Stock Markets
ABIONYX Pharma has completed a successful pre-IND meeting with the FDA for CER-001 Phase 2b/3 Clinical Trial for Patients with Sepsis
- Based on encouraging Phase 2a data and a productive pre-IND Type B meeting with U.S. Food and Drug Administration (FDA), ABIONYX Pharma intends to file an Investigational New Drug application (IND) in the coming months which will include a Phase 2b/3 clinical trial for CER-001 in Sepsis
TOULOUSE, France & LAKELAND, Mich.–(BUSINESS WIRE)–Regulatory News:
ABIONYX Pharma, (FR0012616852 – ABNX – eligible for PEA PME), a new generation biotech company dedicated to the discovery and development of innovative therapies based on the world’s only natural recombinant apoA-I, today announced that the company has completed a pre-IND (Investigational New Drug Application, IND) meeting with the US Food and Drug Administration and has received feedback to support an IND filing for its candidate drug. This is an important validation of the quality of the project and a significant step towards an application to include American study centers in future clinical trials. ABIONYX Pharma intends to file an IND application to the US authority in the coming months.
Our latest phase 2a clinical study with CER-001, was published by BMC Medicine, in a translational research paper that included important in-vitro data, proof of concept in a pig model of sepsis and a four-arm controlled study in patients with sepsis. All sets of data showed statistically significant effects on parameters such as endotoxin levels, key inflammatory cytokines such as IL-6 and TNF-α and endothelial markers of inflammation such as sVCAM-1, sICAM-1 and MCP-1.
The positive pre-IND meeting with the FDA reflects the quality and strength of the combined preclinical and clinical generated so far during the development of CER-001. We appreciate the FDA’s guidance as we prepare to advance our novel therapy into phase 2b/3″, said Dr. Rob Scott, Head of R&D and CMO at ABIONYX Pharma. “The successful completion of this pre-IND engagement is an important milestone that provides much regulatory clarity for the future path forward for CER-001. Based on the wealth of scientific evidence for the role of apoA-I in sepsis produced by us and others, including compelling genetic validation, we believe our recombinant apoA-I has potential to change the outcomes for patients with sepsis. We are now eager to move ahead in the future clinical development phases.
About Sepsis
Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis affects an estimated 49 million people worldwide each year, including more than 20 million children under age 5, and 1.7 million people in the U.S alone. It is a leading cause of mortality worldwide and causes more than 350,000 deaths per year in the U.S., which makes it the third leading cause of overall mortality and the leading cause of in-hospital death. Sepsis causes more deaths than chronic lower respiratory diseases, stroke, Alzheimer’s disease, diabetes, or accidental death. Sepsis is also the most expensive in-hospital condition in the U.S., costing an estimated $62 billion each year, counting just acute in-hospital care and skilled nursing costs. There are no approved treatments that specifically target sepsis and current management relies on anti-microbial therapy and supportive care. Without any approved therapies for sepsis, the global sepsis market size is still estimated to reach $7 billion in 2030 and grow at a compound annual growth rate of 5.6% between 2024 to 2030.
About CER-001
CER-001 is an engineered pre-β HDL particle which contains recombinant human apolipoprotein A-I (apoA-I), complexed with phospholipids. Pre-β HDL particles have been shown to be highly effective scavengers of bacterial endotoxins, thereby inactivating lipopolysaccharide (LPS) for removal by the liver.
About ABIONYX Pharma
ABIONYX Pharma is a next-generation biotech company focused on developing innovative medicines for diseases where there is no effective or existing treatment, even the rarest ones. The company expedites the development of novel therapeutics through an extensive expertise in lipid science and a differentiated apoA-I-based technology platform. ABIONYX Pharma is committed to radically improving treatment outcomes in Sepsis and critical care.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240613991966/en/
NewCap
Investor relations
Nicolas Fossiez
Louis-Victor Delouvrier
abionyx@newcap.eu
+33 (0)1 44 71 98 53
NewCap
Media relations
Arthur Rouillé
abionyx@newcap.eu
+33 (0)1 44 71 00 15
Source: ABIONYX Pharma
Stock Markets
BioAge Labs (BIOA) Azelaprag Trial Halt Raises Questions About Pre-IPO Disclosures – Hagens Berman
San Francisco, California–(Newsfile Corp. – December 25, 2024) – On December 9, 2024, just months after conducting an initial public offering in September 2024, BioAge Labs, Inc. (NASDAQ: BIOA) made the startling announcement that it was discontinuing a Phase 2 study for its lead product, azelaprag, intended to treat metabolic diseases such as obesity.
Hagens Berman has opened an investigation and urges investors in BioAge who purchased shares in the company’s IPO or on the open market and suffered substantial losses to submit your losses now.
Visit: www.hbsslaw.com/investor-fraud/bioa
Contact the Firm Now: BIOA@hbsslaw.com
844-916-0895
BioAge Labs, Inc. (BIOA) Investigation:
The investigation is focused on the propriety of BioAge’s disclosures about the safety data and other matters related to azelaprag, which the company said in its IPO documents has been “well-tolerated in 265 individuals across eight Phase 1 clinical trials.”
BioAge’s disclosures came into question after the market closed on December 6, 2024, when the company announced the discontinuation of the STRIDES Phase 2 clinical trial evaluating azelaprag in combination with tirzepatide for the treatment of obesity. BioAge said that liver transaminitis was observed in patients receiving azelaprag.
This news drove the price of BioAge shares down almost 80% on December 9, 2024.
“We’re focused on whether BioAge was transparent to investors about the azelaprag safety profile before the December 6 announcement,” said Reed Kathrein, the Hagens Berman partner leading the investigation.
If you invested in BioAge and have substantial losses, or have knowledge that may assist the firm’s investigation, submit your losses now »
If you’d like more information and answers to frequently asked questions about the BioAge investigation, read more »
Whistleblowers: Persons with non-public information regarding BioAge should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email BIOA@hbsslaw.com.
# # #
About Hagens Berman
Hagens Berman is a global plaintiffs’ rights complex litigation firm focusing on corporate accountability. The firm is home to a robust practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and other wrongdoings. Hagens Berman’s team has secured more than $2.9 billion in this area of law. More about the firm and its successes can be found at hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/235182
Stock Markets
Celsius Holdings (CELH) Hit with Investor Class Action Amid Accusations of Oversold Inventory to Pepsi- Hagens Berman
CELH Investors with Losses Encouraged to Contact the Firm
San Francisco, California–(Newsfile Corp. – December 25, 2024) – Celsius Holdings (NASDAQ:), Inc. (NASDAQ: CELH) and certain of its C-Suite officers are embroiled in a securities class action lawsuit, claiming they misrepresented and concealed crucial information about the company’s financial performance, especially concerning its key customer, PepsiCo (NASDAQ:).
Hagens Berman is investigating the allegations and urges investors in Celsius who purchased shares and suffered substantial losses to submit your losses now.
Class Period: Feb. 29, 2024 – Sept. 4, 2024
Lead Plaintiff Deadline: Jan. 21, 2025
Visit: www.hbsslaw.com/investor-fraud/celh
Contact the Firm Now: CELH@hbsslaw.com
844-916-0895
Celsius Holdings, Inc. (CELH) Securities Class Action (WA:):
The lawsuit alleges that during the Class Period, Celsius failed to disclose to investors several critical points:
- Oversold Inventory: Celsius significantly oversold inventory to Pepsi beyond demand, leading to a potential drastic reduction in future purchases.
- Declining Sales: As Pepsi depleted its overstock, Celsius’ sales were projected to decline, impacting its financial health and outlook.
- Unsustainable Sales Rates: The sales rates to Pepsi were unsustainable and created a misleading impression of the company’s performance.
- Misleading Metrics: Consequently, Celsius’ business metrics and financial prospects were overstated
The situation came to light on May 28, 2024, when Celsius’ stock price plummeted nearly 13% following reports from Nielsen indicating slowed sales growth. Analysts highlighted the possibility of significantly reduced sales as Pepsi cut back its inventory.
The stock took another hit on September 4, 2024, dropping over 11% after a company presentation revealed a shortfall of $100 million to $120 million in Pepsi orders compared to the previous year. It was also disclosed that Pepsi had held several million excess cases over the last 18 months.
These revelations have led shareholder rights firm Hagens Berman to investigate the allegations.
“We’re investigating whether Celsius deliberately painted an overly optimistic picture of its relationship with Pepsi, misleading investors about the true state of its financial health and sales sustainability,” said Reed Kathrein, the Hagens Berman partner leading the investigation.
If you invested in Celsius and have substantial losses, or have knowledge that may assist the firm’s investigation, submit your losses now »
If you’d like more information and answers to frequently asked questions about the Celsius case and our investigation, read more »
Whistleblowers: Persons with non-public information regarding Celsius Holdings should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email CELH@hbsslaw.com.
# # #
About Hagens Berman
Hagens Berman is a global plaintiffs’ rights complex litigation firm focusing on corporate accountability. The firm is home to a robust practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and other wrongdoings. Hagens Berman’s team has secured more than $2.9 billion in this area of law. More about the firm and its successes can be found at hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/235180
By Ank Kuipers
PARAMARIBO (Reuters) -Suriname’s fugitive former President Desi Bouterse has died aged 79, the country’s government said on Wednesday, almost a year after he fled authorities to avoid jail following his conviction over the murder of 15 political activists in 1982.
“The government has been informed through the family and its own investigations of the passing of Mr. D. Bouterse, ex-President of the Republic of Suriname,” Foreign Minister Albert Ramdin told Reuters.
The former leader died on Tuesday, the government said, without confirming where, or even in which country. Last week Surinamese authorities raided his home – where supporters gathered to pay their respects on Wednesday morning – but did not find him.
Surinamese President Chan Santokhi, who investigated the case as a police commissioner and later as justice minister, expressed condolences to Bouterse’s family and urged calm in a statement.
“In the spirit of the holiday season and year-end, the president calls on all to remain dignified and calm, maintain peace and order and engage in prayer in the spirit of these special days,” the statement said.
Bouterse dominated politics in the tiny South American country for decades, leading a coup in 1980 and finally leaving office in 2020.
In 2019 he and six others were convicted for their role in the 1982 murders of 15 leading government critics – including lawyers, journalists, union leaders, soldiers and university professors – for which Bouterse received a 20-year prison sentence.
Bouterse had claimed the murdered men were connected to a planned invasion of the former Dutch colony.
Following years of legal back and forth, Bouterse was ordered to report to prison in January but he did not show up on the appointed date.
Though Bouterse avoided prison by going on the run, Reed Brody, a U.S. war crimes prosecutor who monitored the case for the International Commission of Jurists, said justice had caught up with the convicted former president before he died.
“Thanks to the victims’ relatives and their supporters who never gave up, Bouterse will go down in history as a convicted murderer,” Brody said.
The former president’s family will make a statement later on Wednesday, members of his political party told journalists.
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