Latest news with #Oxbryta
Yahoo
7 hours ago
- Health
- Yahoo
Pfizer's sickle cell disease candidate fails Phase III trial
Pfizer is mulling its options after its investigational sickle cell disease drug failed to meet the primary endpoint in a Phase III trial. The THRIVE-131 study (NCT04935879) was evaluating inclacumab, an investigational P-selectin inhibitor, in patients 16 years of age and older with sickle cell disease. The trial failed to meet its primary endpoint of a significant reduction in the rate of vaso-occlusive crises (VOCs) after 48 weeks, placing the drug's future in jeopardy. Pfizer's chief inflammation and immunology officer Dr Michael Vincent, said: 'While the THRIVE-131 results did not meet our expectations, we remain committed to better understanding these results and sharing them with the medical and sickle cell community in the interest of advancing our collective understanding of sickle cell disease. We remain focused on our mission of bringing much-needed treatments to patients with sickle cell disease.' The therapy was generally well tolerated in THRIVE-131, with the most common adverse events (AEs) being anaemia, arthralgia, back pain, headache, malaria, sickle cell anaemia with crisis, and upper respiratory tract infection. Analyses of the data will be shared with the scientific and patient community in due course. The therapy is still being assessed in the THRIVE-133 OLE trial (NCT05348915) to evaluate the long-term safety of inclacumab. If approved, GlobalData predicts global sales of the drug to reach $267m in 2031. GlobalData is the parent company of Clinical Trials Arena. Pfizer's sickle cell disease woes This is the latest hit in sickle cell disease for Pfizer. In September 2024, it withdrew its therapy Oxbryta (voxelotor) in all approved markets after data suggested an imbalance in VOCs and fatal events. The company has reviewed and shared the data with the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). The company is also awaiting the lifting of a partial clinical hold by the FDA on its Phase III trial of osivelotor, a haemoglobin S polymerisation inhibitor, in sickle cell disease. The FDA's order has paused enrolment into the trial, with Pfizer stating data will be shared as it becomes available. Approved therapies in the sickle disease treatment space are combating slow growth. Vertex and CRISPR Therapeutics' Casgevy (exagamglogene autotemcel) only reached revenue of $10m in 2024, with a $2.2m price tag per patient proving a barrier to initial uptake. Vertex said it expects the number of new patients initiating cell collection to grow significantly throughout 2025, with signals that this is already happening. GlobalData predicts Casgevy sales will increase significantly in 2025, with a forecast of $107m, with projections that the gene therapy will reach blockbuster status in 2030. The therapy gained approval by the National Institute for Health and Care Excellence (NICE) for use in sickle cell disease in January 2025, meaning it is now available for use on the UK's National Health Service (NHS). "Pfizer's sickle cell disease candidate fails Phase III trial" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Reuters
3 days ago
- Business
- Reuters
Pfizer's sickle-cell treatment efforts falter as drug fails study
Aug 15 (Reuters) - In the latest setback for Pfizer's (PFE.N), opens new tab sickle cell anemia treatments, experimental drug inclacumab failed to meet the main goal in a late-stage trial for patients aged 16 and older. The trial results showed no significant difference in the number of vaso-occlusive crises — or painful events common in sickle cell disease — among people who took the drug versus those who took the placebo, the drugmaker said on Friday. This makes inclacumab the second drug from Pfizer's 2022 acquisition of Global Blood Therapeutics to yield unfavorable results. Oxbryta - the centerpiece of the $5.4 billion buyout - was withdrawn last September over risks of painful complications and deaths. "Pfizer's acquisition of Global Blood has proven disappointing with inclacumab's failure coming after Oxbryta's 2024 withdrawal from all approved markets" said BMO Capital Markets analyst Evan Seigerman. The previously estimated $3 billion in revenue contributions from the deal now seems unlikely to materialize, Seigerman said. Pfizer said it was disappointed by inclacumab's results but remains committed to supporting the sickle cell community. The company will keep working on its sickle cell treatments, including Oxbryta and osivelotor, another therapy secured from the Global Blood deal. Sickle cell anemia is an inherited blood disorder in which red blood cells become sickle- or crescent-shaped and can cause strokes, organ damage and death. Existing FDA-approved therapies for the genetic blood disorder includes Vertex Pharmaceuticals' (VRTX.O), opens new tab and CRISPR Therapeutics' ( opens new tab Casgevy and Bluebird Bio's Lyfgenia.
Yahoo
25-05-2025
- Business
- Yahoo
1 Ultra-High-Yield Dividend Stock Down 57% to Buy Hand Over Fist
Pfizer faces several challenges, including looming patent expirations. However, the drugmaker's story is better than meets the eye. Pfizer's attractive valuation and ultra-high dividend yield make it a great pick right now. 10 stocks we like better than Pfizer › Most people like to buy products when prices are cheaper. That's why you'll probably see lots of car dealers, furniture stores, and retailers advertising special sales during the Memorial Day weekend. However, many investors are leery of buying a stock that has fallen sharply. Why? It's often because they're worried about getting caught in a value trap. But sometimes beaten-down stocks offer great bargains to forward-thinking investors. Pfizer (NYSE: PFE) is a great example, with its shares down around 57% below the previous high. I think, though, that this ultra-high-yield dividend stock is one to buy hand over fist. When a stock plunges as much as Pfizer has, there must be a reason behind the decline. Pfizer faces some real challenges that investors shouldn't ignore. The main factor causing the big pharma stock to initially sink back in late 2022 and 2023 was rapidly declining sales of its COVID-19 products. Waning worries about the pandemic, combined with increased vaccine skepticism, delivered a double-whammy to Pfizer. Product and pipeline setbacks have also hurt the drugmaker to some extent. Last year, Pfizer voluntarily withdrew its sickle cell disease therapy, Oxbryta, from the market because the benefits didn't outweigh the risks. More recently, the company discontinued development of experimental oral obesity drug danuglipron after a patient in a clinical trial had a drug-induced liver injury. Pfizer is also preparing for the patent expirations for several top-selling products. Cancer drug Inlyta loses patent exclusivity this year. Autoimmune disease drug Xeljanz and blood thinner Eliquis go off-patent next year. If all that isn't enough, Pfizer could be impacted by President Donald Trump's policies. The president has threatened tariffs on pharmaceutical imports. His administration also plans to implement international reference pricing, also known as most-favored nation (MFN) pricing. This would tie the prices paid for drugs in the U.S. to the lowest price paid by other developed countries. You might think Wall Street would scream for investors to avoid Pfizer like the plague with all that bad news. However, that's not the case. Eight of the 25 analysts surveyed by LSEG in May rate Pfizer as a buy or strong buy. All of the others surveyed, except for one outlier, recommend holding the stock. The average 12-month price target for Pfizer reflects an upside potential of 28%. Why is there a significant level of optimism on Wall Street about this beaten-down pharma stock? For one thing, Pfizer isn't nearly as reliant on COVID-19 product sales as it was during the peak of the pandemic. In the first quarter of 2025, COVID-19 vaccine Comirnaty and antiviral therapy Paxlovid made up less than 7.7% of total revenue. Pfizer hopes to delay the loss of exclusivity for several drugs by securing patent term extensions. More importantly, the company has multiple rising stars that it thinks can more than offset the sales declines from the drugs that lose exclusivity over the next few years. Look for business development deals to help further boost growth. Pfizer recently announced it's licensing a promising cancer drug being developed by Chinese drugmaker 3SBio. CEO Albert Bourla hinted on the company's Q1 earnings call that Pfizer could pursue partnerships or acquisitions to bolster its pipeline and specifically mentioned obesity. The Trump administration's policies create uncertainty for Pfizer. However, President Trump himself assured pharmaceutical industry leaders they would have plenty of time to adjust operations before steep pharmaceutical tariffs go into effect. Also, global law firm Reed Smith concluded after reviewing the president's executive order about MFN drug pricing: [A]bsent congressional legislation authorizing the imposition of MFN prices -- which the pharmaceutical industry and many in Congress still oppose -- it remains highly questionable whether the Trump Administration will be able to impose any reduction of pharmaceutical prices to match those in other countries. I don't think that Pfizer is a stock to buy hand over fist just because its story is better than meets the eye (although this is good news). Instead, I have two key reasons for liking Pfizer right now. First, the price is right. Pfizer's shares trade at a little over 8 times forward earnings. That cheap multiple might be justified if the company had no growth prospects, but that's not the case. Pfizer's price-to-earnings-to-growth (PEG) ratio, based on five-year earnings growth projections, is a low 0.6. This indicates the stock's valuation is very attractive relative to its growth prospects. Second, Pfizer's forward dividend yield stands at 7.47%. At first glance, the drugmaker's dividend payout ratio of 122.5% might seem concerning. However, Pfizer has sufficient free cash flow to fund its dividend at the current level. It also anticipates cost savings of $7.2 billion by 2027 that should provide more financial flexibility. The bottom line is that Pfizer should be in a pretty good position to navigate its challenges. The stock is dirt cheap. Its ultra-high dividend yield provides a nice platform from which to deliver solid total returns. All in all, I think Pfizer meets the bar as a stock to buy hand over fist. Before you buy stock in Pfizer, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Pfizer wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $640,662!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $814,127!* Now, it's worth noting Stock Advisor's total average return is 963% — a market-crushing outperformance compared to 168% for the S&P 500. Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of May 19, 2025 Keith Speights has positions in Pfizer. The Motley Fool has positions in and recommends Pfizer. The Motley Fool has a disclosure policy. 1 Ultra-High-Yield Dividend Stock Down 57% to Buy Hand Over Fist was originally published by The Motley Fool Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
21-02-2025
- Business
- Yahoo
Pfizer Discontinues Hemophilia Gene Therapy Beqvez As Interest Wanes
According to multiple media reports on Thursday, Pfizer Inc. (NYSE:PFE) has terminated the global development and commercialization of its hemophilia B gene therapy, Beqvez. In April 2024, the FDA approved Beqvez for moderate to severe hemophilia B in adult patients who currently use factor IX prophylaxis therapy or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes, and do not have neutralizing antibodies to adeno-associated virus serotype Rh74var capsid. Also Read: In a statement to Nikkei Asia, Pfizer said the decision was due to "the limited interest patients and their doctors have demonstrated in hemophilia gene therapies.' The U.S. drugmaker said it would focus on different treatment for the disorder, citing low interest. In December 2024, Pfizer walked away from its hemophilia A co-development pact with Sangamo Therapeutics Inc (NASDAQ:SGMO) giroctocogene fitelparvovec, an investigational gene therapy product candidate. According to a Reuters report, Pfizer will continue to invest resources in Hympavzi (marstacimab-hncq), which is approved for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients with hemophilia A or hemophilia B. Hympavzi is the first and only anti-tissue factor pathway inhibitor (anti-TFPI) approved in the U.S. for hemophilia A or B and the first hemophilia medicine approved in the U.S. to be administered via a pre-filled, auto-injector pen. Earlier this month, Novo Nordisk A/S (NYSE:NVO) announced interim results from the phase 3 FRONTIER3 trial of 70 children (aged 1-11 years old) with hemophilia A with and without inhibitors. Novo Nordisk expects Mim8 regulatory submission during 2025. Data from the ongoing phase 3 FRONTIER program will be disclosed at upcoming congresses and in publications in 2025 and 2026. In September 2024, Pfizer voluntarily withdrew all lots of Oxbryta (voxelotor) for sickle cell disease (SCD) in all markets where it is approved. Pfizer's decision is based on the totality of clinical data indicating that the overall benefit of Oxbryta no longer outweighs the risk in the approved sickle cell patient population. Price Action: PFE stock is up 0.87% at $26.13 at the last check on Friday. Read Next:Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? PFIZER (PFE): Free Stock Analysis Report This article Pfizer Discontinues Hemophilia Gene Therapy Beqvez As Interest Wanes originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Sign in to access your portfolio
