Women whose HER2-positive early breast cancers were treated with Genentech Inc.'s Herceptin (trastuzumab) and chemotherapy after surgery saw greater risk reductions for invasive disease recurrence or death when Perjeta (pertuzumab) was added to treatment, a phase III study found.
Neuroderm Ltd. shares (NASDAQ: NDRM) climbed 26.6 percent Wednesday to $29.30 on word that a 24-hour regimen of its continuous delivery levodopa/carbidopa (LD/CD) candidate, ND0612H, significantly decreased the amount of time in which Parkinson's disease (PD) patients faced a reemergence of PD symptoms on medication, eliminating it altogether for some patients.
Accera Inc.'s metabolic-focused Alzheimer's candidate, AC-1204, has foundered in the company's phase III NOURISH AD trial, failing to deliver statistically significant improvements in memory and cognition vs. placebo for people with mild to moderate Alzheimer's disease. A reformulation of the drug between a successful phase II trial and the phase III study yielded suboptimal exposure, contributing to the lack of efficacy, the company said.
Arrakis Therapeutics Inc., a company seeking to develop a pipeline of RNA-targeted small molecules for neurology, oncology and rare genetic disorders, has completed a $38 million series A financing. The funds are expected to help it establish its RNA-focused drug discovery platform this year and then bring its most advanced program close to being ready for studies to back its first investigational new drug application.
Cempra Inc. shares (NASDAQ:CEMP) rose 28.6 percent to $4.05 on Friday as the company reported that early clinical responses to its oral antibiotic, Taksta (fusidic acid), proved noninferior to those for Pfizer Inc.’s oral Zyvox (linezolid) during a phase III trial, meeting the primary endpoint.
PMV Pharmaceuticals Inc., a company developing cancer therapies to restore p53, a protein commonly mutated in tumors, has landed a $74 million series B financing. Topspin Biotech Fund and Euclidean Capital led the round. Orbimed Advisors, Osage University Partners and founding investor Interwest Partners also chipped in after backing the company's $30 million series A financing in 2014.
Duchenne muscular dystrophy specialist Sarepta Therapeutics Inc. gained $125 million by selling to Gilead Sciences Inc. an FDA priority review voucher (PRV) won with its approval of Exondys 51 (eteplirsen).
The oral c-Met inhibitor tivantinib missed its primary endpoint of improving overall survival vs. placebo in a phase III hepatocellular carcinoma (HCC) study, calling into question the future of the program, licensed by Arqule Inc. to Tokyo-based Daiichi Sankyo Group in December 2008, even as another phase III study of the candidate in Japan progresses. Shares in Arqule (NASDAQ:ARQL) fell 18.4 percent, closing at $1.20 on Friday.
The oral c-Met inhibitor tivantinib missed its primary endpoint of improving overall survival vs. placebo in a phase III hepatocellular carcinoma (HCC) study, calling into question the future of the program, licensed by Arqule Inc. to Daiichi Sankyo Group in December 2008, even as another phase III study of the candidate in Japan progresses. Shares in Arqule (NASDAQ:ARQL) fell 18.4 percent, closing at $1.20 on Friday.
Valeant Pharmaceuticals International Inc. won a widely anticipated FDA approval for its moderate to severe plaque psoriasis drug, Siliq (brodalumab), complete with an expected black box warning for suicidal ideation and behavior that analysts expect could hamper sales. U.S. availability of the drug, licensed from Astrazeneca plc, is set for the second half of this year. Acceptance of the drug's EMA marketing authorization application arrived in late 2015.
