In an SEC filing earlier today, Rule Breakers pick Momenta Pharmaceuticals
Momenta and partner Novartis
With the guidance now nearing its end, Momenta is extending the timeline by an indeterminate amount of time "due to a change in the projected timing of certain activities required for the completion of the FDA's review."
Details on these needed activities were not mentioned in the SEC filing, so it's unclear whether the delay amounts to a request for more data on the drug (which could mean years of extra work on it), or some sort of internal FDA delay (which could perhaps cause only months or weeks of delay on the generic drug application).
June hasn't been all bad for Momenta. The complex generics and biosimilar industry received some good news from a bill making its way through Congress. European Union medical authorities also brought good news last week with a positive opinion and upcoming approval of the second generic biologic in the EU, which was a biosimilar developed by Novartis.
Even if you take the worst-case scenario that Momenta's generic Lovenox never gets approved, investors don't seem to be prescribing too much value to the rest of its pipeline, including its in-house blood thinner candidate in a phase 1 study. Trading at an enterprise value of around $245 million, shares of Momenta are a good deal for long-term investors wanting to get a foot in the nascent generic biologics industry.