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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. The FDA's briefing document to the panel had raised concerns about the marginal
135:
Puma was founded in
September 2010 by Alan Auerbach to identify and in-license compounds that were already in clinical development. This was the same business plan Auerbach had followed at Cougar Biotechnology, which he founded in 2003, and through which he in-licensed
179:
In 2016 Puma discovered that Robert
Gadimian, senior director of regulatory affairs, had twice bought and sold stock based on his knowledge of unpublished clinical trial results; Puma quickly fired him after conducting an internal investigation and reported the
219:
for an upfront payment of $ 60 million and milestone payments that could reach $ 345 million. Previously, Puma licensed rights in
Greater China to CANbrdige Life Sciences, rights in Israel to Medison Pharma, rights in Canada to
171:
with the shell company
Innovative Acquisitions Corp., formed in 2007. In April 2012 the company's stock began trading over the counter. In October 2012 the company raised around $ 138 million and its shares were listed on the
211:
In
January 2018 an EMA committee gave a negative review to neratinib. In June 2018 this same EMA committee recommended the approval of neratinib, which received European Commission (EC) approval in September 2018.
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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.
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benefit of the drug and the side effects. In July 2017 the FDA approved neratinib for use in preventing the return of breast cancer after treatment that included
362:
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541:"Merck's Keytruda wins first checkpoint inhibitor lung cancer approval in China; Puma sells rights to Nerlynx in Europe, parts of Africa for $ 60M upfront"
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208:, and with warnings about the risk of severe diarrhea. U.S. sales of neratinib totaled $ 200.5 million in 2018.
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418:
363:"Puma shares jump 40% after FDA review but brief leaves scope for AdComm grilling and neratinib rejection"
120:
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224:, rights in South East Asian to Specialised Therapeutics and rights in Latin America to Pint Pharma.
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As part of an approximately $ 60 million financing round in
October 2011, Puma entered into a
517:"Is Puma off the cancer M&A list? With Nerlyx marketing deal, some investors think so"
205:
181:
124:
322:"Former Puma Biotechnology exec is accused of making $ 1.2 million from insider trading"
448:"Puma Biotechnology shares tank after CHMP looks ready to hit a red light on neratinib"
168:
148:
in 2009. Auerbach brought many Cougar employees with him after founding Puma in 2010.
637:
36:
26:
303:"Puma Biotech raises $ 138M in public offering to advance cancer drug from Pfizer"
201:
51:
215:
In 2019 Puma licensed commercialization rights in Europe and part of Africa to
565:"Knight Therapeutics Acquires Exclusive Marketing Rights to Nerlynx in Canada"
161:
401:"Puma wins big FDA OK for neratinib after running the gamut with investors"
242:"Puma Biotechnology Reports Fourth Quarter and Full Year Financial Results"
469:"Puma Biotechnology sinks after Europe unlikely to OK breast cancer dru"
590:"License deal for early-stage breast cancer drug Nerlynx in South East"
141:
341:"Ex-Puma exec charged with insider trading, hit with criminal charges"
144:. Cougar further developed abiraterone before the company was sold to
157:
32:
105:
164:(PB272) and an analog (PB357) to serve as a backup candidate.
419:"Puma Biotech (PBYI) Q4 Loss Narrows, Nerlynx Pulls Stock Up"
382:"FDA panel backs Puma's neratinib, clearing path to approval"
488:"Puma Biotechnology's breast cancer drug approved in Europe"
291:. Puma Biotechnology, Inc. via SEC Edgar. December 2, 2011.
614:"Puma shares plummet as results from key trial delayed"
156:
In August 2011 Puma licensed two drug candidates from
100:
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24:
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266:Damouni, Sasha; Tirrell, Meg (12 March 2013).
644:Pharmaceutical companies of the United States
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649:Health care companies based in California
268:"Puma Biotechnology stoking predictions"
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339:Taylor, Nick Paul (20 September 2016).
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320:Petersen, Melody (29 September 2016).
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7:
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188:Approval and licensing of neratinib
16:American biopharmaceutical company
14:
446:Carroll, John (23 January 2018).
380:Taylor, Nick Paul (25 May 2017).
361:Taylor, Nick Paul (23 May 2017).
123:(NASDAQ: PBYI) headquartered in
82:
81:
192:In March 2016 Puma held a pre-
1:
399:Caroll, John (17 July 2017).
665:
486:Wnuk, Piotr (2018-09-05).
204:and without any need for
121:biopharmaceutical company
594:www.thepharmaletter.com
272:San Francisco Chronicle
174:New York Stock Exchange
152:Funding for development
41:Russell 2000 Component
146:Johnson & Johnson
119:is a publicly traded
86:$ 200.1 Million(2019)
309:. October 26, 2012.
222:Knight Therapeutics
138:abiraterone acetate
92:Number of employees
65:United States
21:
569:Breast Cancer News
475:. 23 January 2018.
117:Puma Biotechnology
20:Puma Biotechnology
423:finance.yahoo.com
326:Los Angeles Times
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106:pumabiotechnology
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621:. Retrieved
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571:. 2019-02-06
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521:FiercePharma
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495:. Retrieved
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425:. March 2019
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184:to the SEC.
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47:Headquarters
202:trastuzumab
52:Los Angeles
638:Categories
623:2019-07-24
599:2019-07-24
575:2019-07-24
550:2019-07-24
526:2019-07-24
497:2019-07-24
429:2019-07-24
289:"Form S-1"
228:References
96:265 (2019)
452:Endpoints
405:Endpoints
162:neratinib
27:Traded as
131:Creation
473:Reuters
142:BTG plc
101:Website
78:Revenue
35::
158:Pfizer
54:
33:Nasdaq
140:from
108:.com
37:PBYI
194:NDA
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Text is available under the Creative Commons Attribution-ShareAlike License. Additional terms may apply.
