Puma Biotechnology is boasting that its experimental cancer drug neratinib bested Herceptin in a head-to-head study of HER2-positive breast cancer when used ahead of surgery.
The brouhaha that erupted on Twitter when Puma Biotechnology switched to a Bayesian statistical model in its I-SPY 2 study to predict the likelihood of late-stage success of neratinib for metastatic HER2-positive breast cancer indicates that this approach could make the industry pause before the Bayesian predictive formula is widely adopted in the biotech world.
Karyopharm has scored an additional $19 million for its Series B round of financing, padding the $48.2 million raised for the round in May, for a total of more than $67 million, among the largest this year for a drug developer.
The cancer drug developer's shares have risen more than 50% in 2013 as the company begins late-stage development of its lead drug neratinib for patients with metastatic HER2-positive breast cancer.
Puma Biotechnology, which is swiftly moving its experimental cancer drug PB272 (neratinib) into a pivotal Phase III program, has now reached agreement with the FDA on a special protocol assessment, pushing a combo approach of the experimental treatment with Xeloda into a head-to-head showdown with Tykerb plus Xeloda for treatment-resistant, HER2 positive breast cancer.
Following a well-defined trail of venture groups into late-stage investing, San Francisco-based Foresite Capital Management says it has wrapped a $100 million fund that will be heavily focused on the most disruptive and most promising late-stage technology it can find in biotech, genomics and diagnostics, among other healthcare fields.
The company said on Thursday afternoon it sold more than 8.6 million shares for $16 per share, netting $129.1 million and adding to its coffers as the company readies for late-stage development of a potential breast cancer drug in-licensed from the drug giant Pfizer last year.
Puma Biotechnology aims to list its shares on the New York Stock Exchange as the Los Angeles-based company, which now trades over the counter, advances a drug licensed from Pfizer ($PFE) to late-stage development for women with HER2-positive breast cancer, according to an SEC filing Friday.
Puma Biotechnology made its debut at the San Antonio Breast Cancer Symposium, presenting some positive data from mid-stage studies of the cancer drug the developer licensed from Pfizer ($PFE). The
The former CEO and founder of Cougar Biotechnology, Alan Auerbach, is back in the business of developing cancer drugs. In a series of maneuvers unveiled yesterday, Auerbach's Puma Biotechnology