Shares in CymaBay Therapeutics (CBAY) exploded over 105% in after-hours trading Monday after the company revealed a positive update for its seladelpar liver disease drug, which has been on clinical hold since November.
Sujal Shah, President and CEO of CymaBay, stated, “Last week a panel of some of the most experienced and distinguished liver pathologists and hepatologists in the world completed an independent review analyzing findings from our Phase 2b study of seladelpar in patients with NASH.”
“I am pleased to report that the panel unanimously concluded there was no clinical, biochemical or histological evidence of seladelpar-induced liver injury in the study, and as a result they also unanimously supported the lifting of the clinical hold and re-initiation of clinical development.”
CymaBay now intends to reach out to the FDA to discuss all of the data it has collected to date and the results of the panel review meetings. Once initial feedback is gathered, CymaBay wants to submit a complete response to the seladelpar clinical hold to the FDA.
At the same time the company announced Q1 GAAP EPS of -$0.19, which beat the Street consensus by $0.11. Research and development expenses for the three months ended March 31, 2020 were $9.5 million, compared to $18.6 million for the three months ended March 31, 2019.
Meanwhile cash, equivalents and marketable securities came in at $176.23M (down 7.7% from the previous quarter). “We remain focused on cost containment and will look at additional steps we can take into fiscal year 2020 in order to closely control the Company’s operating expenses and associated cash burn” commented Shah.
The Street gives CBAY a cautiously optimistic Moderate Buy analyst consensus with 3 recent buy ratings and 2 hold ratings. The average analyst price target stands at $2.78 (51% upside potential). (See CymaBay stock analysis on TipRanks).