Company Overview and News

126
Your Daily Scoop: Recro Proceeds, MannKind Zooms, Aduro's Publication

2018-09-07 seekingalpha - 3
Discussion: On September 4, Recro Pharma (REPH) reported positive outcome of its meeting with the FDA regarding its NDA for IV meloxicam that was rejected in last May. Based on the discussion with the FDA, the company now plans to submit a revised NDA by the end of this month. Suggestions offered by the FDA now guides the company to include revised labelling language and further information on extractable and leachable items.
DOVA MNKD SYBX TSRO REDIF AST OPK RDHL PBYI ZGNX SNGX DVAX ADRO ALXN BIIB AGLE EIGR HZNP EYEG HSDT CHEK EYEGW SNY BCRX SAGE REPH JNJ UTHR APLS

22
Puma Biotech Gets EU Nod for Breast Cancer Drug Nerlynx

2018-09-06 zacks
Puma Biotechnology Inc. (PBYI - Free Report) announced that the European Commission has given a marketing approval to its kinase inhibitor Nerlynx (neratinib). The drug has been approved as an extended adjuvant treatment of early stage hormone receptor positive (HER2-positive) breast cancer in patients, previously treated with Roche’s (RHHBY - Free Report) Herceptin-based adjuvant therapy.
GILD KHC PBYI ILMN

19
Biotech Stock Roundup: AMGN, PBYI Get EC Nod for Their Drugs, MNKD Soars

2018-09-05 zacks
The major pipeline and regulatory updates in the biotech sector over the past week included Amgen (AMGN - Free Report) ’s Blincyto getting EC approval for a label expansion and Puma Biotechnology (PBYI - Free Report) winning EC approval for Nerlynx. Meanwhile, MannKind (MNKD - Free Report) shares surged on a deal with United Therapeutics Corporation.
MNKD VRTX AMGN PBYI UTHR

18
PBYI / Puma Biotechnology Inc. null

2018-08-28 sec.gov
begin 644 filename1.pdf M)5!$1BTQ+C4-)>+CS],-"C$P(# @;V)J#3P\+TQI;F5A
PBYI

19
Celcuity's (CELC) CEO Brian Sullivan on Q2 2018 Results - Earnings Call Transcript

2018-08-12 seekingalpha - 1
Good day everyone and welcome to today's Celcuity Release of Second Quarter of 2018 Financial Results. At this time, all participants are in a listen-only mode. And later, you will have the opportunity to ask questions during the question-and-answer session. [Operator Instructions] Please note that this call may be recorded and I will be standing by if you should need any assistance.
PBYI CELC

19
Puma Biotechnology - Small, Speculative Position Seems Warranted

2018-08-11 seekingalpha - 1
Puma Biotechnology is an interesting name, trading near its lows while the pick up of its approved product goes quite well.
PBYI

21
Puma Biotech (PBYI) Q2 Loss Narrows, Nerlynx Drives Sales

2018-08-11 zacks - 3
Puma Biotechnology, Inc. (PBYI - Free Report) incurred a loss of $1.17 per share for the second quarter of 2018, narrower than the Zacks Consensus Estimate of a loss of $1.26 per share and the year-ago loss of $2.10.
GJV GILD NWS NWSA PBYI ILMN

19
Puma Biotechnology, Inc. (PBYI) CEO Alan Auerbach on Q2 2018 Results - Earnings Call Transcript

2018-08-10 seekingalpha - 1
Ladies and gentlemen, good afternoon. My name is Adam, and I will be your conference call operator for today. At this time, all participants are in a listen-only mode. After the speakers' formal remarks, there will be a question-and-answer session. [Operator Instructions] As a reminder, this program is being recorded.
PBYI

18
PBYI / Puma Biotechnology Inc. 10-Q (Quarterly Report)

2018-08-09 sec.gov
pbyi-10q_20180630.htm UNITED STATES
PBYI

18
PBYI / Puma Biotechnology Inc. 8-K (Current Report)

2018-08-09 sec.gov
8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549
PBYI

20
Drug/Biotech Stock Q2 Earnings on Aug 9: PRGO, BDSI & More

2018-08-08 zacks
The second-quarter reporting cycle is coming to an end. Though the quarterly results were marked by all around positive surprises and plenty of momentum on the revenue side, the downtrend in earnings estimate revisions for the current period (third quarter 2018) is a concern.
OAS LOXO PRGO PBYI

32
What's in the Cards for Puma Biotech (PBYI) in Q2 Earnings?

2018-08-07 zacks
Puma Biotechnology, Inc. (PBYI - Free Report) is scheduled to report second-quarter results on Aug 9 after the market closes.
DNLI ACIU PBYI BDSI

124
Your Daily Pharma Scoop: Spectrum Trial Proceeds, AzurRx Moves To Phase 3, Aptose Jumps

2018-07-02 seekingalpha - 2
Discussion: Second Phase 3 trial of Spectrum Pharmaceutical’s (SPPI) Rolontis met primary efficacy endpoint. The endpoint was non-inferiority in duration of severe neutropenia (‘DSN) between Rolontis and Neulasta (pegfilgrastin). Neutropenia is a condition of abnormally low level of white blood cell. The condition is often a side effect of some types of chemotherapy. Earlier, first Phase 3 study met endpoint in DSN across all four cycles for non-inferiority of rolontis to non-inferiority of pegfilgrastim.
ACAD AZN GILD AZRX AZN PBYI CNBX NVS APTO APS SNY

50
Puma's Nerlynx: Right Drug, Wrong Target

2018-06-30 seekingalpha - 1
Nerlynx was developed to inhibit HER2/ERBB which can be targeted with multiple other drugs. Nerlynx does little to improve disease-free survival in HER2+ breast cancer operated and treated with Herceptin.
AZN AZN PBYI

17
PBYI / Puma Biotechnology Inc. FORM 8-K (Current Report)

2018-06-29 sec.gov - 6
Form 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549
PBYI

PBYI: Puma Biotechnology Analysis and Research Report

2018-03-12 - Asif

Company Overview Puma Biotechnology is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. The company in-license 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, or TKI, that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. Currently, Puma Biotechnology is primarily focused on the U.S. commercialization of NERLYNX (neratinib), its first U.S. Food and Drug Administration, or FDA, approved product, and on the further development of the oral version of neratinib for additional indications in the treatment of HER2-positive breast cancer. The company believe neratinib has clinical application in the treatment of several other cancers as well, including non-small cell lung cancer and other tumor types tha...

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CUSIP: 74587V107