Puma Biotechnology Inc (NASDAQ:PBYI)’s biotech stocks price went down by 25% early Thursday following the company’s announcement that it intend to change the product descriptions of neratinib, the company’s breast cancer drug in its application for European marketing authorization.
The European product label mostly referred to as summary of product characteristics (SmPC) lists all the major features and properties of a medical product. It is one of the requirements when applying for commercialization and marketing authorization.
The reviewed summary of product characteristics (SmPC) will restrict the target population to only patients starting the neratinib within a period of one year after completing the adjuvant trastuzumab treatment.
The company’s stock was selling at $28.95 per share at the start of business. The stock price rose to $33.05 on Thursday afternoon, a 14% drop from the previous day.
The initial SmPC filed in 2016 mainly targeted the treatment of adult people suffering from early-stage HER2 amplified breast cancer who have previously been treated with adjuvant trastuzumab treatment. The decision to shift the specifications was motivated by the discovery of additional benefits in some patients who were administered with the neratinib over a period of one year since the completion of the previous trastuzumab therapy.
It is expected that this change will limit the number of patients as the company also revealed that the Committee for Medicinal Products for Human Use (CHMP) is yet to decide on the approval of the drug.
In yet another similar development, Perjeta, a breast cancer drug from Roche AG when combined with chemotherapy and Herceptin decreases chances of breast cancer in a significantly big way. The completion from the combination of Perjecta and Herceptin could add even more troubles for neratinib that is yet to be approved and a possible extension of the adjuvant treatment early stage breast cancer. Puma is also still waiting for an FDA final decision on its New Drug Application that the company filed in July 2016. Roche announced positive progress of its breast cancer drug, which may have further caused Puma’s shares to plunge.