Perhaps borrowing from the playbook that Biogen Inc. used to beget the hemophilia and rare blood disease spin-off Bioverativ Inc., Shire plc alerted investors during its second-quarter earnings review that it's considering the same strategy, but in reverse. The Dublin-based company said a formal evaluation of strategic options for its neuroscience franchise is underway – a process Flemming Ornskov, the company's CEO, called "a natural evolution of our strategy post the Baxalta integration."
Milestone Pharmaceuticals Inc. collected its biggest raise to date, completing a $55 million series C led by Novo Holdings A/S that included new investors Forbion Capital Partners and funds managed by Tekla Capital Management.
Intercept Pharmaceuticals Inc. reported $30.4 million in second-quarter global net sales of Ocaliva (obeticholic acid, or OCA), beating consensus estimates of $26 million to $27 million. Moreover, the phase II AESOP trial of OCA in individuals with primary sclerosing cholangitis (PSC) met its primary endpoint of statistically significant reduction in alkaline phosphatase (ALP), an accepted biomarker, while the phase II CONTROL trial also met its objective, confirming statin co-administration with OCA reduces LDL to levels below baseline in patients with nonalcoholic steatohepatitis (NASH).
Precithera Inc. completed a series A financing of C$36 million (US$29 million) from an investor syndicate that included Sanderling Ventures, Arix Bioscience Ltd., Fonds de solidarité FTQ, CTI Life Sciences and Emerillon Capital.
Under Dave Ricks, sworn in at the outset of the year as CEO and elevated to the chairman's job on June 1, Eli Lilly and Co. shook up biopharma on Tuesday with its decision to de-prioritize a broad swath of early to mid-stage oncology assets.
"This is an exciting opportunity for us," Rich Daly, chairman and CEO of Neuralstem Inc., said about top-line phase II data of NSI-189 to treat major depressive disorder (MDD). Those aren't necessarily words that might follow a miss on the primary efficacy endpoint – a statistically significant reduction in depression symptoms on the Montgomery-Asberg Depression Rating Scale (MADRS) – which sent the company's shares (NASDAQ:CUR) tumbling as much as 60 percent Tuesday before closing at $2.81 for a loss of $2.77, or 49.6 percent.
Nektar Therapeutics Inc. continued its string of partnerships by hooking Eli Lilly and Co. as a collaborator to co-develop NKTR-358, a candidate advanced from inception to the clinic in a mere 15 months. Terms call for Nektar, of San Francisco, to receive $150 million up front with the potential for up to $250 million in additional development and regulatory milestones.
Merck & Co. Inc. took cardiovascular disease (CVD) experts – and, perhaps, some of its own decision-makers – by surprise last month when it disclosed that the REVEAL (Randomized EValuation of the Effects of Anacetrapib through Lipid modification) outcomes study of its cholesteryl ester transfer protein (CETP) inhibitor, anacetrapib, met its primary endpoint by reducing major coronary events (defined as the composite of coronary death, myocardial infarction and coronary revascularization) compared to placebo in patients at risk for cardiac events who were already receiving a regimen to lower low-density lipoprotein, or LDL.
Oryzon Genomics SA is losing its only partner, for lead candidate ORY-1001 (RG-6016), after Roche Holding AG reprioritized its pipeline and abandoned development of the lysine specific demethylase-1 (LSD1) inhibitor.
Menlo Therapeutics Inc. added new faces to its stable of investors in a $50 million series C designed to move serlopitant, the company's NK-1 receptor antagonist, into a pivotal program as a once-daily oral treatment for the lead indication of chronic pruritus, or itch, associated with the skin disease prurigo nodularis. The company, aptly based in Menlo Park, Calif., also is advancing serlopitant to treat chronic pruritus associated with the broader indications of atopic dermatitis and psoriasis and to treat refractory chronic cough.
