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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.
(Reuters) -Private equity firm Insight Partners is on the brink of closing a new $10 billion-plus fund, roughly half the amount originally targeted, the Financial Times reported on Sunday, citing five people with knowledge of its plans.
Insight will not formally close its 13th fund until early next year, the report said, adding that the final figure may be closer to $12 billion.
Insight Partners declined to comment on the report.
The report said Insight is using a private equity-style structure to sell more than $1 billion worth of stakes in start-ups and to free up cash to return to investors.
One of the start-ups is Israeli cybersecurity firm Wiz, which had called off a $23 billion deal with Google parent Alphabet (NASDAQ:) in July, the report said.
New York-based Insight raised $20 billion for its 12th flagship fund in 2022, aiming to ramp up investments in software and technology companies.
JERUSALEM (Reuters) -Prime Minister Benjamin Netanyahu said Israel would inflict a “heavy price” on the Iran-aligned Houthis who control northern Yemen, after they reached central Israel with a missile on Sunday for the first time.
Houthi military spokesman Yahya Sarea said the group struck with a new hypersonic ballistic missile that travelled 2,040 km (1270 miles) in just 11 1/2 minutes.
After initially saying the missile had fallen in an open area, Israel’s military later said it had probably fragmented in the air, and that pieces of interceptors had landed in fields and near a railway station. Nobody was reported hurt.
Air raid sirens had sounded in Tel Aviv and across central Israel moments before the impact at around 6:35 a.m. local time (0335 GMT), sending residents running for shelter. Loud booms were heard.
Reuters saw smoke billowing in an open field in central Israel.
At a weekly cabinet meeting, Netanyahu said the Houthis should have known that Israel would exact a “heavy price” for attacks on Israel.
“Whoever needs a reminder of that is invited to visit the Hodeida port,” Netanyahu said, referring to an Israeli retaliatory air strike against Yemen in July for a Houthi drone that hit Tel Aviv.
The Houthis have fired missiles and drones at Israel repeatedly in what they say is solidarity with the Palestinians, since the Gaza war began with a Hamas attack on Israel in October.
The drone that hit Tel Aviv for the first time in July killed a man and wounded four people. Israeli air strikes in response on Houthi military targets near the port of Hodeidah killed six and wounded 80.
Previously, Houthi missiles have not penetrated deep into Israeli air space, with the only one reported to have hit Israeli territory falling in an open area near the Red Sea port of Eilat in March.
Israel should expect more strikes in the future “as we approach the first anniversary of the Oct. 7 operation, including responding to its aggression on the city of Hodeidah,” Sarea said.
The deputy head of the Houthi’s media office, Nasruddin Amer, said in a post on X on Sunday that the missile had reached Israel after “20 missiles failed to intercept” it, describing it as the “beginning”.
The Israeli military also said that 40 projectiles were fired towards Israel from Lebanon on Sunday and were either intercepted or landed in open areas.
“No injuries were reported,” the military said.
PARIS (Reuters) – Eight people have died trying to cross the Channel from France to England, French authorities said on Sunday, confirming earlier media reports.
This latest incident follows the deaths of 12 people earlier this month when their boat capsized in the Channel on its way to Britain and highlights the pressure on the British and French governments to find ways to tackle the boat crossings.
Jacques Billant, the Prefect of the Pas-de-Calais region, said that rescue crews were alerted that a boat with 59 people onboard was in difficulty in waters off the coast of Ambleteuse in the Pas-de-Calais area.
“A new drama took place around one in the morning and we deplore the death of eight people,” he told a news conference, adding that the other 51 onboard were now in the care of rescue and medical crews.
The dead were men from Eritrea, Sudan, Syria, Egypt, Iran and Afghanistan, he added.
The Channel is one of the world’s busiest shipping lanes and currents are strong, which makes crossing on small boats dangerous.
The latest incident brings to 46 the number of people who have died trying to cross the Channel from France since the start of the year, Billant said.
On September 14 alone there were eight attempts to cross the Channel from France and some 200 migrants were rescued, he said.
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