FDA clearance of Retrophin Inc.'s enteric-coated (EC) version of Thiola (tiopronin) 100-mg and 300-mg tablets for cystinuria – a rare, inherited disorder that causes levels of cystine to build up in urine, which leads to recurrent kidney stones – gave patients new dosing flexibility and set Wall Street abuzz about options for the San Diego-based firm as well.
Alexion Pharmaceuticals Inc. gained expansion from the FDA of the label for Soliris (eculizumab) to treat neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive.
Recent bad phase IIb news from Inflarx NV with IFX-1, a first-in-class anti-human complement factor C5a monoclonal antibody in the moderate to severe skin disease hidradenitis suppurativa (HS), also dinged shares of Chemocentryx Inc., which has small-molecule avacopan targeting the C5a receptor in a registration-grade phase II study targeting the same indication – but the story's hardly over in HS or vasculitis.
Abbvie Inc.'s agreement to take over Allergan plc in a cash and stock deal worth about $63 billion jarred Wall Street and set pundits mulling the price tag – seen by some as too low – along with the prospects for a satisfying marriage as pipelines are sorted out.
Abbvie Inc.'s agreement to take over Allergan plc in a cash and stock deal worth about $63 billion jarred Wall Street and set pundits mulling the price tag – seen by some as too low – along with the prospects for a satisfying marriage as pipelines are sorted out.
With the FDA go-ahead for Vyleesi (bremelanotide) in generalized hypoactive sexual desire disorder (HSDD), Amag Pharmaceuticals Inc.'s comparison of prospects for the compound to those of depression drugs in an earlier time gained more scrutiny, as Wall Street continued trying to guess revenues due from the auto-injectable melanocortin receptor agonist.
Attendees of the International Conference on Malignant Lymphoma in Lugano, Switzerland, got even more interim data than expected from Epizyme Inc.'s phase II trial with lead candidate tazemetostat for relapsed or refractory follicular lymphoma (FL) in patients who have undergone at least two prior lines of systemic therapy.
Minneapolis-based Diamedica Therapeutics Inc. shares (NASDAQ:DMAC) closed Thursday at $4.94, up $1.12, or 29%, after trading as high as $5.93 as Wall Street made known its appreciation of positive interim data from the phase Ib study from 28 evaluable participants with moderate and severe chronic kidney disease (CKD).
As the weekend PDUFA date for bremelanotide approaches, investors in Waltham, Mass.-based Amag Pharmaceuticals Inc. hope an approval will revive the stock, on the slide since last summer. Generating interest at the same time, though, is ciraparantag, brought in-house via the buyout in December of Perosphere Pharmaceuticals Inc., of Danbury, Conn.
