announced a strategic restructuring plan to extend its cash runway into Q1 of 2026 and prioritize resources on the commercialization and potential label extension of Danyelza and development of the SADA (Self-Assembly DisAssembly PRIT 2-STEP) technology platform.
The company plans to discuss omburtamab at its upcoming Type A meeting with the FDA; however, it has assumed a deprioritization of the omburtamab program, including all indications, in designing its restructuring plan and in its estimates for 2023.
In October, FDA's adcomm voted 16 to 0 that the company had not provided sufficient evidence to conclude that omburtamab improves overall survival.
In addition, the company plans to deprioritize other pipeline programs, including activities relating to GD2-GD3 Vaccine and CD33 bispecific antibody constructs.
Y-mAbs will reduce its workforce by approximately 35% by the end of May 2023.
Operating expenses, including restructuring costs expected to be recognized in Q1 2023, are expected to decrease by approximately 28% to $115-120 million, compared to previously announced 2022 guidance for operating expenses of $162-167 million.
The total cash burn for FY23 is expected to be $50-55 million.
Estimated DANYELZA net product revenues for FY23 are expected to be $60-65 million, compared to approximately $47-48 million expected for FY22.
has decided to modify the clinical development plan of lanifibranor for non-alcoholic steatohepatitis (NASH).
The changes follow a consultation with the FDA, Inventiva said.*
Inventiva had initially designed a two-part study where part one would support accelerated approval with data from 900 patients, and part two would follow 2,000 patients for up to seven years.
The company is now replacing part 2 with a new, separate Phase 3 trial that will enroll around 800 patients and last for about three years.
Part one of the NATiV3 study should provide data on liver histology from tissue biopsies. Enrollment is set to be completed in the second half of 2023, and patients will be followed for 72 weeks.
If the results are positive, the company anticipates it will support submitting a marketing application for full approval and the potential expansion of the addressable patient population beyond patients with F2 and F3 fibrosis.
President Joe Biden on Thursday will read remarks regarding border security, as his administration has now flip-flopped, and is working to expand Title 42, the Trump-era policy which allows the US Government to expel immigrants while they wait for asylum hearings, as opposed to allowing them to walk free in the United States.
Walgreens Boots Alliance said on Thursday it will not strike new deals in the short term after a spate of acquisitions in recent years, as it focuses on ramping up sales at its newer healthcare business.
The company, one of the largest U.S. pharmacies, has been looking to gain a bigger foothold in the healthcare space at a time when sales at its traditional brick-and-mortar stores are hit by lower demand for COVID-19 vaccines and testing compared to last-year's peak.
"We're not considering any M&A type activity in the short term. We're taking a pause. We need to focus on integration activities," Chief Financial Officer James Kehoe said in a post-earnings conference call.
The company could still make targeted acquisitions, but those would likely be in the hundreds of millions of dollars range, Kehoe said.
Shares of the company fell over 6% after same-store sales at its pharmacy business missed expectations in the first quarter, and as it reported a quarterly loss versus a year-ago profit due to a $6.5 billion opioid-related litigation charge.
Walgreens spent $5.5 billion in 2021 to take majority stakes in healthcare providers VillageMD and CareCentrix, and VillageMD later struck a $9 billion deal to buy urgent care provider Summit Health in November 2022.
Pharmacy sales during the quarter dropped about 4% even amid high demand for cough and cold drugs during one of the worst U.S. flu seasons in a decade.
Walgreens said same-store pharmacy sales rose 4.8% in the reported quarter from a year earlier, but below Evercore ISI's estimates of 5% growth.
Comparisons from last year when there was a COVID surge are "masking some positive changes we are seeing with Walgreens building its U.S. Healthcare business and improvements the company has made in its drugstores post-pandemic," Edward Jones analyst John Boylan said.
Net loss attributable to Walgreens was $3.72 billion, for the quarter ended Nov. 30, compared with a profit of $3.58 billion, a year earlier.
New York Attorney General Letitia James sued former Celsius Network CEO Alex Mashinsky on Thursday, alleging that Mashinsky defrauded hundreds of thousands of investors at his now-bankrupt crypto exchange.
Mashinsky publicly assured his customers that investing with Celsius was both safer and more lucrative than leaving their investments in a traditional bank. At one point, deposits at the crypto exchange were valued at $20 billion, according to the complaint. But Mashinsky’s statements were false, James alleges, and became part of the former Celsius CEO’s efforts to hide deep losses on risky crypto-lending investments.
“As the former CEO of Celsius, Alex Mashinsky promised to lead investors to financial freedom but led them down a path of financial ruin,” James said in a statement.
The attorney general’s office is seeking to fine Mashinsky and levy monetary damages, and bar him from leading a company or working in the securities industry in New York.
The action is civil, not criminal, and is brought under the Martin Act, New York state’s wide-ranging securities law. The Martin Act does give prosecutors sweeping search and subpoena powers to investigate potential wrongdoing.
The Terra/Luna crash in 2022 forced 3AC into bankruptcy and deepened an ongoing “crypto winter.” Celsius was exposed to the fall of Terra and Luna both through loans to 3AC and through $935 million of direct investment in “highly speculative” Terra bets, all funded by investor funds, the complaint claims.
Mashinsky claimed that Celsius had “very small losses” and that the exchange had “basically reduced or eliminated any exposure” to borrowers with investments in Terra or Luna.
Those statements were false, James’ complaint alleges, and were part of a wider campaign to prevent user outflows that could have precipitated a run on the bank similar to what happened at FTX, another bankrupted exchange.
But Mashinsky made “materially false and misleading” statements designed to hide the actual extent of Celsius’ exposure, claiming that the crypto exchange had “billions in liquidity” just days before Celsius filed for bankruptcy on Jul. 13, 2022, the complaint alleges.
Celsius investors were left bereft and so despondent that some considered suicide, CNBC previously reported.
“Mashinsky never disclosed that Celsius had close to a billion-dollar deficit,” the complaint alleges. Celsius entered bankruptcy proceedings with only $1.75 billion in crypto assets, a far cry from the $4.7 billion it owed users.
Mashinsky resigned from his position as CEO in September 2022. At the time, he apologized for the “increasing distraction” that his leadership had caused.
“Alex Mashinsky is no longer employed by Celsius and is not involved in the management of the company,” a spokesperson for Celsius told CNBC.
