Puma Biotechnologies is walking back some bullish prognostications for its breast cancer treatment, delaying its planned FDA submission by as much as a year and lending weight to some creeping doubts about its top prospect.
Puma Biotechnology's closely watched neratinib failed to beat out the blockbuster Herceptin in a mid-stage breast cancer trial, a miss the company said was no surprise as it touted success on a secondary goal.
Shares of Puma Biotechnology soared more than 220% after the markets closed on Tuesday as investors cheered the biotech's positive Phase III numbers for a late-stage study of their lead drug neratinib (PB272).
Puma Biotechnology's stock plunged 25% on Monday after investors soured on its "positive" news about neratinib, or PB272, with only three of 40 breast cancer patients in a study demonstrating a partial response.
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.