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer.

 

A negative trend vote means it is unlikely that CHMP will provide a positive opinion related to the Company’s MAA at the formal CHMP decision vote scheduled in February 2018, and that additional steps would need to be taken to gain marketing approval in Europe.

 

CHMP indicated that, in its opinion, the benefit risk assessment is negative as the study results are based on evidence from a single pivotal trial and the 2- and 5-year invasive disease free survival benefits observed to-date may lack sufficient clinical relevance.

 

CHMP’s opinion was based on the results from both the Phase III ExteNET trial in extended adjuvant early stage HER2-positive breast cancer and the Phase II CONTROL trial in extended adjuvant early stage HER2-positive breast cancer.

BACKGROUND

 On July 17, 2017, the company announced that the U.S. FDA has approved #NERLYNX (neratinib), formerly known as #PB272, a once-daily oral tyrosine kinase inhibitor for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy. The drug became commercially available in September of 2017 under the trade name as NERLYNX.

EUROPEAN  DATA 

Last September, Puma Biotechnology (PBYI) presented positive results from the Phase III clinical trial of Puma’s drug neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer following trastuzumab-based therapy in a proffered paper oral session at the European Society of Medical Oncology 2017 Congress in Madrid, Spain.

PRICE ACTION

Today’s EMA decision was a surprise to the market. PBYI closed at $90.90. Shares last traded at $66.00 in extended trading.

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Nasdaq to trade bitcoin futures

Nasdaq assessing bitcoin futures that are different to rivals

Bitcoin hits $8000. See Stockwinners.com for details
Nasdaq assessing bitcoin futures that are different to rivals

Nasdaq (NDAQ) is reviewing ways to offer cryptocurrency futures that operate differently from those offered by Cboe (CBOE) and CME Group (CME), CNBC reports, citing CEO Adena Friedman.

“We are continuing to investigate the idea of a cryptocurrency futures with a partner and we continue to look at the risk management around that, making sure we are putting the right protocols in place, making sure there’s proper demand, and that the contract is different from what’s already out there,” Friedman told CNBC.

“What we might look at is more of a total return futures, so it’s a little bit of a different construct,” adding that it meant it was “more of an investment than a tracking stock.”


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Qualcomm urges shareholders to re-elect board 

Qualcomm urges shareholders to re-elect board

Qualcomm urges shareholders to re-elect board 

“Dear Qualcomm Stockholder, Last week we released a presentation and a video that we believe clearly demonstrate why Broadcom’s hostile takeover proposal dramatically undervalues your Company and is not in the best interests of all Qualcomm’s stockholders.

In this letter, we highlight the significant regulatory issues with Broadcom’s (AVGO) proposal that Qualcomm (QCOM) stockholders must consider.

In summary: Even if Broadcom were to make a proposal that delivered fair value to Qualcomm stockholders, the complex regulatory challenges mean that Broadcom would not deliver that value to Qualcomm stockholders for what is likely to be 18 months or more – if ever.

Broadcom’s claim that it can deliver immediate cash to Qualcomm stockholders through its proposal is completely false.

Broadcom launched a proxy fight to replace Qualcomm’s world-class Board with nominees selected by it and its private equity backer, Silver Lake Partners.

If elected, these nominees – who lack significant large-cap technology Board experience – would be given control of one of the largest, most complex technology companies in the world.

In over two months since making their hostile proposal, Broadcom hasn’t taken the necessary steps to start the regulatory approval process in most countries around the world.

This is the largest proposed technology transaction in history and will require thorough reviews from both antitrust regulators and national security groups in multiple countries around the world.

Regulators in many countries may call for conflicting remedies based on their specific concerns. The regulatory process will be very long and complicated, and we believe it is highly doubtful that the proposed transaction will ultimately be approved.

In short, the Broadcom proposal raises significant regulatory and national security risks which will be compounded by the public and private customer opposition.

With these facts in mind, we believe electing Broadcom’s nominees makes no sense for Qualcomm stockholders and puts your Company at risk of significant value loss in the likely case the deal is not approved.”


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