After years of turbulent development that included a clinical hold, a COVID-19 stumble, a withdrawn approval application and an extended PDUFA date, the FDA has approved CTI Biopharma Corp.’s Vonjo (pacritinib) for treating the bone marrow cancer myelofibrosis.
Sierra Oncology Inc. plans an NDA in the second quarter of this year for momelotinib (MMB), thanks to data from the phase III Momentum study with the drug in myelofibrosis (MF) patients who are symptomatic and anemic after treatment with an approved JAK inhibitor. Momentum, which pitted momelotinib against the androgen danazol, met all of its primary and key secondary endpoints. MMB inhibits JAK1/2 and ACVR1/ALK2. Shares of San Mateo, Calif.-based Sierra (NASDAQ:SRRA) closed Jan. 25 at $22.68, up $7.17, or 46%.
Disc Medicine Inc. closed a $90 million series B round to move its two lead assets into clinical trials in patients next year. Bitopertin, an oral inhibitor of glycine transporter 1 (GlyT1), is entering a phase II trial in patients with erythropoietic porphyrias (EPPs), a set of rare genetic disorders caused by mutations that disrupt heme synthesis. Disc-0974, an antibody directed against hemojuvelin, will enter a phase II trial in myelofibrosis patients with transfusion-dependent anemia. The molecule, which Disc Medicine in-licensed from North Chicago-based Abbvie Inc., is currently undergoing a phase I trial in healthy volunteers.
Sierra Oncology Inc. has swooped in on an early stage BET inhibitor from Astrazeneca plc, paying just $8 million up front for the myelofibrosis drug – a price that raises questions about the $1.7 billion Morphosys AG stumped up to buy Constellation Pharmaceuticals and its class rival.
New data on a variety of blood disorder therapies announced at the 62nd American Society of Hematology (ASH) annual meeting moved company shares on Dec. 7. Shares of Fate Therapeutics Inc. (NASDAQ:FATE) hit a record high, rising 37.8% to $83.77 by day's end on news of clinical activity for one candidate in refractory diffuse large B-cell lymphoma.
As Constellation Pharmaceuticals Inc. gears up to start the pivotal phase III study of CPI-0610 in myelofibrosis (MF), Wall Street is mulling how likely are the stars to align for the Cambridge, Mass.-based company with its small-molecule inhibitor of bromodomain and extra-terminal (BET) proteins.
SAN DIEGO – At Biocom's 10th Annual Global Life Sciences Partnering Conference, a panel of players intimately familiar with last year's approval of myelofibrosis treatment Inrebic (fedratinib) explained the backstory of how they got the JAK2 kinase inhibitor off an FDA clinical hold, wrangled the rights to the drug back from the big pharma owner that had acquired the drug from Targegen Inc. and eventually helped the drug gain FDA approval after selling the rights to another large company.
ORLANDO, Fla. – Preliminary data from a phase II test of Constellation Pharmaceuticals Inc.'s CPI-0610 in patients with myelofibrosis (MF), previewed to market adulation in November, got a full airing Monday at the American Society of Hematology (ASH) annual meeting.
Emerging from the tsunami of abstracts from the nearly here American Society of Hematology (ASH) annual meeting in Orlando, Fla., were data that sent some stocks upward on Wednesday. Most notably, Constellation Pharmaceuticals Inc. (NASDAQ:CNST) was a huge winner as its shares nearly doubled in value as they closed at $28,10, up $13.33, for a gain of 90.25%.
