Organon Announces US Food and Drug Administration Approval of Supplemental New Drug Application Extending Duration of Use of NEXPLANON® (etonogestrel implant) 68 mg Radiopaque




Organon Announces US Food and Drug Administration Approval of Supplemental New Drug Application Extending Duration of Use of NEXPLANON® (etonogestrel implant) 68 mg Radiopaque

JERSEY CITY, N.J.–(BUSINESS WIRE)–Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced today that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for NEXPLANON^® (etonogestrel implant), which is indicated for use by women of reproductive potential to prevent pregnancy. The sNDA extends the duration of use of NEXPLANON for up to five years, an extension of the previous three-year indication. During the clinical trial to assess the contraceptive efficacy and safety of extended use (years 4 and 5), no pregnancies were reported and there were no new safety findings.¹ Additionally, the study enrolled women with a range of body mass index (BMI) values (17.2 to 64.3 kg/m²), with 38.1% of them having a BMI ≥30 kg/m².

“Today marks an important milestone for women seeking a highly effective long-acting reversible contraceptive option, as well as another advancement in Organon’s women’s health franchise,” said Organon’s Head of Research and Development and Chief Medical Officer, Juan Camilo Arjona Ferreira, MD. “The sNDA approval of an extended duration up to five years, along with data about the use of NEXPLANON in women with varying BMIs, including women with overweight or obesity, is a testament to Organon’s commitment to inclusive and comprehensive women’s healthcare.”

In addition, this approval includes a new Risk Evaluation and Mitigation Strategy (REMS) program in the US to mitigate complications due to improper insertion and removal.² This REMS program will enhance Organon’s existing Clinical Training Program (CTP) and controlled distribution program, which has been in place since 2006, by instituting important proactive measures to certify providers in the proper insertion and removal of our product. See additional safety information below.

“The updated label for NEXPLANON reflects the diversity of patients we see every day—women throughout their reproductive ages, those seeking a long-acting option of up to five years, those who prefer birth control that goes in the arm rather than the uterus, and women across a wide range of BMIs,” said Anita Nelson, MD, Professor, Obstetrics and Gynecology at Western University of Health Sciences. “The REMS program builds on existing training requirements to ensure providers maintain the highest standards for insertion and removal, reinforcing confidence and best clinical practice.”

About the Extended-Use Trial for NEXPLANON

The contraceptive efficacy of NEXPLANON during use from 3 to 5 years was evaluated in a multicenter, single-arm, open-label study (NCT04626596) conducted in the United States.¹ A total of 399 women were evaluated, having a mean age of 27 years, ranging from 18 to 35 years, and having been using NEXPLANON for 36 months (± 2 weeks) from the date of insertion at the time of enrollment. Participants were 74.2% White, 16.8% Black/African American, 3.8% Asian, 1.3% American Indian or Alaska Native, 0.5% Native Hawaiian or Other Pacific Islander, and 3.5% multiple or missing races. The mean BMI was 29.4 kg/m² (range: 17.2-64.3 kg/m²), and the mean weight was 78.7 kg (range: 40.8-180.8 kg). One hundred fifty-two participants (38.1%) had a BMI ≥30 kg/m², including 40 participants (10.0%) with a BMI ≥40 kg/m².

The primary efficacy endpoint was the Pearl Index (PI) at years 4 and 5. No pregnancies were reported during this period, resulting in a PI of 0.0 (95% CI: 0.00, 0.69) pregnancies per 100 women-years of use, and there were no new safety findings.¹

About NEXPLANON REMS

A REMS is a strategy used by the FDA to manage known or potential risks associated with a product.² To mitigate complications due to improper insertion and removal, the FDA is requiring the implementation of a REMS program for NEXPLANON. NEXPLANON will only be available in the US through the NEXPLANON REMS program, which is planned to be available starting on February 23, 2026. Providers will have six months to enroll in the program in order to maintain their access to NEXPLANON for insertion.

If providers have questions, they can contact their Organon representative. They can also visit www.NEXPLANONREMS.com or call the Organon Service Center at 1-844-674-3200. If patients have questions, they should contact their healthcare provider.

Indication

NEXPLANON^® is indicated for prevention of pregnancy in women of reproductive potential for up to 5 years.

Selected Safety Information

WARNING: RISK OF COMPLICATIONS DUE TO IMPROPER INSERTION and REMOVAL

Improper insertion of NEXPLANON increases the risk of complications.

Proper training prior to first use of NEXPLANON can minimize the risk of improper NEXPLANON insertion.

Because of the risk of complications due to improper insertion and removal NEXPLANON is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the NEXPLANON REMS.

CONTRAINDICATIONS

• NEXPLANON should not be used in women who have known or suspected pregnancy; current or past history of thrombosis or thromboembolic disorders; liver tumors, benign or malignant, or active liver disease; undiagnosed abnormal uterine bleeding; known or suspected breast cancer, personal history of breast cancer, or other progestin-sensitive cancer, now or in the past; and/or allergic reaction to any of the components of NEXPLANON.

WARNINGS and PRECAUTIONS

Risk of Complications Due to Improper Insertion and Removal

Complications of Insertion and Removal

• NEXPLANON should be inserted subdermally so that it will be palpable after insertion, and this should be confirmed by palpation immediately after insertion. Failure to insert NEXPLANON properly may go unnoticed unless it is palpated immediately after insertion. Undetected failure to insert the implant may lead to an unintended pregnancy. Failure to remove the implant may result in continued effects of etonogestrel, such as compromised fertility, ectopic pregnancy, or persistence or occurrence of a drug-related adverse event.

• Complications related to insertion and removal procedures may occur, e.g., pain, paresthesia, bleeding, hematoma, scarring, or infection. If NEXPLANON is inserted deeply (intramuscular or intrafascial), neural or vascular injury may occur.

• Postmarketing reports of implants located within the vessels of the arm and the pulmonary artery may have been related to deep insertions or intravascular insertions. Endovascular or surgical procedures may be needed for removal.

• Implant removal may be difficult or impossible if the implant is not inserted correctly, is inserted too deeply, not palpable, encased in fibrous tissue, or has migrated. If at any time the implant cannot be palpated, it should be localized, and removal is recommended. When an implant is removed, it is important to remove it in its entirety. Failure to remove the implant may result in continued effects of etonogestrel, such as compromised fertility, ectopic pregnancy, or persistence or occurrence of a drug-related adverse event.

Broken or Bent Implants

• Cases of breakage or bending of implants while inserted within a patient’s arm have been reported. Cases of migration of a broken implant fragment within the arm have also occurred. These cases may be related to external forces, e.g., manipulation of the implant or contact sports. The release rate of etonogestrel may be slightly increased in a broken or bent implant, based on in vitro data.

NEXPLANON is available only through a restricted program under a REMS.

NEXPLANON REMS

• NEXPLANON is only available through a restricted program under a REMS called NEXPLANON REMS because of the risk of complications due to improper insertion and removal.

Notable requirements of the NEXPLANON REMS include the following:

• Healthcare providers must be certified with the program by enrolling and completing training on the proper insertion and removal of NEXPLANON prior to first use.
• Pharmacies must be certified with the program and must only dispense NEXPLANON to certified healthcare providers who dispense NEXPLANON for insertion.
• Wholesalers and distributors must be registered with the program and must only distribute to certified pharmacies and certified healthcare providers.

Further information is available at www.NEXPLANONREMS.com and 1-833-697-7367.

Changes in Menstrual Bleeding Patterns

• After starting NEXPLANON, women are likely to have changes in their menstrual bleeding pattern. These may include changes in frequency, intensity, or duration. Abnormal bleeding should be evaluated as needed to exclude pathologic conditions or pregnancy. In clinical studies of the non-radiopaque etonogestrel implant, reports of changes in bleeding pattern were the most common reason for stopping treatment (11.1%). Women should be counseled regarding bleeding pattern changes that they may experience.

Ectopic Pregnancies

• Be alert to the possibility of an ectopic pregnancy in women using NEXPLANON who become pregnant or complain of lower abdominal pain.

Thrombotic and Other Vascular Events

• The use of combination hormonal contraceptives increases the risk of vascular events, including arterial events (strokes and myocardial infarctions) or deep venous thrombotic events (venous thromboembolism, deep venous thrombosis, retinal vein thrombosis, and pulmonary embolism). It is recommended that women with risk factors known to increase the risk of venous and arterial thromboembolism be carefully assessed. There have been postmarketing reports of serious arterial thrombotic and venous thromboembolic events, including cases of pulmonary emboli (some fatal), deep vein thrombosis, myocardial infarction, and strokes, in women using etonogestrel implants. NEXPLANON should be removed in the event of a thrombosis. Due to the risk of thromboembolism associated with pregnancy and immediately following delivery, NEXPLANON should not be used prior to 21 days postpartum. Women with a history of thromboembolic disorders should be made aware of the possibility of a recurrence. Consider removal of the NEXPLANON implant in case of long-term immobilization due to surgery or illness.

Ovarian Cysts

• If follicular development occurs, atresia of the follicle is sometimes delayed, and the follicle may continue to grow beyond the size it would attain in a normal cycle. Generally, these enlarged follicles disappear spontaneously. Rarely, surgery may be required.

Carcinoma of the Breast and Reproductive Organs

• Some studies suggest that the use of combination hormonal contraceptives might increase the incidence of breast cancer and increase the risk of cervical cancer or intraepithelial neoplasia. Women with a family history of breast cancer or who develop breast nodules should be carefully monitored.

Liver Disease

• NEXPLANON should be removed if jaundice occurs.

Elevated Blood Pressure

• The NEXPLANON implant should be removed if blood pressure rises significantly and becomes uncontrolled.

Gallbladder Disease

• Studies suggest a small increased relative risk of developing gallbladder disease among combination hormonal contraceptive users. It is not known whether a similar risk exists with progestin-only methods like NEXPLANON.

Carbohydrate and Lipid Metabolic Effects

• Prediabetic and diabetic women using NEXPLANON should be carefully monitored.

Depressed Mood

• Women with a history of depressed mood should be carefully observed. Consideration should be given to removing NEXPLANON in patients who become significantly depressed.

Return to Ovulation

• In clinical trials with the non-radiopaque etonogestrel implant (IMPLANON), the etonogestrel levels in blood decreased below sensitivity of the assay by one week after removal of the implant. In addition, pregnancies were observed to occur as early as 7 to 14 days after removal. Therefore, a woman should re-start contraception immediately after removal of the implant if continued contraceptive protection is desired.

Fluid Retention

• Hormonal contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention. It is unknown if NEXPLANON causes fluid retention.

Contact Lenses

• Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.

ADVERSE REACTIONS

Clinical Trial Experience

• The most common adverse reaction causing discontinuation of use of the implant in 3-year clinical trials was change in menstrual bleeding patterns (11.1%).The most common adverse reactions (≥5%) reported in these clinical trials were headache (24.9%), vaginitis (14.5%), weight increase (13.7%), acne (13.5%), breast pain (12.8%), abdominal pain (10.9%), and pharyngitis (10.5%). In a separate clinical trial to assess contraceptive efficacy and safety of NEXPLANON beyond 3 years, up to 5 years, a similar adverse reaction profile was observed as in Years 1 through 3. The most frequently reported adverse reaction >5% was intermenstrual bleeding (5.4%). Changes in menstrual bleeding patterns were the most frequently reported adverse reaction leading to discontinuation occurring in 4.0% of participants.

DRUG INTERACTIONS

Effects of Other Drugs on Hormonal Contraceptives

Substances decreasing the plasma concentrations of hormonal contraceptives and potentially diminishing the efficacy of hormonal contraceptives:

• Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of hormonal contraceptives and potentially diminish the effectiveness of hormonal contraceptives or increase breakthrough bleeding. Women should use an alternative non-hormonal method of contraception or a back-up method when enzyme inducers are used with hormonal contraceptives, and continue back-up non-hormonal contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.

Substances increasing the plasma concentrations of hormonal contraceptives:

• Co-administration of certain hormonal contraceptives and strong or moderate CYP3A4 inhibitors may increase the serum concentrations of progestins, including etonogestrel.

Human Immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors:

• Significant changes (increase or decrease) in the plasma concentrations of progestin have been noted in cases of co-administration with HIV protease inhibitors, HCV protease inhibitors, or non-nucleoside reverse transcriptase inhibitors. These changes may be clinically relevant.

Effects of Hormonal Contraceptives on Other Drugs

• Hormonal contraceptives may affect the metabolism of other drugs. Consequently, plasma concentrations may either increase (for example, cyclosporine) or decrease (for example, lamotrigine).

USE IN SPECIFIC POPULATIONS

Pregnancy

• Rule out pregnancy before inserting NEXPLANON.

Lactation

• Small amounts of contraceptive steroids and/or metabolites, including etonogestrel are present in human milk. No significant adverse effects have been observed in the production or quality of breast milk, or on the physical and psychomotor development of breastfed infants.
• Hormonal contraceptives, including etonogestrel, can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women.

Pediatric Use

• The safety and effectiveness of NEXPLANON have been established in women of reproductive potential. Safety and effectiveness of NEXPLANON are expected to be the same in postpubertal adolescents as in adult women. NEXPLANON is not indicated before menarche.

PATIENT COUNSELING INFORMATION

• Advise women to contact their healthcare professional immediately if, at any time, they are unable to palpate the implant.

• NEXPLANON does not protect against HIV or other STDs.

Before prescribing NEXPLANON, please read the Prescribing Information, including the Boxed Warning. The Patient Information also is available.

About Organon

Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets.

Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at http://www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook.

Cautionary Note Regarding Forward-Looking Statements

Except for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about Organon’s expectations for the market potential for the five-year indication for NEXPLANON. Forward-looking statements may be identified by words such as “continue,” “forward,” “seek,” “strategy,” “commitment,” “mission,” “expect,” “future,” “believes,” “will,” “potential,” or words of similar meaning. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include, but are not limited to, an inability to grow the market for NEXPLANON as expected; expanded brand and class competition in the markets in which Organon operates; trade protection measures and import or export licensing requirements, including the direct and indirect impacts of tariffs (including any potential pharmaceutical sector tariffs), trade sanctions or similar restrictions by the US or other governments; changes in US and foreign federal, state and local governmental funding allocations including the timing and amounts allocated to Organon’s customers and business partners; economic factors over which Organon has no control, including changes in inflation, interest rates, recessionary pressures, and foreign currency exchange rates; difficulties with performance of third parties Organon relies on for its business growth; the failure of any supplier to provide substances, materials, or services as agreed, or otherwise meet their obligations to us; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to or affecting Medicare, Medicaid and health care reform, pharmaceutical pricing and reimbursement, access to our products, international reference pricing, including Most-Favored-Nation drug pricing, and other pricing-related initiatives and policy efforts; an inability to fully execute on Organon’s product development and commercialization plans; manufacturing difficulties or delays; disruptions at the US Food and Drug Administration, the US Securities and Exchange Commission (the “SEC”) and other US and comparable foreign government agencies; changes in government laws and regulations in the United States and other jurisdictions, including laws and regulations governing the research, development, approval, clearance, manufacturing, supply, distribution, and/or marketing of our products and related intellectual property, environmental regulations, and the enforcement thereof affecting Organon’s business; efficacy, safety or other quality concerns with respect to Organon’s marketed products, whether or not scientifically justified, leading to product recalls, withdrawals, labeling changes, or declining sales; future actions of third parties, including significant changes in customer relationships or changes in the behavior and spending patterns of purchasers of health care products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits and forgoing health care insurance coverage; the failure by Organon or its third party collaborators and/or their suppliers to fulfill our or their regulatory or quality obligations; and volatility of commodity prices, fuel, shipping rates that impact the costs and/or ability to supply Organon’s products. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s filings with the SEC, including the company’s most recent Annual Report on Form 10-K (as amended), Quarterly Reports on Form 10-Q (as amended), Current Reports on Form 8-K, and other SEC filings, available at the SEC’s Internet site (www.sec.gov).

________________

¹ Data available on request from Organon Professional Services-DAP (Marketing Operations), 30 Hudson St., Jersey City, NJ 07302. Please specify information package US-XPL-117854.

² Risk evaluation and mitigation strategies | REMS. US Food and Drug Administration. Updated May 20, 2025. Accessed September 10, 2025. https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems

Contacts

Media Contacts:

Janine Colavita

(732) 861-3806

Kate Vossen

(732) 675-8448

Investor Contacts:

Jennifer Halchak

(201) 275-2711

Renee McKnight

(551) 204-6129

DiaMedica Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)




DiaMedica Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

MINNEAPOLIS–(BUSINESS WIRE)–DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for preeclampsia, fetal growth restriction and acute ischemic stroke, today announced that on January 15, 2026, it granted options to purchase an aggregate of 50,000 shares of DiaMedica’s common stock to a newly hired non-executive employee whose employment commenced in December 2025. The stock options were a material inducement to the employee’s acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) as a component of their compensation.

The stock options were approved by the Compensation Committee of the Board of Directors and issued under the DiaMedica Therapeutics Inc. Amended and Restated 2021 Employment Inducement Incentive Plan. The options have an exercise price of $8.54 per share, which is equal to the closing price of the Company’s common stock on January 15, 2026, and are scheduled to vest and become exercisable, on a cumulative basis, with respect to 25% of such underlying shares on the one-year anniversary of the grant date and with respect to the remaining 75% of such underlying shares in 12 quarterly installments commencing three months after the one-year anniversary of the grant date, subject to the employee’s continued service with the Company. The options have a ten-year term.

About DiaMedica Therapeutics Inc.

DiaMedica Therapeutics Inc. is a clinical-stage biopharmaceutical company committed to improving the lives of people suffering from serious ischemic diseases with a focus on preeclampsia, fetal growth restriction and acute ischemic stroke. DiaMedica’s lead candidate, DM199, is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, an established therapeutic modality in Asia for the treatment of acute ischemic stroke, preeclampsia and other vascular diseases. For more information, visit DiaMedica’s website at www.diamedica.com.

Contacts

Corporate Contact:
Scott Kellen, Chief Financial Officer

(763) 496-5118 | skellen@diamedica.com

Investor Contact:
Mike Moyer, Managing Director, LifeSci Advisors

mmoyer@lifesciadvisors.com

Media Contact:
Madelin Hawtin, LifeSci Communications

mhawtin@lifescicomms.com

Repare Shareholders Approve Acquisition by XenoTherapeutics, Inc.




Repare Shareholders Approve Acquisition by XenoTherapeutics, Inc.

CAMBRIDGE, Mass. & MONTREAL–(BUSINESS WIRE)–Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a clinical-stage precision oncology company, today announced that its Shareholders (as defined below) have approved the acquisition of all of the issued and outstanding common shares of the Company (the “Common Shares” and the holders of the Common Shares, the “Shareholders”) by XenoTherapeutics, Inc. and Xeno Acquisition Corp. (jointly “Xeno”) a non-profit biotechnology company, by way of a statutory plan of arrangement (the “Transaction” or the “Arrangement”) at the special meeting of Shareholders held today (the “Meeting”).

The special resolution approving the Arrangement was approved by: (i) 99.76% of the votes cast by Shareholders present in person or represented by proxy at the Meeting, and (ii) 99.76% of the votes cast by Shareholders, present in person or represented by proxy at the Meeting, excluding for this purpose the votes required to be excluded pursuant to Multilateral Instrument 61- 101 Protection of Minority Security Holders in Special Transactions.

At the Meeting, Shareholders also approved: (a) on an advisory and non-binding basis, the compensation to be paid or become payable to the Company’s named executive officers that is based on or otherwise relates to the Arrangement by 99.34% of the votes cast by Shareholders present in person or represented by proxy at the Meeting; and (b) in the event the Arrangement is terminated, (i) the voluntary liquidation and dissolution of the Company by 99.75% of the votes cast by Shareholders present in person or represented by proxy at the Meeting and (ii) the appointment of KPMG LLP or, in the alternative, another liquidator of nationally recognized experience, as the liquidator of the Company with authorization for the board of directors of the Company to set the remuneration of the liquidator by 99.75% of the votes cast by Shareholders present in person or represented by proxy at the Meeting.

The Arrangement is subject to the approval of the Superior Court of Québec (the “Court”) and other customary closing conditions. The Court hearing for the final order to approve the Arrangement is expected to take place on January 23, 2026 and, assuming receipt of the approval of the Court and satisfaction of other customary conditions to closing, the completion of the Arrangement is expected to occur on or about January 28, 2026.

About Repare Therapeutics Inc.

Repare Therapeutics is a clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. Repare Therapeutics has developed highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s clinical-stage pipeline includes RP-3467, a Phase 1 Polθ ATPase inhibitor; and RP-1664, a Phase 1 PLK4 inhibitor. For more information, please visit www.reparerx.com and follow @Reparerx on X (formerly Twitter) and LinkedIn.

About XenoTherapeutics, Inc.

XenoTherapeutics, Inc. is a Massachusetts-based 501(c)(3) research foundation focused on advancing xenotransplantation through scientific research, clinical development, and public education. For more information, please visit www.xenotx.org.

Forward Looking Statements

This news release contains certain information which, as presented, constitutes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of applicable securities laws in Canada. All statements in this news release other than statements of historical facts are forward-looking statements and forward-looking information. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this news release include, but are not limited to, statements regarding: the proposed timing and completion of the Transaction; the timing and receipt of Court approval of the Transaction; the satisfaction of the conditions to the completion of the Transaction; and any other statements that are not statements of historical fact. These forward-looking statements are based on the Company’s expectations and assumptions as of the date of this news release. Each of these forward-looking statements involves risks and uncertainties, many of which are outside of the control of Repare, that could cause the Company’s actual results to differ materially from those expressed or implied by the forward-looking statements, including the consummation of the Transaction and the anticipated benefits thereof. Many factors may cause differences between current expectations and actual results, including, but not limited to those related to: (i) the completion of the Transaction on anticipated terms and timing, including obtaining required Court approvals, and the satisfaction of other conditions to the completion of the Transaction; (ii) potential litigation relating to the Transaction that could be instituted by or against the Company, Xeno, XOMA Royalty Corporation or their respective directors or officers, including the effects of any outcomes related thereto; (iii) the risk that disruptions from the Transaction will harm the Company’s business, including current plans and operations; (iv) the ability of the Company to retain and hire key personnel; (v) potential adverse reactions or changes to business relationships resulting from the announcement or completion of the Transaction; (vi) continued availability of capital and financing and rating agency actions; (vii) legislative, regulatory and economic developments affecting the Company’s business; (viii) the accuracy of the Company’s financial projections; (ix) general business, market and economic conditions; (x) certain restrictions during the pendency of the Transaction that may impact the Company’s ability to pursue certain business opportunities or strategic transactions; (xi) unpredictability and severity of catastrophic events, including but not limited to acts of terrorism, pandemics, outbreaks of war or hostilities, as well as the Company’s response to any of the aforementioned factors; (xii) significant transaction costs associated with the Transaction; (xiii) the possibility that the Transaction may be more expensive to complete than anticipated, including as a result of unexpected factors or events; (xiv) competitive responses to the Transaction; and (xv) the risks and uncertainties that are described in the Company’s definitive proxy statement on Schedule 14A in respect of the Transaction (the “Proxy Statement”), which is available on the Company’s EDGAR and SEDAR+ profiles and as otherwise disclosed from time to time on the Company’s EDGAR and SEDAR+ profiles. While the list of factors presented here and in the Proxy Statement is considered representative, no such list should be considered a complete statement of all potential risks and uncertainties related to the Transaction.

Other factors that may cause the Company’s actual results to differ from those expressed or implied in the forward-looking statements in this news release are identified in the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the U.S. Securities and Exchange Commission (the “SEC”) and the Autorité des Marchés Financiers (Quebec) (“AMF”) on March 3, 2025, and in other filings made with the SEC and AMF from time to time, including the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025. The Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. For more information, please visit reparerx.com and follow Repare on X (formerly Twitter) at @RepareRx and on LinkedIn at https://www.linkedin.com/company/repare-therapeutics/.

Contacts

Investor Relations & Media Contact:


Matthew DeYoung

Investor Relations and Media

Argot Partners

investor@reparerx.com

Bayer welcomes the U.S. Supreme Court decision to review the Durnell case in the Roundup™ litigation




Bayer welcomes the U.S. Supreme Court decision to review the Durnell case in the Roundup™ litigation

• Decision on the merits expected by June 2026
• Favorable outcome would contribute to significantly containing the Roundup™ litigation as the company continues its multi-pronged strategy

LEVERKUSEN–(BUSINESS WIRE)–The U.S. Supreme Court today announced that it will review the Durnell Roundup™ case. Monsanto petitioned the court to hear Durnell in April 2025 and address the split in authority among federal circuit courts on the application of federal preemption, a cross-cutting issue in the Roundup™ litigation. The company expects a decision on the merits during the Court’s 2026 session, which ends in June.

“The Supreme Court decision to take the case is good news for U.S. farmers, who need regulatory clarity,” said Bayer CEO Bill Anderson. “It’s also an important step in our multi-pronged strategy to significantly contain this litigation. It is time for the U.S. legal system to establish that companies should not be punished under state laws for complying with federal warning label requirements.” Every leading regulator worldwide has concluded that glyphosate-based herbicides can be used safely.

The Supreme Court previously called for the views of the Solicitor General, who submitted a brief in December on behalf of the United States Government agreeing with the company that the Court should hear the case, resolve the circuit split and rule in the company’s favor.

In his brief, Solicitor General John Sauer argued that upholding the Durnell decision would allow juries to ignore the expert scientific decisions made by the U.S. EPA regarding the safety of glyphosate, saying, “EPA has repeatedly determined that glyphosate is not likely to be carcinogenic in humans, and the agency has repeatedly approved Roundup labels that did not contain cancer warnings….This Court’s intervention is warranted to give FIFRA’s preemption provision its proper force.”

He also warned of the consequences of upholding Durnell, citing a prior Supreme Court holding: writing “where, as here, EPA has specified the health warnings that should appear on a particular pesticide’s label, a manufacturer should not be left subject to ‘50 different labeling regimes prescribing’ different requirements.”

In its petition, the company argues that a split among federal circuit courts in the Roundup™ litigation warrants review and resolution by the country’s top court. The Third Circuit Court of Appeals unanimously held in Schaffner that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) expressly preempts the plaintiff’s claims which were based on state failure-to-warn theories like those in Durnell. The Ninth and Eleventh Circuits and Missouri’s intermediate appellate court have reached different conclusions, and the petition argues that state and federal courts require guidance that only the U.S. Supreme Court can provide.

In October 2023, Durnell was tried in the Missouri Circuit Court for the City of St. Louis and the jury returned a verdict in favor of the plaintiff on just one of three claims. The jury found the company failed to warn of the product’s risk and awarded 1.25 million US-Dollars, but rejected all other claims and declined to award punitive damages. The company appealed the verdict in August 2024 and the Missouri Court of Appeals, Eastern District upheld the verdict in February 2025. Monsanto promptly filed a writ to transfer the case to the Missouri Supreme Court and it declined review on April 1, making it ripe for U.S. Supreme Court review. Monsanto filed its petition for certiorari just three days later.

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 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 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.

Contacts

Contact for media inquiries:

Brian Leake, phone +1 314.370.3285
Email: brian.leake@bayer.com

Philipp Blank, phone +49 214 30-20499
Email: philipp.blank@bayer.com

Contact for investor inquiries:
Bayer Investor Relations Team, phone +49 214 30-72704
Email: ir@bayer.com
www.bayer.com/en/investors/ir-team

Contact for U.S. investor inquiries:
Erica Mulligan, phone +1 314-985-7457
Email: erica.mulligan@bayer.com

Emmecell Appoints Ramin Valian as Chief Executive Officer to Advance Magnetic Cell Delivery Platform




Emmecell Appoints Ramin Valian as Chief Executive Officer to Advance Magnetic Cell Delivery Platform

MENLO PARK, Calif.–(BUSINESS WIRE)–Emmecell, a clinical-stage biotechnology company pioneering magnetic cell delivery technologies for ophthalmic disease, today announced the appointment of Ramin Valian as Chief Executive Officer. A veteran biopharmaceutical executive, Valian brings more than 20 years of global commercial and strategic leadership in eye care, with expertise spanning corneal disease, surgical and interventional glaucoma, retina, and consumer eye care. He has successfully led the launch of six ophthalmic products across therapeutics and medical technologies.

Valian joins Emmecell following a distinguished career at Allergan and AbbVie, where he played key roles in global strategy, clinical development, and commercialization of high-impact ophthalmic products. His decision to join Emmecell underscores his confidence in the company’s science, platform, and potential to deliver meaningful clinical impact for patients.

“I believe Emmecell’s magnetic cell delivery technology has the potential to fundamentally redefine ophthalmic treatment—from corneal disease to geographic atrophy,” said Ramin Valian, Chief Executive Officer of Emmecell. “The ability to precisely and non-invasively position therapeutic cells opens new possibilities for regenerative medicine. I’m honored to lead Emmecell as it advances toward pivotal clinical development and commercialization.”

Emmecell’s magnetic cell delivery (MCD) platform enables targeted placement of therapeutic cells through a minimally invasive procedure. The company’s lead program is being developed as a potential non-surgical alternative to corneal transplant, addressing limitations in donor tissue availability and surgical burden. Emmecell is also advancing a novel cell therapy for geographic atrophy, a significant unmet need in retinal disease.

“We are pleased to welcome Ramin to Emmecell,” said Jeffrey L. Goldberg, M.D., Ph.D., Co-Founder and Chairman of the Board. “His leadership experience and commitment to patient-centered innovation make him the right CEO for Emmecell as we advance programs in both corneal and retinal disease.”

As CEO, Valian will oversee corporate strategy, clinical and regulatory development, partnerships, and operational growth as the company prepares for pivotal cornea trials and commercialization.

About Emmecell

Emmecell is a clinical-stage biotechnology company developing magnetic cell delivery technologies to treat corneal disease, geographic atrophy, and other ophthalmic conditions. Its platform enables controlled, targeted positioning of therapeutic cells to support minimally invasive, regenerative alternatives to traditional surgical and pharmacologic therapies.

Contacts

Noelia Kunzevitzky, PhD

Chief Operating Officer

Emmecell

info@emmecell.com
650-769-4232

AGC Biologics Celebrates U.S. and EU Approval of Fondazione Telethon’s Waskyra™ Treatment for Wiskott-Aldrich Syndrome




AGC Biologics Celebrates U.S. and EU Approval of Fondazione Telethon’s Waskyra™ Treatment for Wiskott-Aldrich Syndrome

This further establishes the global leadership of AGC Biologics’ Milan Cell and Gene Center of Excellence in number of commercial products approved

MILAN–(BUSINESS WIRE)–#CGT–With the decision by the U.S. Food and Drug Administration and the European Commission to grant market authorization for Waskyra™, a gene therapy to treat Wiskott-Aldrich syndrome, AGC Biologics’ Milan Cell and Gene Center of Excellence announced it will continue to support the commercial development of this vital, life-changing therapy for young patients worldwide.

Wiskott-Aldrich syndrome is a rare immune disorder affecting approximately 1 in 250,000 live male births, leading to severe infections, increased bruising and bleeding, and other complications starting in early childhood due to problems with platelet production. Current treatment options include supportive therapies aimed at managing and preventing clinical manifestations, or a stem cell transplant from a familial donor.

Developed by Fondazione Telethon, a longtime client of AGC Biologics Milan, Waskyra is an ex vivo gene therapy using autologous CD34+ hematopoietic stem and progenitor cells that have been transduced with a lentiviral vector. Waskyra received orphan drug designation in both the EU/US and on November 13, 2025, the Committee for Medicinal Products for Human Use adopted a positive opinion of Waskyra that was sent to the European Commission to decide on EU marketing authorization.

To assist the effort to create a better treatment option for those afflicted by Wiskott-Aldrich syndrome, AGC Biologics developed and produced clinical grade lentiviral vectors carrying the relevant therapeutic gene and manufactured patient-specific genetically engineered cells from preclinical to commercial, assisting with regulatory filings at every step.

This adds to a growing list of cell and gene therapies manufactured by AGC Biologics approved for commercial use, and the third time AGC Biologics partnered with developers to continue manufacturing a rare disease drug considered not economically viable by traditional industry standards due to small population size and high manufacturing price per patient. In 2023, Fondazione Telethon became the first non-profit organization to take on the commercialization of a gene therapy, with AGC Biologics as their chosen manufacturer for lentiviral vectors and genetically engineered cells through the preclinical, clinical, and commercial development of their ultra-rare disease treatment pipeline for the last two decades.

“For nearly 15 years, we’ve worked with Fondazione Telethon to produce the lentiviral vector and the genetically modified cells that enable this therapy as part of our commitment to advancing innovative therapies for patients worldwide,” said Luca Alberici, General Manager, AGC Biologics Milan. “Fondazione Telethon has an ethical responsibility to ensure this life-changing therapy reaches every patient who needs it and AGC is fully committed to deliver on this responsibility.”

“We are extremely proud of the FDA approval and the positive CHMP opinion for Waskyra™—milestones made possible also thanks to the high-quality services provided by AGC Biologics,” said Celeste Scotti, Head of Research and Development at Fondazione Telethon. “Their expertise in producing lentiviral vectors and genetically modified cells has been instrumental in bringing this therapy to patients and in strengthening Fondazione Telethon’s role as a leading player in the field of advanced therapies.”

With its 30-year track record of regulatory approvals by the EMA and FDA, the AGC Biologics Milan site is a global leader with deep expertise in complex cell and gene therapy projects. The team has guided numerous products to commercial stages, manufactured hundreds of batches for clinical supply, and consistently met the highest global regulatory guidelines, quality performance metrics, and the unique complexities of technology transfers and manufacturing scale-up.

About Fondazione Telethon

Fondazione Telethon is an Italian non-profit biomedical organization committed to advancing research on rare and complex genetic diseases. For over 35 years, it has supported high-impact science aimed at developing innovative treatments and improving the lives of people affected by these conditions.

About AGC Biologics

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, to provide friendly and expert services. We provide world-class development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with locations in Seattle, Washington; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba and Yokohama, Japan. AGC Biologics is a part of AGC Inc.’s Life Science Business. The Life Science Business runs 10+ facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com.

Contacts

AGC Inc. corporate contact: info-pr@agc.com

AGC Biologics media contact: ksills@agcbio.com

Genmab Announces Topline Results for Epcoritamab (DuoBody® CD3xCD20) from Phase 3 EPCORE® DLBCL-1 Trial in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)




Genmab Announces Topline Results for Epcoritamab (DuoBody® CD3xCD20) from Phase 3 EPCORE® DLBCL-1 Trial in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Company Announcement

• Based on the topline results from the EPCORE^® DLBCL-1 trial, Genmab will engage global regulatory authorities to discuss next steps

COPENHAGEN, Denmark–(BUSINESS WIRE)–Genmab A/S (Nasdaq: GMAB) today announced topline results from the Phase 3 EPCORE DLBCL-1 trial evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, which demonstrated an improvement in progression-free survival (PFS) (HR: 0.74 [95% CI 0.60 to 0.92])^* in patients treated with epcoritamab monotherapy. Additionally, improvements were observed in the complete response rate, duration of response, and time to next treatment among patients treated with epcoritamab monotherapy. EPCORE DLBCL-1 is the first Phase 3 study to demonstrate an improvement in PFS in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who were treated with a CD3xCD20 T-cell engaging bispecific monotherapy. The study demonstrated an overall survival (OS) of HR: 0.96 [95% CI 0.77 to 1.20], which did not reach statistical significance.

The global study enrolled 483 patients with R/R DLBCL with at least one prior line of therapy (73% had received two or more prior lines) who were ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT). The study evaluated the safety and efficacy of epcoritamab monotherapy compared to investigator’s choice of either rituximab plus gemcitabine and oxaliplatin (R-GemOx), or bendamustine plus rituximab (BR).

The adverse events observed in this study appear consistent with the known safety profile of epcoritamab. Further analysis of the results is ongoing, including the potential impact of various factors, such as the COVID-19 pandemic and increasing availability of novel anti-lymphoma therapies. The full trial results will be submitted for presentation at a future medical meeting. Genmab and AbbVie will engage with global regulatory authorities to discuss next steps.

Data is anticipated in 2026 from two Phase 3 trials evaluating fixed duration epcoritamab in patients with DLBCL, including EPCORE DLBCL-2, a front-line study evaluating epcoritamab in combination with standard-of-care rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP), and EPCORE DLBCL-4, evaluating epcoritamab in combination with lenalidomide versus chemo-immunotherapy in patients with relapsed or refractory DLBCL.

“The EPCORE DLBCL-1 trial is the first Phase 3 study evaluating a bispecific antibody monotherapy to demonstrate improvements in progression-free survival in patients with relapsed or refractory DLBCL,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “The results from this global trial contribute to the growing body of evidence supporting epcoritamab and build upon the robust foundation established by epcoritamab, which has been used to treat thousands of patients in need of additional therapeutic options. Together with our partner, AbbVie, we remain deeply committed to advancing the development of epcoritamab as a potential core therapy across a broad range of B-cell malignancies.”

Epcoritamab (approved under the brand name EPKINLY^® in countries including the U.S. and Japan, and as TEPKINLY^® in the European Union) has received regulatory approval in certain lymphoma indications in more than 65 countries. Genmab and AbbVie remain committed to advancing the potential of epcoritamab, with ongoing clinical programs evaluating the therapy as a monotherapy and in combination regimens across treatment lines and a broad range of hematologic malignancies.

About Diffuse Large B-Cell Lymphoma

Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma (NHL) worldwide, accounting for approximately 25-30 percent of all NHL cases.^i,ii In the U.S., there are approximately 25,000 new cases of DLBCL diagnosed each year.ⁱⁱⁱ DLBCL can arise in lymph nodes as well as in organs outside of the lymphatic system, occurs more commonly in the elderly and is slightly more prevalent in men.^iv,v DLBCL is a fast-growing type of NHL, a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. For many people living with DLBCL, their cancer either relapses, which means it may return after treatment, or becomes refractory, meaning it does not respond to treatment. Although new therapies have become available, treatment management can remain a challenge.^iv,vi

About the EPCORE DLBCL-1 Trial

EPCORE DLBCL-1 (NCT04628494) is a global Phase 3 open label, multi-center, randomized trial to evaluate the efficacy of epcoritamab (GEN3013, DuoBody^®-CD3xCD20) compared to investigator’s choice of chemotherapy, either rituximab plus gemcitabine plus and oxaliplatin (R-GemOx), or bendamustine plus rituximab (BR), in patients with relapsed or refractory DLBCL who are ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT). The trial started on January 13, 2021, and is ongoing.

More information on this trial can be found at https://www.clinicaltrials.gov/.

About Epcoritamab

Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.^vii

Epcoritamab (approved under the brand name EPKINLY^® in the U.S. and Japan, and TEPKINLY^® in the EU) has received regulatory approval in certain lymphoma indications in several territories. Where approved, epcoritamab is a readily accessible therapy. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication.

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes three ongoing Phase 3, open-label, randomized trials, among them a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658), and a trial evaluating epcoritamab in combination with lenalidomide and rituximab (R²) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.

EPKINLY^® (epcoritamab-bysp) U.S. INDICATIONS AND IMPORTANT SAFETY INFORMATION

What is EPKINLY?

EPKINLY is a prescription medicine used to treat adults with:

• certain types of diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma that has come back (relapsed) or that did not respond (refractory), after 2 or more treatments.
  • EPKINLY for the treatment of DLBCL is approved based on patient response data. Studies are ongoing to confirm the clinical benefit of EPKINLY.
• follicular lymphoma (FL) that has come back or that did not respond to previous treatment, together with lenalidomide and rituximab
• follicular lymphoma (FL) that has come back or that did not respond after receiving 2 or more treatments.

It is not known if EPKINLY is safe and effective in children.

Important Warnings—EPKINLY can cause serious side effects, including:

• Cytokine release syndrome (CRS), which is common during treatment with EPKINLY and can be serious or lead to death. To help reduce your risk of CRS, you will receive EPKINLY on a step-up dosing schedule (when you receive 2 or 3 smaller step-up doses of EPKINLY before your first full dose during your first cycle of treatment), and you may also receive other medicines before and for 3 days after receiving EPKINLY. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule.
• Neurologic problems that can be serious, and can be life-threatening, and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY.

People with DLBCL or high-grade B-cell lymphoma should be hospitalized for 24 hours after receiving their first full dose of EPKINLY on Day 15 of Cycle 1 due to the risk of CRS and neurologic problems.

People with follicular lymphoma (FL) may need to be hospitalized after receiving their first full dose of EPKINLY on Day 22 of Cycle 1 due to the risk of CRS.

Tell your healthcare provider or get medical help right away if you develop a fever of 100.4°F (38°C) or higher; dizziness or lightheadedness; trouble breathing; chills; fast heartbeat; feeling anxious; headache; confusion; shaking (tremors); problems with balance and movement, such as trouble walking; trouble speaking or writing; confusion and disorientation; drowsiness, tiredness or lack of energy; muscle weakness; seizures; or memory loss. These may be symptoms of CRS or neurologic problems. If you have any symptoms that impair consciousness, do not drive or use heavy machinery or do other dangerous activities until your symptoms go away.

EPKINLY can cause other serious side effects, including:

• Infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment and treat you as needed if you develop an infection. You should receive medicines from your healthcare provider before you start treatment to help prevent infection. Tell your healthcare provider right away if you develop any symptoms of infection during treatment, including fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, feeling weak or generally unwell, or confusion.
• Low blood cell counts, which can be serious or severe. Your healthcare provider will check your blood cell counts during treatment. EPKINLY may cause low blood cell counts, including low white blood cells (neutropenia and lymphopenia), which can increase your risk for infection; low red blood cells (anemia), which can cause tiredness and shortness of breath; and low platelets (thrombocytopenia), which can cause bruising or bleeding problems.

Your healthcare provider will monitor you for symptoms of CRS, neurologic problems, infections, and low blood cell counts during treatment with EPKINLY. Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects.

Before you receive EPKINLY, tell your healthcare provider about all your medical conditions, including if you have an infection, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. If you receive EPKINLY while pregnant, it may harm your unborn baby. If you are a female who can become pregnant, your healthcare provider should do a pregnancy test before you start treatment with EPKINLY and you should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY.

The most common side effects of EPKINLY when used alone in DLBCL or high-grade B-cell lymphoma or FL include CRS, injection site reactions, tiredness, muscle and bone pain, fever, diarrhea, COVID-19, rash, and stomach-area (abdominal) pain. The most common severe abnormal laboratory test results with EPKINLY when used alone include decreased white blood cells, decreased red blood cells, and decreased platelets.

The most common side effects of EPKINLY when used together with lenalidomide and rituximab in FL include rash, upper respiratory tract infections, tiredness, injection site reactions, constipation, diarrhea, CRS, pneumonia, COVID-19, and fever. The most common severe abnormal laboratory test results with EPKINLY when used together with lenalidomide and rituximab include decreased white blood cells and decreased platelets.

These are not all of the possible side effects of EPKINLY. Call your doctor for medical advice about side effects.

You are encouraged to report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622).

Please see Full Prescribing Information and Medication Guide, including Important Warnings.

Globally, prescribing information varies; refer to the individual product label for complete information.

About Genmab

Genmab is an international biotechnology company dedicated to improving the lives of people with cancer and other serious diseases through innovative antibody medicines. For over 25 years, its passionate, innovative and collaborative team has advanced a broad range of antibody-based therapeutic formats, including bispecific antibodies, antibody–drug conjugates (ADCs), immune-modulating antibodies and other next-generation modalities. Genmab’s science powers eight approved antibody medicines, and the company is advancing a strong late-stage clinical pipeline, including wholly owned programs, with the goal of delivering transformative medicines to patients.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

This Company Announcement contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab^®; the Y-shaped Genmab logo^®; Genmab in combination with the Y-shaped Genmab logo^®; HuMax^®; DuoBody^®; HexaBody^®; DuoHexaBody^®, HexElect^® and KYSO™. EPCORE^®, EPKINLY^®, TEPKINLY^® and their designs are trademarks of AbbVie Biotechnology Ltd.

Contacts

Contact:
Marisol Peron, Senior Vice President, Global Communications & Corporate Affairs

T: +1 609 524 0065; E: mmp@genmab.com

Andrew Carlsen, Vice President, Head of Investor Relations

T: +45 3377 9558; E: acn@genmab.com

Fluoxetine Hydrochloride (CAS 56296-78-7) Industry Research 2025: Global Market Trends 2019-2024 and Forecasts 2025-2029 – Applications, Manufacturing Method, Patents, Suppliers, Prices, End-users – ResearchAndMarkets.com




Fluoxetine Hydrochloride (CAS 56296-78-7) Industry Research 2025: Global Market Trends 2019-2024 and Forecasts 2025-2029 – Applications, Manufacturing Method, Patents, Suppliers, Prices, End-users – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Fluoxetine Hydrochloride (CAS 56296-78-7) Industry Research 2025: Global and Regional Market Trends 2019-2024 and Forecast to 2029” report has been added to ResearchAndMarkets.com’s offering.

This report on Fluoxetine hydrochloride provides comprehensive insights, including general information, synonyms, chemical composition, safety, hazards, handling, storage, and toxicological and ecological details, along with transport information. This in-depth study serves as a vital resource for understanding the Fluoxetine hydrochloride market landscape and its growth potential worldwide.

It explores various applications and examines manufacturing methods, supported by an analysis of relevant patents. The global market analysis covers constraints, drivers, and opportunities from 2019 to 2024, supply and demand dynamics, suppliers and regional overviews across Europe, Asia, North America, and other regions.

The report forecasts future trends and supply-demand scenarios up to 2029, with detailed market predictions by region. Additionally, it analyzes market prices across different regions and evaluates the end-use sectors for Fluoxetine hydrochloride.

The Fluoxetine hydrochloride global market report covers the following key points:

• Fluoxetine hydrochloride description, applications and related patterns
• Fluoxetine hydrochloride market drivers and challenges
• Fluoxetine hydrochloride manufacturers and distributors
• Fluoxetine hydrochloride prices
• Fluoxetine hydrochloride end-users
• Fluoxetine hydrochloride downstream industries trends

Key questions answered in the report:

• What were the main trends of the global Fluoxetine hydrochloride market in 2019-2024?
• What was the size of the global Fluoxetine hydrochloride market in 2019-2024?
• Who are the main players in the global Fluoxetine hydrochloride market?
• Which drivers and challenges will determine the development of the global Fluoxetine hydrochloride market during 2025-2029?
• What will the CAGRs be for the global product industry?

Key Topics Covered:

1. FLUOXETINE HYDROCHLORIDE

1.1. General information, synonyms

1.2. Composition, chemical structure

1.3. Safety information

1.4. Hazards identification

1.5. Handling and storage

1.6. Toxicological & ecological information

1.7. Transport information

2. FLUOXETINE HYDROCHLORIDE APPLICATIONS

3. FLUOXETINE HYDROCHLORIDE MANUFACTURING METHODS

4. FLUOXETINE HYDROCHLORIDE PATENTS

5. FLUOXETINE HYDROCHLORIDE WORLD MARKET ANALYSIS

5.1. Fluoxetine hydrochloride market constraints, drivers and opportunities in 2019-2024

5.2. Fluoxetine hydrochloride supply/demand in 2019-2024

5.3. Fluoxetine hydrochloride market overview by region – Europe, Asia, North America, etc.

6. MANUFACTURERS OF FLUOXETINE HYDROCHLORIDE

6.1. Fluoxetine hydrochloride manufacturers in Europe

6.2. Fluoxetine hydrochloride manufacturers in Asia

6.3. Fluoxetine hydrochloride manufacturers in North America

6.4. Fluoxetine hydrochloride manufacturers in RoW

7. SUPPLIERS OF FLUOXETINE HYDROCHLORIDE

7.1. Fluoxetine hydrochloride suppliers in Europe

7.2. Fluoxetine hydrochloride suppliers in Asia

7.3. Fluoxetine hydrochloride suppliers in North America

7.4. Fluoxetine hydrochloride suppliers in RoW

8. FLUOXETINE HYDROCHLORIDE WORLD MARKET FORECAST

8.1. Future trends in global Fluoxetine hydrochloride market

8.2. Fluoxetine hydrochloride supply/demand forecast to 2029

8.3. Fluoxetine hydrochloride market forecast to 2029 by region (Europe, Asia, North America, etc.)

9. FLUOXETINE HYDROCHLORIDE MARKET PRICES

9.1. Fluoxetine hydrochloride prices in Europe

9.2. Fluoxetine hydrochloride prices in Asia

9.3. Fluoxetine hydrochloride prices in North America

9.4. Fluoxetine hydrochloride prices in RoW

10. FLUOXETINE HYDROCHLORIDE END-USE SECTOR

For more information about this report visit https://www.researchandmarkets.com/r/qp8ifv

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Brotizolam (CAS 57801-81-7) Industry Research 2025: Global Market Trends 2019-2024 and Forecasts 2025-2029 – Applications, Manufacturing Method, Patents, Suppliers, Prices, End-users – ResearchAndMarkets.com




Brotizolam (CAS 57801-81-7) Industry Research 2025: Global Market Trends 2019-2024 and Forecasts 2025-2029 – Applications, Manufacturing Method, Patents, Suppliers, Prices, End-users – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Brotizolam (CAS 57801-81-7) Industry Research 2025: Global and Regional Market Trends 2019-2024 and Forecast to 2029” report has been added to ResearchAndMarkets.com’s offering.

This report on Brotizolam provides comprehensive insights, including general information, synonyms, chemical composition, safety, hazards, handling, storage, and toxicological and ecological details, along with transport information. This in-depth study serves as a vital resource for understanding the Brotizolam market landscape and its growth potential worldwide.

It explores various applications and examines manufacturing methods, supported by an analysis of relevant patents. The global market analysis covers constraints, drivers, and opportunities from 2019 to 2024, supply and demand dynamics, suppliers and regional overviews across Europe, Asia, North America, and other regions.

The report forecasts future trends and supply-demand scenarios up to 2029, with detailed market predictions by region. Additionally, it analyzes market prices across different regions and evaluates the end-use sectors for Brotizolam.

The Brotizolam global market report covers the following key points:

• Brotizolam description, applications and related patterns
• Brotizolam market drivers and challenges
• Brotizolam manufacturers and distributors
• Brotizolam prices
• Brotizolam end-users
• Brotizolam downstream industries trends

Key questions answered in the report:

• What were the main trends of the global Brotizolam market in 2019-2024?
• What was the size of the global Brotizolam market in 2019-2024?
• Who are the main players in the global Brotizolam market?
• Which drivers and challenges will determine the development of the global Brotizolam market during 2025-2029?
• What will the CAGRs be for the global product industry?
• And many others

Key Topics Covered:

1. BROTIZOLAM

1.1. General information, synonyms

1.2. Composition, chemical structure

1.3. Safety information

1.4. Hazards identification

1.5. Handling and storage

1.6. Toxicological & ecological information

1.7. Transport information

2. BROTIZOLAM APPLICATIONS

3. BROTIZOLAM MANUFACTURING METHODS

4. BROTIZOLAM PATENTS

5. BROTIZOLAM WORLD MARKET ANALYSIS

5.1. Brotizolam market constraints, drivers and opportunities in 2019-2024

5.2. Brotizolam supply/demand in 2019-2024

5.3. Brotizolam market overview by region – Europe, Asia, North America, etc.

6. MANUFACTURERS OF BROTIZOLAM

6.1. Brotizolam manufacturers in Europe

6.2. Brotizolam manufacturers in Asia

6.3. Brotizolam manufacturers in North America

6.4. Brotizolam manufacturers in RoW

7. SUPPLIERS OF BROTIZOLAM

7.1. Brotizolam suppliers in Europe

7.2. Brotizolam suppliers in Asia

7.3. Brotizolam suppliers in North America

7.4. Brotizolam suppliers in RoW

8. BROTIZOLAM WORLD MARKET FORECAST

8.1. Future trends in global Brotizolam market

8.2. Brotizolam supply/demand forecast to 2029

8.3. Brotizolam market forecast to 2029 by region (Europe, Asia, North America, etc.)

9. BROTIZOLAM MARKET PRICES

9.1. Brotizolam prices in Europe

9.2. Brotizolam prices in Asia

9.3. Brotizolam prices in North America

9.4. Brotizolam prices in RoW

10. BROTIZOLAM END-USE SECTOR

For more information about this report visit https://www.researchandmarkets.com/r/1rwrf8

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BeOne Medicines Highlights Global Oncology Leadership at 44th Annual J.P. Morgan Healthcare Conference




BeOne Medicines Highlights Global Oncology Leadership at 44th Annual J.P. Morgan Healthcare Conference

Company outlines foundational hematology leadership, multiple 2026 data catalysts, a unique global clinical development superhighway, and continued financial excellence

SAN CARLOS, Calif.–(BUSINESS WIRE)–$ONC #BeOne—BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, will outline the pillars of its growing global oncology leadership during its presentation today at the 44^th Annual J.P. Morgan Healthcare Conference in San Francisco.

John V. Oyler, Co-Founder, Chairman, and CEO at BeOne, will highlight the Company’s transformative leadership in treating B-cell malignancies. The presentation will feature BRUKINSA^®, the global leader among Bruton’s tyrosine kinase (BTK) inhibitors, as well as foundational hematology assets: sonrotoclax, a next-generation and potentially best-in-class B-cell lymphoma 2 (BCL2) inhibitor that received its first global regulatory approvals on December 30, and BGB-16673, a potentially first-in-class and best-in-class BTK chimeric degradation activation compound (CDAC). In addition, Mr. Oyler will share further information on BeOne’s global development superhighway, which encompasses global, wholly internal, and competitively advantaged clinical capabilities that can greatly reduce the cost and time to develop a new medicine, thereby increasing the speed of access to innovation for patients around the world.

“BeOne is emerging as the world’s leading oncology company with established leadership in the treatment of B-cell malignancies, an industry-leading pipeline and a unique set of internal capabilities to address tremendous unmet patient need around the world,” Mr. Oyler said. “BRUKINSA has entrenched itself as the best-in-class, foundational BTK inhibitor and global revenue leader with an unparallelled long-term efficacy and safety profile across all approved indications. The investigational combination of BRUKINSA and BCL2 inhibitor sonrotoclax has the potential to change the fixed-duration treatment landscape for CLL with best-in-class rates and kinetics of minimal residual disease. BGB-16673 is the most advanced BTK degrader in the clinic and continues to emerge as a potential first-in-class and best-in-class treatment. Combining one of the industry’s most innovative research teams with our vertically integrated clinical development capabilities puts us in a strong position for our next phase of growth with a solid financial profile and a growing global footprint.”

Key themes from BeOne’s presentation (7:30 a.m. PT, Tuesday, Jan. 13, 2026) at the J.P. Morgan Healthcare Conference include:

BeOne is the only company with potentially best-in-class, foundational medicines in three key MOAs in CLL

BeOne is the leading company in the treatment of chronic lymphocytic leukemia (CLL) with three approved or clinical-stage foundational medicines addressing all patient subtypes.

BRUKINSA is now the global revenue leader in the BTKi class and the only BTKi to demonstrate superior progression-free survival (PFS) and cardiac safety profile versus ibrutinib in a Phase 3 head-to-head trial. At the American Society of Hematology (ASH) Annual Meeting in December, the Company presented landmark six-year results from the global, Phase 3 SEQUOIA trial of BRUKINSA versus bendustamine plus rituximab (BR) in treatment-naïve CLL or small lymphocytic lymphoma with an estimated 74% PFS compared with 32% PFS for BR. The overall survival (OS) at 72 months was 84% for BRUKINSA and 80% with BR. After adjusting for COVID-19, the OS rates were 88% and 82%, respectively.

BeOne is rapidly advancing the investigational combination of BRUKINSA and sonrotoclax as a potential best-in-class fixed-duration regimen for the treatment of first-line CLL with clinical results showing potential best-in-class rates of undetectable minimal residual disease (uMRD) at the earliest time as exploratory endpoints. The Company anticipates uMRD results from the Phase 3 CELESTIAL trial of zanubrutinib plus sonrotoclax (ZS) versus venetoclax plus obinutuzumab (VO) in 2026.

In addition, the Company continues to advance BGB-16673 as a potentially first-in-class and best-in-class targeted degrader of BTK with Phase 1 trial results in heavily pretreated CLL patients at a median follow-up of 18 months demonstrating an overall response rate of 86% and 12-month progression-free survival of 79%. The Company anticipates potentially pivotal Phase 2 trial results for BGB-16673 in R/R CLL in 2026.

BeOne’s peerless global development superhighway combined with an industry-leading oncology R&D team drives faster development, accelerated regulatory registrations, and broader global patient access

BeOne is leveraging one of the largest oncology research teams in the industry alongside nearly 6,000 clinical development and manufacturing colleagues supporting the Company’s wholly internal, strategically advantaged global development superhighway to rapidly bring our medicines to cancer patients around the world.

The Company’s dedicated team of research scientists holds deep expertise in designing innovative small-molecule inhibitors, biologics, targeted protein degraders, multispecific antibodies and antibody drug conjugates. In the past 18 months, the Company has advanced 15 New Molecular Entities (NME) into the clinic across a broad range of modalities and expects to deliver an additional eight to 10 NMEs per year into the clinic starting in 2026. BeOne plans to share updates for the following programs, each of which has achieved clinical proof of concept and presents a significant market opportunity: CDK4 inhibitor, B7-H4 ADC, PRMT5 inhibitor, GPC3x41BB bispecific antibody, and CEA ADC.

A strong financial profile enables investment for BeOne’s future growth

BeOne’s strong financial position enables the Company to achieve greater global scale while maintaining profitability in 2026 and beyond.

The Company generated more than $350 million in free cash flow in the third quarter of 2025 with more than $4 billion in cash on hand. BeOne will continue to invest in driving innovation across its hematology and solid tumor pipelines to maximize long-term value for patients and shareholders while pursuing value-creating business development, including opportunities to leverage the Company’s global development superhighway.

Live webcast of BeOne’s presentation can be accessed from the investors section of the Company’s website at https://ir.beonemedicines.com. Archived replays will be available on the Company’s website.

About BeOne Medicines

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. The Company has a growing global team of nearly 12,000 colleagues spanning six continents who are driven by scientific excellence and exceptional speed to reach more patients than ever before.

To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeOne’s anticipated presentation at the 44^th Annual J.P. Morgan Healthcare Conference; the potential of sonrotoclax to be a best-in-class BCL2 inhibitor and BGB-16673 to be a first-in-class BTK CDAC; BeOne’s internal capabilities to drive innovation to address unmet patient need around the world; the potential of the combination of BRUKINSA and sonrotoclax to treat CLL; BeOne’s positioning for growth; anticipated timing of results from BeOne’s clinical trials of ZS versus VO and BGB-16673; BeOne’s expectations with respect to advancing NMEs into the clinic; BeOne’s ability to achieve greater global scale while maintaining profitability; BeOne’s plans to continue to invest in commercial assets and geographies that drive profitable growth; and BeOne’s plans, commitments, aspirations and goals under the caption “About BeOne.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeOne’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeOne’s ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeOne’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law. BeOne’s financial guidance is based on estimates and assumptions that are subject to significant uncertainties.

Contacts

Investor Contact
Liza Heapes

+1 857-302-5663

ir@beonemed.com

Media Contact
Kyle Blankenship

+1 667-351-5176

media@beonemed.com