Stock Markets
Infigratinib shows promise in pediatric growth trial
PALO ALTO, Calif. – BridgeBio Pharma, Inc. (NASDAQ:) has announced positive outcomes from its PROPEL 2 trial, evaluating the efficacy of infigratinib in children with achondroplasia, a genetic condition leading to dwarfism.
The Phase 2 trial data revealed a significant increase in annualized height velocity (AHV) and improvement in body proportionality in participants, indicating potential benefits for those affected by the condition.
The study, which included children receiving a daily oral dose of infigratinib, showed a sustained mean increase in AHV of +2.51cm/year at 12 months and +2.50 cm/yr at 18 months, with a p-value of 0.0015. Moreover, a meaningful change in body proportionality was observed, with the mean upper to lower body segment ratio improving from 2.02 at baseline to 1.88 at 18 months (p=0.001).
The safety profile of infigratinib has been well-received, as no treatment-related adverse events were reported among the trial participants. The ongoing PROPEL 3, a global Phase 3 registrational study of infigratinib, continues to enroll as planned, with completion anticipated by the end of 2024.
In parallel, BridgeBio has initiated ACCEL, an observational study for infigratinib in children with hypochondroplasia, a skeletal dysplasia closely related to achondroplasia. The first child consented to participate in the study in May 2024.
The findings from PROPEL 2 suggest that infigratinib could enhance functionality for those living with achondroplasia, beyond promoting growth. Dr. Ravi Savarirayan, the global lead investigator for the trial, expressed optimism for the ongoing studies to establish infigratinib as a safe and effective oral therapy for the achondroplasia community.
BridgeBio’s commitment to addressing unmet needs in skeletal dysplasias extends to the development of infigratinib for hypochondroplasia. The company has garnered positive feedback from the U.S. FDA and EMA, supporting the advancement of infigratinib in children with this condition.
The company plans to share further insights during an investor call scheduled for today at 8:00 am ET. This information is based on a press release statement.
InvestingPro Insights
As BridgeBio Pharma, Inc. (NASDAQ:BBIO) progresses with its clinical trials for infigratinib, investors have been closely monitoring the company’s financial health and market potential. The latest data from InvestingPro shows a company with a market capitalization of $5.42 billion and significant revenue growth over the last twelve months as of Q1 2024, with a striking 181.05% increase. This rapid growth is further highlighted by an astronomical quarterly revenue growth of 11,461.88% in Q1 2024.
While the company does not pay dividends, indicating a reinvestment of earnings into research and development, there are positive signs from analysts who have revised their earnings upwards for the upcoming period. This could be a reflection of the company’s promising trial outcomes and the potential market for infigratinib. Still, it is worth noting that analysts do not anticipate the company to be profitable this year, and it is trading at a high revenue valuation multiple, with a current P/E ratio of -9.01.
For those considering an investment in BridgeBio, it’s important to recognize the company’s high return over the last year, with a 103.23% one-year price total return as of the 156th day of 2024. This performance may be appealing to investors seeking growth in the biotech sector.
For more detailed analysis and additional InvestingPro Tips, such as the observation that BridgeBio’s liquid assets exceed short-term obligations, interested parties can visit https://www.investing.com/pro/BBIO. There are currently 7 additional InvestingPro Tips available, which could provide further insights into making informed investment decisions.
Prospective subscribers can also take advantage of a special offer using the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, providing access to a wealth of investment data and expert analysis.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
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
Stock Markets
Suriname fugitive ex-President Desi Bouterse dead at 79
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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