Denali: Despite ALS Primary Endpoint Failure, Possible Path Forward Remains
Denali Therapeutics Inc.'s stock remains stable despite trial setback in ALS. BLA filing for MPS II treatment on track. Click ...
pharmaphorum1 天
Navigating the regulatory pathway with innovative products
Another major challenge is when a drug is in its final stage and ready for the approval process; there may not be enough reliable information on the regulatory pathways to get it approved by the ...
Outsourcing-pharma3 天
Denali Therapeutics’ ALS drug fails to improve function and survival in phase 2/3 trial
Denali Therapeutics has announced topline results from the phase 2/3 Healey ALS Platform Trial ... DNL343 was able to penetrate the cerebrospinal fluid and inhibit the ISR pathway in blood samples ...
BioPharma Dive4 天
ALS drugs from Denali, Calico come up short, marking setback for Healey trial
Cudkowicz and her team came up with — and for the last several years have been running — the “Healey platform trial,” an innovative experiment structured to quickly test a variety of potential ALS ...
Yahoo3 天
ALS drugs from Denali, Calico come up short, marking setback for Healey trial
Like many brain diseases, ALS has been exceptionally difficult to crack for even the world’s most powerful drug developers. Only a few medicines have received approval from the Food and Drug ...
Reuters5 天
Denali Therapeutics' ALS drug fails in mid-to-late stage trial
FDA-approved ALS treatments available in the U.S. include Mitsubishi Tanabe's Radicava, generic drug riluzole, and Biogen's (BIIB.O), opens new tab Qalsody. Sign up here. Reporting by Puyaan Singh ...
pharmaphorum2 天
Amylyx ALS drug draws criticism over $158,000 price tag
The third ALS treatment to be given FDA approval, following Mitsubishi Tanabe’s Radicava ($170,000 per year) and generic drug riluzole – Relyvrio is priced at around $12,500 per 28-day ...
来自MSN1 天
DNLI's Hunter Syndrome Drug Gets Breakthrough Therapy Designation
Denali Therapeutics Inc. DNLI announced that the FDA has granted Breakthrough Therapy Designation to its pipeline candidate, ...
The Business Journals4 天
ALS drug from Google-backed anti-aging company Calico fails clinical test
Calico ignited the race by drug companies to find treatments for aging-related diseases. An ALS-fighting drug from Calico Life Sciences LLC — the Alphabet-backed anti-aging company founded by ...
devdiscourse3 天
Health Headlines: From ALS Drug Setbacks to Bird Flu Misfortunes
Recent health updates include Denali Therapeutics' ALS drug failure in trials, Louisiana's first bird flu-related death, WuXi Biologics selling its Irish facility due to U.S. curbs, and France's new ...
The Pharma Letter4 天
Denali suffers ALS drug failure in Phase II/III trial
A late-stage trial failure has dented Denali Therapeutics (Nasdaq: DNLI) stock, with an announcement Monday revealing the HEALEY ALS study missed all endpoints. Denali is testing its amyotrophic ...