01:43 , Jun 9, 2018 |  BioCentury  |  Product Development

Past not prologue

Loxo Oncology Inc.’s two-year streak of stunning data at ASCO appears to be the result of good decisions on the back of a healthy dose of luck. But it will be a tall order to...
19:16 , Jun 1, 2018 |  BC Week In Review  |  Clinical News

Priority review for Loxo's larotrectinib in tissue-agnostic indication

FDA accepted and granted Priority Review to an NDA for larotrectinib (LOXO-101) from Loxo Oncology Inc. (NASDAQ:LOXO) to treat locally advanced or metastatic solid tumors with neurotrophic tyrosine kinase receptor (Trk) fusion proteins, regardless of...
14:43 , May 29, 2018 |  BC Extra  |  Company News

Priority Review for Loxo's larotrectinib in tissue-agnostic indication

FDA accepted and granted Priority Review to an NDA for larotrectinib (LOXO-101) from Loxo Oncology Inc. (NASDAQ:LOXO) to treat locally advanced or metastatic solid tumors with neurotrophic tyrosine kinase receptor (Trk) fusion proteins, regardless of...
22:56 , May 22, 2018 |  BC Extra  |  Tools & Techniques

Trinity identifies hurdles for tissue-agnostic therapies

While the use of basket trials to test therapies in tissue agnostic, biomarker-based cancer indications is increasing, the long-term implications rely on a handful of factors, many of which may affect postmarket uptake of agents...
16:52 , Apr 13, 2018 |  BC Week In Review  |  Company News

Veracyte, Loxo team up for TRK, RET targeted therapies

Molecular diagnostics company Veracyte Inc. (NASDAQ:VCYT) said Loxo Oncology Inc. (NASDAQ:LOXO) will use Veracyte's Afirma Xpression Atlas platform to develop targeted therapies for thyroid cancers with tropomyosin receptor kinase (TRK) fusions and Ret proto-oncogene (RET)...
15:38 , Mar 30, 2018 |  BC Week In Review  |  Clinical News

Loxo completes larotrectinib NDA

Loxo Oncology Inc. (NASDAQ:LOXO) completed submission of a rolling NDA to FDA for larotrectinib (LOXO-101) to treat locally advanced or metastatic solid tumors with neurotrophic tyrosine kinase receptor (Trk) fusion-proteins, regardless of tissue of origin. Larotrectinib...
20:38 , Mar 26, 2018 |  BC Extra  |  Company News

Loxo completes larotrectinib NDA

Loxo Oncology Inc. (NASDAQ:LOXO) completed submission of a rolling NDA to FDA for larotrectinib (LOXO-101) to treat locally advanced or metastatic solid tumors with neurotrophic tyrosine kinase receptor (Trk) fusion-proteins, regardless of tissue of origin. Larotrectinib...
22:25 , Feb 26, 2018 |  BC Extra  |  Politics & Policy

FDA to meet on Orphan tissue-agnostic therapies

FDA said it will hold a public workshop on May 9 to discuss utilizing Orphan Drug designation for tissue-agnostic therapies: drugs and biologics that target a tumor’s specific genetic features rather than its tissue of...
22:52 , Jan 5, 2018 |  BC Week In Review  |  Company News

China investment company SARI acquiring majority stake in Nerviano

China investment company SARI will acquire a 90% stake in cancer company Nerviano Medical Sciences s.r.l. (Nerviano, Italy) for about €300 million ($360 million), which includes an equity investment and a debt restructuring. The deal...
22:06 , Jan 5, 2018 |  BC Week In Review  |  Company News

Roche acquiring Ignyta for $1.7B

Roche (SIX:ROG; OTCQX:RHHBY) is acquiring cancer company Ignyta Inc. (NASDAQ:RXDX) for $27 per share, or $1.7 billion, in cash. The price is a 74% premium to Ignyta's close Thursday of $15.55. The deal gives Roche entrectinib...