Phase II is an in-between time in clinical development and results can be difficult to place in context. Investors should take into account factors such as rigor of study design, validation of mechanism or concept, and emerging safety signals.
Early clinical trial results can be tricky to interpret. Phase I studies are designed to assess safety and tolerability, but early signs of therapeutic potential can be difficult to ignore. Here's what to look for in Phase I and how to avoid getting carried away.
After a phase 3 failure in non-small cell lung cancer, Merck is pushing ahead with a second phase 3 trial based on promising results in a group of patients within the original trial.
Idera's strugging stock was partially redeemed by good Phase II trial results in psoriasis. The moderate efficacy left investors unenthused, but Idera is touting its candidate as more than just another psoriasis drug, but a potential first-in-class contender in cancer and autoimmune disease.
The CHMP decision recommending European approval is great news for Endocyte, but success in the U.S. will require meeting a more stringent standard for efficacy.
ThromboGenics's expansion from the small neighborhood of vitreomacular adhesion to the big city of diabetic macular edema is a solid long term strategy for building is pipeline of ophthalmologic drugs.
Idera took a 25 percent stock hit when the FDA approved Celgene's competing psoriasis drug Otezla. But investors who unloaded Idera may regret it if upcoming Phase II results are positive for Idera.
Celldex's potential Soliris-killer bites the dust, leaving Alexion large and in charge in its corner of the complement-mediated rare kidney disease world.
Omeros's newest clinical program, OMS721, for thrombotic microangiopathies, together with its lead drug program OMS302 for lens replacement surgery, show a lot of promise and all by themselves would be worth paying attention to. But a peek at Omeros's early stage pipeline shows some potential for pants-wetting excitement.
Investors barely twitched when Amarin Corp. (NASDAQ: AMRN) announced earlier that the FDA had denied new chemical entity status for Vascepa, its fish oil-based therapy for high triglycerides—and for good reason. Amarin's stock hit bottom hard in October when the EMDAC vote went against the drug, and the biotech's flatlined stock is unlikely to do anything interesting until the outcome of its legal wrangling with the FDA is determined.