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NEW YORK, May 11, 2017 (GLOBE NEWSWIRE) -- The following statement is being issued by Levi & Korsinsky, LLP: To: All persons or entities who purchased or otherwise acquired securities of Puma Biotechnology, Inc. ("Puma Biotechnology") (NASDAQ:PBYI) between February 29, 2016 and May 4, 2017. You are hereby notified that a securities class action lawsuit has been commenced in the United States District Court for the Central District of California. To get more information go to: or contact Joseph E. Levi, Esq. either via email at jlevi@levikorsinsky.com or by telephone at (212) 363-7500, toll-free: (877) 363-5972. There is no cost or obligation to you. The complaint alleges that throughout the class period Defendants issued materially false and/or misleading statements and/or failed to disclose that: (i) the Company did not anticipate that the U.S. Food and Drug Administration (“FDA”) would ultimately approve PB272 (“neratinib”) for the treatment of breast cancer; (ii) as such, Puma Biotechnology had overstated the drug’s approval prospects and/or commercial viability; and (iii) as a result, Puma Biotechnology’s public statements were materially false and misleading at all relevant times. If you suffered a loss in Puma Biotechnology you have until July 7, 2017 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn’t require that you serve as a lead plaintiff. Levi & Korsinsky is a national firm with offices in New York, California, Connecticut, and Washington D.C. The firm’s attorneys have extensive expertise and experience representing investors in securities litigation, and have recovered hundreds of millions of dollars for aggrieved shareholders. Attorney advertising. Prior results do not guarantee similar outcomes.


Puma Biotechnology, Inc. is a development-stage pharmaceutical company that is primarily focused on acquiring and developing drug products. At all relevant times, Puma's primary focus has been the development of the drug PB272 ("neratinib"). Neratinib was initially developed by the pharmaceutical companies Wyeth and Pfizer Inc. ("Pfizer"), and Puma acquired the rights to license the drug in 2011. Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operational and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) the Company did not anticipate that the U.S. Food and Drug Administration's ("FDA") would ultimately approve neratinib for the treatment of breast cancer; (ii) as such, Puma had overstated the drug's approval prospects and/or commercial viability; and (iii) as a result, Puma's public statements were materially false and misleading at all relevant times. On May 4, 2017, post-market, Puma disclosed the resignation of Dr. Robert Charnas, the Company's Senior Vice President, Regulatory Affairs, citing "health reasons." Dr. Charnas' resignation will be effective as of May 15, 2017, nine days before the FDA scheduled review of Puma's breast cancer drug neratinib on May 24. On this news, Puma's share price fell $5.85, or 16.01%, to close at $30.70 on May 5, 2017. On May 5, 2017, Fox Business published an online article entitled "Why Puma Biotechnology Shares are Crashing 18.2% Today." The Pomerantz Firm, with offices in New York, Chicago, Florida, and Los Angeles, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/shareholder-alert-pomerantz-law-firm-reminds-shareholders-with-losses-on-their-investment-in-puma-biotechnology-inc-of-class-action-lawsuit-and-upcoming-deadline---pbyi-300457095.html


The complaint alleges that throughout the class period Defendants issued materially false and/or misleading statements and/or failed to disclose that: (1) Puma did not anticipate that the U.S. Food and Drug Administration ("FDA") would ultimately approve PB272 ("neratinib") for the treatment of breast cancer; (2) consequently, Puma Biotechnology had overstated the drug's approval prospects and/or commercial viability; and (iii) as a result, Puma Biotechnology's public statements were materially false and misleading at all relevant times. On May 4, 2017, post-market, Puma revealed that Dr. Robert Charnas, the Company's Senior Vice President, Regulatory Affairs, would be stepping down for "health reasons."  Dr. Charnas's resignation will be effective as of May 15, 2017, nine days before the U.S. Food and Drug Administration's scheduled review of Puma's breast cancer drug neratinib on May 24. Following this news, Puma stock dropped. A class action lawsuit has already been filed. If you wish to review a copy of the Complaint you can visit the firm's site: http://www.bgandg.com/pbyi  or you may contact Peretz Bronstein, Esq. or his Investor Relations Analyst, Yael Hurwitz of Bronstein, Gewirtz & Grossman, LLC at 212-697-6484. If you suffered a loss in Puma you have until July 7, 2017 to request that the Court appoint you as lead plaintiff.  Your ability to share in any recovery doesn't require that you serve as a lead plaintiff. Bronstein, Gewirtz & Grossman, LLC is a corporate litigation boutique.  Our primary expertise is the aggressive pursuit of litigation claims on behalf of our clients.  In addition to representing institutions and other investor plaintiffs in class action security litigation, the firm's expertise includes general corporate and commercial litigation, as well as securities arbitration.   Attorney advertising. Prior results do not guarantee similar outcomes. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/shareholder-alert-bronstein-gewirtz--grossman-llc-notifies-investors-of-class-action-against-puma-biotechnology-inc-pbyi-and-lead-plaintiff-deadline-july-7-2017-300456300.html


NEW YORK--(BUSINESS WIRE)--Faruqi & Faruqi, LLP, a leading national securities law firm, reminds investors Puma Biotechnology, Inc. (“Puma Biotechnology” or the “Company”) (NASDAQ:PBYI) of the July 7, 2017 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company. If you invested in Puma Biotechnology stock or options between February 29, 2016 and May 4, 2017 and would like to discuss your legal rights, click here: www.faruqilaw.com/PBYI. There is no cost or obligation to you. You can also contact us by calling Richard Gonnello toll free at 877-247-4292 or at 212-983-9330 or by sending an e-mail to rgonnello@faruqilaw.com. The lawsuit has been filed in the U.S. District Court for the Central District of California on behalf of all those who purchased Puma Biotechnologies common stock between February 29, 2016 and May 4, 2017 (the “Class Period”). The case, Nadaskay v. Puma Biotechnology, Inc. et al, No. 2:17-cv-03455 was filed on May 8, 2017. The lawsuit focuses on whether the Company and its executives violated federal securities laws by making false and/or misleading statements and/or failing to disclose that: (i) the Company did not anticipate that the U.S. Food and Drug Administration (“FDA”) would ultimately approve PB272 (“neratinib”) for the treatment of breast cancer; (ii) as such, Puma Biotechnology had overstated the drug’s approval prospects and/or commercial viability; and (iii) as a result, Puma Biotechnology’s public statements were materially false and misleading at all relevant times. Specifically, after market close on May 4, 2017, Puma Biotechnology disclosed the resignation of Dr. Robert Charnas (“Charnas”), the Company’s Senior Vice President, Regulatory Affairs, citing “health reasons.” Furthermore, Dr. Charnas’ resignation will be effective as of May 15, 2017, nine days before the FDA scheduled review of Puma’s breast cancer drug neratinib on May 24. After the announcement, Puma Biotechnology’s share price fell from $36.55 per share on May 4, 2017 to a closing price of $30.70 per share on May 5, 2017 —a $5.85 or a 16.01% drop. The court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class who is adequate and typical of class members who directs and oversees the litigation on behalf of the putative class. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member. Your ability to share in any recovery is not affected by the decision to serve as a lead plaintiff or not. Faruqi & Faruqi, LLP also encourages anyone with information regarding Puma Biotechnology’s conduct to contact the firm, including whistleblowers, former employees, shareholders and others. Attorney Advertising. The law firm responsible for this advertisement is Faruqi & Faruqi, LLP (www.faruqilaw.com). Prior results do not guarantee or predict a similar outcome with respect to any future matter. We welcome the opportunity to discuss your particular case. All communications will be treated in a confidential manner.


LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced publication of abstracts on neratinib for the American Association for Cancer Research (AACR) Annual Meeting 2017. The AACR Annual Meeting will be held at the Walter E. Washington Convention Center in Washington, D.C. from April 1 to April 5. Full abstracts of the following presentations are available online at www.aacr.org: Apr. 4, 2017, 1:00 - 5:00 p.m. EDT – Abstract 4818 (Poster): Neratinib/fulvestrant but not fulvestrant alone maintain complete tumor responses after treatment with trastuzumab + paclitaxel of mice bearing ER+/HER2+ xenografts. L.J. Schwarz et al, Vanderbilt University Medical Center. April 4, 2017, 1:00 - 5:00 p.m. EDT – Abstract 4157 (Poster): Co-blockade of mTORC1, ERBB and estrogen receptor signaling pathways in endocrine resistant breast cancer: combating tumour plasticity. R. Ribas et al, Institute of Cancer Research. April 4, 2017, 1:00 - 5:00 p.m. EDT – Abstract 4038 (Poster): Exploring optimal targeted combination therapies with neratinib for HER2+ breast cancer. M. Zhao et al, MD Anderson Cancer Center. April 5, 2017, 8:00 - 12:00 p.m. EDT – Abstract 5167 (Poster): Stem-like colorectal cancer cell lines show response to the ERK1/2 inhibitor, SCH772984, alone and in combination with neratinib while the combination of MEK-162 and neratinib work to decrease tumor growth in inflammatory colorectal cancer subtypes. R. Pal et al, NSABP. April 5, 2017, 8:00 - 12:00 p.m. EDT – Abstract 5684 (Poster): NSABP FC-7 Correlative Study: HER2 amplification in circulating cell-free DNA (cfDNA) in metastatic colorectal cancer (mCRC) resistant to anti-EGFR therapy. S. Rim Kim et al, NSABP. Full abstracts of the following presentations are expected to be available online March 31, 2017, after 4:00 p.m. EDT: April 2, 2017, 12:45 - 3:00 p.m. EDT – Abstract CT001 (Oral, Clinical Trials Plenary Session): Neratinib in HER2 or HER3 mutant solid tumors: SUMMIT, a global, multi-histology, open-label, phase 2 ‘basket’ study. D. Hyman et al, Memorial Sloan Kettering Cancer Center. April 2, 2017, 3:00 - 5:00 p.m. EDT – Abstract CT011 (Oral, Minisymposium): Circulating tumor DNA (ctDNA) sequencing for HER2 mutation (HER2mut) screening and response monitoring to neratinib in metastatic breast cancer (MBC). C. Ma et al, Washington University School of Medicine. April 2, 2017, 3:00 - 5:00 p.m. EDT – Abstract CT013 (Oral, Minisymposium): NSABP FB-10: Phase Ib dose-escalation trial evaluating trastuzumab emtansine (T-DM1) with neratinib (N) in women with metastatic HER2+ breast cancer (MBC). J. Abraham et al, NSABP. April 3, 2017, 10:30 a.m. – 12:45 p.m. EDT – Abstract LB103 (Oral, Major Symposium): Landscape of Somatic ERBB2 Mutations - Findings from AACR GENIE and Comparison to Ongoing ERBB2 Mutant Basket Study. A. Schram et al, Memorial Sloan Kettering Cancer Center. April 4, 2017, 1:00 - 5:00 p.m. EDT – Abstract CT128 (Poster): Effects of adding budesonide or colestipol to loperamide prophylaxis on neratinib-associated diarrhea in patients (pts) with HER2+ early-stage breast cancer (eBC): the CONTROL trial. E. Ibrahim et al, Beaver Medical Group LP. Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. The Company in-licenses the global development and commercialization rights to three drug candidates—PB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357. Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. Currently, the Company is primarily focused on the development of the oral version of neratinib, and its most advanced drug candidates are directed at the treatment of HER2-positive breast cancer. The Company believes that neratinib has clinical application in the treatment of several other cancers as well, including non-small cell lung cancer and other tumor types that over-express or have a mutation in HER2. Further information about Puma Biotechnology may be found at www.pumabiotechnology.com. This press release contains forward-looking statements that involve risks and uncertainties that could cause the Company's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the risk factors disclosed in the periodic reports filed by the Company with the Securities and Exchange Commission from time to time. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update these forward-looking statements, except as required by law.


NEW YORK, February 24, 2017 /PRNewswire/ -- In today's pre-market research, Stock-Callers.com explores the Biotech arena with the following companies in focus: Puma Biotechnology Inc. (NASDAQ: PBYI), Dipexium Pharmaceuticals Inc. (NASDAQ: DPRX), BioCryst Pharmaceuticals Inc. (NASDAQ:...


News Article | February 15, 2017
Site: www.businesswire.com

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at 2:05 p.m. EST on Wednesday, February 22, at the RBC Capital Markets 2017 Global Healthcare Conference. The conference will be held at the Lotte New York Palace Hotel in New York City. A live webcast of the presentation will be available on the Company’s website at www.pumabiotechnology.com. The presentation will be archived on the website and available for 30 days. Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. The Company in-licenses the global development and commercialization rights to three drug candidates—PB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357. Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. Currently, the Company is primarily focused on the development of the oral version of neratinib, and its most advanced drug candidates are directed at the treatment of HER2-positive breast cancer. The Company believes that neratinib has clinical application in the treatment of several other cancers as well, including non-small cell lung cancer and other tumor types that over-express or have a mutation in HER2. Further information about Puma Biotechnology may be found at www.pumabiotechnology.com. This press release contains forward-looking statements that involve risks and uncertainties that could cause the Company's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the risk factors disclosed in the periodic reports filed by the Company with the Securities and Exchange Commission from time to time. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update these forward-looking statements, except as required by law.


News Article | March 2, 2017
Site: www.businesswire.com

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at 3:20 p.m. EST on Monday, March 6, at the Cowen and Company 37th Annual Health Care Conference. The conference will be held at the Boston Marriott Copley Place. A live webcast of the presentation will be available on the Company’s website at www.pumabiotechnology.com. The presentation will be archived on the website and available for 30 days. Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. The Company in-licenses the global development and commercialization rights to three drug candidates—PB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357. Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. Currently, the Company is primarily focused on the development of the oral version of neratinib, and its most advanced drug candidates are directed at the treatment of HER2-positive breast cancer. The Company believes that neratinib has clinical application in the treatment of several other cancers as well, including non-small cell lung cancer and other tumor types that over-express or have a mutation in HER2. Further information about Puma Biotechnology may be found at www.pumabiotechnology.com. This press release contains forward-looking statements that involve risks and uncertainties that could cause the Company's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the risk factors disclosed in the periodic reports filed by the Company with the Securities and Exchange Commission from time to time. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update these forward-looking statements, except as required by law.


News Article | March 1, 2017
Site: www.businesswire.com

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced financial results for the fourth quarter and year ended December 31, 2016. Unless otherwise stated, all comparisons are for the fourth quarter and full year 2016 compared to the fourth quarter and full year 2015. Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss applicable to common stock of $72.7 million, or $2.04 per share, for the fourth quarter of 2016, compared to a net loss of $61.7 million, or $1.90 per share, for the fourth quarter of 2015. Net loss applicable to common stock for the full year 2016 was $276.0 million, or $8.29 per share, compared to $239.3 million, or $7.45 per share, for the full year 2015. Non-GAAP adjusted net loss was $43.4 million, or $1.22 per share, for the fourth quarter of 2016, compared to non-GAAP adjusted net loss of $40.0 million, or $1.23 per share, for the fourth quarter of 2015. Non-GAAP adjusted net loss for the full year 2016 was $158.8 million, or $4.77 per share, compared to $144.3 million, or $4.49 per share, for the full year 2015. Non-GAAP adjusted net loss excludes stock-based compensation expense, which represents a significant portion of overall expense and has no impact on the cash position of the Company. For a reconciliation of GAAP net loss to non-GAAP adjusted net loss and GAAP net loss per share to non-GAAP adjusted net loss per share, please see the financial tables at the end of this news release. Net cash used in operating activities for the fourth quarter of 2016 was $41.0 million. Net cash used in operating activities for the full year 2016 was $141.7 million. At December 31, 2016, Puma had cash and cash equivalents of $194.5 million and marketable securities of $35.0 million, compared to cash and cash equivalents of $31.6 million and marketable securities of $184.3 million at December 31, 2015. The Company’s balance of cash, cash equivalents and marketable securities at year-end 2016 includes the net proceeds of approximately $162 million received from the Company’s public offering in October 2016. “We made significant progress with the neratinib clinical program during the fourth quarter,” said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. “We presented additional results of several ongoing studies at the 2016 San Antonio Breast Cancer Symposium, including our Phase II CONTROL trial of PB272 in the extended adjuvant treatment of HER2-positive early stage breast cancer; a biomarker analysis of the NSABP FB-7 Phase II trial for the neoadjuvant treatment of HER2-positive locally advanced breast cancer; and the Phase II SUMMIT trial of PB272 for ERBB2 (HER2) mutant, HER2 non-amplified metastatic breast cancer. We also initiated a Managed Access Program for PB272 (neratinib) outside the United States, providing physicians and patients access to PB272 when there are limited or no other therapeutic options available.” Mr. Auerbach added, “During 2017, we anticipate the following key milestones with neratinib: (i) reporting additional data in the second quarter of 2017 from the Phase II CONTROL trial of neratinib as an extended adjuvant treatment in HER2-positive early stage breast cancer using antidiarrheal prophylaxis with loperamide and other agents (budesonide, colestipol); (ii) reporting interim Phase I/II data in the second quarter of 2017 from the NSABP FB-10 trial of neratinib plus Kadcyla (T-DM1) in HER2-positive metastatic breast cancer (MBC); (iii) reporting data in the second quarter of 2017 from the Phase II SUMMIT basket trial of neratinib in patients with HER2 non-amplified solid tumors that have a HER2 mutation; (iv) reporting data from the Phase III trial in third-line HER2-positive MBC patients in the first half of 2017; (v) reporting data in the second quarter of 2017 from the TBCRC-022 Phase II trial of neratinib plus capecitabine in HER2-positive MBC patients with brain metastases; (vi) reporting Phase II data in the second quarter of 2017 from the SUMMIT basket trial of neratinib in HER2-negative breast cancer patients with HER2 mutations; (vii) reporting final 5-year disease free survival (DFS) data during the second half of 2017 from the ExteNET Phase III trial of neratinib as an extended adjuvant treatment in HER2-positive early stage breast cancer; and (viii) announcing regulatory decisions in the United States and European Union on neratinib for the extended adjuvant treatment of patients with HER2-positive early stage breast cancer in the third quarter of 2017.” Operating expenses were $72.9 million for the fourth quarter of 2016, compared to $62.1 million for the fourth quarter of 2015. Operating expenses for the full year 2016 were $276.6 million compared to $240.3 million for the full year 2015. General and administrative expenses were $16.5 million for the fourth quarter of 2016, compared to $9.6 million for the fourth quarter of 2015. General and administrative expenses for the full year 2016 were $53.8 million compared to $31.8 million for the full year 2015. The increase of approximately $22.0 million during the full year 2016 compared to the same period in 2015 resulted primarily from increases of approximately $9.4 million in stock-based compensation, $2.8 million in payroll and related costs, $7.1 million in professional fees and expenses and $2.2 million in facility and equipment costs. These increases reflect higher legal and compliance expenses, as well as overall corporate growth. Research and development expenses were $56.4 million for the fourth quarter of 2016, compared to $52.5 million for the fourth quarter of 2015. Research and development expenses for the full year 2016 were $222.8 million, compared to $208.5 million for the full year 2015. The increase of approximately $14.3 million during the full year 2016 compared to the same period in 2015 resulted primarily from increases of approximately $12.8 million in stock-based compensation, $6.2 million for internal clinical development, regulatory affairs and quality assurance and internal chemical manufacturing expenses and $2.0 million in consultants and contractors related expenses, offset by a $6.8 million decrease in clinical trial expenses. Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. The Company in-licenses the global development and commercialization rights to three drug candidates—PB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357. Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. Currently, the Company is primarily focused on the development of the oral version of neratinib, and its most advanced drug candidates are directed at the treatment of HER2-positive breast cancer. The Company believes that neratinib has clinical application in the treatment of several other cancers as well, including non-small cell lung cancer and other tumor types that over-express or have a mutation in HER2. Further information about Puma Biotechnology can be found at www.pumabiotechnology.com. This press release contains forward-looking statements, including statements regarding the potential announcement of regulatory decisions in the United States and European Union on neratinib for the extended adjuvant treatment of patients with HER2-positive early stage breast cancer and the Company’s clinical trials and the announcement of data relative to these trials. All forward-looking statements included in this press release involve risks and uncertainties that could cause the Company’s actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the fact that the Company has no product revenue and no products approved for marketing, the Company’s dependence on PB272, which is still under development and may never receive regulatory approval, the challenges associated with conducting and enrolling clinical trials, the risk that the results of clinical trials may not support the Company’s drug candidate claims, even if approved, the risk that physicians and patients may not accept or use the Company’s products, the Company’s reliance on third parties to conduct its clinical trials and to formulate and manufacture its drug candidates, the Company’s dependence on licensed intellectual property, and the other risk factors disclosed in the periodic reports filed by the Company with the Securities and Exchange Commission from time to time, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2016. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update these forward-looking statements, except as required by law. In addition to operating results as calculated in accordance with generally accepted accounting principles, or GAAP, the Company uses certain non-GAAP financial measures when planning, monitoring, and evaluating operational performance. The following table presents the Company’s net loss and net loss per share calculated in accordance with GAAP and as adjusted to remove the impact of employee stock-based compensation. For the three and twelve months ended December 31, 2016, stock-based compensation represented approximately 40.4% and 42.5% of net loss, respectively. Although net loss is important to measure financial performance, the Company currently places an emphasis on cash burn and, more specifically, cash used in operations. Stock-based compensation appears in GAAP net loss but is removed from net loss to arrive at cash used in operations on the statement of cash flows. Due to its noncash nature, the Company believes these non-GAAP measures enhance understanding of financial performance, are more indicative of operational performance and facilitate a better comparison among fiscal periods. These non-GAAP financial measures are not, and should not be viewed as, substitutes for GAAP reporting measures.


LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that based on its recent meeting with the Rapporteur, Co-Rapporteur and review team members, as well as the European Medicines Agency (EMA), the Company plans to modify the summary of product characteristics (SmPC), sometimes referred to as the European product label, in its Marketing Authorisation Application (MAA) to restrict the intended population to patients initiating neratinib treatment within one year after completion of adjuvant trastuzumab therapy. The proposed SmPC will continue to include both hormone receptor positive and hormone receptor negative patients. Puma recently conducted a meeting with the Rapporteur, Co-rapporteur and members of the review team as well as EMA to discuss the responses to the 120-day list of questions received in connection with the Company’s MAA for neratinib that was submitted in the summer of 2016. The initially 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.” During this meeting it was discussed that neratinib would likely be sequenced immediately after adjuvant trastuzumab and more benefit was observed in the subgroup of patients who received neratinib within 1 year from prior trastuzumab completion when compared with those patients receiving neratinib after 1 year from the completion of prior trastuzumab treatment. 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. Based on this meeting, Puma will be revising the proposed SmPC in its MAA for neratinib to restrict the intended population to those patients initiating neratinib treatment within one year after completion of adjuvant trastuzumab therapy. 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. The tables below, based on the interim 5 year analysis announced in July 2016, show results for the invasive disease free survival (DFS) of the initially proposed intent to treat population and the intent to treat population (both hormone receptor positive and hormone receptor negative) in the subgroup of patients who initiated neratinib treatment within one year after completion of adjuvant trastuzumab therapy. Puma plans to file a Current Report on Form 8-K with the Securities and Exchange Commission containing the updated Kaplan-Meier curves for the subgroup of patients randomized within one year after completion of adjuvant trastuzumab therapy for: (i) the intent to treat population; (ii) the subgroup of patients with centrally confirmed HER2 positive disease; (iii) the hormone receptor positive subgroup of patients and (iv) the hormone receptor negative subgroup of patients. Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. The Company in-licenses the global development and commercialization rights to three drug candidates—PB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357. Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. Currently, the Company is primarily focused on the development of the oral version of neratinib, and its most advanced drug candidates are directed at the treatment of HER2-positive breast cancer. The Company believes that neratinib has clinical application in the treatment of several other cancers as well, including non-small cell lung cancer and other tumor types that over-express or have a mutation in HER2. Further information about Puma Biotechnology can be found at www.pumabiotechnology.com. This press release contains forward-looking statements, including statements regarding the Company’s plans to modify the SmPC in its MAA to restrict the intended population to patients initiating neratinib treatment within one year after completion of adjuvant trastuzumab therapy. All forward-looking statements included in this press release involve risks and uncertainties that could cause the Company’s actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the fact that the Company has no product revenue and no products approved for marketing, the Company’s dependence on PB272, which is still under development and may never receive regulatory approval, the challenges associated with conducting and enrolling clinical trials, the risk that the results of clinical trials may not support the Company’s drug candidate claims, even if approved, the risk that physicians and patients may not accept or use the Company’s products, the Company’s reliance on third parties to conduct its clinical trials and to formulate and manufacture its drug candidates, the Company’s dependence on licensed intellectual property, and the other risk factors disclosed in the periodic reports filed by the Company with the Securities and Exchange Commission from time to time, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2016. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update these forward-looking statements, except as required by law.

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