Latest news with #FcRn
Yahoo
28-05-2025
- Business
- Yahoo
H.C. Wainwright Keeps Buy Rating on Roivant Sciences (ROIV) Stock
On May 28, H.C. Wainwright analyst Douglas Tsao reiterated a Buy rating on Roivant Sciences Ltd. (NASDAQ:ROIV) while keeping the price target the same at $18. The reiteration comes after the company appointed the current President and COO of Roivant, Dr. Eric Venker as CEO of Immunovant. Roivant Sciences Ltd. (NASDAQ:ROIV) is the founding parent and majority shareholder of Immunovant. A research scientist in a lab coat examining a sample of blood for sickle cell diseases. In April, the company appointed Dr. Erin Venker, M.D. as CEO of Immunovant and Tiago Girao. The analyst expects this leadership change to enhance clinical execution and strategic decision-making. Tsao believes the change will accelerate the development of the company's lead FcRn inhibitor, IMVT-1402. Additionally, IMVT-1402 is being developed for multiple high-value autoimmune indications including Graves Disease, rheumatoid arthritis, Sjögren's Disease, and more. Tsao anticipates the approval of IMVT-1402 will enhance the strategic and financial prospects of the company thereby justifying the Buy rating. Roivant Sciences Ltd. (NASDAQ:ROIV) is a commercial-stage biopharmaceutical company that develops treatments for unmet medical needs. Its key products include VTAMA, IMVT-1402, Batoclimab, Brepocitinib, Mosliciguat, and Namilumab. While we acknowledge the potential of ROIV as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than ROIV and that has 100x upside potential, check out our report about the . READ NEXT: and . Disclosure: None. 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
07-05-2025
- Business
- Yahoo
argenx SE (ARGX): A Bull Case Theory
We came across a bullish thesis on argenx SE (ARGX) on Substack by FluentInQuality. In this article, we will summarize the bulls' thesis on ARGX. argenx SE (ARGX)'s share was trading at $629.51 as of April 29th. ARGX's trailing and forward P/E were 49.26 and 90.91 respectively according to Yahoo Finance. Is Alzamend Neuro, Inc. (ALZN) the Cheapest Stock Insiders Are Buying In March? A biopharmaceutical facility with technicians working on a manufacturing line of treatments and preventions. argenx SE (ARGX) is emerging as a transformative force in the autoimmune space, not as a traditional biotech chasing one-off blockbuster drugs, but as a platform company methodically scaling a repeatable, high-leverage model. Its core strength lies in a single mechanism—FcRn inhibition—which is being deployed across a range of autoimmune conditions. The flagship therapy, Vyvgart, a first-in-class FcRn blocker, has already been approved for generalized myasthenia gravis (gMG), with promising expansion into chronic inflammatory demyelinating polyneuropathy (CIDP) and trials underway in autoimmune hematology, dermatology, and nephrology. This strategic expansion isn't random—it reflects a deliberate, pipeline-as-platform approach where each successful indication unlocks adjacent markets, accelerating scale and reach. What makes argenx particularly compelling is the chronic nature of the diseases it targets. Autoimmune conditions don't resolve; they require long-term management, translating into durable, recurring revenue. Vyvgart has already crossed €1 billion in annualized revenue, aided by the introduction of a subcutaneous formulation that enhances ease of access and adherence. As global rollout efforts continue across Europe, Japan, and China, and new indications come online, the addressable market keeps expanding. This isn't one-time therapy revenue—it's foundational, high-margin income in largely underserved, fragmented markets. Beyond Vyvgart, argenx is leveraging its FcRn-focused antibody platform to build a deep pipeline, including multiple efgartigimod variants targeting new autoimmune indications, with preclinical efforts also branching into oncology and nephrology. This diversification, grounded in a single, validated biological mechanism, reduces risk with each subsequent success. It's a textbook example of platform biotech, where discovery scale and efficiency create significant long-term optionality—far beyond the narrow view of being a 'single-asset' or 'rare disease' player. Financially, while current R&D investments remain substantial, they are the fuel driving platform expansion. As revenues scale, manufacturing efficiencies and global reach are set to unlock meaningful operating leverage. Argenx is now transitioning from the heavy investment phase to one where margins are expected to expand materially.
Yahoo
01-05-2025
- Health
- Yahoo
FDA approves J&J's Imaavy for generalised myasthenia gravis
Johnson & Johnson's (J&J) human neonatal Fc receptor (FcRn)-blocking monoclonal antibody Imaavy (nipocalimab-aahu) has received US Food and Drug Administration (FDA) approval for treating generalised myasthenia gravis (gMG), a chronic autoantibody condition. The approval comes after the agency's priority review designation, which provides a new treatment alternative for the adult and paediatric population aged 12 and above who are positive for anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibodies. Imaavy's approval is based on data from the pivotal Vivacity-MG3 trial. It demonstrated that the antibody with standard of care (SOC) significantly improved disease control over 24 weeks against placebo plus SOC, as assessed by the Myasthenia Gravis-Activities of Daily Living score. This improvement allowed subjects to regain essential daily functions such as swallowing, speaking, breathing and chewing. Subjects maintained these improvements for up to 20 months of follow-up in the ongoing open-label extension study. The antibody rapidly and sustainably reduces immunoglobulin G (IgG) levels, a root cause of gMG, in both adult and paediatric pivotal trials. In the ongoing Phase II/III Vibrance paediatric trial, it has reported a 69% decrease in total serum IgG over 24 weeks. The safety profile is consistent across the Vivacity-MG3 and the ongoing Vibrance-MG trials, with comparable tolerability observed in both age groups. Regulatory bodies worldwide are reviewing health authority submissions for the approval of the antibody in the treatment of gMG. The antibody is tailored to decrease levels of the circulating IgG antibodies that cause gMG, without affecting other adaptive and innate immune functions. Johnson & Johnson innovative medicine global immunology therapeutic area head David Lee stated: 'This approval is the result of years of scientific commitment, collaboration and determination for our nipocalimab programme, and we're proud to bring this new treatment option to patients living with anti-AChR or anti-MuSK antibody positive gMG.' In March 2025, Johnson & Johnson innovative medicine announced a $55bn investment over the next four years to expand its US footprint. "FDA approves J&J's Imaavy for generalised myasthenia gravis" 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
Yahoo
25-04-2025
- Business
- Yahoo
Leap Therapeutics to Present Preclinical Data of FL-501, a Novel GDF-15 Neutralizing Antibody, at the AACR 2025 Annual Meeting
FL-501 fully restored body composition and reversed key indicators of cachexia in preclinical models Findings confirm GDF-15's role in cachexia and support advancing FL-501 into the clinic CAMBRIDGE, Mass., April 25, 2025 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today announced it will present preclinical data of FL-501 in a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting taking place April 25-30 in Chicago, Illinois. FL-501 is a potential best-in-class monoclonal antibody targeting growth differentiation factor 15 (GDF-15), a cytokine that is implicated in multiple diseases and therapeutic areas, including cancer cachexia. "Cancer cachexia is a devasting and potentially life-threatening condition characterized by significant weight loss, muscle wasting, fatigue, and severely reduced quality of life. It is a major contributor to cancer-related mortality, and unfortunately there are no effective treatment options available to patients," said Jason Baum, PhD, Chief Scientific Officer of Leap. "These data not only demonstrate that FL-501 is a novel and potential best-in-class anti-GDF-15 antibody, but also capable of fully restoring body composition in preclinical models that is comparable or better than other, clinical-stage antibodies. We look forward to progressing the development of FL-501 and bringing the asset into the clinic in 2026." Key Findings: In humanized FcRn mouse studies, FL-501 demonstrated a 2-3-fold longer half-life and 50% reduced clearance compared to its wild-type precursor and ponsegromab In mouse cachexia models using GDF-15-overexpressing colorectal cancer cells, FL-501 fully restored body composition, comparably or better than clinical-stage antibodies visugromab and ponsegromab In a non-small cell lung cancer patient-derived xenograft model, FL-501 effectively countered cisplatin-induced weight loss, restoring body weight, composition, and condition scores These findings confirm GDF-15's role in cachexia and support FL-501's advancement in development Poster Details: Title: FL-501 is a potential best in class GDF-15 inhibitor with extended half-life and potent anti-cachexia activity in preclinical modelsPresenter: Roma Kaul, PhD, Leap TherapeuticsSession Category: Experimental and Molecular TherapeuticsSession Title: New and Emerging Cancer Drug TargetsDate and Time: Tuesday, April 29, 2025, 9:00 a.m. – 12:00 p.m. CTPoster Board Number: 15Published Abstract Number: 4258 About FL-501FL-501 is a potential best-in-class monoclonal antibody in preclinical development that targets growth differentiation factor-15 (GDF-15), a cytokine that is produced at elevated levels in response to various stresses, including chronic inflammation, obesity, cardiovascular diseases, cancers, and chemotherapy treatment. High GDF-15 expression is associated with cancer cachexia including loss of appetite, nausea and weight loss. FL-501 was engineered for higher affinity to GDF-15 and longer plasma half-life compared to competing therapies. In addition to cachexia, FL-501 may be able to reverse immunosuppression in cancers where elevated GDF-15 is correlated with poor survival, as well as play a role in treating other GDF-15-related diseases. FL-501 is being developed through a collaboration agreement with Adimab. About LeapLeap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, sirexatamab (DKN-01), is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. Sirexatamab is being studied in patients with colorectal cancer. Leap's pipeline also includes FL-501, a humanized monoclonal antibody targeting the growth differentiation factor 15 (GDF-15) protein, in preclinical development. For more information about Leap Therapeutics, visit or view our public filings with the SEC that are available via EDGAR at or via FORWARD-LOOKING STATEMENTSThis press release contains forward-looking statements within the meaning of the federal securities laws. Such statements are based upon current plans, estimates and expectations of the management of Leap that are subject to various risks and uncertainties that could cause actual results to differ materially from such statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Words such as "anticipate," "expect," "project," "intend," "believe," "may," "will," "should," "plan," "could," "continue," "target," "contemplate," "estimate," "forecast," "guidance," "predict," "possible," "potential," "pursue," "likely," and words and terms of similar substance used in connection with any discussion of future plans, actions or events identify forward-looking statements. All statements, other than historical facts, including statements regarding the potential safety, efficacy, and regulatory and clinical progress of Leap's product candidates; the anticipated timing for initiation or completion of clinical trials and release of clinical trial data and the expectations surrounding the outcomes thereof; Leap's future clinical or preclinical product development plans for any of Leap's product candidates; Leap's estimations of projected cash runway; and any assumptions underlying any of the foregoing, are forward-looking statements. Important factors that could cause actual results to differ materially from Leap's plans, estimates or expectations could include, but are not limited to: (i) the results of Leap's clinical trials and pre-clinical studies, including the final data from Part B of the DeFianCe study and additional preclinical data for FL-501, (ii) Leap's ability to successfully finance or enter into new strategic partnerships for sirexatamab or FL-501; (iii) any regulatory feedback that Leap may receive from U.S. Food and Drug Administration (FDA) or equivalent foreign regulatory agency with respect to the sirexatamab or FL-501; (v) whether any Leap products will receive approval from the FDA or equivalent foreign regulatory agencies; and (vi) exposure to inflation and interest rate fluctuations, as well as fluctuations in the market price of Leap's traded securities. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Leap may not actually achieve the forecasts disclosed in such forward-looking statements, and you should not place undue reliance on such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk Factors" in Leap's most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in its subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither Leap, nor any of its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing Leap's views as of any date subsequent to the date hereof. CONTACT: Douglas E. OnsiPresident & Chief Executive OfficerLeap Therapeutics, Inc.617-714-0360donsi@ Matthew DeYoungInvestor RelationsArgot Partners212-600-1902leap@ View original content to download multimedia: SOURCE Leap Therapeutics, Inc. Sign in to access your portfolio
Yahoo
21-03-2025
- Business
- Yahoo
Immunovant's batoclimab shows ‘impressive' efficacy in MG, says H.C. Wainwright
Immunovant (IMVT) reported best absolute improvements with IMVT-1402 in myasthenia gravis and chronic inflammatory demyelinating polyneuropathy, and while H.C. Wainwright analyst Douglas Tsao was encouraged to see the impressive absolute improvements in MG-Activities of Daily Living, the firm acknowledges that the placebo-adjusted readout was mid-pack among FcRn inhibitors-better than nipocalimab but below argenx's (ARGX) Vyvgart and UCB's (UCBY) Rystiggo, the analyst tells investors. The company also reported positive initial CIDP results from Period 1 of the study, which showed that following standard of care washout, patients were randomized into 680mg and 340mg batoclimab only, the firm says. The firm has a Buy rating and $51 price target on Immunovant shares, and says the 'more is better' debate has not yet been settled. Easily identify stocks' risks and opportunities. Discover stocks' market position with detailed competitor analyses. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See the top stocks recommended by analysts >> Read More on IMVT: Questions or Comments about the article? Write to editor@ Immunovant Announces Positive Phase 3 Study Results Immunovant announces results from Phase 3 study of batoclimab in MG Roivant says Immunovant announces results from Phase 3 study of batoclimab in MG Immunovant's Phase 3 Trial of Batoclimab: A Catalyst for Future Growth and Market Impact Biohaven price target lowered to $57 from $73 at Bernstein
