Word from the FDA to Axsome Therapeutics Inc. about the effort with oral N-methyl-D-aspartate (NMDA) receptor antagonist AXS-05 in depression – and the company's accelerated push with the compound – had Wall Street watching the NMDA space with even more interest than usual.
Since the mid-April pricing of Hookipa Pharma Inc.'s IPO, the New York-based firm has endured a bumpy ride on Wall Street, with shares sliding steadily since backers bought 6 million at $14 each for $84 million in proceeds. But among those keeping the faith are analysts at Evercore ISI, who recently hosted a webinar to highlight the research ongoing at Hookipa, which Ravi Mehrotra called "one of the most interesting companies we've come across."
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.