Adamas Pharmaceuticals Inc (ADMS) Shares Slip Ahead of PDUFA Date; Mizuho More Cautious
Adamas Pharmaceuticals Inc (NASDAQ:ADMS) saw its shares slipping nearly 17% this month ahead of the August 24 PDUFA date for ADS-5102 in the treatment of levodopa-induced dyskinesia, LID in Parkinson’s disease, PD.
Mizuho analyst Irina Rivkind Koffler has turned somewhat more cautious heading into the binary event after reviewing the 10-Q filing and 2Q:17 commentary.
The analyst stated, “We spoke with management and expressed a number of our concerns heading into the PDUFA following the 2Q:17 call. These include: 1) the company’s sudden decision to utilize its own sales force and not a contract force (a pivot from 1Q:17). We find this strange b/c mgmt. is extremely experienced and organized, in our view, and now plans to hire this team after the PDUFA and launch in Jan 2018 instead of having reps on standby with contingent offers. 2) The company introduced new risk language in the 10-Q filing regarding the potential for new safety findings from the ongoing open label safety trial to change FDA’s interpretation of the data, and moved up statements that newly observed toxicities or worsening of amantadine’s known toxicities or FDA reconsideration of these toxicities could lead to increased regulatory scrutiny. Adamas also added risk language about the potential for not getting clinical claims to successfully promote the product.”
“Management countered that it is normal to move up risk statements ahead of a PDUFA and made a number of reassuring comments to indicate that it is “feeling good” and also that its manufacturing is unlikely to pose a delay risk,” the analyst continued.
That said, Koffler keeps her rating on Adamas Pharmaceuticals at Buy, with a price target of $26, which represents a potential upside of 81% from where the stock is currently trading. (To watch Koffler’s track record, click here)
Overall, the 4 analysts polled in the past 3 months rate Adamas stock a Buy. With a return potential of 111%, the stock’s consensus target price stands at $31.