Litany of deficiencies, including product quality shortcomings and a failed Phase III clinical efficacy study, may make it impossible for the agency to exercise the type of flexibility it has with the approval of other treatments for ALS and neurodegenerative diseases.

Chief operating officer Christina Rossi talked to Scrip about the company’s new blockbuster-sized commercial opportunity for Ayvakit and the company’s next phase: financial sustainability.

Among the newer modalities to tackle cancer, antibody-drug conjugates are fast emerging to rival targeted antibodies and China is fast emerging as a world class source of innovation in the field, as evidenced by a string of recent deals.

Biotech has always been a volatile sector, and it is important for investors to recognize the phases its stocks go through. In particular, the journey through the post-bubble wilderness can be a protracted affair.