While Geron Corp. awaits formal notification by letter from the FDA regarding the full clinical hold placed on imetelstat, shares crashed and investors had few answers to their questions about the surprising move.
The higher-dose glitch in otherwise strong phase II results with its galectin-3-targeting chronic kidney disease (CKD) therapy did little to hold back shares of La Jolla Pharmaceutical Co. (NASDAQ:LJPC), which closed Tuesday at $17.96, up $7.06, or 64.8 percent.
Last Thursday’s midday sell-off in the sector raised some eyebrows, but market watchers say the sudden moves were no cause for alarm, with ISI Group analyst Mark Schoenebaum pinning the seismic rumble on remarks made during a luncheon by Federal Reserve Bank president William Dudley.
Incyte Corp. could achieve label expansion with the already successful myelofibrosis (MF) drug Jakafi (ruxolitinib) by the end of this year, thanks to a phase III victory in the myeloproliferative neoplasm known as polycythemia vera (PV), which sometimes advances to MF.
As investors await data from phase III trials with ALKS 9070 (aripiprazole lauroxil) in schizophrenia, Alkermes plc is starting its pivotal program with once-daily, oral ALKS 5461 for major depressive disorder (MDD).
Acadia Pharmaceuticals Inc.’s bigger-than-expected public offering grossed about $182 million that will fund ongoing efforts to expand the indications for pimavanserin, due to become the subject of a new drug application (NDA) in Parkinson’s disease psychosis (PDP) before the year is done.
With a wholly owned drug for Parkinson’s disease (PD) at the phase III stage, Adamas Pharmaceuticals Inc. said Forest Laboratories Inc. – its partner for a combo Alzheimer’s disease (AD) therapy – submitted a new drug application (NDA) to the FDA for the once-daily capsule MDX-8704 to treat AD-related dementia.
Bolstering its phase III push with the JAK2/FLT3 inhibitor pacritinib in the heating-up myelofibrosis (MF) space, Cell Therapeutics Inc. (CTI) began Persist-2, a study in patients with the disease and platelet counts less than or equal to 100,000 per microliter.
A $50 million up-front payment from new partner Celgene Corp. gives Abide Therapeutics Inc. time to “focus entirely on the science, without worrying for a while about raising extra capital,” and the company likely has enough runway to reach “substantial milestones that would validate what we’re trying to do,” CEO Alan Ezekowitz told BioWorld Today.
Pulling down about $142 million from a public offering of 8 million shares priced at $17.75 each, Neurocrine Biosciences Inc. is moving ahead with phase III plans for the vesicular monoamine transporter 2 (VMAT2) inhibitor for tardive dyskinesia candidate NBI-98854.
