Cempra Inc (NASDAQ:CEMP) shares collapsed 57% yesterday after the firm received a Complete Response Letter (CRL) from the FDA for its pipeline drug oral and intravenous solithromycin for the treatment of community-acquired bacterial pneumonia (CABP) in adults. This considerable stock crash reached a new low for CEMP, whose shares have not teetered at such a drastic low since its public inception in 2012.
The agency anchors its letter on back of safety and chemistry, manufacturing, and controls (CMC) concerns.
As long as the pneumonia antibiotic is produced by Wockhardt manufacturing, the FDA is saying the drug shall not pass its doors to approval, considering Wockhardt carries associations to GMP systems, tagged with various FDA import bans in these past years. For the agency, it will take further safety “information” and a comeback in a big way with manufacturing shortcomings to turn its head on the matter.
Today shares have recovered almost 6% in pre-market trading. Yet, Cowen analyst Ritu Baral remains sidelined on the biotech firm, believing this crucial setback that pinpoints cracks in both safety as well as in the manufacturing of the drug is now “jeopardizing [the] program’s feasibility.” In reaction, the analyst reiterates a Market Perform rating on shares of CEMP without suggesting a price target.
In light of the agency’s misgivings for the program, Baral notes, the “FDA is requiring manufacturing fixes at the current API facility and recommending a new VERY large pre-approval trial better characterizing hepatotoxicity. FDA will also very likely limit the labeled population significantly. We have moved solithromycin approval to 2019 and reduced US peak sales to $319M.”
Just how “large” will this premarketing trial’s size circle? Baral projects 12,000 patients plus. Currently, the trial size for determining the drug’s adverse effects capped at a trial of 920 patients. Clearly, from the FDA’s standpoint, CEMP’s safety database sample size reveals gaping inadequacy.
Moreover, the analyst believes, “The fact that this may not be specifically focused on CEMP’s product or processes is arguably worse for timing.”
Looking ahead, the road looks bleak for the firm from Baral’s eyes. “While we await CEMP to start and complete talks with FDA on the design of the upcoming study, we have grave concerns around the feasibility of a 3014-like trial, especially given a potential >$50M price tag in support a limited market,” the analyst concludes.
Time will tell if Cempra will be able to provide the agency the characterization about the risk of hepatotoxicity that it requires for solithromycin- the very drug that the FDA Ad Comm only narrowly voted in favor of its clinical benefits against hepatotoxicity apprehensions.
According to TipRanks, which measures analysts’ and bloggers’ success rate based on how their calls perform, three-star analyst Ritu Baral is ranked #1,752 out of 4,291 analysts. Baral has a 36% success rate and earns 1.1% in her annual returns. However, when recommending CEMP, Baral loses 33.6% in average profits on the stock.
TipRanks analytics exhibit CEMP as a Hold. Based on 12 analysts polled by TipRanks in the last 3 months, 1 rates a Buy on CEMP stock, 8 maintain a Hold, while 3 issue a Sell. The 12-month average price target stands at $10.42, marking a nearly 301% upside from where the shares last closed.