BC Extra | Jan 9, 2020
Clinical News

ADC’s loncastuximab data could clear path for BLA, IPO filing

Months after scuttling a planned listing, ADC Therapeutics intends to refile for an IPO as it prepares to submit a BLA in 3Q19 seeking accelerated approval for its antibody-drug conjugate to treat DLBCL in a...
BC Extra | Dec 17, 2019
Clinical News

BeiGene looks beyond Phase III setback to build case for Brukinsa

Although a Phase III miss in Waldenström’s macroglobulinemia scuttles Brukinsa’s near-term chances to add a superiority claim to its label, BeiGene believes the Btk inhibitor's combined efficacy and safety profile differentiates it from Imbruvica. BeiGene...
BC Extra | Dec 13, 2019
Preclinical News

Dec. 12 Preclinical Quick Takes: POC for Aptose blood cancer candidate, plus Penn-Acorn AI, Neurimmune-Biogen and Syndax

Efficacy for Btk, FLT3 inhibitor in blood cancers  In a pair of posters at the American Society of Hematology (ASH) meeting in Orlando, Aptose Biosciences Inc. (NASDAQ:APTO; TSX:APS) and University of Texas MD Anderson Cancer...
BC Extra | Dec 9, 2019
Company News

With $2.7B ArQule buyout, Merck is latest pharma to jump into Btk race

With its proposed acquisition of ArQule, Merck will join the ranks of at least three other pharmas adding Btk inhibitors to their portfolios while appearing to pay much less than its peers. The $2.7 billion...
BC Extra | Nov 15, 2019
Company News

BeiGene enters U.S. market with first approval for in-house pipeline

With its first approval for an internally developed drug, BeiGene faces tough competition as it seeks to carve out a niche for Brukinsa. But the third-to-market Btk inhibitor could have an edge on efficacy without...
BC Extra | Nov 12, 2019
Clinical News

Early success in GvHD sets up NDA for Kadmon’s lead

With its lead clinical candidate meeting the primary endpoint at an interim analysis of a pivotal trial for third-line chronic graft-versus-host disease, Kadmon plans to submit an NDA next year for KD025 following next half's...
BC Extra | Nov 6, 2019
Clinical News

Lilly, ArQule jockey for best-in-class next-gen Btk inhibitor at ASH

While investors punished ArQule on Phase I data for ARQ 531, the Bruton’s tyrosine kinase inhibitor was tested in a slightly sicker population than Lilly's competing LOXO-305, and each company used different endpoints, making it...
BioCentury | Oct 5, 2019
Finance

Seeking bright spots in 4Q19 amid continued underperformance

Biotech watchers are hoping a busy fourth quarter of data readouts, regulatory actions and IPOs will provide some bright spots to counteract the sector’s continued overall underperformance, which is not expected to improve in 2020....
BC Extra | Aug 29, 2019
Company News

With Rova-T killed, spotlight shifts to AbbVie’s hematology, immunology franchises

The final clinical failure of a program AbbVie once regarded as the "anchor asset" in its solid tumor portfolio leaves AbbVie with little or nothing to show for its acquisition of Stemcentrx in 2016 for...
BC Innovations | Aug 29, 2019
Distillery Therapeutics

MLANA-loaded nanoparticle vaccine plus mAbs against PD-1 and OX40 to sensitize melanoma to Imbruvica

DISEASE CATEGORY: Cancer INDICATION: Melanoma Immunization with an MLANA-loaded nanoparticle vaccine in combination with mAbs against PD-1 and OX40 could sensitize melanomas to Imbruvica ibrutinib. The vaccine consists of polylactic-co-glycolic acid polymer nanoparticles loaded with...
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