Satsuma's Migraine Drug Flunks Late-Stage Study, Stock Sinks To Record Low

Shares of micro-cap biopharma Satsuma Pharmaceuticals Inc STSA are plummeting to a record low on above-average volume following an adverse clinical trial readout.

What Happened: South San Francisco, California-based Satsuma, which went public late last year, announced negative topline results Thurday from the Phase 3 EMERGE study that is evaluating STS101 powder as an acute treatment option for migraines.

At 3.9mg and 5.2mg dosage strengths, STS101 did not meet the co-primary endpoints of freedom from pain and the most bothersome symptom at two hours post-administration with statistical significance, the company said. 

Both dosage strengths did show significant effects on freedom from pain and the most bothersome symptom by three hours post-dose and later time points, the company said.

On safety, Satsuma said both dosage strengths were well-tolerated, with low adverse event rates and no serious adverse events reported.

"We are surprised and disappointed that STS101 did not achieve statistical significance on the co-primary endpoints in our EMERGE trial," CEO John Kollins said in a statement. 

Why It's Important: Satsuma has a single product pipeline, and therefore the adverse readout is likely to hit the stock hard.

STS101 — dihydroergotamine mesylate nasal powder — is Satsuma's lead product candidate. It consists of the company's proprietary dry powder nasal formulation and delivery device.

The company said further analysis of EMERGE trial data is ongoing, and it expects to provide a more detailed update on its business plans after the analysis is completed. 

As of June 30, 2020, Satsuma's cash, cash equivalents and marketable securities stood at $93.7 million. 

STSA Price Action: At last check, Satsuma shares were plunging 73.56% to $6.17. 

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