Latest news with #Gubra
Yahoo
12-03-2025
- Business
- Yahoo
Roche signs $5.3 billion deal with Danish obesity drugmaker, Novo stock slides 4%
Roche (RHHBY) is increasing its investment into the obesity space with an up to $5.3 billion deal with Danish drugmaker Zealand Pharma (ZLDPF), the companies announced Wednesday. The deal would give Zealand a partner to co-develop petrelintide, an amylin therapy, as a new anti-obesity drug. The drug is currently in Phase 2 trials. Amylin therapies are considered the next generation of obesity medication from the current GLP-1 products sold by Danish drug giant Novo Nordisk (NVO) and Eli Lilly (LLY). Novo's stock slid earlier this week on news that CargriSema, its combination therapy using the GLP-1 semaglutide and the amylin cagrilintide, didn't have a significantly higher weight-loss result than the current market products. The deal with Zealand includes a standalone treatment as well as exploring a combination product with Roche's GLP-1 candidate, which is still in its clinical phase. Roche is paying Zealand $1.65 billion upfront and $1.4 billion after the deal closes. The remainder will be paid out over the next few years. The news sent Roche's stock up more than 4% in trading Wednesday, and Zealand's stock skyrocketed 40% on the news. Meanwhile, Novo Nordisk's stock was hit, sliding 4%, and Eli Lilly's stock was down just under 1%. The impact to Novo's stock is largely due to the CagriSema news earlier this week, along with the increased competition in the amylin space. Lilly, meanwhile, is focused on changing the game with a weight-loss pill, so its stock was less affected. Mizuho Securities healthcare sector expert Jared Holz noted that Novo will need to take "proactive [measures] to get ahead of various pricing dynamics — both in terms of the IRA and patent expiry. Needs an oral option no doubt — that will likely remain the focus for investors over the next couple of quarters." JPM analyst Hardik Parikh wrote in a note to clients Wednesday that the deal adds to Roche's efforts in the obesity space and that the next-gen amylin space is likely to heat up. "Roche had already acquired Carmot in early 2024 for $3 billion and we could see other pharma companies taking multiple shots on goal in this space with multiple MOAs. And as evidenced by ABBV's [AbbVie's] partnership with Gubra (also an amylin analog) earlier this month, we see a broad group of companies interested including those who don't historically have a major foot print in the cardiometabolic space," Parikh wrote. Investors are waiting to see how Zealand's products compete in the obesity drug space, which has seen as much as 24% weight loss — a bar set by Lilly's products — become the norm. Jefferies analysts wrote in a note Wednesday that Zealand's drug is already proving more potent than Novo's in smaller doses, but only late-stage trials will provide clarity on effectiveness and side effects and give investors a chance to better compare the products. Anjalee Khemlani is the senior health reporter at Yahoo Finance, covering all things pharma, insurance, care services, digital health, PBMs, and health policy and politics. That includes GLP-1s, of course. Follow Anjalee on social media platforms X, LinkedIn, and Bluesky @AnjKhem. Click here for in-depth analysis of the latest health industry news and events impacting stock prices Sign in to access your portfolio
Yahoo
07-03-2025
- Business
- Yahoo
Pharma Stock Roundup: BAYRY's Q4 Results, ABBV's Obesity Deal & More
This week, Bayer BAYRY announced its fourth-quarter and full-year 2024 results. AbbVie ABBV announced a licensing deal with Danish firm Gubra for an amylin-targeting obesity treatment, which marked the company's entry into the obesity space. Novo Nordisk NVO announced that it is cutting the price of its popular obesity injection, Wegovy, for the uninsured following a similar move by rival Eli Lilly. J&J JNJ discontinued a phase III study on a candidate being evaluated as an adjunctive treatment for major depressive disorder (aMDD). The FDA accepted Roche's RHHBY application seeking expanded use of its lymphoma drug, Gazyva/Gazyvaro, for the treatment of lupus nephritis. Here's a recap of the week's most important stories. Novo Nordisk is launching a new direct-to-patient online pharmacy called NovoCare, which will offer Wegovy at a discounted price of $499 per month, less than half of its listed price. This offer is for patients who do not have insurance coverage and pay by cash as well as those with insurance but have no coverage for obesity medicines. The website provides an option for these patients to have their injections delivered to their homes. Novo Nordisk's announcement follows a similar move by rival Eli Lilly. Last week, Lilly also announced that it is reducing the prices of its 7.5 mg and 10 mg single-dose vials of obesity treatment Zepbound to $499 per month for customers paying through a new self-pay program called LillyDirect Self-Pay Pharmacy Solutions. Bayer's fourth-quarter core earnings of €1.05 per share declined 43.2% year over year. Sales of €11.7 billion rose 0.1% on a currency and portfolio-adjusted basis. Sales in the Crop Science segment decreased 2.3%. Pharmaceuticals segment sales increased 2.4%, while Consumer Health sales declined 0.9% on a currency and portfolio-adjusted basis. In the Pharmaceuticals segment, sales of new products, cancer drug Nubeqa and kidney drug, Kerendia, remained strong, offsetting the loss of exclusivity impact on sales of oral anticoagulant Xarelto. The pace of growth in the Consumer Health business has slowed down. The Crop Science business was adversely impacted by lower prices in the crop protection business due to competitive pricing pressure. Bayer issued a financial guidance for 2025. The company expects 2025 to be a 'pivotal year' and the most difficult in terms of financial performance. Sales are expected to be in the range of €45-€47 billion in 2025. Core EPS is projected to be in the band of €4.50-€5.00. Bayer expects its performance to improve from 2026. AbbVie in-licensed rights to develop a phase I candidate, GUB014295, a long-acting amylin analog for the treatment of obesity from Danish biotech, Gubra. AbbVie will lead the development of the candidate. For the deal, which marks AbbVie's entry into the obesity space, it will make an upfront payment of $350 million to Gubra. It will also pay milestone payments of up to $1.875 billion to Gubra. The FDA accepted a supplemental biologics license application (sBLA) seeking approval for Roche's Gazyva/Gazyvaro for the treatment of lupus nephritis. The sBLA was based on based on data from the phase III REGENCY study. The FDA's decision on the sBLA is expected by October 2024. A similar application is also under review in the EU. Gazyva/Gazyvaro is presently approved for treating various types of lymphoma. J&J announced the discontinuation of the phase III VENTURA program on pipeline candidate, aticaprant, for aMDD. The decision to end the program was based on the lack of sufficient efficacy observed in the target patient population. Data from the study showed that aticaprant was safe and well tolerated. J&J, Novo Nordisk, Roche, AbbVie and Bayer carry a Zacks Rank #3 (Hold) each. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. The NYSE ARCA Pharmaceutical Index has risen 2% in the past five trading sessions. Large Cap Pharmaceuticals Industry 5YR % Return Here's how the eight major stocks performed in the previous five trading sessions. Image Source: Zacks Investment Research In the last five trading sessions, Merck rose the most (3.8%), while Novo Nordisk declined the most (1.3%). In the past six months, AbbVie rose the most (7.3%), while Novo Nordisk declined the most (33.3%). (See the last pharma stock roundup here: LLY Ups U.S. Manufacturing Investments & More) Watch this space for regular pipeline and regulatory updates next week. 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 Roche Holding AG (RHHBY) : Free Stock Analysis Report Johnson & Johnson (JNJ) : Free Stock Analysis Report Novo Nordisk A/S (NVO) : Free Stock Analysis Report Bayer Aktiengesellschaft (BAYRY) : Free Stock Analysis Report AbbVie Inc. (ABBV) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
Yahoo
05-03-2025
- Business
- Yahoo
Here's How to Play AbbVie Stock as it Enters the Obesity Space
Earlier this week, AbbVie ABBV announced that it is in-licensing rights to develop phase I candidate, GUB014295, a long-acting amylin analog for the treatment of obesity, from Danish research company, Gubra. While the obesity field is greatly dominated by GLP-1 products, the amylin hormone is gaining steam as a potential target for treating obesity. It regulates appetite by slowing down stomach emptying, which makes a person feel full and helps prevent overeating. AbbVie will lead the development of the candidate. For the deal, AbbVie will pay Gubra an upfront payment of $350 million and be entitled to make milestone payments of up to $1.875 billion to the latter. The obesity market has gained tremendous popularity and is expected to reach $100 billion by 2030, per a Goldman Sachs report. Eli Lilly LLY and Novo Nordisk NVO currently dominate the space with their respective GLP-1 drugs Zepbound and Wegovy. However, several large drugmakers like Merck MRK, Pfizer, Amgen, and AstraZeneca, among others, are trying to get a share of the obesity space either by developing candidates in-house or buying rights to obesity candidates through licensing deals with smaller biotechs. The deal marks AbbVie's entry into the obesity space. Long-term investors, however, are not focused on one-off news like these. They focus on the company's fundamentals to understand how to play the stock. AbbVie lost patent protection for Humira in the United States in January 2023 and in the EU in 2018. Humira's sales are declining due to the loss of exclusivity and biosimilar erosion. However, AbbVie has successfully navigated Humira's loss of exclusivity by launching two other successful new immunology medicines, Skyrizi and Rinvoq, which are performing extremely well. Skyrizi and Rinvoq generated combined sales of $17.7 billion in 2024. The drugs are seeing strong performance across all their approved indications, especially in the popular inflammatory bowel disease (IBD) space, which includes two conditions — ulcerative colitis (UC) and Crohn's disease (CD). Importantly, Skyrizi and Rinvoq have demonstrated compelling head-to-head data against several novel therapies in clinical studies, which have given them a competitive advantage. AbbVie expects to record combined Skyrizi and Rinvoq sales of more than $31 billion in 2027. Strong immunology market growth, market share gains and momentum from new indications, such as the recent launch of Skyrizi in UC, as well as the potential for five new indications for Rinvoq over the next few years, are expected to drive these drugs' growth. AbbVie has several early/mid-stage pipeline candidates with blockbuster potential. The company expects several regulatory submissions, approvals and key data readouts in the next 12 months. ABBV also has an exciting and diverse pipeline of promising new therapies in blood cancers and solid tumors like ABBV-383, a BCMA CD3 bispecific (relapsed/refractory multiple myeloma) and Temab-A (metastatic colorectal cancer). Teliso-V, a promising c-Met ADC, is under review in the United States for nonsquamous non-small cell lung cancer, with an approval decision expected in the first half of 2025. In November, AbbVie gained approval for Vyalev, a transformative therapy for treating advanced Parkinson's disease. Studies are also ongoing to evaluate new indications for Botox and Juvederm collection of fillers. The company has been on an acquisition spree in the past couple of years, which is strengthening its pipeline. It has signed several M&A deals in the immunology space, its core area, while also signing some early-stage deals in oncology and neuroscience areas. It has inked more than 20 early-stage deals since the beginning of 2024, including promising technologies and innovative mechanisms that can elevate the standard of care in immunology, oncology and neuroscience. The latest deal with Gubra is a testament to this trend. Sales of AbbVie's blockbuster drug Humira are declining due to biosimilar erosion. Humira volume is rapidly eroding compared to other novel mechanisms (including Skyrizi and Rinvoq). The decline expected to be sharper in 2025 as more plans exclude branded Humira and move to exclusive biosimilar contracts. AbbVie is witnessing declining sales of Juvederm fillers in the United States and China due to challenging market conditions. The slowing growth of the U.S. facial injectables market and persistent economic headwinds, which are affecting consumer spending in China, are hurting Juvederm's sales due to its higher price point. Juvederm sales declined 14.6% in 2024. ABBV's global sales of aesthetics portfolio declined 0.6% in 2024. On the fourth-quarter conference call, AbbVie also lowered its guidance for its aesthetics franchise's long-term growth. It expects a high single-digit CAGR for this franchise through 2029. This guidance translates to a little more than $7 billion, much lower than the previous expectation of more than $9 billion for 2030. AbbVie stock has gained 14.8% in the past year compared with an increase of 0.3% for the industry. Image Source: Zacks Investment Research From a valuation standpoint, AbbVie is not very cheap. Going by the price/earnings ratio, the company's shares currently trade at 16.52 forward earnings, just slightly lower than 17.80 for the industry. The stock is cheaper than some other large drugmakers like Eli Lilly and Novo Nordisk but priced much higher than most other large drugmakers. The stock is also trading above its five-year mean of 11.76. Image Source: Zacks Investment Research The Zacks Consensus Estimate for 2025 earnings has risen from $12.24 per share to $12.29 while that for 2026 has increased from $13.81 to $13.93 per share over the past 30 days. Image Source: Zacks Investment Research AbbVie faces its share of headwinds, such as Humira biosimilar erosion, increasing competitive pressure on cancer drug Imbruvica and slow market growth trends for fillers in the United States and China. It also faced some key pipeline setbacks in 2024. However, AbbVie has faced its biggest challenge — Humira's patent cliff — quite well and looks well-positioned for continued strong growth in the years ahead. The company saw a rapid return to sales growth in 2024 after revenues declined in 2023 due to Humira loss of exclusivity (LOE), driven by its ex-Humira platform. AbbVie's ex-Humira drugs rose around 19% (on a reported basis) in 2024, exceeding its internal expectations. Boosted by its new product launches, AbbVie expects to return to robust mid-single-digit revenue growth in 2025 with a high single-digit CAGR through 2029 as it has no significant LOE event for the rest of this decade. A substantial portion of this growth is expected to be driven by robust performances from Skyrizi and Rinvoq. AbbVie's rising estimates, a solid pipeline and the prospect of growth in 2025 sales and profits are good enough reasons to stay invested in this Zacks Rank #3 (Hold) stock. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. 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 Novo Nordisk A/S (NVO) : Free Stock Analysis Report Merck & Co., Inc. (MRK) : Free Stock Analysis Report Eli Lilly and Company (LLY) : Free Stock Analysis Report AbbVie Inc. (ABBV) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Sign in to access your portfolio
Yahoo
03-03-2025
- Business
- Yahoo
ABBV Enters Obesity Bandwagon, Inks $2.2B Licensing Deal for Amylin Drug
AbbVie ABBV announced that it has entered into a licensing agreement with Denmark-based biotech Gubra for the latter's experimental obesity drug, GUB014295. This marks the American drugmaker's foray into the lucrative obesity market. Per the terms, AbbVie will lead the development and commercialization of GUB014295. In return, Gubra will receive an upfront cash payment of $350 million. The Denmark-based biotech will also be eligible to receive up to $1.875 billion in milestone payments, along with tiered royalties based on global net sales. GUB014295 is a long-acting amylin analog currently being evaluated in an early-stage study. It has been designed to target receptors linked to appetite control, mimicking the effects of amylin — a hormone that helps signal fullness, reduce food intake and slow digestion. By extending these effects, AbbVie believes that GUB014295 could offer a long-lasting solution for weight management, making it an intriguing candidate in the growing market for obesity therapies. This deal's closure is subject to the fulfillment of customary closing conditions, including regulatory approvals. Year to date, shares of AbbVie have risen 18% compared with the industry's 12% growth. Image Source: Zacks Investment Research The obesity market has garnered much interest lately, with two companies, Eli Lilly LLY and Novo Nordisk NVO, dominating this space with their respective obesity drugs Zepbound and Wegovy. Per a research conducted by Goldman Sachs, the obesity market in the United States is expected to reach $100 billion by 2030. This is also evident from the fact that all large drugmakers are looking to strengthen their presence in this market by expanding their existing obesity pipeline or acquiring smaller biotechs whose pipeline has novel obesity candidates. Lilly is investing broadly in obesity and has several new molecules currently in clinical development. These include two late-stage candidates, orforglipron, an oral GLP-1 small molecule and retatrutide, a GGG tri-agonist and some mid-stage candidates, bimagrumab, eloralintide and mazdutide. Like Lilly, Novo Nordisk is developing multiple other candidates, including the unimolecular GLP-1 and amylin receptor agonist amycretin and next-gen subcutaneous obesity treatment candidate, CagriSema. NVO is also evaluating several other obesity drugs across separate early to mid-stage studies. Another biotech that has shown encouraging potential in the obesity space is Viking Therapeutics VKTX, which is developing its experimental obesity drug VK2735, both as an oral pill and subcutaneous (SC) injection across different stages of clinical development. Last November, VKTX reported updated data from an early-stage study, which showed that patients who received its obesity drug lost up to 8.2% of their body weight after 28 days of daily dosing compared to 1.4% in the placebo group. Based on this data, Viking recently started a mid-stage study on the oral obesity drug. AbbVie entered the obesity space just a few months after Merck secured a licensing deal for an investigational oral weight-loss drug developed by China-based Hansoh Pharma. On Friday, AbbVie announced that the EMA's Committee for Medicinal Products for Human Use ('CHMP') issued a positive opinion on its blockbuster immunology drug Rinvoq to treat adults with giant cell arteritis (GCA). A final decision from the European Commission is expected in first-half 2025. If approved, Rinvoq will be the first approved oral therapy for GCA. The positive CHMP endorsement is supported by data from the pivotal phase III SELECT-GCA study, which evaluated the efficacy and safety of Rinvoq in adults with GCA. The study achieved its primary endpoint of sustained remission and key secondary endpoints. AbbVie Inc. price | AbbVie Inc. Quote AbbVie currently carries a Zacks Rank #3 (Hold).You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. 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 Novo Nordisk A/S (NVO) : Free Stock Analysis Report Eli Lilly and Company (LLY) : Free Stock Analysis Report AbbVie Inc. (ABBV) : Free Stock Analysis Report Viking Therapeutics, Inc. (VKTX) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Sign in to access your portfolio
Yahoo
03-03-2025
- Business
- Yahoo
AbbVie enters obesity space with $2.3bn Gubra deal
AbbVie is entering the obesity treatment market with a $2.3bn licensing agreement to acquire global rights to GUB014295, a long-acting amylin analogue developed by Danish biotech Gubra. Announced on 3 March, the deal marks AbbVie's first move into the increasingly competitive sector. Under the agreement, AbbVie will pay Gubra $350m upfront, with additional milestone payments of up to $1.875bn. Gubra is also eligible for tiered royalties on future sales. Following the announcement, Gubra's stock rose 24% at market open on 3 March. GUB014295 is an amylin receptor agonist that also targets calcitonin receptors. Amylin analogues have been investigated for their role in appetite suppression and delayed gastric emptying, both of which contribute to weight loss. In a Phase I study (NCT06144684) conducted by Gubra, healthy and overweight male participants who received 3.5mg to 6mg of GUB014295 experienced an average weight loss of approximately 3% over six weeks, compared to a 1% weight gain in the placebo group. The asset is currently in the multiple-ascending dose (MAD) portion of the Phase I trial. The obesity treatment market has become a focal point for major pharmaceutical companies, with amylin analogues emerging as a potential alternative or complement to glucagon-like peptide-1 receptor agonists (GLP-1RAs) such as semaglutide, marketed in obesity as Wegovy. However, the path for amylin-based therapies has been mixed. Novo Nordisk's amylin/GLP-1 combination therapy, CagriSema (semaglutide/cagrilintide), recently met its primary endpoint in the Phase III REDEFINE 1 trial (NCT05669755) but failed to achieve the company's target of 25% weight loss, leading to a muted investor response. Unlike GLP-1RAs, which stimulate insulin secretion and reduce glucagon levels, amylin analogues work by suppressing glucagon secretion, increasing satiety, and delaying gastric emptying. Denmark-based Zealand Pharma is developing its own amylin analogue, petrelintide, as a potential best-in-class therapy for obesity and diabetes. Gubra has been actively involved in obesity research, previously collaborating with Boehringer Ingelheim on multiple programmes. In 2021, the two companies signed a deal to co-develop four obesity candidates, but Boehringer later discontinued the development of BI 1820237, a long-acting NPY2 agonist, without providing details. One of their remaining assets, BI 3034701, a long-acting triple agonist peptide, entered a Phase I trial in July 2024. Separately, Gubra also signed a discovery deal with Amylyx for a long-acting GLP-1RA. AbbVie has been one of the last major pharmaceutical companies to enter the obesity treatment market, which has become a key area of interest for drugmakers following the commercial success of GLP-1RAs such as Novo Nordisk's Wegovy and Eli Lilly's Zepbound (tirzepatide). According to a recently published report, GlobalData estimates that the obesity market will exceed $173.5bn by 2031 in the seven major markets (France, Germany, Italy, Japan, Spain, the UK and the US). GlobalData is the parent company of Pharmaceutical Technology. "AbbVie enters obesity space with $2.3bn Gubra deal" 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
