BioRestorative Therapies Receives FDA Fast Track Approval For BRTX-100 To Treat Chronic Lumbar Disc Disease
By Meg Flippin Benzinga
DETROIT, MICHIGAN - April 16, 2025 ( NEWMEDIAWIRE ) - When it comes to treating back pain, particularly chronic lumbar disc disease (cLDD), the industry is falling short. Sure there's surgery, but that's an invasive option that isn't always a success. Pain pills are another option, but that can lead to addiction and a severe change in a patient's quality of life. With more than 16 million Americans suffering from chronic back pain, curing it is a big need that has yet to be met.
It's why the progress BioRestorative Therapies Inc. (NASDAQ: BRTX) is making with BRTX-100, its treatment for chronic back pain, is encouraging. The regenerative medicine company focused on stem cell-based therapies and products was just granted Fast Track designation by the U.S. Food and Drug Administration for BRTX-100, its developmental treatment for cLDD.
Giving It A Speedier In
FDA's Fast Track designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions where there is an unmet medical need. Companies granted Fast Track status are able to have more frequent meetings and written communications with the FDA to discuss the drug's developmental plan, the design of proposed clinical trials and the use of biomarkers. Fast Track designation may also make the company's drug eligible for Priority Review and Accelerated Biologics License Application (BLA) approval.
'We are thrilled that the FDA has granted Fast Track designation, underscoring the potential of BRTX-100 to fill significant unmet medical needs in the treatment of cLDD resulting from ineffective conservative non-surgical approaches or failed surgical interventions, and reflecting the comparatively very positive preliminary Phase 2 clinical data that we have reported to date,' said Lance Alstodt, Chief Executive Officer of BioRestorative. 'Achieving Fast Track designation is an important milestone for BioRestorative, enabling us to work more collaboratively with the FDA as we continue to advance our lead BRTX-100 clinical program toward BLA approval to bring this important and novel stem cell therapy to the millions of cLDD patients waiting for effective pain relief and functional improvement.'
Chronic Back Pain Costs Americans Billions
Without a doubt, cLDD fits the bill for a disease with an unmet need, and many large companies like Pfizer, Abbott Laboratories and Eli Lilly are working on solutions. In the U.S. alone around 80% of adults experience at least one episode of lower back pain in their lifetime. What's more, low back pain is the most common cause of disability among adults 45 to 65 and imposes the highest economic burden on the U.S. healthcare system.
Pain-related conditions cost the U.S. economy a staggering $635 billion annually in medical expenses and lost productivity. Back pain is by far the biggest culprit. Currently, there is no clinical therapy targeting the reversal of disc degeneration or that addresses intervertebral disc cell homeostasis, reports BioRestorative.
It's also a big market opportunity for BioRestorative. The stem cell therapeutics market is projected to reach $54.7 billion by 2033, growing at a CAGR of 12.6% between now and then. It is being driven by demand for regenerative therapies and research grants in this area.
BRTX-100's Promising Results
BRTX-100 is an autologous stem cell product for chronic lower back pain. It uses a patient's stem cells, which are harvested, cultured and then injected directly into the affected disc to start the repair process.
Safety and efficacy endpoints from an ongoing phase 2 trial for the treatment of cLDD have been encouraging, reported BioRestorative. The company said no serious adverse events (SAEs) were reported in any of the 10 first patients of the prospective, randomized, double-blinded and controlled study. BioRestorative said there was also no dose (40X10 6 cells) limiting toxicity at 26-52 weeks. At 26 weeks 70% of the patients reported a greater than 30% increase in function and a more than 30% decrease in pain. If data continues with this trend, the company is confident it will hit its efficacy endpoints for the phase 2 trial.
Chronic back pain is costly and greatly reduces the quality of life for the more than 16 million Americans who are suffering. BioRestorative wants to change that and believes BRTX-100 holds the answer. With Fast Track designation the company is working closely with the FDA to hopefully get this treatment in the hands of patients sooner, giving millions of people much-needed relief.
Featured photo byGioele FazzerionUnsplash.
This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice.
This content was originallypublished on Benzinga.Read further disclosureshere.
View the original release on www.newmediawire.com
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Insider
23 minutes ago
- Business Insider
What A-list economists are saying about Trump's tax bill as Musk rebels against it
Elon Musk has departed his role as a "special government employee" in Trump's White House — and he's using his time outside the administration to hammer the GOP spending bill that's a cornerstone of the president's agenda. "This massive, outrageous, pork-filled Congressional spending bill is a disgusting abomination," Musk wrote on X earlier this week. Trump responded by saying Musk's criticism of the legislation is "disappointing." President Trump's tax bill will likely face a vote in the Senate in the coming weeks after passing the House in May. It would reduce the tax rates of lower-income workers, particularly those earning less than $107,200, and eliminate taxes on tips, social security, and overtime. The bill would also cut spending on social programs like Medicaid and SNAP benefits, which provide food assistance to low-income Americans. Like Musk, investors and economists are seemingly concerned that the bill will cause the national debt to balloon and further widen the US budget deficit. The non-partisan Congressional Budget Office said this week that it would grow the deficit by $2.4 trillion over the next decade . Trump and his allies have pushed back, arguing that higher economic growth from lower taxes would help boost government revenue. Here's what top economists are saying about the bill. Phillip L. Swagel, director of the Congressional Budget Office Despite the lower tax rates for low earners, Swagel said in a May 20 letter that the bill would negatively impact poorer Americans. "CBO estimates that household resources would decrease by an amount equal to about 2 percent of income in the lowest decile (tenth) of the income distribution in 2027 and 4 percent in 2033, mainly as a result of losses of in-kind transfers, such as Medicaid and SNAP," he wrote. "By contrast, resources would increase by an amount equal to 4 percent for households in the highest decile in 2027 and 2 percent in 2033, mainly because of reductions in the taxes they owe." William McBride, chief economist at the Tax Foundation McBride, along with several colleagues at the non-partisan Tax Foundation think tank, said in a May 23 report that while the bill would support economic growth, it wouldn't be enough to offset the revenue loss from tax cuts. "Our preliminary analysis finds the tax provisions included in the House-passed bill would increase long-run GDP by 0.8 percent," the report said. "The bill's tax and spending changes would increase the 10-year budget deficit by $2.6 trillion from 2025 through 2034 on a conventional basis before added interest costs. On a dynamic basis, accounting for economic growth, the deficit would increase by $1.7 trillion over ten years before interest costs." It continued: "The bill's tax provisions alone would reduce federal tax revenue by $4.1 trillion from 2025 through 2034 on a conventional basis before added interest costs. On a dynamic basis, accounting for economic growth, the revenue reduction would fall by nearly 22 percent to $3.2 trillion over 10 years before added interest costs." 6 Nobel Laureates Six Nobel Prize-winning economists — including Daron Acemoglu, Simon Johnson, Peter Diamond, Paul Krugman, Oliver Hart, and Joseph Stiglitz — said in a June 2 letter that the bill would worsen wealth inequality in the US. "The combination of cuts to key safety net programs like Medicaid and SNAP and tax cuts disproportionately benefiting higher-income households means that the House budget constitutes an extremely large upward redistribution of income. Given how much this bill adds to the U.S. debt, it is shocking that it still imposes absolute losses on the bottom 40% of U.S households," the letter said. "The House bill addresses none of the nation's key economic challenges usefully and exacerbates many of them," it added. Ken Rogoff, professor of economics at Harvard University Rogoff, former chief economist at the IMF, cast doubt on the notion that the bill would boost growth in a piece for Project Syndicate this week. "Trump and his acolytes argue that his "big, beautiful bill" will supercharge economic growth, generating enough revenue to make up for sweeping tax cuts. But history offers little support for such claims," he wrote. "While both Democratic-led spending sprees and Republican-backed tax cuts have fueled the growth of US debt over the past two decades, tax reductions have accounted for the lion's share of the increase. Moreover, the notion that tax cuts pay for themselves was already discredited in the 1980s, when President Ronald Reagan's tax cuts led to soaring deficits rather than self-sustaining growth." He added: "Will America's rising debt ultimately trigger a full-blown crisis? Perhaps, but a continued upward drift in long-term interest rates is more likely." Desmond Lachman, senior fellow at the American Enterprise Institute Lachman, a former IMF official who currently works for a conservative-leaning think tank, said in a June 4 post that rising bond yields, a declining dollar, and appreciating gold prices could be harbingers of an economic crisis brought on by Trump-driven policy volatility. Trump's tax bill is adding to investors' fears due to its inflationary implications. But one of its clauses undermines confidence in the reliability of the returns on Treasurys, he said. "That bill includes a clause that has to be sending shivers down foreign investors' spines. According to Section 899, the US Treasury can impose additional taxes of up to 20 percent on income earned by foreign entities from countries that enact taxes deemed 'unfair' to US interests."
Yahoo
24 minutes ago
- Yahoo
How Much Savings Middle-Class Retirees Have, According To Most of America
Saving for retirement looks different for everyone, even those with similar incomes and net worths. Be Aware: Try This: To give you a better idea of how much to save and how fellow Americans are positioned for retirement, GOBankingRates surveyed 1,000 working Americans aged 21 and older. Conducted at the end of 2024, the survey covered various topics, including current 401(k) balances and beliefs about what middle-class Americans need to retire comfortably. To understand public beliefs about retirement savings, we asked how much the typical middle-class American has saved by age 65. The responses revealed a wide range of views shaped by age and financial perspectives. Our survey found that younger respondents (ages 21-34) were more likely to believe retirees have less than $50,000 saved, with 25.95% holding this view. This perception remained consistent across other age groups, with 29.47% of those aged 35-44 and 25% of those aged 55-64 also selecting this range. In contrast, fewer respondents expected higher savings: only 13.92% of younger respondents believed retirees had saved between $300,00 and $500,000, and just 3.16% thought retirees surpassed $1 million. These findings express significant uncertainty about retirement readiness. While some respondents may base their views on personal experience, others might lack awareness of expert recommendations, which often suggest saving 10-12 times one's annual income, a benchmark far beyond what most perceive as typical. This disparity reveals to us the need for clearer guidance on what's truly necessary for a financially secure retirement. See More: The current state of Americans' 401(k) balances highlights significant disparities across age groups: Ages 21 to 34: 19.6% have less than $25,000 saved, while 32.91% report balances between $50,001 and $100,000. Only 10.76% have saved $100,01 to $500,000, and none have surpassed $500,000. Ages 35 to 44: Savings improve slightly, with 17.24% having between $100,001 and $500,000. However, 20.69% still have $25,001 to $50,000 saved. Ages 45 to 54: 20.87% have $100,001 to $500,000 saved, but 16.54% still have less than $25,000. Ages 55 to 64: 17.19% have between $100,001 and $500,000, and only 5.79% have over $500,000 saved. Ages 65 and over: 24.68% have balances between $25,001 and $50,000, but 19.48% do not have a 401(k) at all. Nearly 8% claim to have over $500,000 in their 401(k). Younger respondents are, of course, still building their retirement savings, while older groups often fall short of financial benchmarks. Middle-class Americans vary widely in living expenses and goals, making it hard to pinpoint a universal savings target. While experts suggest benchmarks like saving 10-12 times your annual income, these guidelines depend heavily on personal circumstances such as lifestyle and retirement plans. Aligning savings strategies with individual needs is key to closing the gap between goals and reality. The data highlights a pressing need for Americans to increase their savings rates. Here's how individuals can close the gap: Increase contributions gradually: Fidelity recommends saving at least 15% of your before-tax income yearly towards retirement. If this feels daunting, start small and increase contributions annually by 1% until the target rate is reached. Maximize employer matches: For those with employer-sponsored plans, failing to contribute enough to receive the full match is leaving free money on the table. Monitor progress: Regularly reviewing 401(k) balances and adjusting contributions based on goals can help keep savings on track. Seek expert guidance: Consulting a financial advisor can provide personalized strategies to optimize retirement savings. Modest contributions and low balances risk leaving retirees financially vulnerable. These findings highlight the importance of proactive planning and disciplined savings. While this data focuses on 401(k) balances, it's important to note that not all retirement savings are tied to these accounts. Many retirees rely on alternative methods such as IRAs, pensions, annuities or even real estate investments to fund their retirement years. Additionally, those who are already retired may lean on Social Security benefits or personal savings outside of formal retirement plans. The data presented here offers a rough snapshot of where Americans stand with retirement savings, but it's crucial to consider these additional financial options and your situation when assessing financial readiness. By focusing on consistent contributions and setting realistic goals, middle-class workers can work toward a more secure and well-rounded retirement. More From GOBankingRates Here's the Minimum Salary Required To Be Considered Upper Class in 2025 Mark Cuban Says Trump's Executive Order To Lower Medication Costs Has a 'Real Shot' -- Here's Why This article originally appeared on How Much Savings Middle-Class Retirees Have, According To Most of America
Yahoo
25 minutes ago
- Yahoo
REGN Strengthens Obesity Pipeline: Will the Move Revive the Stock?
Regeneron Pharmaceuticals, Inc. REGN is looking to make inroads in the lucrative obesity market. The company recently entered into an in-licensing agreement for an obesity drug with Hansoh Pharmaceuticals Group Company Limited, in a bid to expand its clinical-stage obesity portfolio. The licensing agreement with Hansoh Pharma provides Regeneron with HS-20094, a GLP-1/GIP receptor agonist. Regeneron will acquire exclusive clinical development and commercial rights for HS-20094, a dual GLP-1/GIP receptor agonist, outside the Chinese Mainland, Hong Kong and Macau. Per the terms of the agreement, Regeneron will make an upfront payment of $80 million to Hansoh, with potential additional payments of up to $1.93 billion for achievement of development, regulatory and sales milestones. Any royalties on global net sales in the future (outside the designated territories) would be in the low double digits. HS-20094 has been evaluated in over 1,000 patients and administered as a weekly subcutaneous injection. The candidate has demonstrated promising efficacy and safety clinical data, suggesting a potentially similar profile to the only FDA-approved GLP-1/GIP receptor agonist. The candidate is currently being evaluated in a phase III study in obesity in China, and a phase IIb study in diabetes is ongoing. The in-licensing agreement for an obesity candidate will expand REGN's obesity pipeline, which includes trevogrumab. Regeneron recently announced positive interim results from the ongoing phase II COURAGE study investigating novel combinations of semaglutide (GLP-1 receptor agonist) and trevogrumab (anti-GDF8/anti-myostatin) with or without garetosmab (anti-activin A) for the treatment of obesity. COURAGE was designed to investigate the quality of weight loss in patients with obesity. Results showed that approximately 35% of semaglutide-induced weight loss was due to loss of lean mass, and further demonstrated that combining semaglutide with trevogrumab with or without garetosmab helped preserve lean mass while increasing loss of fat mass. Garetosmab is being evaluated for the treatment of fibrodysplasia ossificans progressive. The successful development of any obesity treatment will be a great boost for the company. We note that REGN has had a rough time so far this year. The stock got hammered last week after REGN and partner Sanofi SNY reported results from two late-stage studies, AERIFY-1 and AERIFY-2, on itepekimab for the treatment of chronic obstructive pulmonary disease (COPD). While the AERIFY-1 study met the primary endpoint, AERIFY-2 did not meet the same. REGN and SNY are currently reviewing the data and plan to discuss the next steps with regulatory authorities. Year to date, REGN's shares have lost 31.7% compared with the industry's 3.2% decline. Image Source: Zacks Investment Research Regeneron's performance in the first quarter was dismal. The plunge in Eylea sales adversely impacted the top line. Eylea sales have been under pressure for some time now due to competition from Roche's Vabysmo. Regeneron Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Regeneron Pharmaceuticals, Inc. Quote Regeneron has a tough road ahead, as it will take a long time for Eylea HD to contribute significantly to the top line. Apart from Eylea, profits from the sales of asthma drug Dupixent are a primary growth driver for REGN. Regeneron has a collaboration agreement with Sanofi for Dupixent. While the obesity market is lucrative, REGN is a pretty late entrant here. The market is dominated by bigwigs like Novo Nordisk NVO and Eli Lilly LLY. The stupendous success of Novo Nordisk's obesity drug, Wegovy (semaglutide) and Eli Lilly's Zepbound has prompted many companies to join the bandwagon. Buoyed by this success, both Lilly and NVO have taken significant strides in developing their obesity portfolios further. Given the significant market potential of obesity, other players are also striving to grab a chunk of this pie. Regeneron currently has a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report Sanofi (SNY) : Free Stock Analysis Report Novo Nordisk A/S (NVO) : Free Stock Analysis Report Eli Lilly and Company (LLY) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
