Finance · Healthcare
Mountain View, CA, 21 Oct, 2026 - Unicycive Therapeutics, Inc. ("Unicycive" or the "Company") (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for oxylanthanum carbonate (OLC), the Company's investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The NDA was resubmitted following a Complete Response Letter (CRL) received in June 2026. The FDA has deemed the OLC resubmission a Class II with a six-month review period from the resubmission date, and set a Prescription Drug User Fee Act (PDUFA) target action date of March 25, 2027.
Unicycive Therapeutics, Inc. is a B2i Digital Featured Company. See the company's in-depth profile at: https://b2idigital.com/unicycive-therapeutics.
"We are pleased that the FDA has accepted the resubmission of our NDA for OLC and assigned a PDUFA date," said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. "This resubmission includes CMC data from a new third-party drug product manufacturing vendor. The new vendor's facility was last inspected by the FDA in March 2024 and received 'No Action Indicated' status. We hope to continue working with the FDA toward potential approval of this important medication to patients with CKD on dialysis who need additional treatment options for managing hyperphosphatemia."
The Company does not know whether the FDA will decide to conduct a pre-approval inspection of the new third-party DP vendor. Additionally, if the original third-party manufacturing vendor is inspected in the near term and finds that its facility complies with current Good Manufacturing Practice (cGMP), the Company plans to seek FDA alignment on a shorter approval timeline.
The Company resubmitted the NDA following the second CRL, which cited deficiencies previously identified at the original third-party manufacturer of the drug product, which the FDA had not been able to re-inspect during the prior submission review.
The timing and outcome of any FDA inspection of the original third-party vendor will be determined solely by the FDA.
The NDA is supported by data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, as well as CMC data. The FDA did not raise any concerns regarding OLC's preclinical or clinical data, including safety data, included in the original NDA submission.
About Oxylanthanum Carbonate
OLC is an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden. Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.
About Hyperphosphatemia
Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). Annually there are over 450,000 individuals in the U.S. that require medication to control their phosphate levels.[1] Uncontrolled hyperphosphatemia is strongly associated with increased death and hospitalization for CKD patients on dialysis. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.
[1] Flythe JE. Dialysis-Past, Present, and Future: A Kidney360 Perspectives Series. Kidney360. 2023 May 1;4(5):567-568. doi: 10.34067/KID.0000000000000145.
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive's lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit Unicycive.com.
Forward-looking statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Unicycive's expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; Unicycive's clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; Unicycive's dependence on third parties for manufacturing; the possibility that FDA may require inspection of any vendor prior to approval, which could delay or prevent approval of its NDA; the risk that the inspection of the original or new third-party manufacturing vendor may not occur within a timeframe that benefits its regulatory timeline, or may result in adverse findings; risks related to business interruptions, which could seriously harm its financial condition and increase its costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; market acceptance of its products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled 'Risk Factors' in Unicycive's Annual Report on Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Investor Contacts:
Kevin Gardner, LifeSci Advisors, kgardner@lifesciadvisors.com
Media Contact:
Unicycive Therapeutics, media@unicycive.com
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SOURCE: Unicycive Therapeutics, Inc.
Oct 22 · 00:00·ACN Newswire
Legal
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Oct 21 · 20:48·MarketersMEDIA
Insurance · Legal
A new León Law Firm guide explains how uninsured and underinsured motorist coverage works in Texas, why minimum liability limits often fall short and what injured drivers must do to get paid. -- The León Law Firm, P.C. has published a guide to uninsured motorist coverage in Texas, explaining how drivers can recover when the person who hit them has no insurance or not enough of it. The guide is available at https://th
Oct 21 · 20:44·MarketersMEDIA
Finance · Healthcare
Delta Air Lines (NYSE: DAL) today reported financial results for the September quarter and provided its outlook for the December quarter and full year 2026.
“Demand remains strong, supported by consumers’ growing preference for experiences and travel, with air travel continuing to be one of the best values in the consumer economy," said Ed Bastian, Delta's Chief Executive Officer. "Against this backdrop, we delivered September quarter pre-tax profit of $1.5 billion, matching last year's performance, and generated $1.9 billion of free cash flow year-to-date. Our resilience reflects the structural durability we’ve built over many years, enabling us to effectively navigate one of the most elevated fuel environments in recent times. The foundation of that resilience is our people, whose commitment to delivering for our customers continues to set Delta apart."
Bastian continued, "For the full year, we expect to generate a pre-tax profit of roughly $4.5 billion, absorbing a $6 billion increase in fuel costs. Looking ahead, our focus remains on profitable growth and delivering against our long-term financial framework, including mid-teens margins and returns, durable free cash flow and gross leverage of approximately one times."
September Quarter 2026 GAAP Financial Results
Operating revenue of $20.2 billion
Operating income of $1.5 billion with an operating margin of 7.2%
Pre-tax income of $1.1 billion with a pre-tax margin of 5.3%
Earnings per share of $1.15
Operating cash flow of $1.7 billion
September Quarter 2026 Non-GAAP Financial Results
Operating revenue of $17.6 billion
Operating income of $1.7 billion with an operating margin of 9.4%
Pre-tax income of $1.5 billion with a pre-tax margin of 8.5%
Earnings per share of $1.72
Operating cash flow of $1.7 billion
Read the full release on PR Newswire via download.
Forward Looking Statements
Statements made in this press release that are not historical facts, including statements regarding our estimates, expectations, beliefs, intentions, projections, goals, aspirations, commitments or strategies for the future, should be considered “forward-looking statements” under the Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Such statements are not guarantees or promised outcomes and should not be construed as such. All forward-looking statements involve a number of risks and uncertainties that could cause actual results to differ materially from the estimates, expectations, beliefs, intentions, projections, goals, aspirations, commitments and strategies reflected in or suggested by the forward-looking statements. These risks and uncertainties include, but are not limited to, the possible effects of serious accidents involving our aircraft or aircraft of our airline partners; breaches or lapses in the security of technology systems we use and rely on, which could compromise the data stored within them, as well as failure to comply with evolving global privacy and security regulatory obligations or
adequately address increasing customer focus on privacy issues and data security; disruptions in our information technology infrastructure; failure of the technology we use or depend on to perform effectively, including new and emerging technologies; increases in the price of aircraft fuel; extended
disruptions in the supply of aircraft fuel, including from Monroe Energy, LLC (“Monroe”), our wholly-owned subsidiary that operates the Trainer refinery; failure to achieve expected results or returns from our commercial relationships with airlines in other parts of the world and the investments we have in
certain of those airlines; the effects of a significant disruption in the operations or performance of third parties on which we rely; failure to comply with the financial or other covenants in our financing agreements; labor-related disruptions; the effects on our business of seasonality and other factors beyond our control, such as changes in value in our equity investments, severe weather conditions, natural disasters or other environmental events, including from the impact of climate change; failure or inability of insurance to cover a significant liability at Monroe’s refinery; failure to comply with existing and future environmental regulations to which Monroe’s refinery operations are subject, including those relating to the discharge of materials into the environment, waste management, pollution prevention measures and greenhouse gas emissions; significant damage to our reputation and brand, including from exposure to significant adverse publicity or inability to achieve certain sustainability goals; our ability to retain senior management and other key employees, and to maintain our company culture; disease outbreaks or other public health threats, and measures implemented to combat them; the effects of terrorist attacks, geopolitical conflict or security events; competitive conditions in the airline industry; extended interruptions or disruptions in service at major airports where we operate; significant problems associated with types of aircraft or engines we operate; the effects of extensive regulatory and legal compliance requirements we are subject to; the impact of laws and regulations governing environmental protection, including but not limited to regulation of hazardous substances, increased regulation to reduce emissions and other risks associated with climate change, and the cost of compliance with more stringent environmental regulations; and unfavorable economic or political conditions in the markets in which we operate or volatility in currency exchange rates.
Additional information concerning risks and uncertainties that could cause differences between actual results and forward-looking statements is contained in our Securities and Exchange Commission (SEC) filings, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and other filings filed with the SEC from time to time. Caution should be taken not to place undue reliance on our forward-looking statements, which represent our views only as of the date of this press release, and which we undertake no obligation to update except to the extent required by law.
Oct 9 · 10:30·Delta Air Lines
Finance · AI
Leverkusen, August 4, 2026 – The Bayer Group continued to make headway in the second quarter of 2026, capping off a successful first half of the year. “Operationally, we’re well on track to achieve our full-year outlook,” CEO Bill Anderson said when presenting the company’s Half-Year Financial Report on Tuesday. All three divisions are on target, he noted. Bayer has also made decisive progress on its long-term strategic priorities, Anderson emphasized. The landmark US Supreme Court ruling in the Durnell case is one such example, he said, adding that it puts Bayer in a stronger position for the proposed class settlement agreement. “Overall, our containment strategy is in a strong place, with some important milestones ahead,” Anderson explained.
Bayer is also advancing its other strategic priorities, Anderson said, pointing to progress in rejuvenating the Pharmaceuticals pipeline and executing the Five-Year Framework to improve profitability at Crop Science. In addition, Bayer’s lean, entrepreneurial operating model is driving efficiency gains across the entire Group, while also positioning the company well to effectively capitalize on the opportunities of artificial intelligence, he noted. “Over the past two and a half years, we’ve progressed in each of these areas. Each of them has demanded intense focus – and it’s imperative that we maintain that focus,” Anderson emphasized. “We’re concentrating on delivering our commitments and ensuring the best future for Bayer.”
Dr. Judith Hartmann, who took over the CFO role in June, shared her perspective. “I am excited to be part of the team driving Bayer forward at such an important time in its journey. While we’ve delivered strong strategic and financial progress, including meaningful steps on our balance sheet, important opportunities remain ahead of us. Bayer benefits from a powerful innovation engine and growth prospects across all three businesses. Our financial priorities are clear: to further strengthen the balance sheet, enhance productivity and improve cash generation, while continuing to invest behind growth and creating sustainable value,” Hartmann said.
Sales and EBITDA before special items up against prior year
Group sales came in at 10.872 billion euros in the second quarter of 2026, up 2.2 percent on a currency- and portfolio-adjusted basis (Fx & portfolio adj.). There was a negative currency effect of 63 million euros (Q2 2025: 550 million euros). EBITDA before special items increased by 1.9 percent to 2.144 billion euros, and included a negative currency effect of 70 million euros (Q2 2025: 184 million euros). EBIT amounted to 827 million euros (Q2 2025: 13 million euros) after net special charges of 172 million euros (Q2 2025: 981 million euros) that were primarily attributable to litigation-related expenses. Net income came in at 219 million euros (Q2 2025: minus 199 million euros). Core earnings per share decreased by 16.7 percent to 0.95 euros, with the improvement in earnings in the Crop Science Division only partially offsetting a normalization in tax expense and lower earnings in the Reconciliation.
Free cash flow amounted to minus 371 million euros (Q2 2025: 125 million euros), partly due to higher payments to resolve litigation. Net financial debt came in at 33.647 billion euros as of June 30, 2026, representing a 3.5 percent increase against March 31, 2026, and a 1.1 percent rise from a year-on-year perspective.
Crop Science: Topline growth and efficiencies in cost of goods sold drive higher earnings
In the agricultural business (Crop Science), sales increased by 3.5 percent (Fx & portfolio adj.) to 4.910 billion euros. Business was up at Soybean Seed & Traits and Cotton Seed following the return of the dicamba label in the United States, with gains of 16.9 and 69.2 percent (Fx & portfolio adj.), respectively. By contrast, sales at Corn Seed & Traits were down 2.5 percent (Fx & portfolio adj.), with substantial gains in Europe/Middle East/Africa and Asia/Pacific only partially offsetting lower volumes in North America, where business was impacted by volume phasing into the first quarter. In the Crop Protection business, growth was primarily driven by the division’s glyphosate-based herbicides. Sales of these products rose by 12.6 percent (Fx & portfolio adj.) fueled by higher volumes and prices, especially in Europe/Middle East/Africa. The Insecticides business recorded a 15.9 percent (Fx & portfolio adj.) increase in sales that was mainly attributable to higher volumes and prices in Europe/Middle East/Africa and Asia/Pacific.
EBITDA before special items at Crop Science advanced by 30.2 percent to 902 million euros. The increase in earnings was largely fueled by high-margin topline growth as well as a decline in the cost of goods sold that was driven by efficiency programs, as the division continues implementation of its Five-Year Framework. The EBITDA margin before special items increased by 3.9 percentage points to 18.4 percent.
Pharmaceuticals: Continued growth momentum for Nubeqa™ and Kerendia™
Sales of prescription medicines (Pharmaceuticals) came in at 4.458 billion euros, in line with the prior year (Fx & portfolio adj. plus 0.8 percent). The division again registered significant gains for its cancer drug Nubeqa™, as well as for Kerendia™, its product for the treatment of chronic kidney disease and heart failure. Nubeqa™ sales advanced by 63.9 percent (Fx & portfolio adj.), mainly driven by volume growth in the United States and Europe, while the 82.9 percent (Fx & portfolio adj.) rise in Kerendia™ sales was largely fueled by higher volumes in the United States and China. The Mirena™ product family also delivered very strong topline performance, especially in the United States, with global sales rising 9.0 percent (Fx & portfolio adj.). In the Radiology business, the division recorded gains of 26.8 and 8.1 percent (Fx & portfolio adj.) for Ultravist™ and CT Fluid Delivery, respectively. Business benefited from higher volumes, while prices remained stable. By contrast, Xarelto™ and Eylea™ sales were down significantly, as anticipated. After encountering headwinds from patent expirations, the oral anticoagulant posted a decline of 42.4 percent (Fx & portfolio adj.), while business with the ophthalmology drug decreased 32.8 percent (Fx & portfolio adj.). The Eylea™ 8 mg formulation offering extended treatment intervals accounted for around 55 percent of overall Eylea™ sales.
EBITDA before special items at Pharmaceuticals decreased by 3.6 percent to 1.055 billion euros. The decline in earnings was primarily attributable to the division channeling higher investments toward marketing its growth products Lynkuet™ (for the hormone-free treatment of menopause symptoms), Nubeqa™ and Kerendia™. In addition, the prior-year quarter had benefited from proceeds from the sale of non-core businesses. By contrast, earnings benefited from a reduction in allocations to provisions for the Group-wide short-term incentive (STI) program, as well as an inventory write-back. The EBITDA margin before special items decreased by 0.8 percentage points to 23.7 percent.
Consumer Health sales up in almost all categories and regions
Following a strong first quarter, sales of self-care products (Consumer Health) increased by 1.5 percent (Fx & portfolio adj.) to 1.445 billion euros. Business was up in almost all categories, with Digestive Health delivering the strongest growth, at 9.4 percent (Fx & portfolio adj.). By contrast, sales in the Allergy & Cold category were down 8.0 percent (Fx & portfolio adj.) due to soft seasonality. Regionally, the division continued to face headwinds from a weak market environment in the United States, while business was up year on year in Europe/Middle East/Africa, Latin America and Asia/Pacific.
EBITDA before special items at Consumer Health decreased by 3.6 percent to 319 million euros. The decline in earnings was mainly due to an increase in the cost of goods sold and unfavorable product mix effects. These headwinds were only partially offset by the division’s continuous cost and price management efforts. The EBITDA margin before special items declined by 1.1 percentage points to 22.1 percent.
Group sales and earnings up in first half of the year
In the first six months of 2026, Group sales rose by 3.3 percent (Fx & portfolio adj.) to 24.277 billion euros. EBITDA before special items advanced 6.6 percent to 6.597 billion euros, while core earnings per share increased 3.4 percent to 3.66 euros.
Currency-adjusted Group outlook confirmed
Bayer has affirmed its currency-adjusted Group guidance for full-year 2026 for all metrics except net financial debt, which it now expects to come in lower than originally projected, at 29 to 30 billion euros (previous forecast: 32 to 33 billion euros). The revised guidance for this KPI reflects the already announced agreement with Apollo-managed funds and affiliates. They will obtain a minority, non-controlling stake in a newly established entity holding Bayer’s long-acting reversible contraceptives (LARC) business in exchange for a €3.0 billion capital contribution.
In addition, applying the closing rates as of June 30, 2026, instead of March 31, 2026, results in the following changes: Group sales are now expected to come in at 44.7 to 46.7 billion euros (44.5 to 46.5 billion euros at previous closing rates), and core EPS at 4.20 to 4.70 euros (4.10 to 4.60 euros at previous closing rates).
Notes:
The following tables contain the key data for the Bayer Group and its divisions for the second quarter and the first six months of 2026.
The full Half-Year Financial Report is available online at:
www.bayer.com/halfyearreport. There is also a digital version available.
The speech given by Bill Anderson and Dr. Judith Hartmann to the media will be available online from around 9 a.m. CEST at: www.bayer.com/speeches
Live broadcast of the Media Update from around 9 a.m. CEST and recording available from around 12 p.m. CEST at: www.bayer.com/live-mc
Additional information for investors, including presentation charts, and access to the live broadcast of the Investor Video Call (from around 2 p.m. CEST) and recording (from around 6 p.m. CEST) available at: www.bayer.com/live-ic
Print-quality photos can be found online at: www.bayer.com/photo-footage
You can find FAQ on this topic here.
Find more information at www.bayer.com.
Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.
Aug 4 · 05:30·Bayer
SaaS · Healthcare
Leverkusen, June 25, 2026 – The U.S. Supreme Court issued a 7:2 landmark ruling in the Durnell Roundup™ case on Thursday, affirming that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) expressly preempts state-law-based failure-to-warn claims when the U.S. Environmental Protection Agency (EPA) has made a definitive determination on product safety. This decision, which reflects strong support across the ideological spectrum of the Court, helps to bring significant containment to the Roundup™ litigation. Glyphosate remains the most studied crop protection tool in the world and this decision affirms that the EPA’s safety determination is the law of the land, ensuring that companies cannot be punished under a patchwork of state tort laws for complying with federal labeling requirements.
“This decision is good for American farmers who help feed the world. It provides the regulatory clarity necessary for innovators like us to develop the agricultural tools that guarantee an affordable food supply,” said Bayer CEO Bill Anderson. "This litigation has enormous costs for the company and has impacted public trust. The decision brings overdue justice on an issue that should have been clarified much earlier. It’s time to put it behind us. Strengthened by this ruling, we continue to pursue our multi-pronged containment strategy, which includes the previously announced class settlement.”
The majority opinion states: “Durnell’s state law failure-to-warn claim would require a cancer warning on Roundup’s label — a requirement ‘in addition to’ and ‘different from’ the label required by EPA under FIFRA. FIFRA therefore expressly preempts Durnell’s claim.”
Impact of the Ruling
The holding in Durnell should result in the dismissal of current warnings-based claims and foreclose future claims based on state-failure-to-warn theories, which make up the vast majority of claims in the litigation to date.
In February 2026, along with class counsel, Monsanto announced a proposed U.S. nationwide class settlement designed to resolve current and future Roundup™ claims alleging non-Hodgkin lymphoma injuries through a long-term compensation program. Monsanto previously explained that the class settlement and Supreme Court strategies were independently necessary and mutually reinforcing elements of the company’s multi-pronged containment strategy. Together with today’s positive ruling, the class – which has received preliminary approval – will help ensure that Monsanto can significantly contain this litigation.
Good for farmers, food security, and American consumers
For years, American farmers have operated under a cloud of legal uncertainty created not by science, but by the litigation industry. Glyphosate-based herbicides are a foundation of modern, sustainable agriculture. Their safe and effective use supports food security, keeps production costs affordable, makes no-till, sustainable farm practices possible, and allows farmers to do more with less. This ruling restores the regulatory clarity that the agricultural sector, the broader food supply chain, and American consumers deserve after nearly a decade of well-funded attacks by the plaintiffs’ bar. It also provides an opportunity to restore public trust in the scientific consensus on the safety of glyphosate-based herbicides. The studies reviewed by regulatory authorities on glyphosate’s safety in connection with recent registration reviews are publicly available at www.bayer.com/en/glyphosate-studies
Court clarifies law that supports science
The EPA has repeatedly and unequivocally determined that glyphosate is not likely to be carcinogenic. Every leading independent regulatory body worldwide that has conducted its own review of glyphosate safety — from the European Food Safety Authority to regulators across Asia and Latin America — has reached the same conclusion. This is not the judgment of any single agency or administration; it is the settled consensus of the world's foremost scientific experts.
What has challenged this consensus is not new evidence — instead, it is largely a single, decade-old report from the International Agency for Research on Cancer (IARC) used in courtrooms by plaintiffs’ attorneys, despite the fact that every leading regulator in the world that has examined IARC’s report disagrees with its conclusions. Allowing this outlier report to override the expert determinations of federal regulatory agencies and scientists, despite the express uniformity requirements of federal law, has led to a patchwork of jury-by-jury requirements and uncertainties for manufacturers, farmers, and consumers alike. This decision restores the integrity of the scientific regulatory process and the independence of the experts within it.
The long road to this moment
This litigation has spanned years, consumed enormous resources, and distracted from what the company does best — promoting Health for all, Hunger for none. Many billions have been directed toward the Roundup™ litigation — money that could have funded the next generation of sustainable crop protection tools, breakthrough therapies, or other advances that farmers, consumers, and patients urgently need. These litigation costs diminish investments in innovation and are borne not just by the company, but by every patient waiting for a new therapy, every farmer waiting for a better tool, and every shareholder whose capital was diverted. Today marks the beginning of a new chapter in Health for all, Hunger for none.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com.
Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.
Jun 25 · 15:41·Bayer
Healthcare · Sustainability
Leverkusen, June 17, 2026 – On Wednesday, Judge Henry E. Autrey, a federal district court judge in the Eastern District of Missouri, issued a ruling remanding the class settlement case, King v Monsanto, back to Missouri State Court. Monsanto released the following statement in response to the Court’s decision:
This decision returns jurisdiction over the class settlement to Missouri Circuit Court where the vast majority of pending claims in the Roundup™ litigation have been filed. This decision brings much needed clarity to all parties and will enable the class approval process to continue to move forward. It also renders the related JPML proceedings moot, as this Court has determined the case belongs in state, rather than federal court.
Monsanto remains confident that the class settlement, which is supported by plaintiffs’ counsel representing tens of thousands of potential class members, is fair to all parties and the objections have no merit.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com.
Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.
Jun 17 · 16:05·Bayer
Finance · SaaS
Berlin, Germany, June 17, 2026 – Bayer today announced the completion of the acquisition of Perfuse Therapeutics, Inc. As a result, Perfuse Therapeutics will now be fully integrated into Bayer. As announced previously, Bayer now holds the full rights pertaining to PER-001 intravitreal implant, a first in class, sustained release small molecule endothelin receptor antagonist currently in Phase II clinical development for the treatment of Glaucoma and Diabetic Retinopathy (DR).
This acquisition strengthens Bayer’s pharmaceutical pipeline and strategically fits with Bayer’s strong footprint and expertise in ophthalmology.
Under the terms of the agreement, Bayer paid an upfront payment of USD 300 million. The transaction carries a total potential value of up to USD 2.45 billion, comprising of the upfront payment and additional success-based milestone payments.
For Bayer, BofA Securities acted as exclusive financial advisor and Baker McKenzie acted as legal counsel. For Perfuse, Centerview Partners LLC acted as exclusive financial advisor and Goodwin Procter LLP acted as legal counsel.
About Perfuse Therapeutics
Perfuse Therapeutics is a biopharmaceutical company pioneering transformational research into the treatment of ischemia-induced ocular diseases. Enabled by its proprietary sustained-release drug delivery platform, the company is advancing its lead asset PER-001 for global leading causes of blindness. Headquartered in South San Francisco, Calif., and with R&D facilities in Durham, N.C., Perfuse Therapeutics has established a strong team committed to advancing disease-modifying therapies to patients with ocular disease around the world.
About Bayer'
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com.
Find more information at https://pharma.bayer.com/
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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.
Contact for media inquiries:
Lisa Varrelmann, phone: +49 1746466492
Email: lisa.varrelmann@bayer.com
Contact for investor inquiries:'
Bayer Investor Relations Team, phone +49 214 30-72704
Email: ir@bayer.com'
www.bayer.com/de/investoren/ir-team
Jun 17 · 06:30·Bayer
Finance · Healthcare
Leverkusen, May 12, 2026 – The Bayer Group has reported a solid performance across all divisions for the first quarter of 2026. “We’re pleased with how our businesses started the year and we’re confirming our currency-adjusted outlook for 2026,” CEO Bill Anderson said when presenting the company’s Quarterly Statement for the first quarter on Tuesday. Commenting on the company’s strategic priorities, he explained that “we continue to advance our plan and we’re dialed in on delivering our commitments in the current year.”
Group sales came in at 13.405 billion euros in the first quarter of 2026, up 4.1 percent on a currency- and portfolio-adjusted basis (Fx & portfolio adj.). There was a negative currency effect of 886 million euros (Q1 2025: 55 million euros). EBITDA before special items increased by 9.0 percent to 4.453 billion euros. This figure included a negative currency effect of 321 million euros (Q1 2025: 165 million euros). EBIT rose by 51.8 percent to 3.528 billion euros after net special gains of 324 million euros (Q1 2025: net special charges of 587 million euros) that mainly related to the sale of the global Avelox™ business for 250 million euros. Net income came in at 2.763 billion euros, and was therefore more than two times higher than a year earlier. Core earnings per share climbed 12.9 percent to 2.71 euros, largely driven by the increase in earnings at the Crop Science Division. However, growth was partially held back by a negative currency effect of 0.20 euros (Q1 2025: 0.13 euros).
Free cash flow came in at minus 2.320 billion euros (Q1 2025: minus 1.528 billion euros). This was mainly attributable to payments to resolve legal proceedings, which increased as expected and largely related to the PCB and glyphosate litigations. Overall, these payments resulted in a net outflow of 2.002 billion euros (Q1 2025: 66 million euros). Net financial debt as of March 31, 2026, came in at 32.518 billion euros, up 9.0 percent from December 31, 2025, as a result of the negative free cash flow. Compared to March 31, 2025, however, net financial debt was down 5.1 percent.
Crop Science posts gains in seed and traits
In the agricultural business (Crop Science), sales increased by 6.8 percent (Fx & portfolio adj.) to 7.558 billion euros. Growth was mainly driven by Soybean Seed & Traits, which saw sales double (Fx & portfolio adj.) largely due to the previously announced resolution of a licensing agreement with Corteva in North America, with this effect contributing the equivalent of 448 million euros to the topline. The Soybean Seed & Traits business also benefited from price recovery following the return of the dicamba label in the United States. In addition, the division posted a gain of 7.1 percent (Fx & portfolio adj.) at Corn Seed & Traits that was fueled by higher volumes at the start of season in North America and growth across all other regions as well. By contrast, the crop protection business declined, as expected. At Herbicides, for example, sales were down 10.2 percent (Fx & portfolio adj.) overall, with glyphosate-based products experiencing a 15.1 percent decline (Fx & portfolio adj.). In addition, sales at Fungicides decreased 10.7 percent (Fx & portfolio adj.).
EBITDA before special items at Crop Science rose by 17.9 percent to 3.014 billion euros. Strong growth in the Soybean Seed & Traits and Corn Seed & Traits businesses, as well as a decrease in the cost of goods sold due to efficiency programs more than offset the negative currency effect of 277 million euros (Q1 2025: 26 million euros). The EBITDA margin before special items increased by 6.2 percentage points to 39.9 percent, in line with the strategic objectives of the Five-Year Framework announced in 2025.
Pharmaceuticals records further significant gains for Nubeqa™ and Kerendia™
Sales of prescription medicines (Pharmaceuticals) came in at 4.249 billion euros, in line with the prior year (Fx & portfolio adj. minus 0.5 percent). The division again registered significant gains for Nubeqa™, the cancer drug, and Kerendia™, for the treatment of chronic kidney disease and heart failure. Nubeqa™ sales advanced 57.1 percent (Fx & portfolio adj.) thanks to higher volumes in the United States and Europe, while Kerendia™ sales were up 84.2 percent (Fx & portfolio adj.) due to volume growth in the United States and China. In addition, the division posted further gains in the Radiology business, which includes products such as Ultravist™ and CT Fluid Delivery, with growth driven by higher volumes. By contrast, sales of the oral anticoagulant Xarelto™ declined substantially as expected, falling 40.4 percent (Fx & portfolio adj.) due to patent expirations, while business with the ophthalmology drug Eylea™ was down 20.5 percent (Fx & portfolio adj.) as a result of competitive pressure from generics. The launch of Eylea™ 8 mg offering extended treatment intervals accounted for around 46 percent of overall Eylea™ sales.
EBITDA before special items at Pharmaceuticals declined by 7.5 percent to 1.242 billion euros. The decline in earnings was largely due to an increase in selling expenses that primarily related to the marketing of Lynkuet™ (elinzanetant), Bayer’s non-hormonal treatment for menopause symptoms, as well as Nubeqa™ and Kerendia™. Furthermore, the division made higher investments in its R&D activities. In addition, earnings were diminished by price declines, which were mainly attributable to patent expirations and were only partially offset by higher volumes. There was also a negative currency effect of 77 million euros (Q1 2025: 48 million euros). By contrast, earnings benefited from an increase in income from the sale of non-core businesses as well as lower inventory write-offs. The EBITDA margin before special items declined by 0.3 percentage points to 29.2 percent.
Consumer Health reports topline growth (Fx & portfolio adj.) driven by Nutritionals and Dermatology
Sales of self-care products (Consumer Health) rose by 5.3 percent (Fx & portfolio adj.) to 1.491 billion euros. The division registered gains (Fx & portfolio adj.) in almost all categories and regions. Performance was driven by the Nutritionals and Dermatology categories, which saw sales rise 12.5 percent and 9.6 percent (Fx & portfolio adj.), respectively. Growth in the Nutritionals category was fueled by very strong performance in the Natsana e-commerce business, along with good topline results for Elevit™ that were partly driven by a product-line extension. The Dermatology category continued to benefit from substantial gains for Bepanthen™ in Europe/Middle East/Africa. However, the division continued to encounter a weak market environment in the United States, along with a soft cold season, that weighed on growth.
EBITDA before special items at Consumer Health decreased by 1.5 percent to 337 million euros. Earnings were impacted by a negative currency effect of 31 million euros (Q1 2025: no material currency effects) and higher investments in marketing the division’s innovative products. These effects were largely offset by the increase in sales as well as a one-time gain from the sale of minor, non-strategic brands. The EBITDA margin before special items declined by 0.2 percentage points to 22.6 percent.
Currency-adjusted guidance confirmed
Commenting on the company’s expectations for the year, CFO Wolfgang Nickl said: “We reiterate our outlook at constant currencies for the full-year 2026, while continuing to monitor the geopolitical dynamics.” Bayer has also prepared its guidance based on closing-day rates. Applying the rates in effect on March 31, 2026, the company now expects sales to come in at 44.5 to 46.5 billion euros (previous forecast: 44 to 46 billion euros), EBITDA before special items at 9.4 to 9.9 billion euros (previous forecast: 9.1 to 9.6 billion euros) and core earnings per share at 4.10 to 4.60 euros (previous forecast: 4.00 to 4.50 euros), with the changes solely reflecting the impact of currency effects. “This is just a point-in-time analysis,” noted Nickl, adding that “we would still expect ongoing volatility around foreign exchange rate developments for the rest of this year.”
Notes:
The following tables contain the key data for the Bayer Group and its divisions for the first quarter of 2026.
The full Quarterly Statement for the first quarter is available online at: www.bayer.com/quarterly-statement. There is also a digital version available.
The speech given by Bill Anderson and Wolfgang Nickl to the media will be available online from around 10 a.m. CEST at: www.bayer.com/speeches
Live broadcast of the media update from around 10 a.m. CEST and recording available from around 1 p.m. CEST at: www.bayer.com/live-mc
Additional information for investors, including presentation charts, and access to the live broadcast of the Investor Video Call (from around 2 p.m. CEST) and recording (from around 6 p.m. CEST) available at: www.bayer.com/live-ic
Print-quality photos can be found online at: www.bayer.com/photo-footage
Find more information at www.bayer.com.
Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.
May 12 · 05:30·Bayer
Finance · SaaS
Berlin, Germany and San Francisco, California USA, May 6, 2026 – Bayer and Perfuse Therapeutics Inc. today announced an agreement under which Bayer will fully acquire Perfuse Therapeutics, a biopharmaceutical company pioneering transformational research into the treatment of ischemia-induced ocular diseases. With this acquisition, Bayer will hold the full rights pertaining to PER-001, a small molecule endothelin receptor antagonist currently in Phase II clinical development for the treatment of Glaucoma and Diabetic Retinopathy (DR).
This represents one of the first potential treatments for Glaucoma and DR being studied for its ability to improve the visual field for Glaucoma patients and to improve contrast sensitivity and reduce ischemia in DR patients.
“We are excited by the work of the team at Perfuse Therapeutics and encouraged by the potential of PER-001,” said Juergen Eckhardt, M.D., Head of Business Development and Licensing at Bayer Pharmaceuticals. “With this acquisition, we are complementing our expertise in ophthalmology and our pipeline, reinforcing our commitment to developing urgently needed therapies for patients.”
“I’m incredibly proud of what the Perfuse team has accomplished and deeply thankful to all our investors and collaborators," said Sevgi Gurkan, MD, Founder and CEO of Perfuse Therapeutics, Inc. "Bayer’s vision aligns closely with ours, and they have the scale and global resources to unlock the full potential of PER-001 to change the trajectory of human blindness. We are very excited to see our mission continue with even greater momentum.”
Glaucoma is a progressive optic neuropathy that causes the loss of retinal ganglion cells, resulting in loss of visual fields. It is the leading cause of irreversible vision loss1 affecting ~76-80 million people worldwide (2020) and is projected to affect ~112 million people by 2040 due to population aging.2 Despite its prevalence, there are no approved treatments today, preventing disease progression and blindness independently from the saturated approach of lowering intraocular pressure. There is a high unmet medical need for neuroprotective treatments for patients with Glaucoma.
Diabetic Retinopathy (DR) is a microvascular complication of diabetes that damages retinal capillaries, causing ischemia, leakage, and neovascularization affecting about 146 million people globally today. This includes about 25 percent of adults with diabetes and is projected to increase to 160 million people by 2045. Currently, 25 million people have vision‑threatening DR and 1.3 million people are blind.3
Under the terms of the agreement, the transaction carries a total potential value of up to USD 2.45 billion, comprising a USD 300 million upfront payment and additional development, regulatory, and commercial milestone payments based on success criteria.
For Bayer, BofA Securities is acting as exclusive financial advisor and Baker McKenzie is acting as legal counsel. For Perfuse, Centerview Partners LLC is acting as exclusive financial advisor and Goodwin Procter LLP is acting as legal counsel.
The acquisition is subject to and will become effective after receiving the necessary antitrust clearances and Perfuse stockholder approvals.
About PER-001
PER-001 is an investigational small molecule endothelin receptor antagonist being developed for the treatment of ophthalmic diseases. Endothelin is the most potent vasoconstrictor in the human body and is upregulated in glaucoma, diabetic retinopathy, age-related macular degeneration and retinal vein occlusion. Endothelin is involved in inflammation and cell death through its receptors expressed in retinal vascular and neuroretinal cells. The PER-001 intravitreal implant is a bio-erodible implant administered into the vitreous cavity of the eye using a single-use, 25-gauge applicator and designed to provide a sustained release of PER-001, allowing for a convenient dosing regimen.
About Perfuse Therapeutics
Perfuse Therapeutics is a biopharmaceutical company pioneering transformational research into the treatment of ischemia-induced ocular diseases. Enabled by its proprietary sustained-release drug delivery platform, the company is advancing its lead asset PER-001 for global leading causes of blindness. Headquartered in South San Francisco, Calif., and with R&D facilities in Durham, N.C., Perfuse Therapeutics has established a strong team committed to advancing disease-modifying therapies to patients with ocular disease around the world. For more information, visit www.perfusetherapeutics.com and LinkedIn.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com.
Find more information at https://pharma.bayer.com
Follow us on Facebook: http://www.facebook.com/bayer
Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.
1 Vision Loss Expert Group of the Global Burden of Disease, 2024, Eye
² Sarkis et al., 2025, Frontiers in Med
³ WHO, 2019, World report on vision Executive Summary
Bayer Global Media Contact:
Lisa Varrelmann, phone +49 1746466492
Email: lisa.varrelmann@bayer.com
Contact for investor inquiries:
Bayer Investor Relations Team,
phone +49 214 30-72704
Email: ir@bayer.com
www.bayer.com/de/investoren/ir-team
Perfuse Therapeutics Media Contact:
Perfuse Therapeutics Team
Email: info@perfusetherapeutics.com
Perfuse Therapeutics investor inquiries:
Perfuse Therapeutics Team
Email: info@perfusetherapeutics.com
May 6 · 06:30·Bayer
Legal
Delaware Chancery Court has granted the motion to dismiss filed by AnaptysBio, Inc. against TESARO’s claim for anticipatory breach.
Apr 27 · 07:00·GSK