NEW YORK (TheStreet) -- Cempra's (CEMP) stock rating was reduced to "neutral" from "overweight" at JPMorgan after the FDA raised concerns around liver safety related to the company's Solithera pneumonia drug.
The firm also cut its price target to $6 from $25 on shares of the Chapel Hill, NC-based pharmaceutical company.
In a document posted yesterday, the FDA noted that rates of liver enzyme elevations were higher in patients treated with Solithera than those taking the antibiotic moxifloxacin.
The review comes two days before a meeting of outside experts who will review the drug and recommend whether or not it should be approved, according to Reuters.
Solithera is Cempra's lead asset and key value driver, JPMorgan said.
"While we had expected volatility around the briefing docs, these documents are worse than we had anticipated, highlighting strong concerns around liver safety, and laying out a very high bar for FDA approval," the firm said in an analyst note.
JPMorgan is cautious heading into the panel on Friday, adding that while a positive vote isn't entirely out of the realm of possibilities, the firm sees diminished commercial opportunity for the asset.
Cempra's Solithera drug is similar to Sanofi's (SNY) Ketek medication, which was approved by the FDA in 2004 but later linked to serious or fatal liver problems, Reuters reports.
Stifel analysts also believe Cempra's Solithera will see "significantly" limited community selling. The firm downgraded its rating on the stock to "hold" from "buy" and lowered its price target to $8 from $37, according to TheFly.
Shares of Cempra were higher in late-afternoon trading on Thursday.
More than 5.70 million of the company's shares changed hands so far today vs. its average 30-day volume of 1.88 million shares.
Separately, TheStreet Ratings objectively rated this stock according to its "risk-adjusted" total return prospect over a 12-month investment horizon. Not based on the news in any given day, the rating may differ from Jim Cramer's view or that of this articles's author.
The team rates Cempra as a Sell with a ratings score of D. The company's weaknesses can be seen in multiple areas, such as its disappointing return on equity, weak operating cash flow and feeble growth in its earnings per share.