Acadia Pharmaceuticals Inc. (ACAD) has announced that it has filed a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to support a potential new indication for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP).The FDA previously granted Breakthrough Therapy Designation for pimavanserin for this indication.“This is an important step forward for the approximately 2.4 million people in the U.S. who suffer from dementia-related hallucinations and delusions, representing a large unmet need with currently no approved treatment options,” said Steve Davis, Acadia’s CEO.The application follows ACAD’s pivotal Phase 3 HARMONY study, which met its primary endpoint, demonstrating that pimavanserin significantly reduced the risk of relapse of psychosis by 2.8 fold compared to placebo.The sNDA also includes positive efficacy results from two additional placebo-controlled studies, both of which met their respective primary endpoints, and a large safety and tolerability database of over 1500 patients.Dementia affects approximately...
(Bloomberg) -- Banks including Credit Suisse Group AG and Morgan Stanley face a $300 million shortfall on margin loans to the embattled founder of Luckin Coffee Inc.The lenders, which also include Haitong International Securities Group and Goldman Sachs Group Inc., raised about $210 million over the past two months selling Luckin shares that Chairman Lu Zhengyao had pledged as collateral, people familiar with the matter said. Lu defaulted on $518 million of margin debt in early April, Goldman said in a statement at the time, after revelations of accounting fraud caused the Chinese coffee chain’s stock to plunge.The share sales represent the latest attempt by Lu’s creditors to limit losses from a scandal that has fueled calls in Washington for tougher scrutiny of financial ties between the U.S. and China. Luckin’s fall from grace blindsided some of the biggest names on Wall Street just as they were gearing up for a...
(Bloomberg) -- Tesla Inc. will buy cobalt from from Glencore Plc, the world’s biggest miner of the metal, as the carmaker looks to avoid a future supply squeeze on the key battery metal, a person familiar with the matter said.The contract will help Tesla shore up its cobalt supply for new plants in China and Germany, said the person, who asked not to be identified as the details are private. The opening of Tesla’s so-called gigafactory in China this year has helped propel its shares to a record, as investors turn bullish on Elon Musk’s ambition to transform the company into a global mass-market automaker.While there’s enough cobalt supply for now, demand is expected to surge in the coming years as Tesla expands in China and Europe and Volkswagen AG to BMW AG roll out fleets of electric vehicles. Warnings about long-term shortages caused cobalt prices to spike in 2017 and...
Jazz Pharmaceuticals (JAZZ) and partner PharmaMar have announced a surprise early approval from the US FDA for its Zepzelca treatment for adults with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. This comes notably ahead of the 8/16 PDUFA date.Zepzelca (lurbinectedin) was approved under accelerated approval based on overall response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial, the company said.Data from an open-label, multi-center study showed that in patients with relapsed SCLC, Zepzelca demonstrated an ORR of 35 percent and a median duration of response of 5.3 months as measured by investigator assessment.“Small cell lung cancer is a disease with limited treatment options, and the approval of Zepzelca represents an important advance for patients,” said Bruce Cozadd, JAZZ CEO. “While patients may initially respond to traditional chemotherapy, they often experience...
Fracking pioneer Chesapeake Energy Corp (CHK) is preparing to file for bankruptcy as soon as this week, three people familiar with the matter have told Reuters.According to the Reuters sources, CHK is now wrapping up negotiations for a $900 million debtor-in-possession loan. It is also discussing with creditors the potential to “roll up” its existing debt and make it part of the bankruptcy loan, bringing the total debtor-in-possession financing closer to $2 billion, the sources said.At the same time the company is also looking for an equity infusion from creditors. Chesapeake plans to file for bankruptcy on Thursday, but if the financing required further discussions this could move to next week, the sources added.If the company lives on post-bankruptcy, creditors like Franklin Resources Inc will take over Chesapeake in exchange for deleting over $7 billion of debt, Reuters reports.With a massive debt burden of around $9 billion, CHK missed an interest payment...
Companies Reporting Before The Bell • MFA Financial Inc. (NYSE:MFA) is expected to report quarterly earnings at $0.14 per share on revenue of $152.30 million. Companies Reporting After The Bell • Groupon Inc. (NASDAQ:GRPN) is expected to report quarterly earnings at $0.08 per share on revenue of $380.22 million.• Oracle Inc. (NYSE:ORCL) is estimated to report quarterly earnings at $1.20 per share on revenue of $10.90 billion.• H&R Block Inc. (NYSE:HRB) is expected to report quarterly earnings at $2.61 per share on revenue of $1.74 billion.View more earnings on MFA• InnerWorkings Inc. (NASDAQ:INWK) is expected to report quarterly earnings at $0.02 per share on revenue of $270.75 million.• Vince Holding Inc. (NYSE:VNCE) is expected to report quarterly earnings at $0.99 per share on revenue of $36.80 million.• Volt Information Sciences, Inc. Common Stock Inc. (AMEX:VOLT) is estimated to report quarterly earnings at $0.41 per share on revenue of $209.50 million.• ClearSign...
