Latest news with #Xolair
Business Insider
4 days ago
- Business
- Business Insider
Rapt Therapeutics started at Buy at Clear Street on RPT904b opportunity
Clear Street initiated coverage of Rapt Therapeutics (RAPT) with a Buy rating and $3 price target. The firm's bullish call is driven by a strong conviction in RPT904b – a potentially best-in-class anti-IgE antibody for food allergy and chronic spontaneous urticaria that is comparable to Roche (RHHBY) and Novartis' (NVS) Xolair, the analyst tells investors in a research note. Rapt's 76% stock decline over 12 months relative to XBI's 12% is primarily attributable to an unrelated asset discontinuation and has created a 'significant opportunity', the firm added. Confident Investing Starts Here:
Yahoo
23-05-2025
- Business
- Yahoo
Genentech to onshore US manufacturing amid rising drug pricing tensions
Genentech (San Francisco, CA) has announced an investment exceeding $700m to establish its first East Coast manufacturing facility in Holly Springs, North Carolina. This expansive 700,000ft² facility is set to create over 1,500 construction jobs and more than 400 permanent manufacturing positions, marking a substantial economic boost for the region. The company shared that it might increase the investment based on future US policy and business needs. Currently, the facility is expected to support the metabolic medicines portfolio manufacture of Genentech and its parent company Roche (Basel, Switzerland). The announcement of the manufacturing investment follows a positive Q1 2025 earnings call from Roche on 24 April 2025, where the company reported an 8% increase in sales for the pharmaceuticals division due to strong demand for key blockbusters such as Phesego, Vabysmo, Xolair, Xofluza, and Hemlibra. These five drugs generated a total of $4.3bn in Q1 2025 – an increase from Q1 2024. The development of the North Carolina manufacturing facility aligns with Roche's plans to invest $50bn in pharmaceuticals and diagnostics in the US over the next five years, including new and expanding manufacturing facilities in Indiana, Pennsylvania, Massachusetts, and California, as shared in Roche's Q1 2025 earnings call. Genentech's latest manufacturing expansion is one among the many investments into US-based manufacturing operations to counter international tariffs, national security concerns, rising tensions with China, and other executive orders enacted during the first 100 days of Trump's second term that impact the pharmaceutical industry. As the administration pushes for a return to US manufacturing, outsourcing agreements with domestic manufacturers are increasing. Although the total number of Q1 contract service agreements has decreased year-on-year in the past five years, there has been a 10% increase in the number of US-based contract service agreements in Q1 2025 compared to Q1 2024, according to GlobalData's Deals Database (Figure 1). However, the Trump administration's executive order "Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients', announced on 12 May 2025, prompted Roche to state that its $50bn manufacturing investment could be 'reassessed' due to potential fluctuations in the 'current policy environment'. The executive order, which aims to lower US drug prices by aligning them to the lowest prices paid in other developed nations, has created debate among pharmaceutical companies and stakeholders. Stephen Ubl, PhRMA president, argues that the "most-favored-nation plan" will '[jeopardise] the hundreds of billions [their] member companies are planning to invest in America'. During the Financial Times' US Pharma and Biotech Summit, Calley Means, a key member of HHS Secretary Robert F Kennedy, Jr's team, challenged Roche to retract their investment following the company's response to the 'most-favored-nation plan'. However, Roche reaffirmed that they are not pulling their investment. "[The company] still intend[s] to invest $50bn in pharmaceutical R&D and manufacturing and diagnostics in the US," the Roche representative shared. "Genentech to onshore US manufacturing amid rising drug pricing tensions" 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
Time Magazine
08-05-2025
- Health
- Time Magazine
Robert Wood
Living with severe food allergies clouds every day with fear. When the tiniest smidge of peanuts or wheat could kill you, everything revolves around managing that risk. Dr. Robert Wood has worked to give people with food allergies greater peace of mind: the first medication to help reduce allergic reactions to multiple foods. In February 2024, the U.S. Food and Drug Administration expanded its approval of the asthma drug Xolair to include treatment of food allergies in patients over age 1. Researchers had been studying the drug's effectiveness for this use for more than a decade. 'We've treated food allergy just as it was 100 years ago, which was trying to avoid what you're allergic to, and if you have an accident, then you treat the reaction, which can be very serious,' says Wood, director of allergy, immunology, and rheumatology at Johns Hopkins Children's Center and principal investigator of the study that finally led to Xolair's expanded approval. 'It's been a huge unmet need.' In Wood's research, 67% of people who were highly allergic to peanuts and taking Xolair could tolerate a moderate to large amount of the nuts without having a reaction, and those outcomes were similar for other allergens, like eggs and milk. That means a college student who once had to decline her friends' invites to go out to eat, for example, can now tag along and not obsess over cross-contamination. Wood sees patients in his office celebrating that newfound freedom every day. 'It was a long time coming,' he says.
Yahoo
29-04-2025
- Business
- Yahoo
Novartis Beats on Q1 Earnings and Sales, Raises Guidance, Stock Up
Swiss pharma giant Novartis AG NVS reported better-than-expected results for the first quarter of 2025 and upped its annual guidance. Core earnings (excluding one-time charges) of $2.28 per share easily beat the Zacks Consensus Estimate of $2.12 and were up from $1.80 reported a year ago. The year-over-year improvement was driven by strong growth in sales. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.) Revenues of $13.23 billion climbed 12% from the year-ago reported figure. On a constant currency basis, sales increased 15%, driven by the momentum in Entresto, Kesimpta, Kisqali, Cosentyx, Leqvio and Scemblix. The top line comfortably beat the Zacks Consensus Estimate of $12.9 billion. Shares are up in pre-market trading in response to the strong quarterly results and increased guidance. Shares of Novartis have gained 18.4% year to date compared with the industry's growth of 1.6%. Image Source: Zacks Investment Research All growth rates mentioned below are on a year-over-year basis and at constant exchange rates. With the successful spin-off of the Sandoz business in 2023, Novartis now concentrates on four core therapeutic areas — cardiovascular-renal-metabolic, immunology, neuroscience and oncology. Cardiovascular drug Entresto's sales rose 22% from the year-ago level to $2.26 billion. The increase was driven by robust, demand-led growth globally, including China and Japan, with increased penetration in hypertension. Entresto's sales comfortably beat the Zacks Consensus Estimate of $2.25 billion and our model estimate of $2.2 billion. Cosentyx's sales (psoriasis, spondylitis and arthritis) increased 18% to $1.53 billion, which missed the Zacks Consensus Estimate of $1.57 billion and our model estimate of $1.6 billion. The year-over-year improvement was driven by recent launches, including the hidradenitis suppurativa indication (HS) and the intravenous formulation (IV) in the United States, and volume growth in core indications. Kisqali (breast cancer) maintained its stellar performance, with sales surging 56% to $956 million. Sales grew strongly across all regions, driven by exemplary growth in the United States with strong momentum from the recently launched early breast cancer (eBC) indication as well as continued share gains in the metastatic breast cancer indication. Kisqali sales beat both the Zacks Consensus Estimate and our model estimate of $936 million. Kesimpta (multiple sclerosis) sales totaled $899 million, which rose 43% on increased demand. The figure beat the Zacks Consensus Estimate of $872 million and our model estimate of $875 million. Strong performances by Tafinlar + Mekinist (up 19% to $552 million) and Jakavi (up 7% to $492 million) also boosted the top line. Promacta sales totaled $546 million, up 8%. Xolair (asthma and allergies) sales grew 19% year over year to $456 million, driven by the chronic spontaneous urticaria indication, with a strong contribution from emerging growth markets. Novartis has a collaboration agreement with Roche RHHBY for Xolair. Novartis and Roche co-promote Xolair in the United States. Ilaris sales amounted to $419 million, which increased 20% year over year, driven by growth in all regions led by the United States and Europe. Tasigna sales declined 2% to $377 million due to lower demand and increasing competition. Pluvicto (prostate cancer) raked in sales of $371 million, up 21% on solid growth in the United States and Europe in the metastatic castration-resistant prostate cancer (mCRPC) post-taxane setting. The FDA's approval for earlier use of the drug before chemotherapy will approximately triple the eligible patient population. Sales missed the Zacks Consensus Estimate of $381 million and our estimate of $385.7 million. Gene-therapy Zolgensma (spinal muscular atrophy) sales of $327 million were up 13%. Cholesterol drug Leqvio sales soared 72% to $257 million on steady growth in demand. The figure beat the Zacks Consensus Estimate of $243 million and our estimate of $244 million. Scemblix sales surged 76% to $238 million, driven by continued growth in chronic myeloid leukemia indication and strong momentum from the recently launched early-line indication in the United States. Luthathera (cancer) sales totaled $193 million, up 15%. Sales grew mainly in the United States, Europe and Japan due to increased demand and earlier line adoption, particularly in the United States and Japan. Sales of Lucentis plunged 38% to $189 million due to generic competition. Fabhalta generated sales of $81 million, driven by continued launch execution across all markets in PNH and the recent launch in IgAN in the United States. Net sales are now expected to grow in high single digits (previous guidance: mid to high single digits). Core operating income is now expected to grow in low double-digits (previous guidance: high single to low double digits). The FDA expanded Pluvicto's label to include patients with PSMA-positive mCRPC who have been treated with an androgen receptor pathway inhibitor and are considered appropriate to delay chemotherapy, approximately tripling the eligible patient population. The regulatory body also granted accelerated approval for Vanrafia (atrasentan) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. Fabhalta was approved by the FDA, European Commission and China's regulatory body for adult patients with C3 glomerulopathy (C3G), making it the first and only treatment approved for this condition in all three markets. Novartis' performance in the first quarter was impressive, with both earnings and sales beating estimates. Consequently, management raised its guidance for 2025, driven by strong growth of priority drugs, such as Leqvio, Kisqali and Kesimpta, during the first quarter. Novartis AG price-consensus-eps-surprise-chart | Novartis AG Quote Novartis' performance has been pretty good in the past few quarters, buoyed by the solid performance of its priority brands. An increase in guidance implies that this momentum will be sustained in the upcoming quarters. The pipeline progress is also encouraging. The label expansion of Pluvicto and Fabhalta should further fuel sales of these drugs. Approval of new drugs and label expansion of existing drugs should enable the company to offset the adverse impacts from expected generic competition for Tasigna, Promacta and Entresto (mid-2025). While organic growth continues to drive business, NVS is focused on strategic bolt-in acquisitions to strengthen its pipeline. The company acquired Anthos Therapeutics, a clinical-stage biopharmaceutical company, to broaden its cardiovascular portfolio. The acquisition added abelacimab, a potential first-in-class monoclonal antibody targeting the FXI inhibition pathway in development for the prevention of stroke and systemic embolism in patients with atrial fibrillation. Earlier, Novartis entered into a global license and collaboration agreement with PTC Therapeutics for the latter's Huntington's disease candidate to strengthen NVS' neuroscience pipeline. Meanwhile, NVS recently announced a planned $23 billion investment over five years in U.S.-based infrastructure as it intends to manufacture all key drugs in the country. NVS' decision to expand its current manufacturing, research and technology presence across the country follows President Trump's announcement of tariffs on pharmaceutical imports. Novartis currently carries a Zacks Rank #3 (Hold). A couple of better-ranked large-cap pharmaceutical stocks are Bayer BAYRY and Pfizer PFE, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. In the past 60 days, estimates for Bayer's 2025 earnings per share (EPS) have increased to $1.19 from $1.14. During the same time, EPS estimate for 2026 has increased to $1.28 from $1.123. Year to date, shares of Bayer have surged 34.6%. Estimates for Pfizer's 2025 EPS have risen from $2.96 to $2.99 over the past 60 days. Estimates for 2026 EPS have risen from $2.99 to $3.02 over the same timeframe. Pfizer beat on earnings in each of the trailing four quarters, delivering an average surprise of 4.16%. 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 Novartis AG (NVS) : Free Stock Analysis Report Roche Holding AG (RHHBY) : Free Stock Analysis Report Pfizer Inc. (PFE) : Free Stock Analysis Report Bayer Aktiengesellschaft (BAYRY) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
Yahoo
24-04-2025
- Business
- Yahoo
US drug firm Merck says existing Trump tariffs will cost it $200m this year
The US pharmaceutical company Merck has said it expects to pay an extra $200m (£150m) in costs this year from tariffs that Donald Trump has already imposed, including his 10% tax on imports from around the world. Merck said the projected costs also included retaliatory tariffs imposed by foreign governments on the US, particularly those related to China. However, the projections do not account for threatened 'major' tariffs that could be imposed just on pharmaceutical imports. The Trump administration opened a 21-day national security investigation into the industry earlier this month, seen as a first step to the imposition of levies in the coming weeks. Related: US begins inquiry into pharmaceutical and chip imports in bid to impose tariffs The US president has promised to repatriate jobs and taxes he believes the pharma companies are dodging by manufacturing drugs consumed in the US elsewhere in the world including Ireland, where Merck has a base, which he has singled out for criticism. The Swiss company Roche said on Thursday it was petitioning Washington directly for exemption from tariffs, arguing it shipped as much to the US as it exported from its manufacturing bases in the US. Earlier this week it signalled a further commitment to the US, announcing plans to invest $50bn there. In an earnings call on Thursday, Roche's chief executive, Thomas Schinecker, said the company was going through volatile times but was well positioned. He said four of its medicines accounted for 92% of Roche's 'potential tariff exposure' and that production of three of them had already been moved to the US. Declining to name the drugs, he added that the company had begun the lengthy and highly regulated procedures for setting up US production sites. Schinecker said indiscriminate tariffs did not take into account the sizeable manufacturing base Roche already had in the US and the complexity of the drugs it manufactured. 'For diagnostics, when you have 10,000 products, you cannot produce 10,000 products in every country.' He said the company's drug exports from its US plants were a key industry that was vulnerable to being hit by retaliatory tariffs. Switzerland could face 31% US tariffs, which Trump put on hold for 90 days earlier this month along with sweeping tariffs on almost all goods from dozens of other countries. Pharmaceuticals are rated at a zero tariff around the world under a 1995 World Trade Organization agreement aimed at making medicines more accessible. Schinecker said Roche was in touch with various levels of Trump's administration, arguing that a US drive for all goods used in the country to be produced there would inflate manufacturing costs. On Thursday, the company confirmed its full-year financial guidance and reported a forecast-beating 7% rise in first-quarter sales, driven by the breast cancer drug Phesgo, the eye drug Vabysmo and the allergy treatment Xolair. Trump earlier this month reiterated plans for a 'major' tariff on pharmaceutical imports, threatening an interwoven global supply chain and weighing on shares across the drug industry. Sign in to access your portfolio
