Puma Biotechnology

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Puma Biotechnology
Traded asNASDAQPBYI
Russell 2000 Component

Puma Biotechnology is a publicly-traded pharmaceutical company (NASDAQGS: PBYI) headquartered in Los Angeles, CA.

Puma was founded in September 2010 by Alan Auerbach as a vehicle to identify and in-license compounds that were already in clinical development; this was the same business plan Auerbach had followed with Cougar Biotechnology, which was founded in 2003, in-licensed abiraterone acetate from BTG plc then further developed it, and was acquired by Johnson & Johnson in 2009.[1] Auerbach brought many Cougar employees with him into Puma.[1]

In August 2011 Puma licensed two drug candidates from Pfizer: neratinib (PB272) and an analog (PB357) to serve as a backup candidate.[2]:6,23 In October 2011 as part of an approximately $60 million financing round, it performed a reverse merger with the shell company, Innovative Acquisitions Corp., which had been formed in 2007.[1][2]:4 In April 2012 the company's stock began trading over the counter[1] and in October 2012 the company raised around $138 million on the New York Stock Exchange.[3]

In 2016 Puma discovered that Robert Gadimian, its senior director of regulatory affairs, had twice bought and sold stock based on his knowledge of unpublished clinical trial results; Puma fired him and reported the insider trading to the SEC.[4][5]

In March 2016 Puma held a pre-NDA meeting with the FDA in which the FDA raised concerns about the design and conduct of clinical trials that Puma had run and recommended that Puma not file the NDA with that data.[6]

Puma did file the NDA, and in May 2017 an FDA review panel recommended that the FDA approve neratinib but raised concerns that the intended use was too broad and should be limited to people with specific mutations.[7] The FDA's briefing document to the panel had raised concerns about the marginal benefit of the drug and the side effects.[6] In July 2017 the FDA approved neratinib for use in preventing the return of breast cancer after treatment that included trastuzumab and without any need for genetic testing, and with warnings about the risk of severe diarrhea.[8]

In January 2018 an EMA committee gave a negative review to neratinib.[9][10]

References[edit]

  1. ^ a b c d Damouni, Sasha; Tirrell, Meg (12 March 2013). "Puma Biotechnology stoking predictions". San Francisco Chronicle.
  2. ^ a b "Form S-1". Puma Biotechnology, Inc. via SEC Edgar. December 2, 2011.
  3. ^ "Puma Biotech raises $138M in public offering to advance cancer drug from Pfizer". FierceBiotech. October 26, 2012.
  4. ^ Petersen, Melody (29 September 2016). "Former Puma Biotechnology exec is accused of making $1.2 million from insider trading". Los Angeles Times.
  5. ^ Taylor, Nick Paul (20 September 2016). "Ex-Puma exec charged with insider trading, hit with criminal charges". FierceBiotech.
  6. ^ a b Taylor, Nick Paul (23 May 2017). "Puma shares jump 40% after FDA review but brief leaves scope for AdComm grilling and neratinib rejection". FierceBiotech.
  7. ^ Taylor, Nick Paul (25 May 2017). "FDA panel backs Puma's neratinib, clearing path to approval". FierceBiotech.
  8. ^ Caroll, John (17 July 2017). "Puma wins big FDA OK for neratinib after running the gamut with investors". Endpoints.
  9. ^ Carroll, John (23 January 2018). "Puma Biotechnology shares tank after CHMP looks ready to hit a red light on neratinib". Endpoints.
  10. ^ "Puma Biotechnology sinks after Europe unlikely to OK breast cancer dru". Reuters. 23 January 2018.