December 14 was a game-changing day for clinical-stage biopharmaceutical firm Galera Therapeutics (GRTX). The GRTX stock price rose a whopping 95.7% at yesterday’s market close. The rally continues into the pre-market trading session, with a further rise of 16.7% as I write.
In October this year, Galera had announced that it had failed to pass the Phase 3 ROMAN trial of avasopasem as a treatment for radiation-induced severe oral mucositis (SOM) in head and neck cancer patients.
However yesterday, the company released the corrected data that showed that the trial did, in fact, achieve statistical significance, 16% to be precise, on reducing the incidence of SOM in the group being treated with the avasopasem drug, as compared with the group placed on placebo testing.
What Does this Mean for Galera?
The company’s recently released single-arm Phase 2a EUSOM trial of avasopasem in Europe also confirmed that Avasopasem seems to be well tolerated and effective in target patients. Galera now plans to discuss the possibility of a new drug application submission, based on these trial results.
The company does not currently have any commercial product candidate that generates revenues. If the FDA approves the drug for commercial use, it can be the first product candidate to generate revenues for Galera.
The Wall Street analyst consensus is cautiously optimistic about the GRTX stock, with a Moderate Buy rating, based on 1 Buy and 2 Holds. The average Galera price target of $7 indicates an upside potential of 159.26%.
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