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Globe and Mail
2 days ago
- Business
- Globe and Mail
BMY Focuses on Label Expansion of Drugs: Will This Revive Growth?
BMY is focused on developing drugs with presence in oncology, hematology, immunology, cardiovascular, neuroscience and other therapeutic areas. BMY depends on label expansion of approved drugs and approval of new drugs to stabilize its revenue base as its legacy drugs (Revlimid, Pomalyst, Sprycel and Abraxane) face generic competition. The company recently announced that the late-stage study on Sotyktu (deucravacitinib), an oral, selective tyrosine kinase 2 (TYK2) inhibitor, in adults with active psoriatic arthritis met its primary endpoint. The drug is already approved in numerous countries around the world for the treatment of adults with moderate-to-severe plaque psoriasis. BMY is also evaluating Sotyktu in late-stage studies for the treatment of Sjögren's syndrome and systemic lupus erythematosus. However, Sotyktu faces stiff competition from Amgen 's AMGN Otezla in the psoriasis space. Notably, Amgen acquired global commercial rights to Otezla from erstwhile Celgene (now part of Bristol-Myers). Amgen is also evaluating Otezla in additional indications. Last month, the European Commission ('EC') approved the subcutaneous formulation of Opdivo (nivolumab) across multiple solid tumor indications. The EC had earlier approved a perioperative regimen of neoadjuvant Opdivo and chemotherapy followed by adjuvant Opdivo for resectable, high-risk non-small cell lung cancer with PD-L1 Expression ≥1%. Opdivo is a key drug in BMY's Growth Portfolio. The FDA had earlier approved Opdivo plus Yervoy as a first-line treatment for adult patients with unresectable or metastatic hepatocellular carcinoma. While the label expansion of Opdivo is positive, the immuno-oncology space is dominated by pharma giant Merck 's MRK blockbuster drug Keytruda (pembrolizumab). Keytruda is approved for several types of cancer and alone accounts for around 50% of its MRK's pharmaceutical sales. Merck is currently working on different strategies to drive long-term growth of Keytruda. BMY's Price Performance, Valuation and Estimates Shares of Bristol Myers have lost 8.4% year to date against the industry 's growth of 1.2%. Image Source: Zacks Investment Research From a valuation standpoint, BMY is trading at a discount to the large-cap pharma industry. Going by the price/earnings ratio, BMY's shares currently trade at 7.80x forward earnings, lower than its mean of 8.55x and the large-cap pharma industry's 15.71X. The Zacks Consensus Estimate for 2025 earnings per share has moved up to $6.85 from $6.78 in the past 60 days, while that for 2026 has moved south. BMY currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. 7 Best Stocks for the Next 30 Days Just released: Experts distill 7 elite stocks from the current list of 220 Zacks Rank #1 Strong Buys. They deem these tickers "Most Likely for Early Price Pops." Since 1988, the full list has beaten the market more than 2X over with an average gain of +23.5% per year. So be sure to give these hand picked 7 your immediate attention. See them now >> 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 Bristol Myers Squibb Company (BMY): Free Stock Analysis Report Merck & Co., Inc. (MRK): Free Stock Analysis Report Amgen Inc. (AMGN): Free Stock Analysis Report This article originally published on Zacks Investment Research (
Yahoo
06-06-2025
- Business
- Yahoo
Nkarta Appoints Shawn Rose Chief Medical Officer & Head of R&D as Company Resets Senior Leadership Role for Autoimmune Focus
SOUTH SAN FRANCISCO, Calif., June 06, 2025 (GLOBE NEWSWIRE) -- Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat autoimmune disease, today announced the appointment of Shawn Rose, M.D. Ph.D., as its next Chief Medical Officer (CMO) and Head of Research and Development (R&D) starting on June 23, 2025. He replaces David R. Shook, M.D., who will be stepping down from the role to pursue other opportunities in the oncology space. Dr. Rose has dedicated his career to immunology translational medicine and advancing new treatment options for autoimmune patients. In various leadership roles, he has brought forward more than a dozen programs from discovery into clinical development, and he has developed multiple pioneering approved medicines such as Sotyktu, Stelara, and Tremfya. 'Dr. Rose joins the Nkarta team at a critical threshold as we discover the power of our NK cell platform to treat autoimmune diseases,' said Paul J. Hastings, CEO of Nkarta. 'He is an enterprise leader with a deep clinical background in rheumatology and immunology that's ideally suited to maximize the potential of our allogeneic NK cell platform. Shawn's proven track record as an expert clinician gives me full confidence that he will hit the ground running on day one and meaningfully advance our work in the clinic.' Dr. Rose most recently served as Chief Development Officer, Immunology, at Vividion Therapeutics, working to expand their portfolio by advancing previously undruggable targets in immunology. He also served as interim CMO and Head of Clinical Development at Magenta Therapeutics, working on cell-based therapeutic approaches for patients with cancer, genetic disorders and immune-mediated inflammatory diseases. Dr. Rose also held multiple clinical and development leadership roles at Annexon Biosciences, Janssen Pharmaceuticals, and Bristol-Myers Squibb. He did his postdoctoral research training and clinical training in Internal Medicine and Rheumatology at the Northwestern University Feinberg School of Medicine. 'I am thrilled to join Nkarta to advance innovative cell therapies for patients,' said Dr. Rose. 'I strongly believe that Nkarta's allogeneic NK cell platform has the potential to be a transformational approach for patients with immune-mediated inflammatory disease. I look forward to working closely with Paul and the broader Nkarta team on developing more treatment options for patients.' During the transition, Dr. Rose will work with Dr. Shook, who will remain on as a consultant through July 11. 'Dave was an early pioneer of NK cell therapy while working under Nkarta's scientific founder, Dario Campana, at St. Jude Children's Research Hospital, and he has tirelessly pursued options that were more convenient for patients with safety utmost in mind,' Hastings said. 'Dave has devoted much of his career to make important contributions to the advancement of natural killer cell therapy, leading our early clinical work in cancer and overseeing key aspects of our strategic shift into a new disease area with agility and flexibility. But Dave is a dedicated oncologist, and he has decided to return to the field he loves. He is a fearless advocate for patients and their well-being and a very good friend who will be missed.' About NKX019NKX019 is an allogeneic, cryopreserved, off-the-shelf immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed chimeric antigen receptor (CAR) for enhanced cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal B cells as well as those implicated in autoimmune disease and B cell-derived malignancies. Nkarta is evaluating NKX019 in multiple autoimmune conditions. About NkartaNkarta is a clinical-stage biotechnology company advancing the development of allogeneic, off-the-shelf natural killer (NK) cell therapies for autoimmune diseases. By combining its cell expansion and cryopreservation platform with proprietary cell engineering technologies, Nkarta is building a pipeline of future cell therapies engineered for deep therapeutic activity and intended for broad access in the outpatient treatment setting. For more information, please visit the company's website at Cautionary Note on Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," 'plans,' 'potential,' "projects,' 'would' and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include, but are not limited to, statements concerning Nkarta's expectations regarding any or all of the following: Nkarta's position, plans, strategies, and timelines for the continued and future clinical development and commercial potential of NKX019 (including the future availability and disclosure of clinical data and other updates from Nkarta's clinical trials). Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Nkarta's limited operating history and historical losses; Nkarta's lack of any products approved for sale and its ability to achieve profitability; the risk that the results of preclinical studies and early-stage clinical trials may not be predictive of future results; Nkarta's ability to raise additional funding to complete the development and any commercialization of its product candidates; Nkarta's dependence on the clinical success of NKX019; that Nkarta may be delayed in initiating, enrolling patients in or completing its clinical trials; competition from third parties that are developing products for similar uses; Nkarta's ability to obtain, maintain and protect its intellectual property; Nkarta's dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; the complexity of the manufacturing process for CAR NK cell therapies; and the success of Nkarta's recent (and any future) cost containment measures. These and other risks and uncertainties are described more fully in Nkarta's filings with the Securities and Exchange Commission ('SEC'), including the 'Risk Factors' section of Nkarta's Annual Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 14, 2025, and Nkarta's other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Nkarta undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Nkarta Media/Investor Contact:Nadir MahmoodNkarta, 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
Associated Press
14-04-2025
- Business
- Associated Press
Johnson & Johnson's Oral IL-23, Icotrokinra, Poised to Redefine the Psoriasis Treatment Landscape Following Positive Phase 3 Data, According to Spherix Global Insights
EXTON, PA, April 14, 2025 (GLOBE NEWSWIRE) -- Johnson & Johnson's recent announcement of positive Phase 3 data for its oral IL-23 receptor antagonist, icotrokinra (JNJ-2113), has sparked notable enthusiasm across the dermatology community. According to the company's recent release, the once-daily oral therapy met all primary and secondary endpoints across both the FRONTIER 1 and FRONTIER 2 studies in moderate-to-severe plaque psoriasis, achieving 65% PASI 90 response and 74% IGA 0/1 at Week 24 with its higher dose regimen. These efficacy outcomes and a favorable safety profile suggest that icotrokinra may become the first oral IL-23 pathway inhibitor to reshape the current psoriasis treatment algorithm. Data from Spherix Global Insights' RealTime Dynamix™: Plaque Psoriasis (US) Q1 2025 report confirms heightened interest in icotrokinra among dermatologists (n=103), with many already envisioning its role as a first-line systemic treatment. While unaided awareness of the Phase 3 results was modest, prompted exposure to the data led to a significant uptick in prescriber enthusiasm. In fact, dermatologists rated icotrokinra as the top pipeline agent by a considerable margin, and they would like to see it approved, with interest and likelihood to prescribe scores surpassing all other late-stage psoriasis assets. Notably, over half of dermatologists reported that icotrokinra would be used as a first-line advanced systemic treatment. At the same time, most agree that its availability would expand the pool of psoriasis patients on advanced treatments—a strong indicator that icotrokinra may help bridge the gap between topical and biologic therapies. Importantly, a sizable portion of patients currently treated with oral small molecules (i.e., Otezla or Sotyktu) who are not considered well-managed may be switched to icotrokinra upon availability, underscoring its potential to disrupt the existing oral systemic market. Dermatologists cited its oral convenience, high response rates, and mechanistic familiarity with successful IL-23 biologics like Skyrizi and Tremfya as primary drivers of interest. Data from Spherix's Special Topix™: The Oral Opportunity in Plaque Psoriasis, 2024 study indicate that the availability of efficacious and safe oral agents is the top unmet need for treating psoriasis. Moreover, most dermatologists believe that oral treatment can be just as efficacious as injectable treatment. Despite the positive momentum, some prescribers remain cautiously optimistic, pointing to the need for real-world data and long-term safety monitoring before making widespread practice changes. However, with robust Phase 3 results and clear differentiation from existing oral therapies, icotrokinra is poised to be a game-changer in moderate-to-severe plaque psoriasis. As J&J advances icotrokinra toward regulatory submission, ongoing dermatologist perception tracking will be critical in determining its commercial potential and ultimate impact on the psoriasis landscape. Spherix continues to monitor the PsO market with these insights and more available via its quarterly RealTime Dynamix™ service, and will continuously evaluate the oral opportunities in psoriasis via the Special Topix™ service. RealTime Dynamix™ is an independent service providing strategic guidance through quarterly or semiannual reports, which include market trending and a fresh infusion of event-driven and variable content with each wave. The reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of experts. Special Topix™ is an independent service that includes access to a report or series of reports based on current events or topics of interest in specialty markets covered by Spherix. About Spherix Global Insights Spherix is a leading independent market intelligence and advisory firm that delivers commercial value to the global life sciences industry, across the brand lifecycle. The seasoned team of Spherix experts provides an unbiased and holistic view of the landscape within rapidly evolving specialty markets, including dermatology, gastroenterology, rheumatology, nephrology, neurology, ophthalmology, and hematology. Spherix clients stay ahead of the curve with the perspective of the extensive Spherix Physician Community. As a trusted advisor and industry thought leader, Spherix's unparalleled market insights and advisory services empower clients to make better decisions and unlock opportunities for growth. To learn more about Spherix Global Insights, visit or connect through LinkedIn. For more details on Spherix's primary market research reports and interactive dashboard offerings, visit or register here: NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and opinions expressed within are based on Spherix Global Insight's analysis and do not imply a relationship with or endorsement of the companies or brands mentioned in this press release. Andy Stankus, Dermatology Franchise Head Spherix Global Insights 4848794284 [email protected]
Yahoo
14-04-2025
- Business
- Yahoo
Johnson & Johnson's Oral IL-23, Icotrokinra, Poised to Redefine the Psoriasis Treatment Landscape Following Positive Phase 3 Data, According to Spherix Global Insights
Perceived first-line utility, patient pool expansion, and paradigm-shifting potential distinguish Icotrokinra in the eyes of US dermatologists EXTON, PA, April 14, 2025 (GLOBE NEWSWIRE) -- Johnson & Johnson's recent announcement of positive Phase 3 data for its oral IL-23 receptor antagonist, icotrokinra (JNJ-2113), has sparked notable enthusiasm across the dermatology community. According to the company's recent release, the once-daily oral therapy met all primary and secondary endpoints across both the FRONTIER 1 and FRONTIER 2 studies in moderate-to-severe plaque psoriasis, achieving 65% PASI 90 response and 74% IGA 0/1 at Week 24 with its higher dose regimen. These efficacy outcomes and a favorable safety profile suggest that icotrokinra may become the first oral IL-23 pathway inhibitor to reshape the current psoriasis treatment algorithm. Data from Spherix Global Insights' RealTime Dynamix™: Plaque Psoriasis (US) Q1 2025 report confirms heightened interest in icotrokinra among dermatologists (n=103), with many already envisioning its role as a first-line systemic treatment. While unaided awareness of the Phase 3 results was modest, prompted exposure to the data led to a significant uptick in prescriber enthusiasm. In fact, dermatologists rated icotrokinra as the top pipeline agent by a considerable margin, and they would like to see it approved, with interest and likelihood to prescribe scores surpassing all other late-stage psoriasis assets. Notably, over half of dermatologists reported that icotrokinra would be used as a first-line advanced systemic treatment. At the same time, most agree that its availability would expand the pool of psoriasis patients on advanced treatments—a strong indicator that icotrokinra may help bridge the gap between topical and biologic therapies. Importantly, a sizable portion of patients currently treated with oral small molecules (i.e., Otezla or Sotyktu) who are not considered well-managed may be switched to icotrokinra upon availability, underscoring its potential to disrupt the existing oral systemic market. Dermatologists cited its oral convenience, high response rates, and mechanistic familiarity with successful IL-23 biologics like Skyrizi and Tremfya as primary drivers of interest. Data from Spherix's Special Topix™: The Oral Opportunity in Plaque Psoriasis, 2024 study indicate that the availability of efficacious and safe oral agents is the top unmet need for treating psoriasis. Moreover, most dermatologists believe that oral treatment can be just as efficacious as injectable treatment. Despite the positive momentum, some prescribers remain cautiously optimistic, pointing to the need for real-world data and long-term safety monitoring before making widespread practice changes. However, with robust Phase 3 results and clear differentiation from existing oral therapies, icotrokinra is poised to be a game-changer in moderate-to-severe plaque psoriasis. As J&J advances icotrokinra toward regulatory submission, ongoing dermatologist perception tracking will be critical in determining its commercial potential and ultimate impact on the psoriasis landscape. Spherix continues to monitor the PsO market with these insights and more available via its quarterly RealTime Dynamix™ service, and will continuously evaluate the oral opportunities in psoriasis via the Special Topix™ service. RealTime Dynamix™ is an independent service providing strategic guidance through quarterly or semiannual reports, which include market trending and a fresh infusion of event-driven and variable content with each wave. The reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of experts. is an independent service that includes access to a report or series of reports based on current events or topics of interest in specialty markets covered by Spherix. About Spherix Global Insights Spherix is a leading independent market intelligence and advisory firm that delivers commercial value to the global life sciences industry, across the brand lifecycle. The seasoned team of Spherix experts provides an unbiased and holistic view of the landscape within rapidly evolving specialty markets, including dermatology, gastroenterology, rheumatology, nephrology, neurology, ophthalmology, and hematology. Spherix clients stay ahead of the curve with the perspective of the extensive Spherix Physician Community. As a trusted advisor and industry thought leader, Spherix's unparalleled market insights and advisory services empower clients to make better decisions and unlock opportunities for growth. To learn more about Spherix Global Insights, visit or connect through LinkedIn. For more details on Spherix's primary market research reports and interactive dashboard offerings, visit or register here: NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and opinions expressed within are based on Spherix Global Insight's analysis and do not imply a relationship with or endorsement of the companies or brands mentioned in this press release. CONTACT: Andy Stankus, Dermatology Franchise Head Spherix Global Insights 4848794284 in to access your portfolio
Yahoo
28-03-2025
- Business
- Yahoo
Bristol-Myers Squibb (NYSE:BMY) Sees Rising Interest in Sotyktu Despite 3% Share Price Dip
Bristol-Myers Squibb recently announced positive topline results from its Phase 3 trials for Sotyktu, generating increased interest from rheumatologists despite some skepticism on efficacy metrics. This announcement, along with the European Commission's approval of Breyanzi for non-Hodgkin lymphoma treatment and Opdivo's approval for liver cancer treatment, could have influenced investor sentiment, contributing to a 2.12% price increase for the company over the last quarter. These developments contrast with broader market trends, as major indices experienced downturns amidst inflation concerns and weak consumer sentiment. This suggests BMY's performance was buoyant relative to a challenging market scenario. We've identified 2 risks with Bristol-Myers Squibb and understanding the impact should be part of your investment process. Diversify your portfolio with solid dividend payers offering reliable income streams to weather potential market turbulence. Over the last five years, Bristol-Myers Squibb delivered a total shareholder return of 26.73%, encompassing both share price appreciation and dividends. This period has been characterized by a series of impactful events, underscoring the company's resilience and adaptability in the healthcare industry. In March 2025, the relaunch into neuroscience with Cobenfy offered promise for diversifying the revenue stream, especially within Alzheimer's and bipolar disorder treatments. At the same time, full-year 2024 results reported US$48.30 billion in revenue and a net loss of US$8.95 billion, reflecting challenges in the company's financial health despite continued product approvals and portfolio enhancements. While navigating an unprofitable phase, Bristol-Myers Squibb has succeeded in surpassing the US Pharmaceuticals industry's 1-year return of 3.6%, indicating relative strength. Critical drug approvals like Breyanzi in Europe and collaborations such as the one with BioArctic for the PyroGlu-Aβ antibody program have enriched its clinical pipeline. Continuous dividend payouts have also contributed to maintaining investor confidence, as evidenced by the corporate actions on dividends. These efforts have positioned Bristol-Myers Squibb favorably in a competitive landscape, complemented by strategic operational modifications aimed at enhancing profitability. Examine Bristol-Myers Squibb's past performance report to understand how it has performed in prior years. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NYSE:BMY. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Sign in to access your portfolio
