PoZdroweek 9/2025: One step away from access to steatohepatitis therapy for EU patients
This was one of the weakest weeks for healthcare stockholders since politykazdrowotna.com initiated the weekly PoZdroweek, which aims to bring closer the most important events on the healthcare scene. On the other hand, something else was happening in the immediate environment of companies. Many patients are eagerly awaiting the approval in Europe of Rezdiffry, a drug that can bring relief to those suffering from steatohepatitis associated with metabolic disorders. Zealand Pharma showed interesting results of clinical trials for dapiglutide for obesity therapy. In Poland, the most important was the judgment of the ECJ, which "disenchanted" the ban on advertising pharmacies.
The WIGmed index lost 1.2% over the past week. Companies included in the European MSCI Europe Health Care (SPYH) fell by a similar amount. The health care industry index of companies from the Old Continent lost 1.1%. Things were much worse on a global scale - the global MSCI World Health Care (XDWH) weakened by 2.6% over the last 5 trading sessions.
As a result, it slowly approached this year's minimum, which was set in early April this year, when Donald Trump delighted investors with the announcement of a massive increase in customs tariffs in trade with the rest of the world.
Source: TradingView
A clear sign of the stock market downturn in the global healthcare industry was that among the top twenty MSCI World Health Care, only Boston Scientific shares rose slightly (by 1.6%). The rest of the companies were underwater. The most important players in the type 2 diabetes and obesity therapy segment stood out in this group – Eli Lilly and Novo Nordisk shares fell by 7.6% and 6.9%, respectively.
Source: own study based on stooq.pl
Among the top twenty largest companies in the WIGmed index, the shares of Medicalghoritmics (+6.4%) stood out, which may have been due to personnel changes in the management board. In addition, the leading three also included Ryv (+2.9%) and Bioton (+1.2%). The shares of Voxel (-5.7%), Bioceltix (-4.3%) and Genomtec (-4.2%) trailed behind.
Source: own study based on stooq.pl
Weeks away from Rezdiffra approval, a breakthrough for European MASH patients
The European Medicines Agency (EMA) Committee has recommended conditional marketing authorisation for Rezdiffra (resmetirom) from Madrigal Pharmaceuticals for the treatment of adults with metabolic acidosis (MASH) and moderate to advanced liver fibrosis, in combination with diet and exercise.
Approval of the selective THR-β agonist is likely to occur in August 2025. And if that happens, it would be a breakthrough for EU patients, as it would mean the first approval for the drug in this indication. The drug was already approved last year by the US FDA.
MASH, previously known as nonalcoholic steatohepatitis, is a serious liver disease that can lead to cirrhosis, liver failure, liver cancer, liver transplantation, and premature mortality. MASH is the leading cause of liver transplantation in women and the second leading cause of all liver transplants in the United States and the fastest growing indication for liver transplantation in Europe.
As the disease progresses to stage F2 (moderate fibrosis) and stage F3 (advanced fibrosis) , the risk of liver-related outcomes increases dramatically. These patients have a 10- to 17-fold increased risk of liver-related mortality compared with patients without fibrosis. Those who progress to cirrhosis (stage F4) have a 42-fold increased risk of liver-related mortality.
The decision by the EMA's Committee for Medicinal Products for Human Use (CHMP) was announced on Friday 20 June 2025, although it was made a day earlier. It was based on interim results from the MAESTRO-NASH study, which showed that after one year of treatment in patients with stage F2 and F3 liver fibrosis , 30% of those receiving Rezdiffry 100 mg and 26% of those receiving 80 mg achieved clearance of MASH , compared with 10% in the placebo group.
The EMA explained that the results of the pivotal study, which is still ongoing, and the results of another ongoing supporting study are necessary to provide further data on the therapeutic effectiveness of Rezdiffry.
On May 1, Madrigal Pharmeceuticals reported that MASH therapy using Rezdiffry was used by more than 17,000 patients in the U.S. According to company estimates, this represented about 5% of the total American population suffering from this disease.
According to healthcare analysts, the fair value of Madrigal Pharmaceuticals shares over the next 12 months is $423.14. The stock exchange price from the last session was around $280, which would give a 51% potential for price growth in relation to analysts' expectations.
Rezdiffra is taken orally once daily in tablet form. According to singlecare.com, the cost of acquiring the drug in a 100 mg dose, which is enough for 30 days, ranges from $4,000 to $4,600 (after discounts for singlecare.com loyalty program members).
Source: Madrigal Pharmaceuticals
Zealand Pharma wants to grab a piece of the pie from the bountiful obesity therapy table
Zealand Pharma looks with admiration at the achievements of leaders Eli Lilly and Novo Nordisk, wanting to take over part of the obesity drug market. The race for those aspiring to take a certain position in the lucrative segment is therefore gaining momentum - more about what the therapeutic matrix for GLP-1 agonists looks like can be found at this link: https://politykazdrowia.com/artykul/niesubiektywa-kariera-n1619935
On June 18 this year (Wednesday), the Danish listed company reported Phase Ib results for dapiglutide . It is a dual GLP-1/GLP-2 agonist. The drug candidate led to a weight loss of 11.6% . This was in a population that does not follow any diet, no exercise and usually does not respond well to obesity treatment.
“We are very encouraged by the impressive weight loss at 28 weeks, which appears to be on par with the most effective once-weekly GLP-1 receptor agonist-based therapy currently available on the market, despite the almost exclusively male and relatively lean study population,” explained David Kendall, Medical Director at Zealand Pharma.
"Dapiglutide is a unique GLP-1 receptor agonist-based therapy designed to leverage a dual mechanism involving GLP-2. Our treatment pipeline for mid- to late-stage obesity includes a diverse portfolio of GLP-1 receptor agonist-based therapies that target individuals with obesity-related comorbidities, and our amylin analogue, petrelintide, which has the potential to be a primary therapy for weight management, addressing the unmet needs of the majority of overweight and obese individuals," he added.
The study included 30 participants (approximately 93% men) with a median age of 44.5 years, a median baseline body weight of 91.9 kg, and a median baseline BMI of 28.8 kg/m 2 . Dapiglutide, which is administered by injection, reduced body weight by 11.6%, compared with 0.2% in the placebo group.
According to the study sponsor, the results indicate the safety and good tolerability of the drug. There were no severe or serious adverse events among those taking dapiglutide. Side effects were mild, most often gastrointestinal complaints, including nausea and vomiting.
Analysts at investment firm Jefferies called Zealand Pharma's results encouraging. Supporting this view was the fact that the study population consisted almost entirely of men, who tend to lose less weight during treatment.
“We argue that the data support a Phase III target of 20+% weight loss,” Jefferies experts said. They said the drug candidate could also be positioned to address obesity-related comorbidities driven by low-grade inflammation, with the benefits driven by its GLP-2 component.
Jefferies analysts remain optimistic that broader anti-inflammatory benefits will be demonstrated in late-stage trials. They estimate peak sales of the drug candidate if approved. Zealand Pharma's stock currently has a market capitalization of about $4.3 billion. The stock has fallen about 49% since the beginning of the year.
POLAND
Monday (16.6.2025)
- Molecure has decided to change the dosing escalation regimen in the OATD-02 study and switch to a twice-daily dosing regimen to optimize its therapeutic potential.
"Based on the safety, pharmacokinetic and pharmacodynamic results to date, after obtaining support from the external SRC (Safety Review Committee), as well as obtaining the approval of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, including the opinion of the relevant bioethics committee, the company decided to change the dosing escalation regimen and switch to a twice-daily dosing regimen to optimize its therapeutic potential," the company said.
Additionally, the company revealed that the drug has been administered to 14 patients so far, with no dose-limiting toxicities reported and the drug being well tolerated.
- Medinice has received patent protection from the South Korean Patent Office for the invention "Cryoapplicator for minimally invasive cardiac ablation with a functional tip", which is part of the CoolCryo project.
Wednesday (18.6.2025)
- Stryker , one of the global leaders in the healthcare segment, has opened its first production plant in Skawina. It will produce, among others, orthopedic implants (e.g. hip and knee joints), spine plates and foot screws.
In December 2024, the Krakow Technology Park - the operator of the Polish Investment Zone in Małopolska and Jędrzejów County - provided support to Stryker for the third time in the amount of PLN 475 million.
- From June 30, 2025, three series of futures contracts for Diagnostyka shares will be available on the Warsaw Stock Exchange. These will be contracts with a multiplier of 100, expiring in September and December 2025 and March 2026. Thus, the national leader in laboratory diagnostics will join the group of 42 listed companies for which futures contracts are traded.
- Neuka's general meeting approved a dividend payment of PLN 16 per share - a total of PLN 71.7 million will be paid to it. In 2024, the company shared a dividend of PLN 14.5 per share with its shareholders. The dividend record date is July 16 , and the payment will be made on July 28, 2025.
Thursday (19.6.2025)
- The Court of Justice of the European Union (CJEU) has ruled that the ban on advertising pharmacies and pharmacy points in force in our country is incompatible with EU law. The ruling was issued following a complaint filed last year by the European Commission (EC) against Poland (in case C-200/24) at the request of the Lewiatan Confederation - the content of the CJEU judgment in Polish can be found at the following link: https://curia.europa.eu/juris/document/document.jsf;jsessionid=84E373607E72AF0E70870B192FBA9912?text=&docid=301356&pageIndex=0&doclang=PL&mode=req&dir=&occ=first&part=1&cid=339600
The CJEU decision referred to Polish regulations that came into force in 2012, prohibiting the advertising of pharmacies under penalty of a financial penalty of up to PLN 50,000. According to the national regulation, they could publicly provide information about their location and opening hours.
The court found that the Polish regulations violate the E-commerce Directive , which allows regulated professionals, including pharmacists, to advertise their services online. The content of such advertisements must be consistent with the rules of the profession, but the regulations cannot lead to a total ban on advertising.
Moreover, in relation to other - non-electronic - forms of advertising, the institution found that Polish regulations violate the freedom of establishment and provision of services , guaranteed by the Treaty on the Functioning of the EU. The court noted that Poland had not demonstrated that the restriction of these freedoms was necessary to protect public health.
Poland must now immediately adapt its regulations to the ruling. If it fails to do so, the EC may refer the case to court again and demand financial penalties be imposed on Poland.
According to some lawyers, the judgment of the Luxembourg court will have far-reaching consequences for Polish entrepreneurs – we wrote about it at this link: https://politykazdrowia.com/artykul/wyrok-tsue-w-sprawie/1666127 .
Friday (20/06/2025)
- The European Commission has put a barrier on China's large medical equipment orders , as Chinese manufacturers will be excluded from EU public procurement orders exceeding EUR 5 million. The only exception to this rule will be situations where a replacement for Chinese equipment cannot be found to fulfill the order.
The measure was taken in retaliation to the barriers to access to the Chinese market that EU companies face. 87% of tenders for medical equipment in China exclude European producers, according to the EC.
WORLD
Monday (16.6.2025)
- Even the little guys can do it. D&D Pharmatech , a South Korean biotechnology company, announced that its experimental Phase II study of its drug candidate DD01 has shown encouraging results in treating steatohepatitis associated with metabolic dysfunction.
The 12-week study showed that 75.8% of patients taking DD01 had at least a 30% reduction in liver fat , compared with 11.8% of patients taking placebo. The drug was associated with a 62.3% relative reduction in liver fat, compared with 8.3% for placebo. In addition, 72.7% of the study participants had their liver fat halved, compared with 5.9% for placebo.
D&D Pharmatech shares are traded on the KOSDAQ stock exchange. They have risen 190% since the beginning of this year.
Wednesday (18.6.2025)
- Incyte has received a second U.S. FDA approval for Monjuvi (tafasitamab-cxix), a drug for use in combination with rituximab and lenalidomide for the treatment of adults with relapsed/refractory follicular lymphoma. Lymphoma is a cancer of the lymphatic system, which includes the lymph nodes, spleen, thymus, and bone marrow, which is responsible for fighting bacteria and viruses in the body.
The decision of the American regulator was made based on the results of the phase III inMIND study. Monjuvi in combination with the two previously mentioned drugs led to a 57% reduction in the risk of disease progression or death compared with placebo. In patients taking Monjuvi, the median time without disease worsening was 22.4 months, compared with 13.9 months in the control group.
Regarding safety, 33% of patients receiving Monjuvi in combination experienced serious adverse events and 24% experienced serious infections. Common adverse events were respiratory tract infections, diarrhea, rashes, and fatigue. Adverse events leading to death occurred in 1.5% of patients.
Friday (20/06/2025)
- Novo Nordisk has released updated data on amycretin in obesity treatment. During the American Diabetes Association, the Danish company reported that patients in the phase Ib/IIa trial who received the highest dose of amycretin - a 60 mg injection once a week - achieved an average weight loss of 24.3% after 36 weeks , compared with 1.1% with placebo (the results were also published in the latest issue of The Lancet).
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