Astellas files application in Japan for expanded use of roxadustat
Astellas Pharma (OTCPK:ALPMF) has submitted a supplemental marketing application in Japan seeking approval to use Evrenzo (roxadustat) to treat chronic kidney disease-associated anemia in non-dialysis-dependent patients.
It is currently approved there for dialysis-dependent patients.
OpGen up 6% on planned coronavirus testing service in Europe
Nano cap OpGen (NASDAQ:OPGN) perks up 6% premarket on increased volume in response to its announcement that Ares Genetics GmbH, a subsidiary of merger partner Curetis GmbH, will collaborate with Chinese genomics outfit BGI Group on making molecular testing for the 2019-nCoV coronavirus available in Europe.
BGI was the first to sequence the genome of 2019-nCoV and has developed a polymerase chain reaction (PCR) test for its detection.
Alector prices upsized equity offering; shares down 3% premarket
Alector (NASDAQ:ALEC) slips 3% premarket on light volume in reaction to its public offering of 8.35M (from ~5.1M) common shares at $25/share. Gross proceeds should be ~$209M.
Underwriter’s over-allotment is an additional ~1.3M shares. Closing date is February 3.
Yesterday’s close was $25.94.
Bayer’s darolutamide extends survival in late-state prostate cancer study
A Phase 3 clinical trial, ARAMIS, evaluating Bayer’s (OTCPK:BAYRY) darolutamide plus androgen deprivation therapy (ADT) in men with non-metastatic castration-resistant prostate cancer demonstrated a statistically significant improvement in overall survival (OS) compared to placebo plus ADT, a key secondary endpoint.
Previously published data showed that darolutamide + ADT met the primary endpoint of metastasis-free survival compared to placebo + ADT.
Detailed results will be presented at a future medical conference.
Darolutamide, branded as Nubeqa, is currently approved in the U.S., Japan and Brazil. Filings in the EU and other regions are in process or planned.
Lilly baricitinib successful in fourth late-stage dermatitis study
Eli Lilly (NYSE:LLY) and licensor Incyte (NASDAQ:INCY) announce positive results from another Phase 3 clinical trial, BREEZE-AD5, evaluating two strengths of oral JAK inhibitor baricitinib in adults with moderate-to-severe atopic dermatitis (AD).
The 1 mg dose failed to hit the primary endpoint of a statistically significant proportion of patients achieving at least a 75% improvement in AD (EASI75) at week 16 versus placebo.
The 2 mg dose was successful. 29.5% (n=43/146) of treated patients achieved EASI75 compared to 8.2% (n=12/147) in the control arm (p=0.001).
No new safety signals were observed.
Complete results will be submitted for presentation at future medical conferences and publication.
Three previous late-stage studies, BREEZE-AD1, AD2 and AD7, were also successful.
Lilly recently filed a marketing Europe. It expects to submit applications in the U.S. and Japan this year.
