Immunomedics CEO Michael Pehl hits the exit on the heels of a CRL and accusations of a data integrity breach
Following a rough few weeks, the revolving door at the executive suite to Immunomedics $IMMU is turning once more.
After the market closed on Monday the company put out word that CEO Michael Pehl has decided to leave for personal reasons. His abrupt exit after 15 months on the job comes a little more than a month after the FDA handed the company a CRL for its application to market the antibody drug conjugate IMMU-132, or sacituzumab govitecan.
The biotech’s shares slid 8% in after-market trading.
At the time the rejection letter arrived, Pehl and Immunomedics said that the FDA had cited manufacturing issues for the rejection.
This latest disruption occurred just days after an agency report began to circulate showing that the FDA had cited the company for a breach of data integrity after an August inspection. The regulatory report on the facility spotlighted the agency’s concerns about manipulated samples and backdated documents.
Pehl was brought in to end the long-running drama over the drug and the company, which had been taken over by the crew led by venBio’s Behzad Aghazadeh. Aghazadeh derailed a $300 million upfront pact with Immunomedics on their lead drug — ousting the husband and wife team who had run the company for years in the process — in the spring of 2017 and later landed a $250 million royalty deal to fund the company’s work.
Charles Baum, the CEO of Mirati Therapeutics, meanwhile has joined the Immunomedics board of directors.
“Our primary focus is to ensure a high-quality BLA resubmission and gain FDA approval of sacituzumab govitecan for patients with metastatic triple-negative breast cancer (mTNBC). In that regard, we have implemented a dedicated CRL team, led by our executive board member, Scott Canute, a recognized expert in manufacturing and quality spanning decades in the biopharmaceutical industry,” executive chairman Aghazadeh said in a prepared statement.