Impact of a FDA Breakthrough designationAnother example of the impact of a FDA Breakthrough designation. For something that shrank tumors. Not destroy! And that was discriminating among patients (genetic profile). Not us.
From 12$ in 2014, to 20$ in 2015 to 235$/share (8B$) in Jan. 2019. The stock climbed on presentation of data at ASCO in June 2017 (Hey Gorf79 ... DATA ... do you get it?) from 45$ to 80$. Then to 190$ mid-2018, then a pullback to 140$ end of December 2018 (shorted) before the takeover from Lilly @235$ (8B$).
LOXO 6 Years Stock Chart History And Gorf39 whines! Poor guy!
Loxo Oncology drug gains FDA Breakthrough status Sep. 6, 2018 Loxo Oncology, which is developing cancer treatments, announced this week that it had gained Breakthrough Therapy Designation from the U.S. Food and Drug Administration for its Loxo-292 drug.
The Breakthrough classification aims to speed up the development and review of a drug intended to treat certain types of lung and thyroid cancers based on their genetic characteristics and that has already undergone extensive clinical testing.
Clinical progress has galvanized investor support for Loxo. At the American Society of Clinical Oncology’s June 2017 annual meeting, a doctor from Memorial Sloan Kettering Cancer announced larotrectinib significantly shrank tumors in 76% of patients participating in recent trials.
Lilly Announces Agreement To Acquire Loxo Oncology INDIANAPOLIS and STAMFORD, Conn.,
- Acquisition will broaden the scope of Lilly's oncology portfolio into precision medicines through the addition of a marketed therapy and a pipeline of highly selective potential medicines for patients with genomically defined cancers.
- Loxo Oncology's pipeline includes LOXO-292, an oral RET inhibitor being studied across multiple tumor types, which recently was granted Breakthrough Therapy designation by the FDA and could launch in 2020.
- Loxo Oncology's Vitrakvi® (larotrectinib) is an oral TRK inhibitor developed and commercialized in collaboration with Bayer that was recently approved by the FDA.
- Lilly will commence a tender offer to acquire all outstanding shares of Loxo Oncology for a purchase price of $235.00 per share in cash, or approximately $8.0 billion.