Israel-headquartered drug discovery group Compugen Ltd (NASDAQ:CGEN) saw shares advance on Monday after the key FDA (Food and Drug Administration) gave the green light for COM701, its immuno-oncology therapeutic antibody, to go for clinical trials.
Broker Oppenheimer repeated an outperform rating on the stock and a target price of US$9 - more than double the current price of US$3.44.
"The company’s lead oncology program had been on clinical hold since April due to protocol modifications requested by the FDA, including a lower starting dose, noted analyst Mark Breidenbach.
Initiating trial sites..
"Compugen successfully addressed the FDA requests and is currently in the process of initiating trial sites.
"The drug will be evaluated in patients with solid tumors, and we expect the first Phase 1 patient to be dosed with COM701 monotherapy by early fall."
The analyst also notes that the broker estimates the firm has enough cash to sustain operations until the second quarter of 2019.
Bayer news a bonus too
Significantly today, the company also announced that the FDA had cleared its collaboration partner Bayer and the drug titan's IND (investigational new drug) for BAY1905254, which is based on Compugen’s ILDR2 checkpoint modulator.
"We believe BAY1905254 could be investigated across a range of solid and liquid tumor types," said Breidenbach.
He assumes a milestone payment of around U$5amln from Bayer to the firm in the second half of this year to mark the initiation of a Phase 1 trial.
Compugen shares added 3.79% to stand at US$3.42 in New York.