D-Day For CHRS, ENDP Pained, FDA Lifts Clinical Hold On INO’s VGX-3100 Trial

Today’s Daily Dose brings you news about FDA’s decision on Endo’s marketed opioid pain medication; Adamas’ updated analysis of phase III trial results of ADS-5102 for the treatment of levodopa-induced dyskinesia in people with Parkinson’s disease; BioTime’s clinical trial catalyst to watch out for; Genentech’s “walk-out” of a deal with NewLink and Inovio’s progress related to its phase III program of VGX-3100.

Read on…

Adamas Pharmaceuticals Inc’s (ADMS) updated analysis of efficacy and tolerability data from its phase III long-term safety and efficacy study of ADS-5102 for the treatment of levodopa-induced dyskinesia in people with Parkinson’s disease has shown tolerability and durability out to 88 weeks.

The updated analysis expands on previously reported 64-week data.

ADS-5102 for the treatment of levodopa-induced dyskinesia is currently under FDA review, with a decision date set for August 24, 2017. If approved, ADS-5102 will be the first and only FDA-approved medicine indicated for the treatment of levodopa-induced dyskinesia in people with Parkinson’s disease.

ADMS closed Thursday’s trading at $17.40, down 0.57%.

Applied Genetic Technologies Corp.’s (AGTC) investigational adeno-associated virus (AAV)-based gene therapy for X-linked retinoschisis has been found to be generally well tolerated and demonstrated a good safety profile across treatment groups in a phase 1/2 study.

X-linked retinoschisis, or XLRS, is characterized by abnormal splitting of the layers of the retina, resulting in poor visual function in young boys, which can ultimately result in legal blindness in adult men.

The results are related to the first 12 subjects enrolled in the low, middle and high dose groups of the Phase 1/2 dose escalation study. The Phase 1/2 dose study was initiated in May 2015, and several subjects have been followed for more than one year.

Mild to moderate ocular inflammation was observed in the treated eye for the majority of patients and resolved or was controlled…

Read the full article from the Source…

Leave a Reply

Your email address will not be published. Required fields are marked *