PBYI Puma Biotechnology Inc

10.36
+0.27  (+3%)
Previous Close 10.09
Open 10.2
52 Week Low 5.5
52 Week High 15
Market Cap $411,051,430
Shares 39,676,779
Float 30,470,160
Enterprise Value $413,650,700
Volume 1,298,769
Av. Daily Volume 800,704
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Upcoming Catalysts

Drug Stage Catalyst Date
Neratinib SUMMIT
HER2 non-amplified breast cancer that has a HER2 mutation
Phase 2
Phase 2
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Neratinib monotherapy with high dose loperamide prophylaxis - CONTROL
Extended adjuvant treatment of early stage HER2-positive breast cancer
Phase 2
Phase 2
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Kadcyla plus neratinib (TBCRC-022)
HER2 positive breast cancer with brain metastases
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Neratinib - NALA
Third-line HER2-positive metastatic breast cancer
Approved
Approved
FDA Approval announced February 26, 2020.
Neratinib (NERLYNX)
Extended adjuvant HER2-positive early stage breast cancer
Approved
Approved
Approval announced July 17, 2017. Advisory Committee Meeting May 24, 2017 voted 12-4 in favor of recommending approval.

Latest News

  1. 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 11:30 a.m. EDT on Tuesday, Sept. 15, at the H.C. Wainwright 22nd Annual Global Investment Conference. The conference will be held virtually.

    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.

    About Puma Biotechnology

    Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global…

    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 11:30 a.m. EDT on Tuesday, Sept. 15, at the H.C. Wainwright 22nd Annual Global Investment Conference. The conference will be held virtually.

    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.

    About Puma Biotechnology

    Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.

    Further information about Puma Biotechnology may be found at www.pumabiotechnology.com.

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  2. Puma Biotechnology, Inc. (NASDAQ:PBYI), a biopharmaceutical company, announced that on September 2, 2020 the Compensation Committee of Puma's Board of Directors approved the grant of inducement restricted stock unit awards covering an aggregate of 66,688 shares of Puma common stock to 10 new non-executive employees.

    The awards were granted under Puma's 2017 Employment Inducement Incentive Award Plan, which was adopted on April 27, 2017 and provides for the granting of equity awards to new employees of Puma. The restricted stock unit awards vest over a three-year period, with one-third of the shares underlying each award vesting on the first anniversary of the award's vesting commencement date, September 1, 2020, and one-sixth of the shares…

    Puma Biotechnology, Inc. (NASDAQ:PBYI), a biopharmaceutical company, announced that on September 2, 2020 the Compensation Committee of Puma's Board of Directors approved the grant of inducement restricted stock unit awards covering an aggregate of 66,688 shares of Puma common stock to 10 new non-executive employees.

    The awards were granted under Puma's 2017 Employment Inducement Incentive Award Plan, which was adopted on April 27, 2017 and provides for the granting of equity awards to new employees of Puma. The restricted stock unit awards vest over a three-year period, with one-third of the shares underlying each award vesting on the first anniversary of the award's vesting commencement date, September 1, 2020, and one-sixth of the shares underlying each award vesting on each six-month anniversary of the vesting commencement date thereafter, subject to continued service. The awards were granted as an inducement material to the new employees entering into employment with Puma, in accordance with Nasdaq Listing Rule 5635(c)(4).

    About Puma Biotechnology

    Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.

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  3. MONTREAL, Sept. 03, 2020 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX:GUD) ("Knight"), a pan-American (ex-US) specialty pharmaceutical company, announced filing of the Supplement to a New Drug Submission (SNDS) of NERLYNX for HER2-Positive Metastatic Breast Cancer in Canada.

    NERLYNX was originally approved by Health Canada in July 2019 for the extended adjuvant treatment of women with early stage hormone receptor positive, HER2-overexpressed/amplified breast cancer within one year after completion of trastuzumab-based adjuvant therapy.1

    The SNDS is supported by the results of the Phase III NALA trial, a randomized controlled trial of neratinib plus capecitabine versus Tykerb® (lapatinib) plus capecitabine in HER2-positive metastatic…

    MONTREAL, Sept. 03, 2020 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX:GUD) ("Knight"), a pan-American (ex-US) specialty pharmaceutical company, announced filing of the Supplement to a New Drug Submission (SNDS) of NERLYNX for HER2-Positive Metastatic Breast Cancer in Canada.

    NERLYNX was originally approved by Health Canada in July 2019 for the extended adjuvant treatment of women with early stage hormone receptor positive, HER2-overexpressed/amplified breast cancer within one year after completion of trastuzumab-based adjuvant therapy.1

    The SNDS is supported by the results of the Phase III NALA trial, a randomized controlled trial of neratinib plus capecitabine versus Tykerb® (lapatinib) plus capecitabine in HER2-positive metastatic breast cancer patients previously treated with ≥ 2 HER2-directed regimens.

    "We're excited to submit a new indication of NERLYNX to Health Canada, enabling us to offer a new targeted treatment option for Canadian women and physicians," said Samira Sakhia, President and Chief Operating Officer at Knight Therapeutics.

    Knight and Puma Biotechnology, Inc. (NASDAQ:PBYI) signed a licensing agreement in January 2019 granting Knight the exclusive right to commercialize NERLYNX® (neratinib) in Canada. Under the terms of the License Agreement, Knight will be responsible for all commercial activities and future regulatory submissions for NERLYNX® in Canada.

    About HER2-Positive Breast Cancer

    Up to 20% of patients with breast cancer tumors over-express the HER2 protein (HER2-positive disease). HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death2. About 6.6%-8% of HER2-positive breast cancer is metastatic disease based on a Canadian population study3. The median overall survival for metastatic HER2-positive patients is 28.1 months from a contemporary population-based study4.

    About NALA

    The NALA trial is a randomized controlled Phase III trial of neratinib plus capecitabine versus Tykerb® (lapatinib) plus capecitabine in HER2-positive metastatic breast cancer patients with ≥ 2 previous HER2-directed therapies . The trial enrolled 621 patients who were randomized (1:1) to receive either neratinib plus capecitabine or lapatinib plus capecitabine. The trial was conducted globally at sites in North America, Europe, Asia-Pacific and South America. The co-primary endpoints of the trial are centrally confirmed progression free survival (PFS) and overall survival (OS). Treatment with neratinib in combination with capecitabine resulted in a statistically significant improvement in PFS (Hazard Ratio 0.76; 95% CI: 0.63, 0.93; p=0.0059) compared to treatment with lapatinib plus capecitabine.

    The most common adverse reactions of any grade (>5%) in the neratinib plus capecitabine arm were diarrhea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, weight decreased, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms. The most frequently reported Grade 3 or 4 adverse reactions were diarrhea, nausea, vomiting, fatigue and decreased appetite.

    The recommended neratinib dose for advanced or metastatic breast cancer is 240 mg (6 tablets) given orally once daily with food on days 1-21 of a 21-day cycle plus capecitabine (750 mg/m2 given orally twice daily) on days 1-14 of a 21-day cycle until disease progression or unacceptable toxicities5.

    About Knight Therapeutics Inc.

    Knight Therapeutics Inc., headquartered in Montreal, Canada, is a pan-American (ex-US) specialty pharmaceutical company focused on developing, acquiring or in-licensing and commercializing innovative pharmaceutical products for Canada and Latin America. Knight owns a controlling stake in Grupo Biotoscana, a pan-Latin American specialty pharmaceutical company. Knight Therapeutics Inc.'s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at www.gud-knight.com or www.sedar.com.

    Forward-Looking Statement

    This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2019 as filed on www.sedar.com. Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information or future events, except as required by law.



    For further information, please contact:

    Knight Therapeutics Inc.

    Samira Sakhia

    President and Chief Operating Officer

    T: 514-678-8930

    F: 514-481-4116

    Email:

    Website: www.gud-knight.com

    Knight Therapeutics Inc.

    Arvind Utchanah

    Chief Financial Officer

    T. 514.484.4483 ext. 115

    F. 514.481.4116

    Email:

    Website: www.gud-knight.com

    References

    1. NERLYNX® Product Monograph, September 17, 2019
    2. Slamon DJ, et, al. Science 1987; 235:177–182.
    3. Elizabeth Hammonda, et al. Cancer Epidemiology 45 (2016) 82–90.
    4. Benjamin Daniels, et al. Breast Cancer Research and Treatment. https://doi.org/10.1007/s10549-018-4804-0
    5. Cristina Saura, et al. J Clin Oncol 38. DOI: 10.1200/JCO.20.00147

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  4. - CONTROL Trial Investigates Anti-diarrheal Strategies Including Dose Escalation in Neratinib-treated Patients with Early Stage HER2-positive Breast Cancer

    - Dose Escalation Resulted in Reduced Rate, Severity and Duration of Grade 3 Diarrhea Compared to Phase III ExteNET Trial, Lower Diarrhea-related Discontinuations and Dose Reductions in Multiple CONTROL Cohorts

    Puma Biotechnology, Inc. (NASDAQ:PBYI), a biopharmaceutical company, announced the publication of interim results from its Phase II CONTROL trial of neratinib in the September 2020 Issue (Volume 31, Issue 9) of Annals of Oncology. The publication entitled, "Improved Tolerability of Neratinib in Patients with HER2+ Early-Stage Breast Cancer: Diarrheal Toxicity in the CONTROL Trial…

    - CONTROL Trial Investigates Anti-diarrheal Strategies Including Dose Escalation in Neratinib-treated Patients with Early Stage HER2-positive Breast Cancer

    - Dose Escalation Resulted in Reduced Rate, Severity and Duration of Grade 3 Diarrhea Compared to Phase III ExteNET Trial, Lower Diarrhea-related Discontinuations and Dose Reductions in Multiple CONTROL Cohorts

    Puma Biotechnology, Inc. (NASDAQ:PBYI), a biopharmaceutical company, announced the publication of interim results from its Phase II CONTROL trial of neratinib in the September 2020 Issue (Volume 31, Issue 9) of Annals of Oncology. The publication entitled, "Improved Tolerability of Neratinib in Patients with HER2+ Early-Stage Breast Cancer: Diarrheal Toxicity in the CONTROL Trial," can also be accessed online here.

    Previous studies of neratinib in HER2-positive early stage breast cancer showed that diarrhea was the most common adverse event (AE) associated with neratinib treatment.

    The international, open-label, sequential-cohort Phase II CONTROL trial is investigating several strategies to improve neratinib tolerability. Researchers used data on incidence, duration and onset of diarrhea in the pivotal, multi-center, randomized, double-blind, placebo-controlled Phase III ExteNET trial as a historical comparison. In the ExteNET trial, prophylactic use of anti-diarrheal medication was not mandatory.

    The interim results of the CONTROL trial discussed in this publication demonstrate that neratinib tolerability can be significantly improved using a variety of anti-diarrheal strategies. The most significant impact was seen using a dose escalation strategy with loperamide as needed, which included utilizing a lower dose of neratinib during the first two weeks of a 52-week treatment period. In the dose escalation cohort, of which patients completed one year of treatment or had the highest median treatment duration compared to other cohorts, grade 3 diarrhea was reduced by over 60% (CONTROL 15% versus ExteNet 40%), discontinuations by over 80% (CONTROL 3% versus ExteNet 17%), the need to dose reduce by almost 90% (CONTROL 3% versus ExteNet 26%) and no patients were hospitalized.

    "Achieving a balance between treatment benefit and adverse events is an important clinical consideration in breast cancer, and the CONTROL trial demonstrates that neratinib tolerability can be most optimally improved with dose escalation, which can ultimately improve patient adherence to treatment," said Carlos H. Barcenas, M.D., M.S., associate professor in the department of breast medical oncology at The University of Texas MD Anderson Cancer Center. "These results, and specifically the lessened discontinuation of patients in early neratinib treatment, suggest that managing diarrhea during neratinib treatment allows more patients to receive the potential efficacy benefits of extended adjuvant neratinib therapy."

    Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, "We are pleased with the marked reduction in both the incidence of grade 3 diarrhea and the decrease in discontinuation of therapy demonstrated in the dose-escalation cohort of the CONTROL trial. We believe these are important results and should lead to improved tolerability for neratinib in early stage breast cancer patients. We remain committed to the fight against breast cancer, both in the early stage as well as in the metastatic setting."

    The CONTROL trial initially tested high-dose loperamide prophylaxis given for the first two cycles (56 days) of adjuvant treatment (12 mg on days 1-14, 8 mg on days 15-56 and as needed thereafter). The CONTROL trial was then expanded to include four additional cohorts. One cohort received the combination of loperamide and budesonide, the second cohort received the combination of loperamide plus colestipol, the third cohort received colestipol plus loperamide as needed and the fourth cohort did not use any antidiarrheal drugs as mandatory prophylaxis but instead used a dose escalation schedule plus loperamide as needed during the first month of neratinib treatment. Budesonide is a locally acting corticosteroid that Puma believes targets the inflammation identified in a preclinical model of neratinib-induced diarrhea, and colestipol is a bile acid sequestrant that Puma believes targets potential bile acid malabsorption that could result from such inflammation. The dose escalation schedule involved treating with neratinib with loperamide as needed at 120 mg per day for the first week, 160 mg per day for the second week and 240 mg per day starting at week three and until the end of treatment.

    About HER2-Positive Breast Cancer

    Up to 20% of patients with breast cancer tumors over-express the HER2 protein (HER2-positive disease) and in the ExteNET study, 57% of patients were found to have tumors that were hormone-receptor positive. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer recurring, up to 25% of patients treated with trastuzumab experience recurrence within 10 years, the majority of which are metastatic recurrences.

    About Puma Biotechnology

    Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.

    Further information about Puma Biotechnology may be found at www.pumabiotechnology.com.

    IMPORTANT SAFETY INFORMATION

    NERLYNX® (neratinib) tablets, for oral use

    INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated:

    • As a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.
    • In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer, who have received two or more prior anti-HER2 based regimens in the metastatic setting.

    CONTRAINDICATIONS: None

    WARNINGS AND PRECAUTIONS:

    • Diarrhea: Aggressively manage diarrhea. If diarrhea occurs despite recommended prophylaxis, treat with additional antidiarrheals, fluids, and electrolytes as clinically indicated. Withhold NERLYNX in patients experiencing severe and/or persistent diarrhea. Permanently discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade ≥ 2 diarrhea that occurs after maximal dose reduction.
    • Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities.
    • Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

    ADVERSE REACTIONS:

    The most common adverse reactions (reported in ≥ 5% of patients) were:

    • NERLYNX as a single agent: Diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increased, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased, and urinary tract infection.
    • NERLYNX in combination with capecitabine: Diarrhea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, weight decreased, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms.

    To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) and www.NERLYNX.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    DRUG INTERACTIONS:

    • Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors. When patients require gastric acid reducing agents, use an H2-receptor antagonist or antacid. Separate NERLYNX by at least 3 hours with antacids. Separate NERLYNX by at least 2 hours before or 10 hours after H2-receptor antagonists.
    • Strong CYP3A4 inhibitors: Avoid concomitant use.
    • Moderate CYP3A4 and P-glycoprotein (P-gp) dual inhibitors: Avoid concomitant use.
    • Strong or moderate CYP3A4 inducers: Avoid concomitant use.
    • P-glycoprotein (P-gp) substrates: Monitor for adverse reactions of narrow therapeutic agents that are P-gp substrates when used concomitantly with NERLYNX.

    USE IN SPECIFIC POPULATIONS:

    • Lactation: Advise women not to breastfeed.

    Please see Full Prescribing Information for additional safety information.

    To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at www.NERLYNX.com or 1-855-816-5421.

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  5. Puma Biotechnology, Inc. (NASDAQ:PBYI), a biopharmaceutical company, announced that on August 4, 2020 the Compensation Committee of Puma's Board of Directors approved the grant of inducement restricted stock unit awards covering an aggregate of 32,000 shares of Puma common stock to six new non-executive employees.

    The awards were granted under Puma's 2017 Employment Inducement Incentive Award Plan, which was adopted on April 27, 2017 and provides for the granting of equity awards to new employees of Puma. The restricted stock unit awards vest over a three-year period, with one-third of the shares underlying each award vesting on the first anniversary of the award's vesting commencement date, August 1, 2020, and one-sixth of the shares underlying…

    Puma Biotechnology, Inc. (NASDAQ:PBYI), a biopharmaceutical company, announced that on August 4, 2020 the Compensation Committee of Puma's Board of Directors approved the grant of inducement restricted stock unit awards covering an aggregate of 32,000 shares of Puma common stock to six new non-executive employees.

    The awards were granted under Puma's 2017 Employment Inducement Incentive Award Plan, which was adopted on April 27, 2017 and provides for the granting of equity awards to new employees of Puma. The restricted stock unit awards vest over a three-year period, with one-third of the shares underlying each award vesting on the first anniversary of the award's vesting commencement date, August 1, 2020, and one-sixth of the shares underlying each award vesting on each six-month anniversary of the vesting commencement date thereafter, subject to continued service. The awards were granted as an inducement material to the new employees entering into employment with Puma, in accordance with Nasdaq Listing Rule 5635(c)(4).

    About Puma Biotechnology

    Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.

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