Latest news with #PCSK9
Business Insider
2 days ago
- Business
- Business Insider
Merck Stock (MRK) Slips Despite Positive Clinical Trials Results
Merck (MRK) stock was on the move Monday after the healthcare company announced positive results from two Phase 3 clinical trials. These studies saw meaningful reductions in LDL-C from patients with hyperlipidemia on lipid-lowering therapies who were treated with the investigational drug enlicitide decanoate. Confident Investing Starts Here: Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Dr. Dean Y. Li, President of Merck Research Laboratories, said, 'We are thrilled to bring forward the first Phase 3 results from our clinical development program evaluating enlicitide, which, if approved, would be the first marketed oral PCSK9 inhibitor in the U.S.' While the studies of enlicitide decanoate met all primary and key secondary endpoints, Merck intends to continue investigating the drug. That includes a series of studies with up to 17,000 patients to determine the efficacy and safety of the treatment. If all goes well in these trials, the company will likely submit the drug to the Food and Drug Administration for commercial approval. Merck Stock Analyst Coverage In other news, the latest coverage of Merck stock comes from four-star Bank of America Securities analyst Tim Anderson. He reiterated a Buy rating and $99 price target on Friday, suggesting a 25.28% upside for the shares. MRK stock was down 0.08% on Monday despite its positive clinical trial data. This extends the stock's 19.99% year-to-date drop and 39.94% 12-month fall. While MRK shares climbed in pre-market trading, they couldn't hold onto those gains after the opening bell. Is Merck Stock a Buy, Sell, or Hold? Turning to Wall Street, the analysts' consensus rating for Merck is Moderate Buy, based on 10 Buy and seven Hold ratings over the past three months. With that comes an average MRK stock price target of $100.73, representing a potential 27.55% upside for the shares.
Yahoo
3 days ago
- Business
- Yahoo
FDA approves YolTech's YOLT-101 for familial hypercholesterolemia
YolTech Therapeutics has received the US Food and Drug Administration (FDA) approval for its investigational new drug (IND) application for YOLT-101 to treat heterozygous familial hypercholesterolemia (HeFH). YOLT-101 is an in vivo base editing therapy designed to target proprotein convertase subtilisin/kexin type 9 (PCSK9). Its innovative approach lies in its potential to durably reduce blood low-density lipoprotein cholesterol (LDL-C) levels through a single-dose treatment. The technology behind YOLT-101 incorporates YolTech's adenine base editor, known as hpABE5, which consists of nCas and a new deaminase evolved from Hafnia paralvei. To deliver this therapeutic agent, the company employs an advanced lipid nanoparticle (LNP) delivery system. hpABE5 can perform precise A•T to G•C base conversions without inducing DNA double-strand breaks, thus minimising risks associated with chromosomal abnormalities and off-target effects. YolTech Therapeutics co-founder and CEO Yuxuan Wu stated: 'The FDA IND clearance marks a significant milestone for YolTech. In vivo gene editing represents a new generation of therapeutics — offering one-time, durable solutions for chronic and genetic diseases. 'We are committed to advancing breakthrough gene editing solutions that offer transformative benefits for patients living with severe genetic and cardiovascular diseases.' Currently under evaluation in an ongoing investigator-initiated trial (IIT), YOLT-101 has shown promising results with a favourable safety profile and substantial LDL-C–lowering effects. Familial hypercholesterolemia is a genetic disorder stemming from mutations affecting LDL metabolism-related genes such as LDLR, Apolipoprotein B (APOB) and PCSK9. Individuals suffering from FH typically experience elevated LDL-C levels, which contribute to a heightened risk of developing early-onset atherosclerotic cardiovascular diseases. "FDA approves YolTech's YOLT-101 for familial hypercholesterolemia" was originally created and published by Pharmaceutical Technology, 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.
Yahoo
3 days ago
- Business
- Yahoo
FDA approves YolTech's YOLT-101 for familial hypercholesterolemia
YolTech Therapeutics has received the US Food and Drug Administration (FDA) approval for its investigational new drug (IND) application for YOLT-101 to treat heterozygous familial hypercholesterolemia (HeFH). YOLT-101 is an in vivo base editing therapy designed to target proprotein convertase subtilisin/kexin type 9 (PCSK9). Its innovative approach lies in its potential to durably reduce blood low-density lipoprotein cholesterol (LDL-C) levels through a single-dose treatment. The technology behind YOLT-101 incorporates YolTech's adenine base editor, known as hpABE5, which consists of nCas and a new deaminase evolved from Hafnia paralvei. To deliver this therapeutic agent, the company employs an advanced lipid nanoparticle (LNP) delivery system. hpABE5 can perform precise A•T to G•C base conversions without inducing DNA double-strand breaks, thus minimising risks associated with chromosomal abnormalities and off-target effects. YolTech Therapeutics co-founder and CEO Yuxuan Wu stated: 'The FDA IND clearance marks a significant milestone for YolTech. In vivo gene editing represents a new generation of therapeutics — offering one-time, durable solutions for chronic and genetic diseases. 'We are committed to advancing breakthrough gene editing solutions that offer transformative benefits for patients living with severe genetic and cardiovascular diseases.' Currently under evaluation in an ongoing investigator-initiated trial (IIT), YOLT-101 has shown promising results with a favourable safety profile and substantial LDL-C–lowering effects. Familial hypercholesterolemia is a genetic disorder stemming from mutations affecting LDL metabolism-related genes such as LDLR, Apolipoprotein B (APOB) and PCSK9. Individuals suffering from FH typically experience elevated LDL-C levels, which contribute to a heightened risk of developing early-onset atherosclerotic cardiovascular diseases. "FDA approves YolTech's YOLT-101 for familial hypercholesterolemia" was originally created and published by Pharmaceutical Technology, 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. Sign in to access your portfolio
Medscape
3 days ago
- Business
- Medscape
Merck's Potential Blockbuster Cholesterol Pill Succeeds in Late-stage Studies
(Reuters) -Merck's oral cholesterol pill succeeded in two late-stage studies, marking a win for the drugmaker as it focuses on the development of growth drivers beyond its cancer drugs and vaccines. The company is searching for its next blockbuster candidate as its major revenue driver, Keytruda, is expected to lose patent protection by the end of the decade. Merck's non-statin cholesterol drug, enlicitide decanoate, is being tested for the treatment of hyperlipidemia, a condition that causes elevated buildup of fat in the blood vessels and can lead to heart attacks and strokes. Enlicitide works by blocking PCSK9, a protein that plays a crucial role in regulating cholesterol levels, while statins block an enzyme the liver uses to make cholesterol. BMO Capital Markets analyst Evan Seigerman said Merck's drug could potentially provide a "multi-billion dollar opportunity" that expands the PCSK9 market beyond current injectable therapies. The drug showed meaningful reductions in LDL-C cholesterol, commonly referred to as "bad cholesterol", when compared to placebo and other oral non-statin therapies, Merck said. However, Leerink analysts have noted that Astrazeneca's AZD0780 is a "credible threat" as it has shown a 50.7% reduction in LDL-C levels during a trial. Merck has not given the details on LDL-C reduction for enlicitide. The drug was tested in patients who have a history of, or are at risk for a type of heart disease, and were treated with a statin. Shares of Merck were up 2% in premarket trading. Verve Therapeutics is also developing a gene therapy to reduce high cholesterol levels, which is expected to be used in combination with other drugs. (Reporting by Christy Santhosh in Bengaluru; Editing by Shinjini Ganguli)
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Business Standard
3 days ago
- Business
- Business Standard
Merck's potential cholesterol pill succeeds in late-stage studies
Merck's oral cholesterol pill succeeded in two late-stage studies, marking a win for the drugmaker as it focuses on the development of growth drivers beyond its cancer drugs and vaccines. The company is searching for its next blockbuster candidate as its major revenue driver, Keytruda, is expected to lose patent protection by the end of the decade. Merck's non-statin cholesterol drug, enlicitide decanoate, is being tested for the treatment of hyperlipidemia, a condition that causes elevated buildup of fat in the blood vessels and can lead to heart attacks and strokes. Enlicitide works by blocking PCSK9, a protein that plays a crucial role in regulating cholesterol levels, while statins block an enzyme the liver uses to make cholesterol. BMO Capital Markets analyst Evan Seigerman said Merck's drug could potentially provide a "multi-billion dollar opportunity" that expands the PCSK9 market beyond current injectable therapies. The drug showed meaningful reductions in LDL-C cholesterol, commonly referred to as "bad cholesterol", when compared to placebo and other oral non-statin therapies, Merck said. However, Leerink analysts have noted that Astrazeneca's AZD0780 is a "credible threat" as it has shown a 50.7% reduction in LDL-C levels during a trial. Merck has not given the details on LDL-C reduction for enlicitide. The drug was tested in patients who have a history of, or are at risk for a type of heart disease, and were treated with a statin. Shares of Merck were up 2% in premarket trading.
