Monday, September 30, 2019
Lexicon Pharma -13.8% as Mako warns of deal breakup ‘disaster’
Lexicon Pharmaceuticals (NASDAQ:LXRX) is now off 13.8% today on heavy volume following a very bearish take from Seeking Alpha contributor Mako Research.
A breakup of the company’s deal with Sanofi for develping sotaglifozin will throw responsibility for late-stage trials to Lexicon, accelerating cash burn, Mako says — and the company admits it doesn’t have enough cash to finish the ongoing trials, “much less fund a commercial launch.”
“On closer examination it’s clear that the terms of the termination are a disaster for Lexicon and its investors,” Mako says.
Sell-side analysts rate the stock Outperform on average, while Seeking Alpha authors are Neutral overall. The stock has a Quant Rating of Very Bearish.
AstraZeneca, Merck’s Lynparza meets primary goal in late-stage study
AstraZeneca (AZN -1.1%) and Merck (MRK +1.5%) report PROfound Phase 3 clinical trial results showed statistically significant and clinically meaningful improvement with Lynparza (olaparib) in the primary endpoint of radiographic progression-free survival (rPFS) in certain tumors reducing the risk of disease progression or death by a median of 7.4 months vs. 3.6 months for those receiving abiraterone or enzalutamide; LYNPARZA reduced the risk of disease progression or death by 66% for these men.
Trial also met key secondary endpoint of rPFS in overall HRRm population. where Lynparza reduced the risk of disease progression or death by 51% and improved rPFS to a median of 5.8 months vs. 3.5 months for those receiving abirateron or enzalutamide.
Secondary endpoint of median time to pain progression was not reached.
Trial showed a confirmed overall response rate, a key secondary endpoint of 33.3% for Lynparza vs. 2.3% for abiratone or enzalutammide in patients with BRCA1/2 or ATM mutations.
Safety and tolerability profile of Lynparza in the PROfound trial was in line with that observed in prior clinical trials.
Pfizer reports positive data from late-stage BEACON CRC trial
Pfizer (NYSE:PFE) announces results from the interim analysis of the Phase 3 BEACON CRC trial evaluating the combination of BRAFTOVI (encorafenib), MEKTOVI (binimetinib), and cetuximab (BRAFTOVI Triplet), in patients with advanced BRAFV600E-mutant metastatic colorectal cancer (mCRC), following one or two lines of therapy.
The results show significant improvements in overall survival and objective response rates for the BRAFTOVI Triplet and BRAFTOVI Doublet combination (BRAFTOVI and cetuximab), compared to cetuximab plus irinotecan-containing regimens (Control), and provide analysis of the efficacy and safety of the BRAFTOVI Triplet compared to the BRAFTOVI Doublet.
BRAFTOVI Triplet showed a median OS of 9.0 months, compared to 5.4 months for Control. An improved ORR of 26% was observed in BRAFTOVI Triplet compared to 2% for Control.
These data will be presented today at the 2019 European Society for Medical Oncology Congress in Barcelona, Spain.
The Company expects to submit the results of the trial for marketing approval in U.S. in Q4 2019.
Amgen off after early stage AMG 510 data disappoints
Amgen (NASDAQ:AMGN) moves down 2.0% in premarket trading after disclosing new data from the ongoing early-stage study evaluating AMG 510 in patients with previously treated KRAS G12C-mutant solid tumors.
The Phase 1 study enrolled 76 patients with KRAS G12C-mutant solid tumors; data presented at the European Society for Medical Oncology 2019 Congress include a subset of 55 evaluable patients as of the July 2019 cutoff.
Of 29 with colorectal cancer, 12 patients received target dose of 960 mg once daily and 10 remain on treatment; one patient in dose cohort experienced partial response and 10 had stable disease for a disease control rate of 92%.
For 13 evaluable patients with non-small cell lung cancer, receiving 960 mg, seven (54%) achieved a partial response at one or more timepoints, and six achieved stable disease.
AMG 510 continues to be well-tolerated with no dose-limiting toxicities.
Amgen is initiating combination studies to further explore potential of AMG 510 in lung and colorectal tumors.
Mirati Therapeutics (NASDAQ:MRTX), which has a similar molecule called MRTX849, is falling 2.2% in premarket action.
Subscribe to:
Posts (Atom)