Isis Pharmaceuticals Inc.'s latest antisense deal – this time with AstraZeneca plc, for $25 million and $6 million more possible next year, plus potential milestone payments afterward – helps the company identify more targets and pay for Phase II work with a lymphoma compound, SIS-STAT3Rx, to which the new partner also bought a license.
Grisly and dramatic testimony jarred the public-comment segment of the FDA advisory panel on Zohydro for chronic pain, as parents of opioid casualties begged committee members to turn thumbs down on Zogenix Inc.'s extended-release hydrocodone.
Chelsea Therapeutics Inc.'s primary endpoint-hitting Phase III news about Northera (droxidopa) sent the stock south, as Wall Street reacted to word that effects on dizziness – the main goal of the trial – did not last as long as the FDA may want for approval.
In a decision hailed by some as a free-speech victory and by others as a ruling that gives drugmakers free rein to promote their goods off-label, federal appeals judges threw out the conviction of a former sales representative with Orphan Medical Inc. (acquired by Jazz Pharmaceuticals plc), who claimed his First Amendment rights were violated.
As investors continue to digest news regarding FDA concerns about overall survival trends of renal cell carcinoma patients in a Phase III trial with tivozanib, AVEO Oncology Inc. and Astellas Pharma Inc. have begun a Phase II study with the compound in triple-negative breast cancer.
Investors must wait until a conference call later this week for full details, but the decision by BioCryst Pharmaceuticals Inc. and Presidio Pharmaceuticals Inc. to ditch their $101 million merger might seem almost inevitable, coming in the wake of problems for BioCryst's drug candidates in flu, hepatitis C virus (HCV) and hereditary angioedema.
As expected, Exelixis Inc. won the FDA's nod for cabozantinib, a therapy for medullary thyroid cancer (MTC) – a less common form of the disease, originating in parafollicular C cells – but bigger revenue potential lies ahead, if the compound passes muster in metastatic prostate cancer, where Phase III trials are under way.
Pulling down a $30 million loan against Erivedge royalties and spending $9.5 million to license a Phase II-ready apoptosis promoter from Genentech Inc. – its partner for the skin cancer product – gives Curis Inc. more financial runway, as well as worldwide rights to another promising oncology candidate.
Two strikes – and investor suspense – led up to a home run for Acadia Pharmaceuticals Inc., which tweaked the designs of previous, failed Phase III trials and thereby met all endpoints in the latest one with pimavanserin in Parkinson's disease psychosis (PDP).
Published results from preclinical work with the company's oral Aurora A angiogenic kinase inhibitor boosted shares of EntreMed Inc., leaving the stock (NASDAQ:ENMD) to close Monday at $1.73, up 34 cents, or 24.5 percent, after trading as high as $1.99.
