Tetraphase Pharmaceuticals Inc (NASDAQ:TTPH) shares are jumping up close to 16% after the drug maker released top-line data from its Phase 3 study of IV eravacycline in complicated Intra-Abdominal Infections. Though Needham analyst Alan Carr appreciates that Tetraphrase hit both the FDA’s as well as the EMA’s primary endpoints, he surveys the stock’s potential from the sidelines, apprehensive on how much of a commercial success can await an “IV-only drug-” even anticipating approval.
True, Carr believes these results go to demonstrate “statistical non-inferiority to comparator meropenem,” but he cannot help keeping wide-eyed down the line amid these commercial scale concerns.
As such, the analyst reiterates a Hold rating on the stock without suggesting a price target. (To watch Carr’s track record, click here.)
Carr underscores his misgivings, asserting, “Work is ongoing towards an oral formulation, w/ an update expected later in 3Q17 (unch). We remain skeptical around feasibility given previous challenges and assume only IV formulation will reach market.”
Additionally, on a more positive note, “Tetraphase is exploring alternative dosing regimens of existing oral formulation as well as a new formulation to address food-effect. Mgmt will meet w/ FDA after Phase 1 completed to discuss next steps for development. Greatest opportunity for sales expansion is w/ oral formulation, which would allow better penetration into UTI. There is a clear need for new potent oral antibiotics in this space,” continues the analyst.
“It is possible eravacycline may evolve into a low-price alternative to high price antibiotics targeting Carbapenem-Resistant Enterobacteriaceae (CRE; Avycaz, Vabomere, plazomicin, cefiderocol, relebactam). We believe Tetraphase would first need to conduct ~50pt+ CRE observation trial,” Carr concludes.
The Tetraphrase team is angling for MAA submission in Europe by the third quarter and a NDA submission domestically in the first quarter of next year.
TipRanks analytics exhibit TTPH as a Buy. Out of 4 analysts polled by TipRanks in the last 3 months, 50% are bullish on Tetraphase stock while 50% remain sidelined. With a return potential of 42%, the stock’s consensus target price stands at $11.59.