- The Food and Drug Administration will conduct a re-inspection of Immunomedics' manufacturing facility in Morris Plains, New Jersey, as part of the process for the company to re-submit its new drug application, according to a Thursday filing with the Securities and Exchange Commission.
- The update pushes back the expected regulatory approval timeline for its lead drug candidate, sacituzumab govitecan, to year's end or early 2020, according to analysts. In the meantime, Immunomedics will work to clear up its manufacturing problems as it continues its quest to secure its first drug approval after 37 years of research.
- The stock fell by more than 2% Friday morning. Share prices are down more than 20% since the company first disclosed the FDA had rejected its drug application on Jan. 17 with a Complete Response Letter.
The Morris Plains facility continues to be a hurdle for Immunomedics. Company executives expressed confidence in winning a regulatory OK for sacituzumab govitecan last month, but instead were handed a CRL citing issues with the plant.
Following that setback, the company has provided few specifics on the path forward. FDA policies say a resubmission requiring another inspection be classified as Class 2, which carries a six-month review timeline instead of the speedier two months under Class 1.
The company also disclosed it expects to soon request a meeting with the FDA to finalize its resubmission plans.
Cowen & Co. analyst Phil Nadeau wrote in a Thursday note to investors the disclosure largely aligns with his expectations following the CRL, but leaves a "key uncertainty" over how long it will take the company to fix these manufacturing problems. He expects an approval and launch by year's end or in early 2020.
If sacituzumab can get FDA approval, Nadeau reaffirmed his belief Thursday that the drug carries $1 billion-plus peak sales potential in relapsed or refractory metastatic triple-negative breast cancer, a disease with few good therapeutic options.
The FDA's re-inspection plans came along with an establishment inspection report the company received on Feb. 4 for the Morris Plains facility based on a pre-approval inspection in August 2018.
That August inspection had led to a Form 483. While Immunomedics received it that month, the form wasn't made public until December, revealing agency concerns with the firm's quality control unit. In the following days, shares dropped roughly 20%.
An Immunomedics spokesperson declined to offer further details on its resubmission plans, or on why the company did not disclose the Form 483 last year to investors when it received the document last August.
The spokesperson stated the company plans to provide additional comments on its earnings call, scheduled for Feb. 27.