Biotech Values

[jbog]

Hasn;t FGEN had enough bad news::

FibroGen announces LELANTOS-2 trial did not meet primary endpoint 16:27 FGEN FibroGen announced topline data from the Phase 3 LELANTOS-2 trial of pamrevlumab for the treatment of ambulatory patients with Duchenne muscular dystrophy, or DMD, on background systemic corticosteroids. The study did not meet the primary endpoint of change in the North Star Ambulatory Assessment, or NSAA, total score from baseline to week 52. Secondary endpoints measured by change from baseline at week 52 in 4-stair climb velocity, 10-meter walk/run test, time to stand, time to loss of ambulation, and proportion of patients with greater than 10 seconds in the 10-meter walk/run test were also not met. Preliminary safety data showed that pamrevlumab was generally safe and well tolerated. The majority of treatment emergent adverse events were mild or moderate. Treatment-emergent serious adverse events were observed in 8.3% of patients in the pamrevlumab group and 2.8% of patients in the placebo group. FibroGen is in the process of evaluating the totality of the data, including other pre-specified endpoints, to determine the next steps for the program. The company plans to communicate the full results of the LELANTOS-2 study at an upcoming medical forum.

Read more at:
https://thefly.com/n.php?id=3772174