KemPharm Inc (NASDAQ:KMPH) shares are falling over 25% after the FDA issued a complete response letter (CRL) to the company for Apadaz, an abuse-deterrent product candidate for the short-term management of acute pain.
Despite the bad news, Oppenheimer analyst Rohit Vanjani reiterated an Outperform rating on shares of KemPharm, with a price target of $11, which implies an upside of 138% from current levels.
Vanjani wrote, “Given that the Agency only last week made an amendment request, we were surprised by the CRL issuance. Investors are likely assuming the worst, figuring that the FDA chose to issue a CRL rather than grant a PDUFA extension. However, KemPharm does not yet know whether the FDA considered the amendment in providing the CRL, or whether the amendment was submitted too late in the review process.”
“KMPH will likely submit an End of Review briefing package to the FDA within the next couple of weeks. After that submission, the FDA will have 30 days to schedule the EOR meeting. We believe that meeting’s results will be the next catalyst for KMPH, as the FDA will decide whether there is a path forward on Apadaz’s abuse-deterrent labeling,” the analyst continued.
According to TipRanks.com, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Rohit Vanjani has a yearly average return of 6.9% and a 51% success rate. Vanjani has a -49.5% average return when recommending KMPH, and is ranked #426 out of 3971 analysts.
As of this writing, all the 4 analysts polled by TipRanks rate KemPharm stock a Buy. With a return potential of 516%, the stock’s consensus target price stands at $28.50.
Marinus Pharmaceuticals Inc
Marinus Pharmaceuticals Inc (NASDAQ:MRNS) shares lost almost two-thirds of their value this week, after the company reported that its first Phase 3 epilepsy study for adult focal onset seizures failed to meet its primary endpoint.
In reaction, Vanjani downgraded the stock from Outperform to Perform, without suggesting a price target.
The analyst commented: “Even though management indicated that there were certain populations that were better responders (analysis yet to come), management effectively shut the door on any possibility of moving ganaxolone ahead in adult epilepsy. Marinus will now focus on ganaxolone in the Status Epilepticus and pediatric orphan indications. As we only took into account the adult epilepsy indication in our valuation, and left any contribution from the other programs as upside, we are moving to a Perform rating.”
Out of the 4 analysts polled by TipRanks, 3 rate Marinus stock a Hold, while 1 rates the stock a Buy. With a return potential of 52%, the stock’s consensus target price stands at $2.25.