PoZdroweek 22/2025: Roche wants to enter MASH therapy thanks to the acquisition of 89bio for up to $3.5 billion
The Swiss are acquiring 89bio, which is developing pegosafermin, a drug for the treatment of MASH. Novartis has deepened its cooperation with Monte Rosa, willing to pay up to $5.7 billion for licenses to the molecules being developed by the American company. This transaction lends credibility to investors regarding the potential of degraders, in which Polish company Captor Therapeutics is conducting Phase I clinical trials. The discovery fiasco has painful consequences for investors, who learned from the aTyr failure that shares can drop by 83% in a single day. Bioceltix engineered a unique capital transaction, so unconventional that it left investors baffled.
WIGmed rose 1.6% this week, giving investors another extremely successful period, as 40% of the index's top 20 companies gained at least 5% (compared to 1/3 last week). Things weren't so good abroad. The European MSCI Europe Health Care (SPYH) lost 0.1% . The global MSCI World Health Care (XDWH) suffered a larger decline, falling 1.0% .
WIGmed has thus once again strengthened its lead over its competitors year-to-date. It is the only index above the line (+4%), slowly approaching this year's high from May. The remaining healthcare indices analyzed have been losing ground since the beginning of the year: SPYH (-3%) and XDWH (-10%).
Source: TradingView
Among global stocks in the top 20 of the MSCI Global Health Care Index , Novo Nordisk (+11.9%) was the winner, while Amgen (+3.3%) and AbbVie (+1.9%) also stood out. Among the biggest losers were Boston Scientific (-4.8%), which resulted in a second consecutive significant weekly decline, UnitedHealth Group (-4.5%), and AstraZeneca (-4.1%).
Source: own study based on stooq.pl
In Poland, the green was striking, as seen in the infographic below. Eight companies saw their stock prices rise by at least 5%, with Selvita (+10.6%), Molecure (+9.9%), and Scope Fluidics (+9.0%) standing out. At the other end of the weekly returns were PolTREG (-8.5%), Medicalghoritmics (-7.6%), and Ryvu Therapeutics (-3.7%). Diagnostyka (-3.3%) was fourth, having doubled its share value since its initial public offering and still seeking momentum to continue its upward trajectory.
Source: own study based on stooq.pl
A failure in a research process generally results in a significant share price decline. This can be drastic, as evidenced by the performance of the American company aTyr. On Monday, aTyr's share price fell 83.4%. This was the brutal reaction of investors to the news of the disappointing results from the Phase III clinical trial for the drug candidate efzofitimod , intended for the treatment of pulmonary sarcoidosis . Efzofitimod did not demonstrate a statistically significant reduction in patient dependence on oral corticosteroids (OCS) compared to placebo.
The 52-week EFZO-FIT study, which enrolled 268 patients, evaluated efzofitimod at doses of 3 mg/kg and 5 mg/kg compared with placebo. The study involved a protocol-guided steroid taper over the first 12 weeks, followed by further taper until week 48.
The primary measure of the study – change from baseline in mean daily OCS dose at week 48 – was not met : patients receiving efzofitimod 5 mg/kg reduced their steroid dose to 2.8 mg compared with 3.5 mg in both the 3 mg/kg and placebo groups. aTyr reported that more patients receiving the higher dose of efzofitimod achieved complete steroid weaning (52.6%) than placebo (40.2%), but this difference was not statistically significant.
Despite failing to meet the study's primary objective, the company emphasized some secondary outcomes. Patients taking the higher dose (5 mg/kg) reported greater improvement in the King's Sarcoidosis Questionnaire (KSQ) lung score. Nearly half (46.9%) of patients taking the higher dose were able to completely discontinue steroids while maintaining stable KSQ-Lung scores, compared to about one-third (35.7%) of patients taking placebo. Additionally, 29.5% of patients taking efzofitimod not only completely discontinued steroids but also saw improvement in their KSQ-Lung scores, compared to 14.4% in the placebo group.
"This study demonstrates that patients with chronic, symptomatic sarcoidosis can be treated with significantly lower doses of steroids than previously thought. Despite a higher-than-expected placebo response, we found that efzofitimod treatment was associated with greater steroid reduction and improvement in KSQ-Lung score," said Sanjay Shukla, CEO of aTyr.
The company stated that it wants to work with the FDA to outline a development path for its pulmonary sarcoidosis treatment program, despite the questionable results of the EFZO-FIT study.
The massive decline in aTyr's share price following the news of these results calls into question the viability of any attempts to "reactivate" efzofitimod trials. Jefferies analysts expressed disappointment, believing that a positive Phase III trial for the molecule in development—the most advanced candidate for the treatment of pulmonary sarcoidosis—could pave the way for its first approval. They predicted that the drug could achieve peak sales in the US of approximately $824 million.
An opportunity for efzofitimod may be the ongoing phase II clinical trial (EFZO-Connect) in patients with interstitial musculoskeletal disease.
Novartis has deepened its collaboration with Monte Rosa Therapeutics , which could be interpreted as support for degrader technology in the treatment of immune-mediated diseases. This could improve investor sentiment, as investors doubt the efficacy of degraders, and could also benefit Poland's Captor Therapeutics , which has been conducting a Phase I clinical trial of the CT-01 project since spring of this year.
Last October, Novartis agreed to pay $150 million upfront for rights to Monte Rosa's program targeting the degradation of the molecular glue VAV1, including the oral compound MRT-6160. In March of this year, promising data from the Phase 1 trial were announced. MRT-6160 demonstrated sustained, dose-dependent degradation of VAV1 in peripheral blood T and B lymphocytes.
This time, the Novartis/Monte Rosa agreement is much more substantial. The Big Pharma giant will pay $120 million upfront for an exclusive license for an undisclosed research purpose, as well as an option to license two programs from Monte Rosa's preclinical immunology portfolio. This includes payments of up to $5.7 billion across various stages of development, regulatory, and sales, as well as tiered royalties on sales ranging from single-digit to low-double-digit percentages.
With the transaction, Monte Rosa extends its cash runway for further discoveries in immunology and inflammation. Captor Therapeutics is also counting on this, as it is in talks with potential licensees for CT-01. For a broader picture of the Polish company's research progress, read the interview with Captor representatives, which can be found here: https://politykazdrowia.com/artykul/czterech-doktorow-na-n1774133 .
Markus Warmuth, CEO of Monte Rosa Therapeutics, acknowledged that the company's wholly owned programs include multiple undisclosed targets in autoimmune diseases, and the money from Novartis will provide a runway beyond many of the anticipated Phase II readouts for MRT-8102, MRT-6160, and MRT-2359.
Source: own study based on Monte Rosa
Investors welcomed the agreement between Novartis and Monte Rosa, which was reflected in the licensor's share price. Monte Rosa shares have gained nearly 32% this week.
Bioceltix has entered into an investment agreement with its key shareholders, Alternative Solution and Kvarko Group, under which they agreed to conduct an accelerated bookbuilding (ABB) sale of up to 577,785 existing shares in the company and to use the proceeds to acquire up to 457,785 newly issued shares at an issue price equal to the ABB offering price. The offering price will be no less than PLN 95 .
The funds raised by the company through the issuance of new shares are to be used to partially cover the costs of building the pharmaceutical plant, and the remaining portion to cover current operating costs . The newly issued shares are to be subject to transferability restrictions specified in lock-up agreements (until November 30, 2026).
"The purpose of the transaction is to ensure continued financing for the construction of a large-scale stem cell production facility and to cover operating expenses in the period leading up to production launch and validation. The new facility will also be co-financed by a grant awarded by the Polish Agency for Enterprise Development (PARP) from the FENG program, in which the project was set at PLN 50 million net, of which PLN 17.35 million will be subsidized. Contrary to our earlier assumptions and the analyses prepared by our advisors when the FENG program was announced, the grant agreement signed in July 2025 assumes that this funding is conditional," explained Paweł Wielgus, member of the Bioceltix management board.
The money will be used to commercialize Bioceltix’s projects: two in canine veterinary medicine (for osteoarthritis and atopic dermatitis), and one in equine veterinary medicine (for lameness).
The new facility will multiply maximum production levels. It will also include the full analytical facilities and production cycle of the proprietary ALLO-BCLX technology, from stem cell isolation through proliferation and cryopreservation, to automated product dose packaging and storage.
" The registration procedures for our drugs at the EMA are ongoing and we expect the first recommendation in the first half of 2026. At the beginning of this year, we had to implement new regulations in the area of Good Manufacturing Practice at our current plant, which caused us a lot of additional work. We took over the space for the plant in the summer, and last week we concluded an agreement specifying the investment replacement, which has now taken a very specific shape," Wielgus described.
Bioceltix is currently in the design phase of detailed solutions for the new factory.
"Although we have been granted public support, the final terms of the agreement place the risk largely on the company's side. Obtaining subsequent grant installments will take significantly longer than we anticipated when applying for the grant. […] Of course, the plan is preliminary and still requires support from the general meeting of shareholders, which will be held in October. Planning and building a pharmaceutical plant is a major project, but the benefits will be even greater. Today, at maximum capacity, we can produce up to 30,000 doses per year. This will be enough to begin commercial sales after the product is authorized for marketing on the European market, even before full-scale production begins at the new plant," Wielgus added.
In my opinion, this capital transaction was poorly constructed. And as a result, it's causing confusion among investors. This is all due to the fact that key shareholders don't intend to allocate all the funds obtained from ABB to subscribe for new shares. The proceeds from the sale of 120,000 shares will go to them, not the company. In terms of value, it's not even PLN 12 million.
But the timing of the transaction is also problematic. If a partial divestment is made "momentarily" before significant EMA decisions, the question arises as to the level of confidence in the registration's success among the leading shareholders. For now, we're witnessing a deleveraging of capital commitments ahead of European regulatory approvals. This immediately leads to investors, even if subconsciously, downwardly revising their expectations regarding the likelihood of marketing authorization. This immediately generates a willingness to discount the risk relative to the fair value of Bioceltix shares.
If all the money from the ABB sale went to the company, there would be no doubt at all. This could always be adjusted at the October general meeting, but the original intentions of the two shareholders would remain in mind. The risk discount would certainly decrease, but it would still remain the same compared to what would have happened had the transaction proposal been better developed.
Monday (15/09/2025)
- The Supervisory Board of Scope Fluidics has agreed for the company to take steps to conclude agreements with the European Investment Bank (EIB) regarding obtaining financing for the BACTEROMIC project in the amount of up to EUR 15 million under the framework conditions specified in the term sheet.
Under the terms, the financing will be provided in three tranches: Tranche A of €4 million, Tranche B of €5 million, and Tranche C of €6 million. Each tranche will be subject to a single repayment six years after its disbursement.
The interest rate for each tranche is the same and amounts to 8% per annum, payable together with the repayment of the drawn tranche, and 1% per annum, payable in semi-annual or annual periods.
In addition, the EIB has the right to acquire, free of charge, subscription warrants entitling it to acquire up to approximately 4.95% of the company's shares , and the bank will be linked to the launch of subsequent tranches - the launch of Tranche A, Tranche B and Tranche C will enable the exercise of rights from warrants entitling it to acquire 1.95%, 1.65% and 1.35% of Scope Fluidics shares, respectively.
The warrants also entitle the EIB to additional remuneration, as if they were participating in the dividend payment.
- The Japanese Patent Office has granted Genomtec a patent for an invention for detecting HPV16 and HPV18 viruses . The protection period lasts until October 8, 2040.
Tuesday (16/09/2025)
Synektik has signed two agreements for the da Vinci robotic surgery system. Under the first, the University Clinical Center in Gdańsk will lease the system for 24 months for a maximum of PLN 10.48 million net, while the Masaryk Hospital in Ústí nad Labem, Czech Republic, will purchase the system from its subsidiary Synektik Czech Republic for EUR 3.43 million .
Wednesday (17/09/2025)
- Medicalgorithmics has signed an agreement with Zenicor Medical Systems AB under which it will make available to the company the DeepRhythmAI (DRAI) artificial intelligence algorithms and the Medicalgorithmics DRP platform after the integration process is completed and the relevant regulatory approvals are obtained.
- Captor Therapeutics admitted that it is in talks on early-stage research collaborations and sees the potential to conclude an agreement in this regard within months.
" We don't want to raise excessive expectations, but we are conducting such talks. We believe they have gained momentum this time of year and we see a general recovery in the biotechnology market," said Michał Walczak, CEO of the company.
The head of the Wrocław-based company indicated that one of the potential partners is a company related to the AI segment that needs a laboratory component of Captor, and the second collaborator is comparable in size to Ono Pharmaceutical, with which the company cooperated until April 2025.
It's unclear what financial and operational parameters should be used to assess this comparability with Ono Pharmaceutical. One of them may be sales levels. Japan's Ono Pharmaceutical generated approximately $3.4 billion in cumulative sales revenue over the last 12 months.
At the end of June, Captor Therapeutics had PLN 48.7 million in cash and cash equivalents. This will last until mid-2026, which may be extended due to revenues from collaboration projects and partnering.
"At the end of the first half of the year, we had just under PLN 49 million in cash and financial instruments. We estimate that this will suffice until June of next year, unless something unexpected happens. Unexpected in a positive sense, as we're counting on further research collaborations; perhaps we'll be able to arrange some partnering by then, " explained Adam Łukojć, CFO of the listed company.
As part of an alternative scenario for extending Captor's financing, an issuance of new shares could be considered, but Łukojć believes that if this option were to be considered, it would be very reluctant due to the share price . Over the past 12 months, the company's share price has fallen by 52% .
Thursday (18/09/2025)
- Medinice has signed a letter of intent with the American company CorNav regarding cooperation in research, development and potential commercialization of advanced medical technologies used in the treatment of ventricular tachycardia using an RF ablation catheter.
The parties to the agreement declared their intention to undertake joint activities aimed at developing a product intended for the treatment of ventricular tachycardia (VT), in particular through the development of a common solution including the MiniMax system (Medinice) and the CardioScout system (CorNav) .
"CorNav will contribute its CardioScout system know-how to the joint venture. CorNav has an agreement with Mayo Clinic to collaborate on the development of the CardioScout system, intended for the treatment of VT using RF catheter ablation, leveraging Mayo Clinic's experience and know-how," Medinice reported.
- Celon Pharma deepened its consolidated net loss to PLN 32.8 million in Q2 2025 (compared to PLN 8.03 million loss a year earlier).
Domestic sales in the generics segment reached PLN 75.4 million, representing a 9% increase compared to last year. Growth was recorded across all products in the portfolio, with a key contribution coming from the new drug Zarixa, launched in the second quarter of 2024, which increased segment revenue by PLN 4.3 million.
Export sales increased from PLN 20.8 million in H1 2024 to PLN 25.1 million in H1 2025, representing an annual growth rate of over 20%. At the same time, a significant decline in revenue was recorded in the innovation segment, in the area of subsidies received. Revenues from this source decreased from PLN 16.1 million in H1 2024 to PLN 4.8 million in H1 2025.
The main reason for this state of affairs were delays in the refund of funds resulting from extended deadlines for acceptance of payment applications by the financing institution.
Selvita reported a consolidated net loss of PLN 4.6 million in Q2 2025, which marked an improvement in an undesirable trend, as the loss amounted to PLN 10 million a year earlier. Consolidated operating income reached PLN 95.0 million in Q2 2025, compared to PLN 80.9 million a year earlier.
"The results in the first half of the year are the result of the gradually improving economic situation in the second half of 2024 and early 2025. They show that under favorable conditions, Selvita is able to quickly increase revenues and profitability. Due to the uncertainty introduced at the beginning of the year by the administrative decisions of the world's largest economy, the second half of the year will be more demanding. The stabilization of investor sentiment observed in the third quarter supports our efforts [...]. However, customer caution translates into shorter contract periods, which is why we maintain a conservative approach. [...] The decisive factor for growth prospects in subsequent periods will be the effectiveness in extending cooperation at the turn of the year, " says Bogusław Sieczkowski, CEO of the company.
Friday (19/09/2025)
Selvita's project has been recommended for funding under the FENG program. The project consists of two modules: infrastructure and research, which the company will implement together with the Jagiellonian University Medical College. The project's net eligible costs are estimated at over PLN 199.6 million, of which the funding will amount to approximately PLN 91.8 million . The project will be implemented between 2025 and 2029.
- Changes continue at the top management level at Mabion . Adam Pietruszkiewicz , a member of the management board and the company's director of business development, has resigned from his position with immediate effect. The details of the manager's decision are not known.
Recently this month, Mabion's supervisory board dismissed Krzysztof Kaczmarczyk from his position as president and from the management board. Grzegorz Grabowicz, who was Mabion's financial director, resigned from his position as a management board member due to disagreements between the supervisory board and the management board regarding the implementation of the company's current operations and strategy. Julita Balcerek also left the management board, resigning from her position as management board member for operations, although she remained with the company as chief operating officer.
Monday (15/09/2025)
AstraZeneca shares fell 3.2% on Monday, their biggest single-day decline since May. Handelsbanken's recommendation for the company's stock may have contributed to the decline. Analysts at the investment firm downgraded Astra shares from "buy" to "hold . " Handelsbanken considers its revenue target of $80 billion by 2030 to be overly optimistic .
The market also reported that AstraZeneca plans to halt a £200 million expansion of its research center in Cambridge , which was expected to create around 1,000 jobs. This is a further cut in capital expenditure after the Anglo-Swedish company announced in January that it had abandoned a £450 million investment in a vaccine production facility in Speke, Merseyside.
Tuesday (16/09/2025)
Genmab has abandoned the development of one of its antibody-drug conjugates (GEN1107), which it acquired through last year's $1.8 billion acquisition of ProfoundBio. The conjugate, designed for the treatment of solid tumors, completed a Phase I/II clinical trial last month. However, the company concluded that the overall benefit-risk profile associated with further development of the molecule no longer supports continued discovery.
However, the Danish company is developing two other conjugates acquired through the ProfoundBio acquisition . These are assets in Phase II clinical development (rinatabart sesutecan). The FRα-targeted drug is being studied in platinum-resistant ovarian and endometrial cancer, while GEN1160 is being evaluated in advanced renal cell carcinoma, nasopharyngeal carcinoma, and non-Hodgkin's lymphoma.
At this point, the concerns expressed a year ago by Suzanne van Voorthuizen, an analyst at Van Lanschot Kempen, came to the fore. She said that the ProfoundBio deal, while positive, was at a discouraging price.
Wednesday (17/09/2025)
AstraZeneca announced that its asthma drug Fasenra (benralizumab) failed to meet its primary objective in a Phase III trial in patients with chronic obstructive pulmonary disease (COPD) . Investors were disappointed by the outcome, as expanding the therapeutic indication to COPD was considered a significant growth opportunity for the drug beyond its established use in severe asthma.
Astra relentlessly pursued success after the 2018 GALATHEA and TERRANOVA trials failed in patients with moderate to very severe COPD and a history of exacerbations in baseline blood eosinophil counts. Hence, the idea was to launch the RESOLUTE trial, aiming to commercialize the molecule in people with eosinophil counts ≥300 cells/μL.
Hopes for success in this trial were dashed. The company confirmed that Fasenra failed to achieve statistical significance for the primary endpoint of RESOLUTE , which was the annual rate of moderate to severe exacerbations in patients with three or more exacerbations in the previous year.
Fasenra is currently approved in many markets as an add-on maintenance treatment for severe eosinophilic asthma, as well as for adults with eosinophilic granulomatosis with polyangiitis.
Biogen has received European Commission approval for Zurzuvae (zuranolone) as the first and only drug indicated for the treatment of postpartum depression in the EU . The fast-acting steroid will be available as a once-daily oral treatment for a 14-day treatment period.
“This approval is a significant milestone in addressing a critical unmet need for women in maternal health in Europe, where postpartum depression is underdiagnosed and undertreated,” said Priya Singhal, Biogen’s head of clinical development.
Bristol Myers Squibb announced that it has signed an agreement to sell a 60% stake in the Chinese pharmaceutical joint venture Sino-American Shanghai Squibb Pharmaceuticals (SASS). The price and buyer are not officially disclosed. However, unofficial sources report that Hillhouse Capital, a large Asian investment firm, is involved in the transaction.
- Eli Lilly intends to submit an application for approval of orforgliprone (an oral once-daily obesity medication) soon, with regulatory action planned for 2026.
In August of this year, Lilly's stock price fell more than 14% after a study showed that the highest dose of orforgliprone resulted in a placebo-adjusted 11.5% weight loss after 72 weeks. Meanwhile, Novo Nordisk's oral candidate semaglutide (under review by the FDA) led to a 15.1% weight loss over 68 weeks in the OASIS-1 study.
On Wednesday, the full results of Eli Lilly's ATTAIN-1 trial were announced , which were presented at the European Association for the Study of Diabetes (EASD) meeting and published simultaneously in NEJM.
The study included 3,127 adults who were obese/overweight and had at least one comorbidity but did not have diabetes. Participants were randomly assigned to receive placebo or orforgliprone, which was titrated from 1 mg to maintenance doses of 6, 12, or 36 mg.
At the highest dose, orforgliprone contributed to weight loss. After 72 weeks, 55% of participants achieved a placebo-corrected weight loss of 5% or more. 51% lost 10% or more, 36% lost at least 15%, and nearly one in five achieved a weight loss of 20% or more.
Johnson & Johnson revealed that its drug candidate icotrokinra (JNJ-2113) , an oral IL-23 receptor antagonist, demonstrated significant skin clearing in patients with moderate to severe plaque psoriasis across all pivotal Phase III clinical trials: ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2.
The company has submitted an application for registration of the drug to the FDA, and recently – on September 11 – to the European EMA, seeking approval of the therapy for adults and pediatric patients aged 12 years and over.
If approved, the drug could significantly impact Bristol Myers Squibb's Sotyktu (deucravacitinib) . Sotyktu is approved for marketing in the US (September 2022) and the EU (March 2023). It is used to treat moderate to severe plaque psoriasis.
However, Johnson & Johnson's icotrokinra is more effective than deucravacitinib, as demonstrated in comparative studies. This means that the pace of Sotykt sales growth may be slowed if regulatory authorities approve icotrokinra for sale.
Thursday (18/09/2025)
- Roche will acquire the American biotechnology company 89bio for up to USD 3.5 billion , which will strengthen the Swiss giant's development portfolio with drug candidates for the treatment of liver and cardiometabolic diseases.
The joker in the pack of molecules developed by 89bio seems to be pegosafermin, an FGF21 analogue, which in late-stage clinical trials has shown promising results in the treatment of steatohepatitis with metabolic dysfunction (MASH). This is currently an extremely "hot" therapeutic segment.
The transaction is complex. Roche will pay $14.50 per 89bio share (approximately $2.4 billion) in cash, but will also grant the target's shareholders contingent value rights (CVRs) worth up to $6 per share. The cash component ($14.50) represents a 79% premium to 89bio's closing stock price on September 17.
The CVR component is three-tiered, with $6 per unit being the maximum. Roche will pay an additional $2 under the CVR if pegosafermin achieves commercial sales in MASH patients, then $1.50 when annual sales reach $3 billion, and finally $2.50 when sales reach $4 billion.
Stock market investors appear to be taking this positive payout scenario into account , as 89bio shares traded at $14.87 on Friday, which would represent a premium of 37 cents above the cash payment amount.
Pegosafermin is being studied by 89bio in the Phase III clinical trial of the ENLIGHTEN program. The drug candidate is being administered once weekly in patients with non-cirrhosis associated with fatty liver disease (MASH) as well as in patients with compensated cirrhosis. Phase III results are expected to be public in 2027 .
The approved Rezdiffra Madrigal Pharmaceuticals reigns supreme in the MASH segment. But beyond it, there are potential rivals aspiring to join this lucrative treatment area. FGF21 analogues are also being developed by Akero Therapeutics (efruxifermin) and Boston Pharmaceuticals (efimosfermin alfa), which licensed the rights to the drug candidate to GSK in May.
- Novo Nordisk has reduced its US sales team dedicated to educating physicians on obesity and diabetes. This is part of the intention to reduce employment in the Danish concern by 9,000. full-time positions. The process will end in 2026 and is expected to bring annual savings of 8 billion Danish kroner (almost $1.3 billion).
Novo may draw inspiration from its deadly rival in the obesity/overweight therapy segment, Eli Lilly. The American company did not have a team of educators in its structures.
Investors apparently liked the idea of reducing employment by eliminating educator positions in the US, because Novo Nordisk's stock gained 6.3% on Thursday.
Friday (19/09/2025)
- Regeneron boasted that its biseptic antibody linvoseltamab resulted in complete or partial resolution of a precancerous condition, which can develop into blood cancer, in all patients in a phase II clinical trial. It is designed to connect T cells with cancer cells, which activates the T cells to destroy the cancer. The study included patients with two specific pre-cancerous conditions: high-risk smoldering multiple myeloma (SMM) and monoclonal gammopathy of undetermined significance (MGUS).
Testing involves an initial, incremental dosing regimen before the full dose is administered to limit side effects. The molecule was previously studied in relapsed or refractory multiple myeloma in the pivotal LINKER-MM1 trial, which showed high response rates in heavily pre-treated patients. The entire process took place under the priority drug development path granted by the FDA.
Success in the LINKER trial would be another step towards stopping cancer before it fully develops .
- The European EMA has given the green light to approve a new form of oncology therapy using Merck's Keytruda (subcutaneous administration). It is intended for adult patients in the European Union. By the end of this year, Keytruda will be formally approved by the European Commission.
A breakthrough in therapy is the application method , which simplifies the previously used medical procedure. The medicine will be dosed by a simple injection, which usually takes a few minutes, rather than the 30-60 minute intravenous infusion.
The Committee for Medicinal Products for Human Use (CHMP) recommended the approval of a preparation that combines the pembrolizumab contained in Keytruda with berahialuronidase alfa, an application technology developed by Alteogen. The FDA may decide to take a similar step in the coming days - the cut-off date for the decision in the case is September 23, 2025.
This is some progress in "reviving" the Keytruda product line. The patent for the intravenous version of the drug expires in 2028, which means inevitable competition from generic companies. However, the adoption of the new Keytruda formulation encountered an obstacle, as Halozyme Therapeutics filed a lawsuit against Merck , accusing the Big Pharma company of patent infringement.
- Apple Watch Series 11 models went on sale on Friday with enhanced functionality that allows you to measure blood pressure in an artificial intelligence-powered function instead of a blood pressure monitor.
The Apple Watch heart rate sensor analyzes how the user's blood vessels respond to heartbeats over a 30-day period. The sensor does not notify about specific pressure values, but instead sends an alert "possible hypertension", which is intended to encourage the user to consult a doctor.
Apple invented the function based on advanced machine learning on data from over 100,000. participants in the heart and movement study, which was verified in a separate clinical trial involving 2,000. patients.
The FDA has approved marketing approval for the device, which will be available as part of a software update on Apple Watch Series 9 and newer models. However, the system has some limitations. It is not intended for people under 22 years of age, pregnant women or people diagnosed with hypertension.
Updated: 20/09/2025 18:39
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