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ACADIA Pharmaceuticals $ACAD started a Phase 2 study, SERENE, evaluating pimavanserin (NUPLAZID) for the treatment of agitation in Alzheimer’s disease (AD) patients, a common characteristic in AD sufferers and a major cause of distress for all concerned. The clinical trial is a double-blind, placebo-controlled outpatient study that will target roughly 430 AD patients who have agitation and/or aggression symptoms. The participants will be randomized to receive either a once daily 20 mg or 34 mg oral dose of pimavanserin or placebo for 12 weeks. The primary endpoint of the study is the reduction in the total score of a scale called Cohen-Mansfield Agitation Inventory (CMAI)

FDA to review ARIAD’s NDA for brigatinib -The FDA accepted to review ARIAD Pharmaceuticals’ $ARIA New Drug Application (NDA) seeking approval of brigatinib for the treatment of patients with ALK-positive non-small cell lung cancer (NSCLC) who have progressed on crizotinib [Pfizer's $PFE XALKORI]. The agency's action date (PDUFA) is scheduled onApril 29, 2017 under Priority Review status.

 Capricor’s lead product candidate falls short of clearing early-stage study-Results obtained from a Phase 1 clinical trial labeled as DYNAMIC evaluating Capricor Therapeutics’ $CAPR lead product candidate CAP-1002 in patients with advance heart failure showed mixed treatment effect. The data was shown at the annual scientific symposium of the Cardiovascular Research Foundation called the 28th Transcatheter Cardiovascular Therapeutics in Washington, D.C.

 DURECT’s Phase 1b study on NASH treatment yields positive results-DURECT $DRRX soared in afterhours amid heavy trading volume in response to its announcement of encouraging results from its first cohort in a Phase 1b clinical trial evaluating DUR-928 in patients with nonalcoholic steatohepatitis (NASH). The clinical trial is being conducted on successive cohorts assessing single-dose of orally administered DUR-929.

 Shire ends a tad lower over Express Scripts comments on hemophilia meds-Shire Plc $SHPG eased on Monday amid increased trading volume in apparent response to comments made by Express Scripts $ESRX Chief Medical Officer, Steven Miller, during a phone call, in which he said that the company is looking at ways to manage increasing costs of hemophilia medicines without forcing patients to switch treatments. Shire is one of the big players in this arena after its merger with Baxalta.

 NovaBay fulfills compliance with NYSE listing requirements-NovaBay Pharmaceuticals $NBY announced that it has reclaimed compliance with the NYSE MKT continued listing standards. On April 28th 2015, the drug-maker received notice which said that it was out of compliance with Section 1003 (a) (i) of the NYSE MKT Company Guide pertaining to shareholder equity requirements. Nonetheless, the company, through a series of financings has been able to generate more than $300 million to reclaim compliance and maintain its listings on the exchange.

Catalyst Pharmaceuticals $CPRX announced that the FDA has approved its protocol for its second Phase- 3 study evaluating Firdapse (amifampridine phosphate) for the treatment of symptoms of Lambert-Eaton myasthenic syndrome (LEMS), a sporadic autoimmune disorder characterized by muscle weakness in the limbs.

German drug-maker Merck KGaA $MKGAF and its development partner Pfizer $PFE announced  that the European Medicines Agency (EMA) has approved Merck’s Marketing Authorization Application (MAA) seeking approval of avelumab for the treatment of metastatic Merkel cell carcinoma (MCC), a sporadic and aggressive skin cancer that affects roughly 2,500 Europeans every year. MCC, an Orphan Drug indication, is related with a poor prognosis with a five-year survival rate less than 20%.

No patents to report.

Australian biotech company Novogen Ltd $NVGN acquired Glioblast, a fellow Aussie firm thus showing its commitment to develop a portfolio of brain cancer treatments. It acquired Glioblast Pty Ltd for an upfront payment of AU$2.1 Million in cash and stock in addition to milestones. The privately held company’s lead product candidate is Phase 2 stage GDC-0084, a small molecule inhibitor of the PI3K/AKT/mTOR pathway under development for the treatment of glioblastoma, the most common type of brain cancer. $NVGN other brain cancer candidates are Anisina and Trilexium.

No secondary offerings to report.

No IPOs to report.

 Zimmer Biomet $ZBH reported Q3 EPS of $1.79, which was in-line with the guidance. Revenue was $1.83 Billion, a 4% growth Y-o-Y; but missing guidance by $10 million.

 Spring Bank Pharmaceuticals $SBPH, a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of viral infections, cancer and inflammatory diseases announced third quarter results of 2016. For the recently concluded quarter, which ended September 30, 2016, net loss of was $4.1 million or $0.53 per basic and diluted share as compared to a net loss of $3.4 million or $0.59 per basic and diluted share for the same period in 2015.