After hitting its primary endpoint in a Phase II study last fall, Agenus was already leading a Sanofi-NIH collaboration in efforts to develop the first genital herpes vaccine. Now, it's built on that lead with new Phase II results for its therapeutic candidate, HerpV, which achieved statistical significance in reducing viral load.
Aerie Pharmaceuticals says that a combo glaucoma drug adding its own treatment to the best-selling standard in the field topped the blockbuster solo therapy in a Phase IIb trial. The results set the stage for a confirmatory Phase III trial, sending its share price soaring more than 40% on Wednesday morning.
Shares of Ohr Pharmaceutical slipped and then bounced back this morning after the biotech announced that a mid-stage study of Squalamine eye drops failed the primary endpoint in reducing the number of injections of Lucentis among patients with wet, age-related macular degeneration. The New York-based biotech touted an improvement in visual acuity among the small group of patients in the Phase II trial, which drew a few cheers among the analysts following the company.
AstraZeneca's reconstructed case for the cancer drug olaparib is built on the fundamental premise that the new management team at the pharma giant is a whole lot smarter than the old crew. After a retrospective analysis found a subgroup response in the data for ovarian cancer, CEO Pascal Soriot not only ordered the team to renew its pursuit of an approval, he later assigned a $2 billion peak sales value to the program.
Parexel International has reformatted its clinical trial management software, streamlining its services with an update the company believes can help its clients start studies faster.
Shares of Switzerland's Actelion spiked 15% Monday morning after the biotech reported that its next-gen oral pulmonary arterial hypertension drug selexipag proved a success in Phase III, setting up a showdown with regulators for a drug that's widely billed as a likely blockbuster.
Biogen Idec and AbbVie announced Monday morning that their once-monthly multiple sclerosis drug daclizumab has cleared key hurdles in a Phase III study, setting the stage for a marketing pitch to regulatory authorities.
There's no mistaking Geoffrey Porges' opinion on Vertex's chances of success with its combo study of VX-809 and Kalydeco. After spending the weekend at the European Cystic Fibrosis Society meeting in Sweden, the prominent Bernstein analyst came away even more soured on the experimental CF drug's potential, with pivotal data for the combo looming on the horizon.
On Friday, Celgene followed up on its aggressive $130 million upfront deal to land an option on Agios' experimental therapies by locking in development and commercialization rights to its lead drug, AG-221. On Saturday, Agios explained why, detailing Phase I data that showed an objective response among more than half of the evaluable patients and a complete response from 6 of 25.
Sanofi and its close development partner Regeneron added some positive year-long results to the promising Phase III rheumatoid arthritis data that they've been gathering on sarilumab, an antibody that is billed as one of the pharma giant's top late-stage drug prospects.