Shares of Agios Pharmaceuticals fell nearly 10% on the heels of an earnings report that detailed how the majority of the company's drug programs are facing some sort of delay from to the coronavirus pandemic.
Agios listed six studies in which enrollment has slowed or paused. The Cambridge, Massachusetts-based biotech also said it expects data collection delays from another three studies, including two late-stage trials of a closely watched, experimental drug called mitapivat.
Those trials are looking at whether mitapivat can effectively treat patients with pyruvate kinase deficiency, a rare blood disorder. Both studies have completed patient enrollment, and Agios had anticipated topline results in late 2020. Now, however, the company expects to run into challenges accessing clinical trial sites because of COVID-19, and predicts results will instead come sometime between the end of 2020 and mid-2021. That would push the drug's approval timeline back, with an approval decision slated for 2022 rather than 2021.
The other affected late-stage trial is testing one of Agios' already approved drugs, Tibsovo, in patients with bile duct cancer that's been previously treated.
While the company still expects to have mature overall survival data from this study by mid-2020, additional data collection could be stalled. Agios therefore expects to submit Tibsovo for approval in this patient population between the end of 2020 and mid-2021, versus its prior plan to submit by the end of 2020.
Elsewhere in its pipeline, Agios has decided to stop developing a drug named AG-636 because of limited enrollment in a Phase 1 study. The company said it's evaluate partnering options.
Studies of Agios drugs affected by COVID-19
|Study name/stage||Study drug||Indication||Enrollment updates|
|ACTIVATE||mitapivat||PK deficiency||Topline data now expected between end of 2020 and mid-2021. Previous expectation was end of 2020.|
|ACTIVATE-T||mitapivat||PK deficiency||Topline data now expected between end of 2020 and mid-2021. Previous expectation was end of 2020|
|Phase 2||mitapivat||Sickle cell disease||Enrollment paused|
|AGILE||Tibsovo||frontline AML||Enrollment now expected to complete in 2021. Previous expectation was end of 2020.|
|HOVON150||Tibsovo, Idhifa||frontline AML||Enrollment slowed|
|Phase 1||Tibsovo||Myelodysplastic Syndrome||Enrollment now expected to complete in 2021. Previous expectation was end of 2020.|
|ClarIDHy||Tibsovo||cholangiocarcinoma||Still expects overall survival data in mid-2020, but other data collection could be stalled.|
|INDIGO||vorasidenib||low-grade glioma||Enrollment slowed|
|Phase 1||AG-270||lung, pancreatic cancers||Enrollment slowed|
Agios made a name for itself as a small yet powerful drug developer, having brought two blood cancer treatments to market in Tibsovo and Idhifa.
Those drugs, though, are approved for a select group of leukemia patients, which limits the amount of sales they can generate. For the first quarter of this year, Agios recorded $22.7 million of net product revenue from Tibsovo and about $65 million in collaboration revenue and royalties from Idhifa, to which Bristol Myers Squibb holds rights.
As such, Agios has been under pressure from investors to expand its portfolio of approved medicines and to go after diseases with larger commercial opportunities. The company's spending has also become a point of contention, though Agios noted in its earnings report that cash conservation efforts have extended the company's cash runway to the end of June 2022.
Agios shares traded at $43 apiece at market's open Friday, up about 5% from Thursday afternoon. Their price quickly fell, however, landing below $38 by mid-morning. The company's share price has declined 30% over the last year.
"While we believe the fundamental value of [Agios] is above where shares are currently trading, we think that delays to the pipeline and several key data readouts may keep shares largely in limbo in the near-term," Andrew Berens, an analyst with SVB Leerink, wrote in a note to clients following the Agios earnings report.