FDA Lifts Clinical Curbs On CymaBay Therapeutics Inc (NASDAQ:CBAY)’s Seladelpar

CymaBay Therapeutics Inc (NASDAQ:CBAY) reported significant achievement in Q2 2020 and in early August 2020. The company concluded the scientific investigation and held discussions with the UF FDA to lift the clinical holds on INDs of seladelpar in NASH (nonalcoholic steatohepatitis), PBC (primary biliary cholangitis), and PSC (primary sclerosing cholangitis). The company halted the clinical development of drugs for the three liver diseases in late 2019.

No liver injury in Nash trial

CEO of CymaBay, Sujal Shah, said the company is excited about the progress achieved to date in reviewing the strategic options. One of the options is to restart seladelpar program. The company convened a meeting of hepatologists and liver pathologists in May 2020 and convinced that no biochemical, no clinical or historical evidence showing liver injury caused by the use of seladelpar in patients recruited in the NASH Phase 2b clinical trial.

Lifts all clinical holds

CymaBay submitted the expert panel findings to the FDA and provided all the relevant information to the agency. FDA lifted all the clinical holds on seladelpar in July 2020.

CymaBay investigated the ENHANCE trial of seladelpar in PBC and reported positive topline results last week. It received sufficient data from the clinical study despite terminating early to demonstrate the tolerability and efficacy of seladelpar in these patients. After reviewing the ENHANCE trial data and receiving a notification from the US FDA, the company decided to cease strategic review options.

CymaBay will reinstate the development of seladelpar in PBC. It will continue to investigate seladelpar for other indications. The company also succeeded in reducing operating expenses in H1 2020. Its cash balance is sufficient to continue the operations into 2022.

CymaBay holds short term investments, cash equivalents, and a cash balance of $168.9 million by the end of Q2 2020. Given the ongoing coronavirus, the company conducts all its operations remotely.

As a result, CymaBay is conducting all its business operations seamlessly. The ongoing COVID-19 pandemic has not cast any impact on the financials of CymaBay. However, it will continue the business operations by closely monitoring the coronavirus developments. The company will seek a committee’s advice in implementing measures that ensure the safety and health of its employees and patients recruited in the clinical trials.

CymaBay posted a net loss of $10.7 million in Q2 2020. Its R&D expenses declined to $7.9 million in Q2 2020.