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Merck, the Dow's hottest stock, gets set to report Q4 financialsShareholders of Organon & Co. NYSE: OGN approved the company’s proposed merger agreement with Sun Pharmaceutical Holdings USA, Inc. at a virtual special meeting held Wednesday, according to preliminary voting results announced during the meeting.

The special meeting was convened solely to consider two proposals described in Organon’s proxy statement: adoption of the merger agreement and a non-binding advisory vote on merger-related compensation that may be paid to the company’s named executive officers.

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Merger Agreement Approved Lululemon Athletica Races to New High with S&P 500 EntryKirke Weaver, Organon’s General Counsel and Corporate Secretary, said the merger agreement is dated April 26, 2026, and is among Organon, Sun Pharmaceutical Holdings USA, Inc., referred to during the meeting as Sun Pharma USA, and Sun Pharma America Inc., a wholly owned subsidiary of Sun Pharma USA, referred to as Merger Sub, along with other parties.

Under the agreement described by Weaver, Merger Sub will merge with and into Organon, with Organon surviving the transaction as a wholly owned subsidiary of Sun Pharma USA. Weaver said Organon’s board of directors recommended that shareholders vote in favor of both proposals.

After the polls closed, Weaver said the Inspector of Election had informed him that the preliminary vote report showed the requisite votes had been cast in favor of adopting the merger agreement. Weaver declared the merger agreement proposal approved.

Advisory Compensation Proposal Also Passes Shareholders also approved, on a non-binding advisory basis, compensation that may be paid or become payable to Organon’s named executive officers in connection with the merger.

Weaver said the preliminary vote report indicated that the compensation proposal also received the required shareholder support. The company said final certified voting results will be reported in a Form 8-K filing with the Securities and Exchange Commission in accordance with applicable SEC rules.

Meeting Details and Quorum The meeting was called to order at 10:02 a.m. Eastern Daylight Time by Carrie Cox, Executive Chairman of the Board. Cox said members of Organon’s board and executive leadership team were present, along with representatives of PricewaterhouseCoopers LLP, Organon’s independent registered public accounting firm, and Michael Barbera, who served as Inspector of Election.

Weaver said Organon’s board set June 15, 2026, as the record date for determining shareholders entitled to vote at the special meeting. As of that date, 262,609,433 shares of common stock were outstanding and entitled to vote.

According to Weaver, the Inspector of Election reported that immediately before the meeting began, 195,671,381 shares of common stock were represented in person or by proxy, equal to approximately 74.5% of the voting power as of the record date. Weaver said that amount was sufficient to establish a quorum.

The polls opened at 10:01 a.m. Eastern Daylight Time and closed at 10:06 a.m. Eastern Daylight Time. Cox adjourned the meeting at 10:07 a.m. Eastern Daylight Time, stating that there was no further business to come before shareholders.

About Organon & Co. (NYSE:OGN)Organon & Co is a global healthcare company that was established as an independent, publicly traded entity following its spin-off from Merck & Co in June 2021. Headquartered in Jersey City, New Jersey, Organon focuses on delivering therapeutic solutions across women’s health, biosimilars, and established brands. The company’s creation reflected a strategic effort to concentrate on specialty pharmaceuticals and legacy products with proven patient impact.

In women’s health, Organon provides a broad portfolio of products addressing reproductive and gynecological conditions, including fertility treatments, contraception, and hormone replacement therapies.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].

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Organon (OGN - Free Report) has been one of the most searched-for stocks on Zacks.com lately. So, you might want to look at some of the facts that could shape the stock's performance in the near term.

Shares of this pharmaceutical company have returned +0.6% over the past month versus the Zacks S&P 500 composite's +1.6% change. The Zacks Medical Services industry, to which Organon belongs, has gained 6.2% over this period. Now the key question is: Where could the stock be headed in the near term?

While media releases or rumors about a substantial change in a company's business prospects usually make its stock 'trending' and lead to an immediate price change, there are always some fundamental facts that eventually dominate the buy-and-hold decision-making.

Revisions to Earnings EstimatesHere at Zacks, we prioritize appraising the change in the projection of a company's future earnings over anything else. That's because we believe the present value of its future stream of earnings is what determines the fair value for its stock.

We essentially look at how sell-side analysts covering the stock are revising their earnings estimates to reflect the impact of the latest business trends. And if earnings estimates go up for a company, the fair value for its stock goes up. A higher fair value than the current market price drives investors' interest in buying the stock, leading to its price moving higher. This is why empirical research shows a strong correlation between trends in earnings estimate revisions and near-term stock price movements.

Organon is expected to post earnings of $0.87 per share for the current quarter, representing a year-over-year change of -13%. Over the last 30 days, the Zacks Consensus Estimate remained unchanged.

The consensus earnings estimate of $3.37 for the current fiscal year indicates a year-over-year change of -7.9%. This estimate has remained unchanged over the last 30 days.

For the next fiscal year, the consensus earnings estimate of $3.61 indicates a change of +7% from what Organon is expected to report a year ago. Over the past month, the estimate has remained unchanged.

Having a strong externally audited track record, our proprietary stock rating tool, the Zacks Rank, offers a more conclusive picture of a stock's price direction in the near term, since it effectively harnesses the power of earnings estimate revisions. Due to the size of the recent change in the consensus estimate, along with three other factors related to earnings estimates, Organon is rated Zacks Rank #3 (Hold).

The chart below shows the evolution of the company's forward 12-month consensus EPS estimate:

12 Month EPS

Revenue Growth ForecastWhile earnings growth is arguably the most superior indicator of a company's financial health, nothing happens as such if a business isn't able to grow its revenues. After all, it's nearly impossible for a company to increase its earnings for an extended period without increasing its revenues. So, it's important to know a company's potential revenue growth.

For Organon, the consensus sales estimate for the current quarter of $1.54 billion indicates a year-over-year change of -3.3%. For the current and next fiscal years, $6.11 billion and $6.14 billion estimates indicate -1.6% and +0.4% changes, respectively.

Last Reported Results and Surprise HistoryOrganon reported revenues of $1.46 billion in the last reported quarter, representing a year-over-year change of -3.5%. EPS of $0.71 for the same period compares with $1.02 a year ago.

Compared to the Zacks Consensus Estimate of $1.47 billion, the reported revenues represent a surprise of -0.48%. The EPS surprise was -14.46%.

Over the last four quarters, Organon surpassed consensus EPS estimates two times. The company topped consensus revenue estimates two times over this period.

ValuationWithout considering a stock's valuation, no investment decision can be efficient. In predicting a stock's future price performance, it's crucial to determine whether its current price correctly reflects the intrinsic value of the underlying business and the company's growth prospects.

Comparing the current value of a company's valuation multiples, such as its price-to-earnings (P/E), price-to-sales (P/S), and price-to-cash flow (P/CF), to its own historical values helps ascertain whether its stock is fairly valued, overvalued, or undervalued, whereas comparing the company relative to its peers on these parameters gives a good sense of how reasonable its stock price is.

As part of the Zacks Style Scores system, the Zacks Value Style Score (which evaluates both traditional and unconventional valuation metrics) organizes stocks into five groups ranging from A to F (A is better than B; B is better than C; and so on), making it helpful in identifying whether a stock is overvalued, rightly valued, or temporarily undervalued.

Organon is graded A on this front, indicating that it is trading at a discount to its peers. Click here to see the values of some of the valuation metrics that have driven this grade.

Bottom LineThe facts discussed here and much other information on Zacks.com might help determine whether or not it's worthwhile paying attention to the market buzz about Organon. However, its Zacks Rank #3 does suggest that it may perform in line with the broader market in the near term.

Organon (OGN - Free Report) has been one of the most searched-for stocks on Zacks.com lately. So, you might want to look at some of the facts that could shape the stock's performance in the near term.

Over the past month, shares of this pharmaceutical company have returned +1.1%, compared to the Zacks S&P 500 composite's -1.7% change. During this period, the Zacks Medical Services industry, which Organon falls in, has gained 14.8%. The key question now is: What could be the stock's future direction?

While media releases or rumors about a substantial change in a company's business prospects usually make its stock 'trending' and lead to an immediate price change, there are always some fundamental facts that eventually dominate the buy-and-hold decision-making.

Earnings Estimate RevisionsHere at Zacks, we prioritize appraising the change in the projection of a company's future earnings over anything else. That's because we believe the present value of its future stream of earnings is what determines the fair value for its stock.

We essentially look at how sell-side analysts covering the stock are revising their earnings estimates to reflect the impact of the latest business trends. And if earnings estimates go up for a company, the fair value for its stock goes up. A higher fair value than the current market price drives investors' interest in buying the stock, leading to its price moving higher. This is why empirical research shows a strong correlation between trends in earnings estimate revisions and near-term stock price movements.

For the current quarter, Organon is expected to post earnings of $0.87 per share, indicating a change of -13% from the year-ago quarter. The Zacks Consensus Estimate remained unchanged over the last 30 days.

The consensus earnings estimate of $3.37 for the current fiscal year indicates a year-over-year change of -7.9%. This estimate has remained unchanged over the last 30 days.

For the next fiscal year, the consensus earnings estimate of $3.61 indicates a change of +7% from what Organon is expected to report a year ago. Over the past month, the estimate has remained unchanged.

With an impressive externally audited track record, our proprietary stock rating tool -- the Zacks Rank -- is a more conclusive indicator of a stock's near-term price performance, as it effectively harnesses the power of earnings estimate revisions. The size of the recent change in the consensus estimate, along with three other factors related to earnings estimates, has resulted in a Zacks Rank #3 (Hold) for Organon.

The chart below shows the evolution of the company's forward 12-month consensus EPS estimate:

12 Month EPS

Revenue Growth ForecastWhile earnings growth is arguably the most superior indicator of a company's financial health, nothing happens as such if a business isn't able to grow its revenues. After all, it's nearly impossible for a company to increase its earnings for an extended period without increasing its revenues. So, it's important to know a company's potential revenue growth.

In the case of Organon, the consensus sales estimate of $1.54 billion for the current quarter points to a year-over-year change of -3.3%. The $6.11 billion and $6.14 billion estimates for the current and next fiscal years indicate changes of -1.6% and +0.4%, respectively.

Last Reported Results and Surprise HistoryOrganon reported revenues of $1.46 billion in the last reported quarter, representing a year-over-year change of -3.5%. EPS of $0.71 for the same period compares with $1.02 a year ago.

Compared to the Zacks Consensus Estimate of $1.47 billion, the reported revenues represent a surprise of -0.48%. The EPS surprise was -14.46%.

Over the last four quarters, Organon surpassed consensus EPS estimates two times. The company topped consensus revenue estimates two times over this period.

ValuationWithout considering a stock's valuation, no investment decision can be efficient. In predicting a stock's future price performance, it's crucial to determine whether its current price correctly reflects the intrinsic value of the underlying business and the company's growth prospects.

While comparing the current values of a company's valuation multiples, such as price-to-earnings (P/E), price-to-sales (P/S), and price-to-cash flow (P/CF), with its own historical values helps determine whether its stock is fairly valued, overvalued, or undervalued, comparing the company relative to its peers on these parameters gives a good sense of the reasonability of the stock's price.

The Zacks Value Style Score (part of the Zacks Style Scores system), which pays close attention to both traditional and unconventional valuation metrics to grade stocks from A to F (an A is better than a B; a B is better than a C; and so on), is pretty helpful in identifying whether a stock is overvalued, rightly valued, or temporarily undervalued.

Organon is graded A on this front, indicating that it is trading at a discount to its peers. Click here to see the values of some of the valuation metrics that have driven this grade.

Bottom LineThe facts discussed here and much other information on Zacks.com might help determine whether or not it's worthwhile paying attention to the market buzz about Organon. However, its Zacks Rank #3 does suggest that it may perform in line with the broader market in the near term.

Former Attorney General of Louisiana Charles C. Foti, Jr., Esq. and the law firm of [url="]Kahn Swick and Foti[/url], LLC (“KSF”) are investigating the propo

This transaction strengthens Organon’s contraception portfolio and expands long-acting reversible options for women

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, today announced the completion of a global licensing agreement with Sebela Pharmaceuticals, granting Organon exclusive rights to MIUDELLA®, a hormone-free, copper intrauterine device (IUD). Please see our prior announcement for a summary of the transaction terms.

Approved by the US Food and Drug Administration (FDA) on February 24, 2025, MIUDELLA is the first hormone-free copper IUD to be introduced in the US in over 40 years. Indicated for the prevention of pregnancy for up to three years in females of reproductive potential, MIUDELLA is 99% effective. It features a proprietary SLIMSERTTM technology, which consists of a highly flexible frame and a fully preloaded inserter with a small, tapered insertion tube diameter of 3.7mm.1

MIUDELLA is anticipated to be commercially available in late 2026. The MIUDELLA label includes a Risk Evaluation and Mitigation Strategy (REMS). A REMS is a strategy used by the FDA to manage known or potential risks associated with a product. To mitigate complications due to potential improper insertion, MIUDELLA will only be available in the US through the MIUDELLA REMS program. See additional safety information below.

“MIUDELLA represents an important hormone-free option in contraception, expanding choices for women seeking long‑acting reversible birth control,” said Joe Morrissey, Chief Executive Officer of Organon. “By building on our long history in contraception and leveraging our deep expertise and capabilities, this agreement strengthens Organon’s ability to deliver contraceptive options that meet the needs of women.”

“Developed by Sebela Women’s Health, MIUDELLA represents an effective option for pregnancy prevention,” said Alan Cooke, Chief Executive Officer and President of Sebela Pharmaceuticals. “We are delighted to complete this global license agreement with Organon. Organon offers the scale, launch readiness and access capabilities needed to bring this valuable product efficiently into clinical practice and help ensure MIUDELLA reaches more women who are looking for hormone-free contraception options.”

Truist Securities, Inc. acted as financial advisor to Sebela Pharmaceuticals.

About MIUDELLA

MIUDELLA was investigated in three clinical trials in the US in 1,904 women aged 17 to 45 years. The Phase 3 prospective, multicenter, single-arm, open-label study was conducted in 42 centers in the US with a primary endpoint of contraceptive efficacy through 3 years of use as assessed by the Pearl Index (defined as the number of pregnancies per 100 women over one year).1 In the efficacy cohort of women aged 17 to 35 years from the Phase 3 study (n=1397), the first-year Pearl Index was 0.94 (95% CI, 0.43-1.78) and the cumulative 3-year Pearl Index was 1.05 (95% CI, 0.66-1.60)—in other words, 99% effective, with an overall placement success rate of 98.8%. The most common adverse reactions (≥5%) observed in clinical trials were heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort, procedural pain, pelvic pain, post-procedural hemorrhage, and dyspareunia. In the first year, 8.5% of participants across all three studies discontinued treatment due to bleeding or pain adverse events, which decreased to 3.2% by year 3. Expulsion rates ranged from 1.9% in year 1 to 0.9% in year 3.

Indication

MIUDELLA® is a copper-containing intrauterine system (IUS) indicated for prevention of pregnancy in females of reproductive potential for up to 3 years. Selected Safety Information

WARNING: RISK OF COMPLICATIONS DUE TO IMPROPER INSERTION

Improper insertion of intrauterine systems, including MIUDELLA, increases the risk of complications. Proper training prior to first use of MIUDELLA can minimize the risk of improper insertion. MIUDELLA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MIUDELLA REMS program to ensure all healthcare providers are trained on the proper insertion of MIUDELLA prior to first use. Further information is available at miudellarems.com and 1-855-337-0772. CONTRAINDICATIONS

Use of MIUDELLA is contraindicated when 1 or more of the following conditions exist: Pregnancy or suspicion of pregnancy; congenital or acquired abnormalities of the uterus, including leiomyomas, resulting in distortion of the uterine cavity; acute pelvic inflammatory disease (PID); postpartum endometritis or postabortal endometritis in the past 3 months; known or suspected uterine or cervical malignancy; for use as postcoital contraception (emergency contraception); uterine bleeding of unknown etiology; untreated acute cervicitis or vaginitis or other lower genital tract infection; conditions associated with increased susceptibility to pelvic infections; Wilson's disease; a previously placed IUS that has not been removed; hypersensitivity to any component of MIUDELLA including to polypropylene, copper, nitinol, an alloy of nickel and titanium, or any of the trace elements present in the copper component of MIUDELLA. Persons with allergic reactions to these components may suffer an allergic reaction to this intrauterine system. Prior to placement, patients should be counseled on the materials contained in the IUS, as well as potential for allergy/hypersensitivity to these materials. WARNINGS AND PRECAUTIONS

Risk of Complications Due to Improper Insertion: Improper insertion of IUSs, including MIUDELLA, increases the risk of perforation, infection, undiagnosed abnormal bleeding, pregnancy loss (if pregnancy occurs with IUS in situ), and expulsion. Proper training prior to first use of MIUDELLA can minimize the risk of improper insertion. MIUDELLA is available only through a restricted program under a REMS. MIUDELLA REMS: MIUDELLA is only available through a restricted program under a REMS called MIUDELLA REMS Program to ensure healthcare providers are trained prior to first use. Notable requirements include the following: Healthcare providers must be certified with the program by enrolling and completing training on the proper insertion of MIUDELLA prior to first use. Pharmacies and healthcare settings that dispense MIUDELLA must be certified by enrolling in the REMS and must only dispense MIUDELLA to certified healthcare providers. Further information is available at www.miudellarems.com and 1-855-337-0772.

Ectopic Pregnancy: Promptly evaluate females who become pregnant for ectopic pregnancy while using MIUDELLA. Ectopic pregnancy may require surgery and may result in loss of fertility. Intrauterine Pregnancy: Increased risk of spontaneous abortion, septic abortion, premature delivery, sepsis, septic shock, and death if pregnancy occurs. Remove MIUDELLA if pregnancy occurs with MIUDELLA in place and the thread ends are visible or can be retrieved from the cervical canal. Sepsis: Severe infection or sepsis, including Group A streptococcal sepsis (GAS), have been reported following insertion of other IUSs; strict aseptic technique is essential during insertion. Pelvic Infection: Promptly examine users with complaints of lower abdominal or pelvic pain, odorous discharge, unexplained bleeding, fever, genital lesions or sores after insertion of MIUDELLA. IUSs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion. Remove MIUDELLA in cases of recurrent PID or endometritis, or if an acute pelvic infection is severe or does not respond to treatment. Subclinical PID: PID may be asymptomatic but still result in tubal damage and its sequelae.

Perforation: Partial or total perforation of the uterine wall or cervix may occur during insertions, although the perforation may not be detected until sometime later. Perforation may also occur at any time during IUS use. Perforation that results in embedment or translocation may reduce contraceptive efficacy and result in pregnancy. Risk is increased if inserted in postpartum and lactating females and may be increased if inserted in females with fixed, retroverted uteri or noninvoluted uteri. If perforation is suspected or if known perforation occurs during placement, the IUS should be removed as soon as possible. Surgery may be required. Delayed detection or removal of MIUDELLA in cases of perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal penetration, intestinal obstruction, abscesses and/or damage to adjacent organs. Expulsion: Partial or complete expulsion of MIUDELLA has been reported, resulting in the loss of contraceptive protection. MIUDELLA should be placed no earlier than 4 weeks post-pregnancy to mitigate the risk of expulsion that may be increased when the uterus is not completely involuted at the time of insertion. Remove a partially expelled MIUDELLA and do not attempt to push a partially expelled MIUDELLA into the uterus. Wilson’s Disease: MIUDELLA may exacerbate Wilson’s disease, a rare genetic disease affecting copper excretion; therefore, the use of MIUDELLA is contraindicated in females with Wilson’s disease. Bleeding Pattern Alterations: Menstrual bleeding may be altered and result in heavier and longer bleeding with spotting. Females complaining of heavy vaginal bleeding should be evaluated and treated, and may need to discontinue MIUDELLA. Magnetic Resonance Imaging (MRI) Safety Information: Patients using MIUDELLA can be safely scanned with MRI only under certain conditions. Medical Diathermy: Medical equipment that contains high levels of Radiofrequency (RF) energy such as diathermy may cause health effects (by heating tissue) in females with a metal-containing IUS including MIUDELLA. Avoid using high medical RF transmitter devices in females with MIUDELLA. ADVERSE REACTIONS

Most common adverse reactions (≥5%) observed in clinical trials were heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort, procedural pain, pelvic pain, post-procedural hemorrhage, and dyspareunia. Before prescribing MIUDELLA, please read the full Prescribing Information, including Boxed Warning.

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 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 U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about the potential benefits of Organon’s exclusive license of global rights to MIUDELLA® and expectations regarding the timing of commercialization thereof. Forward-looking statements may be identified by words such as “anticipated, “may”, “will”, and “expected,” among others. 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, weakening of economic conditions that could adversely affect the level of demand for MIUDELLA®; 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 healthcare reform, pharmaceutical pricing and reimbursement, access to the company’s products, international reference pricing, including most-favored-nation drug pricing, and other pricing related initiatives and policy efforts; the impact of tariffs and other trade restrictions or domestic sourcing requirements; expanded brand and class competition in the markets in which the company operates; the failure of any supplier to provide substances, materials, or services as agreed, or otherwise meet their obligations to the company; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties, including Sebela Pharmaceuticals; the impact of higher selling and promotional costs; efficacy, safety or other quality concerns with respect to the company’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 healthcare products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits and forgoing healthcare insurance coverage; the failure by the company or its third party collaborators and/or their suppliers to fulfill their or their regulatory or quality obligations; and volatility of commodity prices, fuel, and shipping rates that impact the costs and/or ability to supply the company’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 and subsequent SEC filings, available at the SEC’s Internet site (www.sec.gov). References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Organon is not responsible for the contents of third-party websites.

About Sebela Pharmaceuticals
At Sebela Pharmaceuticals, we are building a leading gastroenterology company in the US and developing innovative products in women’s health. Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals, has been innovating, developing, manufacturing, and commercializing gastroenterology products for over 40 years. Tegoprazan is Braintree’s lead program in GERD, and in 2025 Sebela Women’s Health obtained FDA approval for Miudella (copper-containing intrauterine system), the first non‑hormonal intra‑uterine device (IUD) for contraception approved in over 40 years. Sebela Pharmaceuticals has operations in Roswell, GA; Braintree, MA; and Dublin, Ireland.

For more information, visit www.sebelapharma.com.

Sebela Forward-Looking Statement
This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sebela Pharmaceuticals, Sebela Women’s Health and Braintree Laboratories under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These statements may be identified by the use of forward-looking words such as "anticipate," "planned," "believe," “may”, “will”, "forecast," "estimated," "expected," and "intend," among others. 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, risks related to the development, launch, introduction and commercial potential of Miudella; growth and opportunity, including peak sales and the potential demand for Miudella, as well as its potential impact on applicable markets; market size; substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third-party payer reimbursement; dependence upon third parties; our financial performance and results, including the risk that we are unable to manage our operating expenses or cash use for operations, or are unable to commercialize our products, within the guided ranges or otherwise as expected; and risks related to noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development and commercialization of new products. There are no guarantees that Miudella will prove to be commercially successful. While the list of factors presented here is considered representative, no such list should be considered a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and neither Sebela Pharmaceuticals, Sebela Women’s Health nor Braintree Laboratories agree to undertake any obligation to update publicly such statements to reflect subsequent events or circumstances except as required by law.

More News From Organon & Co.

The launch expands Organon’s biosimilars portfolio in Canada to eight products spanning five therapeutic areas

KIRKLAND, Quebec & SHANGHAI--(BUSINESS WIRE)--Organon Canada and Shanghai Henlius Biotech, Inc. (2696.HK) today announced that BILDYOS® (denosumab injection) 60 mg/1 mL and TUZEMTY® (denosumab injection) 120 mg/1.7 mL, biosimilars to PROLIA and XGEVA, respectively, are now available in Canada for all indications of reference products. Used across several indications, denosumab products treat osteoporosis and bone events associated with cancer by helping to strengthen bones.

“The approvals represent an important step toward helping broaden access to bone-care treatments in Canada. These biosimilars will introduce additional treatment options across several therapeutic areas, including osteoporosis, which predominantly affects women and impacts 2.3 million Canadians,”1 said Dominic Bégin, President and Managing Director at Organon Canada. “This development reinforces Organon’s commitment to expanding its biosimilar portfolio, improving treatment accessibility, and helping to strengthen the healthcare system while supporting patients in need.”

With this launch, Organon reinforces its commitment to offering patients in Canada more treatment options and helping to reduce healthcare costs by increasing access to biosimilars. BILDYOS® (denosumab injection) and TUZEMTY® (denosumab injection) have joined Organon’s growing biosimilars portfolio in Canada, which spans five therapeutic areas, including oncology, and includes products with more than nine years of market experience.

“The availability of BILDYOS® and TUZEMTY® marks an important step in our collaboration with Organon,” said Darius Panaligan, Chief Commercial Officer, International Markets of Henlius. “Together, we’ve translated our shared vision into tangible outcomes, helping to bring new treatment options to patients in Canada and reinforcing our joint commitment to long-term access.”

These product launches reflect Organon’s long-standing commitment to expanding access to cost-effective treatments and advancing women’s health through a patient-centered approach.

“The addition of new approved denosumab therapies help reinforce a resilient healthcare system and supports clinicians and patients in navigating osteoporosis treatment options with greater flexibility,” said Dr. Famida Jiwa, President and CEO, Osteoporosis Canada.

In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to several biosimilars, including BILDYOS® (denosumab injection) and TUZEMTY® (denosumab injection). The agreement covers exclusive global commercialization rights except for China.

For more information about these products, including important safety information, visit: BILDYOS_PM-E.pdf and TUZEMTY_PM-E.pdf

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, Biosimilars and General Medicines, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets. For more information, visit https://www.organon.com/canada-en/ and connect with us on LinkedIn.

About Henlius
Shanghai Henlius Biotech, Inc. (2696.HK) is a global, innovation-driven biopharmaceutical company committed to delivering high-quality, affordable biologic therapies to patients worldwide. The Company focuses on major disease areas including oncology, autoimmune diseases, and ophthalmic diseases. Founded in 2010, Henlius has established an integrated, end-to-end biopharmaceutical platform encompassing global R&D, clinical operations, regulatory affairs, manufacturing, and commercialisation. The Company employs nearly 4,000 people globally and operates across multiple regions, including China, the United States, and Japan. Leveraging the stable cash flow generated from its biosimilar portfolio to support innovation, Henlius is steadily advancing into its “Globalisation 2.0” phase, building a scalable and sustainable global growth model. As of early 2026, Henlius has achieved regulatory approvals for 10 products across over 60 countries and regions worldwide, including eight approvals in China. The Company has also reached multiple milestones in major biopharmaceutical markets, with four products approved by the U.S. Food and Drug Administration (FDA) and five products approved by the European Commission (EC), reflecting its globally aligned R&D capabilities, quality systems, and manufacturing standards.

Driven by innovation, Henlius has built a diversified, platform-based technology ecosystem through coordinated R&D efforts across Shanghai, the United States, and other regions. Its innovation platforms span immune checkpoint inhibitors, immune cell engager technologies (including multispecific T cell engagers), antibody-drug conjugates (ADCs), and AI-enabled early discovery platforms. The Company currently has more than 50 early-stage innovative assets, approximately 70% of which are expected to be best-in-class, with over 30 clinical trials ongoing globally. Henlius’ core product, serplulimab (trade name: Hetronifly® in Europe), is the world’s first anti–PD-1 mAb approved for first-line treatment of small cell lung cancer and has been approved in 50 markets worldwide with an accelerated globalisation process. In parallel, multiple high-potential innovative assets—including the PD-L1 ADC HLX43 and the novel epitope anti-HER2 mAb HLX22—are advancing through global pivotal clinical development. Supported by a biologics manufacturing network with a total capacity of 84,000L and GMP certifications from regulatory authorities in China, Europe, and the United States, Henlius has established a stable global supply system serving six continents. Guided by a patient-centred mission, Henlius remains focused on addressing unmet medical needs and translating scientific innovation into meaningful clinical value and patient access, contributing sustainably to the global biopharmaceutical ecosystem.

To learn more about Henlius, visit https://www.henlius.com/en/index.html and connect with us on LinkedIn at https://www.linkedin.com/company/henlius/.

1 What is osteoporosis? Osteoporosis Canada. 2024. Accessed April 27, 2026. https://osteoporosis.ca/what-is-osteoporosis/

More News From Organon & Co.

NEW YORK CITY & NEW ORLEANS--(BUSINESS WIRE)--Former Attorney General of Louisiana Charles C. Foti, Jr., Esq. and the law firm of Kahn Swick & Foti, LLC (“KSF”) are investigating the proposed sale of Organon & Co. (NYSE: OGN) to Sun Pharmaceutical Industries Limited. Under the terms of the proposed transaction, shareholders of Organon will receive $14.00 in cash for each share of Organon that they own. KSF is seeking to determine whether this consideration and the process that led to it.

JERSEY CITY, N.J.--(BUSINESS WIRE)--Organon (NYSE: OGN) today announced its results for the first quarter ended March 31, 2026. First Quarter 2026 Revenue in $ millions   Q1 2026   Q1 2025   VPY   VPY ex-FX Women's Health   $ 389   $ 463   (16)%   (19)% General Medicines                 Biosimilars     173     141   23%   21% Established Brands     880     887   (1)%   (7)% Other (1)     18     22   (15)%   (21)% Revenue   $ 1,460   $ 1,513   (4)%   (9)%     Totals may not foot due to rounding.

For the quarter ended March 2026, Organon (OGN - Free Report) reported revenue of $1.46 billion, down 3.5% over the same period last year. EPS came in at $0.71, compared to $1.02 in the year-ago quarter.

The reported revenue represents a surprise of -0.48% over the Zacks Consensus Estimate of $1.47 billion. With the consensus EPS estimate being $0.83, the EPS surprise was -14.87%.

While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectations to determine their next move, some key metrics always offer a more accurate picture of a company's financial health.

Since these metrics play a crucial role in driving the top- and bottom-line numbers, comparing them with the year-ago numbers and what analysts estimated about them helps investors better project a stock's price performance.

Here is how Organon performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts:

Revenue- Established Brands- U.S.- Respiratory- Other: $11 million versus the three-analyst average estimate of $9.57 million. The reported number represents a year-over-year change of +10%.Revenue- Women's Health- Int'l- Nexplanon/Implanon NXT: $74 million compared to the $78.51 million average estimate based on three analysts. The reported number represents a change of +2.8% year over year.Revenue- Women's Health- U.S.- NuvaRing: $6 million versus the three-analyst average estimate of $3.51 million. The reported number represents a year-over-year change of 0%.Revenue- Women's Health- Int'l- Follistim AQ: $39 million versus $35.59 million estimated by three analysts on average. Compared to the year-ago quarter, this number represents a +14.7% change.Revenue- Women's Health- Nexplanon/Implanon NXT: $201 million compared to the $219.22 million average estimate based on three analysts. The reported number represents a change of -19% year over year.Revenue- Established Brands Total: $880 million versus $868.4 million estimated by three analysts on average. Compared to the year-ago quarter, this number represents a -0.8% change.Revenue- Women's Health- NuvaRing: $24 million versus $19.75 million estimated by three analysts on average. Compared to the year-ago quarter, this number represents a +9.1% change.Revenue- Women's Health- Follistim AQ: $61 million versus $67.09 million estimated by three analysts on average. Compared to the year-ago quarter, this number represents a -11.6% change.Revenue- Biosimilars Total: $173 million compared to the $163.68 million average estimate based on three analysts. The reported number represents a change of +22.7% year over year.Revenue- Women?s Health Total: $389 million versus the three-analyst average estimate of $413.45 million. The reported number represents a year-over-year change of -16%.Revenue- Other Total: $18 million versus $22.43 million estimated by three analysts on average. Compared to the year-ago quarter, this number represents a -18.2% change.Revenue- Biosimilars- Renflexis: $57 million versus the three-analyst average estimate of $52.32 million. The reported number represents a year-over-year change of 0%.View all Key Company Metrics for Organon here>>>

Shares of Organon have returned +117.3% over the past month versus the Zacks S&P 500 composite's +12.2% change. The stock currently has a Zacks Rank #3 (Hold), indicating that it could perform in line with the broader market in the near term.

NEW YORK, May 05, 2026 (GLOBE NEWSWIRE) --

Class Action Attorney Juan Monteverde with Monteverde & Associates PC (the “M&A Class Action Firm”), has recovered millions of dollars for shareholders and is recognized as a Top 50 Firm in the 2025 ISS Securities Class Action Services Report. We are headquartered at the Empire State Building in New York City and are investigating

Organon & Co. (NYSE: OGN) related to its sale to Sun Pharmaceuticals Industries Limited. Under the terms of the proposed transaction, Organon shareholders will receive $14.00 per share in cash.
Click here for more information https://monteverdelaw.com/case/organon-co/. It is free and there is no cost or obligation to you.

Miluna Acquisition Corp. (NASDAQ: MMTX) related to its merger with CADV Ventures S.A.
Click here for more information https://monteverdelaw.com/case/miluna-acquisition-corp/. It is free and there is no cost or obligation to you.

Veris Residential, Inc. (NYSE: VRE) related to its sale to an investor consortium led by Affinius Capital in partnership with Vista Hill Partners. Under the terms of the proposed transaction, Veris shareholders are expected to receive $19.00 per share in cash.
ACT NOW. The Shareholder Vote is scheduled for May 21, 2026.

Click here for more information https://monteverdelaw.com/case/veris-residential-inc/. It is free and there is no cost or obligation to you.

Esquire Financial Holdings, Inc. (NASDAQ: ESQ) related to its merger with Signature Bancorporation.
ACT NOW. The Shareholder Vote is scheduled for June 23, 2026.

Click here for more info https://monteverdelaw.com/case/esquire-financial-holdings-inc/. It is free and there is no cost or obligation to you.

NOT ALL LAW FIRMS ARE THE SAME. Before you hire a law firm, you should talk to a lawyer and ask:

Do you file class actions and go to Court?When was the last time you recovered money for shareholders?What cases did you recover money in and how much?
About Monteverde & Associates PC

Our firm litigates and has recovered money for shareholders…and we do it from our offices in the Empire State Building. We are a national class action securities firm with a successful track record in trial and appellate courts, including the U.S. Supreme Court. 

No company, director or officer is above the law. If you own common stock in the above listed company and have concerns or wish to obtain additional information free of charge, please visit our website or contact Juan Monteverde, Esq. either via e-mail at [email protected] or by telephone at (212) 971-1341.

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Juan Monteverde, Esq.
MONTEVERDE & ASSOCIATES PC
The Empire State Building
350 Fifth Ave. Suite 4740
New York, NY 10118
United States of America
[email protected]
Tel: (212) 971-1341

Attorney Advertising. (C) 2026 Monteverde & Associates PC. The law firm responsible for this advertisement is Monteverde & Associates PC (www.monteverdelaw.com). Prior results do not guarantee a similar outcome with respect to any future matter.

VANCOUVER, BC / ACCESS Newswire / May 6, 2026 / (TSXV:OGN)(OTCQB:OGNNF) Orogen Royalties Inc. ("Orogen" or the "Company") is pleased to announce the appointment of Mr. Chad Wells to the Company's Board of Directors.

Mr. Wells is an experienced executive and geologist with over 25 years of multi-commodity expertise in the natural resources sector. Most recently, Chad was Vice President of Altius Minerals Corporation, where he played a key role in the development and commercialization of Altius' project generation platform. During his time at Altius, the business grew from an early-stage exploration company into a diversified mineral royalty company with a current market capitalization of approximately $3 billion. Mr. Wells brings extensive experience in structuring exploration agreements, creating royalty portfolios, and generating significant value through disciplined capital allocation. His background includes involvement in the acquisition and origination of numerous projects and royalties, as well as the co-founding and development of several publicly listed exploration companies.

Orogen CEO Paddy Nicol commented, "Chad has had a successful career in creating value for shareholders in the project generation and royalty space and he will bring a unique and complementary perspective to Orogen's board. His knowledge of markets, structuring transactions and negotiations will help bolster the strategic guidance of the Company. We welcome Chad to our board and look forward to working with him."

Chad Wells commented, "I'm very pleased to be joining the Board of Directors of Orogen Royalties. Orogen's disciplined approach to project generation and organic royalty creation strongly aligns with the philosophy I've worked within throughout my career. I look forward to working with a great team I know well and contributing to the Company's continued growth."

As part of Mr. Wells' compensation, the Board has agreed to grant 55,000 incentive stock options at a price of $3.34 for a period of five years. The foregoing subject to regulatory acceptance.

About Orogen Royalties Inc.

Orogen Royalties is focused on organic royalty creation and royalty acquisitions on precious and base metal discoveries in western North America. The Company's royalty portfolio includes the Ermitaño gold and silver Mine in Sonora, Mexico (2.0% NSR royalty) operated by First Majestic Silver Corp. The Company is well financed with several projects actively being developed by joint venture partners.

On Behalf of the Board
OROGEN ROYALTIES INC.

Paddy Nicol
President & CEO

To find out more about Orogen, please contact Paddy Nicol, President & CEO at 604-248-8648, and Marco LoCascio, Vice President, Corporate Development at 604-248-8648. Visit our website at www.orogenroyalties.com.

Orogen Royalties Inc.
1015 - 789 West Pender Street
Vancouver, BC
Canada V6C 1H2
[email protected]

Forward Looking Information

This news release includes certain statements that may be deemed "forward looking statements". All statements in this presentation, other than statements of historical facts, that address events or developments that Orogen Royalties Inc. (the "Company") expect to occur, are forward looking statements. Forward looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur.

Although the Company believe the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Factors that could cause the actual results to differ materially from those in forward looking statements include market prices, exploitation and exploration successes, and continued availability of capital and financing, and general economic, market or business conditions.

Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of the Company's management on the date the statements are made. Except as required by securities laws, the Company undertakes no obligation to update these forward-looking statements in the event that management's beliefs, estimates or opinions, or other factors, should change.

SOURCE: Orogen Royalties Inc

Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, will present data across women’s health, biosimilars, dermatology, and neurology at ISPOR 2026, the leading global scientific conference hosted by the International Society for Pharmacoeconomics and Outcomes Research. The conference, focused on health economics and outcomes research, will take place May 17-20, 2026, in Philadelphia, Pennsylvania.

Across 8 accepted abstracts, the data reflect Organon’s commitment to generating real-world evidence—rooted in lived experiences—that can help inform healthcare decision-making and improve health outcomes across a range of therapeutic areas.

“Health economics and outcomes research is critical to ensuring the right treatments reach patients and that health systems can sustain this approach over time,” said Juan Camilo Arjona Ferreira, MD, Head of R&D and Chief Medical Officer at Organon. “At ISPOR 2026, Organon is proud to share research findings about the budget impact, referral patterns, and real-world evidence of treatments for contraception, dermatology, and neurology conditions—each grounded in evidence that puts patient and provider perspectives at the center.”

Key data from Organon’s portfolio to be presented include:

An examination of the cost-effectiveness and budget impact of NEXPLANON® (etonogestrel implant) 68 mg Radiopaque in Brazil, including analyses that incorporate real-world utilization data and private payer perspectives. A budget impact analysis of VTAMA® (tapinarof) cream, 1%, for the treatment of atopic dermatitis in adult and pediatric patients (2 years of age and older) from a U.S. Medicaid plan perspective. Analyses related to POHERDY® (pertuzumab-dpzb) 420 mg/14 mL injection for intravenous use in certain HER2-positive breast cancer, as well as a real-world budget impact analysis of biosimilar adoption in a mid-sized Brazilian health maintenance organization. An exploration of real-world referral patterns and healthcare utilization among patients with headache disorders in the United Kingdom, contributing to a better understanding of patient pathways and healthcare resource use in neurology. Details on the abstracts noted above and additional presentations (including dates and times) can be found below. See below for full product information, including indication and selected safety information.

Date and Time (all times listed in EDT)

Abstract Name

Monday, May 18, 2026 | Poster Session 1 | 10:30 AM-1:30 PM

12:30 PM-1:30 PM: EE71 – Management Based on the Institutionalization of Health Technology Assessment (HTA): The Case of the Etonogestrel Subdermal Implant in a Brazilian Private Health Insurance Plan12:30 PM-1:30 PM: EE57 – Budget Impact and Cost Calculator Model for POHERDY® (pertuzumab-dpzb) in the Treatment of HER2-Positive Breast Cancer Monday, May 18, 2026 | Poster Session 2 | 4:00 PM-7:00 PM

6:00 PM-7:00 PM: EE174 – Cost-Effectiveness and Budget Impact of the Etonogestrel Subdermal Contraceptive Implant in Brazil6:00 PM-7:00 PM: EE100 – Real-World Budget Impact Analysis of Biosimilar Adoption in a Mid-Sized Brazilian Health Maintenance Organization6:00 PM-7:00 PM: EE172 – Cost-Effectiveness and Budget Impact of the Etonogestrel Subdermal Implant Incorporating Real-World Utilization Data from a Large Brazilian Private Health Insurer6:00 PM-7:00 PM: HSD27 – Patient Characteristics and Utilization of Adalimumab-bwwd in the U.S. Department of Veterans Affairs Population Tuesday, May 19, 2026 | Poster Session 4 | 4:00 PM-7:00 PM

6:00 PM-7:00 PM: EE412 – Budget Impact of Introducing Tapinarof, a New Aryl Hydrocarbon Receptor Agonist, for the Treatment of Atopic Dermatitis in Adult and Pediatric Patients from a U.S. Medicaid Plan Perspective6:00 PM-7:00 PM: SA40 – Real-World Referral Patterns and Healthcare Utilization Among Patients with Headache Disorders in the United KingdomAbout NEXPLANON® (etonogestrel implant) 68 mg Radiopaque

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 VTAMA® (tapinarof) cream, 1%

INDICATIONS: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor (AhR) agonist indicated for:

the topical treatment of plaque psoriasis in adults the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older SELECTED SAFETY INFORMATION

Adverse Events: In plaque psoriasis, the most common adverse reactions (incidence ≥1%) were: folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza.

Adverse Events: In atopic dermatitis, the most common adverse reactions (incidence ≥1%) were: upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and abdominal pain.

Before prescribing VTAMA cream, please read the Prescribing Information.

About POHERDY® (pertuzumab-dpzb)

INDICATIONS AND USAGE

Metastatic Breast Cancer (MBC)
POHERDY is indicated for use in combination with trastuzumab and docetaxel for the treatment of adults with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

Early Breast Cancer (EBC)
POHERDY is indicated for use in combination with trastuzumab and chemotherapy for:

The neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer The adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence SELECTED SAFETY INFORMATION

LEFT VENTRICULAR DYSFUNCTION and EMBRYO-FETAL TOXICITY

Pertuzumab products can cause subclinical and clinical cardiac failure manifesting as decreased left ventricular ejection fraction (LVEF) and congestive heart failure (CHF). Evaluate cardiac function prior to and during treatment. Discontinue POHERDY treatment for a confirmed clinically significant decrease in left ventricular function.Exposure to pertuzumab products can cause embryo-fetal death and birth defects. Advise patients of these risks and the need for effective contraception.CONTRAINDICATIONS
POHERDY is contraindicated in patients with known hypersensitivity to pertuzumab products or to any of its excipients.

WARNINGS AND PRECAUTIONS

Left Ventricular Dysfunction
Pertuzumab products can cause left ventricular dysfunction, including symptomatic heart failure. Decreases in LVEF have been reported with drugs that block HER2 activity, including pertuzumab products.

Assess LVEF prior to initiation of POHERDY and at regular intervals during treatment to ensure that LVEF is within normal limits. If the LVEF declines and has not improved, or has declined further at the subsequent assessment, consider permanent discontinuation of POHERDY and trastuzumab.

In the pertuzumab-treated patients with MBC in CLEOPATRA, left ventricular dysfunction occurred in 4% of patients, and symptomatic left ventricular systolic dysfunction (LVSD) (congestive heart failure) occurred in 1% of patients. Patients who received prior anthracyclines or prior radiotherapy to the chest area may be at higher risk of decreased LVEF or left ventricular dysfunction.

In patients receiving pertuzumab as a neoadjuvant treatment in combination with trastuzumab and docetaxel in NeoSphere, LVEF decline >10% and a drop to <50% occurred in 8% of patients, and left ventricular dysfunction occurred in 3% of patients. LVEF recovered to ≥50% in all of these patients.

In patients receiving neoadjuvant pertuzumab in TRYPHAENA, LVEF decline >10% and a drop to <50% occurred in 7% of patients treated with pertuzumab plus trastuzumab and fluorouracil, epirubicin, and cyclophosphamide (FEC) followed by pertuzumab plus trastuzumab and docetaxel, 16% of patients treated with pertuzumab plus trastuzumab and docetaxel following FEC, and 11% of patients treated with pertuzumab in combination with docetaxel, carboplatin, and trastuzumab (TCH). Left ventricular dysfunction occurred in 6% of patients treated with pertuzumab plus trastuzumab and FEC followed by pertuzumab plus trastuzumab and docetaxel, 4% of patients treated with pertuzumab plus trastuzumab and docetaxel following FEC, and 3% of patients treated with pertuzumab in combination with TCH. Symptomatic LVSD occurred in 4% of patients treated with pertuzumab plus trastuzumab and docetaxel following FEC, 1% of patients treated with pertuzumab in combination with TCH, and none of the patients treated with pertuzumab plus trastuzumab and FEC followed by pertuzumab plus trastuzumab and docetaxel. LVEF recovered to ≥50% in all but 1 patient.

In patients receiving neoadjuvant pertuzumab in BERENICE, in the neoadjuvant period, LVEF decline ≥10% and a drop to <50% as measured by ECHO/MUGA assessment occurred in 7% of patients treated with pertuzumab plus trastuzumab and paclitaxel following dose-dense doxorubicin and cyclophosphamide (ddAC) and 2% of patients treated with pertuzumab plus trastuzumab and docetaxel following FEC. Ejection fraction decreased (asymptomatic LVD) occurred in 7% of patients treated with pertuzumab plus trastuzumab and paclitaxel following ddAC and 4% of the patients treated with pertuzumab plus trastuzumab and docetaxel following FEC in the neoadjuvant period. Symptomatic LVSD (New York Heart Association [NYHA] Class III/IV Congestive Heart Failure) occurred in 2% of patients treated with pertuzumab plus trastuzumab and paclitaxel following ddAC and none of the patients treated with pertuzumab plus trastuzumab and docetaxel following FEC in the neoadjuvant period.

In patients receiving adjuvant pertuzumab in APHINITY, the incidence of symptomatic heart failure (NYHA Class III/IV) with a LVEF decline ≥10% and a drop to <50% was 0.6%. Of the patients who experienced symptomatic heart failure, 47% of pertuzumab-treated patients had recovered (defined as 2 consecutive LVEF measurements above 50%) at the data cutoff. The majority of the events (86%) were reported in anthracycline-treated patients. Asymptomatic or mildly symptomatic (NYHA Class II) declines in LVEF ≥10% and a drop to <50% were reported in 3% of pertuzumab-treated patients, of whom 80% recovered at the data cutoff.

Pertuzumab products have not been studied in patients with a pretreatment LVEF value of <50%; a prior history of CHF; decreases in LVEF to <50% during prior trastuzumab therapy; or conditions that could impair left ventricular function such as uncontrolled hypertension, recent myocardial infarction, serious cardiac arrhythmia requiring treatment, or a cumulative prior anthracycline exposure to >360 mg/m2 of doxorubicin or its equivalent.

Embryo-Fetal Toxicity
Based on its mechanism of action and findings in animal studies, pertuzumab products can cause fetal harm when administered to a pregnant woman. Pertuzumab products are HER2/neu receptor antagonists. Cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death have been reported with use of another HER2/neu receptor antagonist (trastuzumab) during pregnancy.

Verify the pregnancy status of females of reproductive potential prior to the initiation of POHERDY. Advise pregnant women and females of reproductive potential that exposure to POHERDY in combination with trastuzumab during pregnancy or within 7 months prior to conception can result in fetal harm, including embryo-fetal death or birth defects. Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of POHERDY in combination with trastuzumab.

Infusion-Related Reactions
Pertuzumab products can cause serious infusion reactions, including fatal events.

In CLEOPATRA, on the first day, when only pertuzumab was administered, infusion-related reactions occurred in 13% of patients, and <1% were Grade 3 or 4. The most common infusion reactions (≥1%) were pyrexia, chills, fatigue, headache, asthenia, hypersensitivity, and vomiting. During the second cycle when all drugs were administered on the same day, the most common infusion reactions in the pertuzumab-treated group (≥1%) were fatigue, dysgeusia, hypersensitivity, myalgia, and vomiting.

In APHINITY, when pertuzumab was administered in combination with trastuzumab and chemotherapy on the same day, infusion-related reactions occurred in 21% of patients, with <1% of patients experiencing Grade 3-4 events.

Observe patients closely for 60 minutes after the first infusion and for 30 minutes after subsequent infusions of POHERDY. If a significant infusion-related reaction occurs, slow or interrupt the infusion, and administer appropriate medical therapies. Monitor patients carefully until complete resolution of signs and symptoms. Consider permanent discontinuation in patients with severe infusion reactions.

Hypersensitivity Reactions/Anaphylaxis
Pertuzumab products can cause hypersensitivity reactions, including anaphylaxis.
In CLEOPATRA, the overall frequency of hypersensitivity/anaphylaxis reactions was 11% in pertuzumab-treated patients, with Grade 3-4 hypersensitivity reactions and anaphylaxis occurring in 2% of patients.

In NeoSphere, TRYPHAENA, BERENICE, and APHINITY, hypersensitivity/anaphylaxis events were consistent with those observed in CLEOPATRA. In APHINITY, the overall frequency of hypersensitivity/anaphylaxis was 5% in the pertuzumab-treated group. The incidence was highest in the pertuzumab plus TCH–treated group (8%), with 1% Grade 3-4 events.

Observe patients closely for hypersensitivity reactions. Severe hypersensitivity, including anaphylaxis and fatal events, has been observed in patients treated with pertuzumab products. Angioedema has been described in postmarketing reports. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use prior to administration of POHERDY.

ADVERSE REACTIONS

Metastatic Breast Cancer
The most common adverse reactions (>30%) with pertuzumab in combination with trastuzumab and docetaxel were diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy.

Neoadjuvant Treatment of Breast Cancer
The most common adverse reactions (>30%) with pertuzumab in combination with trastuzumab and docetaxel were alopecia, diarrhea, nausea, and neutropenia.

The most common adverse reactions (>30%) with pertuzumab in combination with trastuzumab and docetaxel when given for 3 cycles following 3 cycles of FEC were fatigue, alopecia, diarrhea, nausea, vomiting, and neutropenia.

The most common adverse reactions (>30%) with pertuzumab in combination with TCH were fatigue, alopecia, diarrhea, nausea, vomiting, neutropenia, thrombocytopenia, and anemia.

The most common adverse reactions (>30%) with pertuzumab in combination with trastuzumab and paclitaxel when given for 4 cycles following 4 cycles of ddAC were nausea, diarrhea, alopecia, fatigue, constipation, peripheral neuropathy, and headache.

The most common adverse reactions (>30%) with pertuzumab in combination with trastuzumab and docetaxel when given for 4 cycles following 4 cycles of FEC were diarrhea, nausea, alopecia, asthenia, constipation, fatigue, mucosal inflammation, vomiting, myalgia, and anemia.

Adjuvant Treatment of Breast Cancer
The most common adverse reactions (>30%) with pertuzumab in combination with trastuzumab and chemotherapy were diarrhea, nausea, alopecia, fatigue, peripheral neuropathy, and vomiting.

Before prescribing POHERDY, please read the Prescribing Information, including the Boxed Warning about left ventricular dysfunction and embryo-fetal toxicity.

About HADLIMA® (adalimumab-bwwd) Injection

INDICATIONS AND USAGE

Rheumatoid Arthritis
HADLIMA is indicated, alone or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs), for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.

Juvenile Idiopathic Arthritis
HADLIMA is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.

Psoriatic Arthritis
HADLIMA is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.

Ankylosing Spondylitis
HADLIMA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

Crohn’s Disease
HADLIMA is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.

Ulcerative Colitis
HADLIMA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.

Limitations of Use:
The effectiveness of HADLIMA has not been established in patients who have lost response to or were intolerant to tumor necrosis factor (TNF) blockers.

Plaque Psoriasis
HADLIMA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HADLIMA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

Hidradenitis Suppurativa
HADLIMA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients.

Uveitis
HADLIMA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

SELECTED SAFETY INFORMATION

SERIOUS INFECTIONS
Patients treated with adalimumab products, including HADLIMA, are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue HADLIMA if a patient develops a serious infection or sepsis.

Reported infections include:

Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before HADLIMA use and during therapy. Initiate treatment for latent TB prior to HADLIMA use.Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.Carefully consider the risks and benefits of treatment with HADLIMA prior to initiating therapy in patients:

with chronic or recurrent infectionwho have been exposed to TBwith a history of opportunistic infectionwho resided in or traveled in regions where mycoses are endemicwith underlying conditions that may predispose them to infectionMonitor patients closely for the development of signs and symptoms of infection during and after treatment with HADLIMA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

Do not start HADLIMA during an active infection, including localized infections. Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection. If an infection develops, monitor carefully and initiate appropriate therapy. Drug interactions with biologic products: A higher rate of serious infections has been observed in rheumatoid arthritis (RA) patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of HADLIMA with other biologic DMARDs (eg, anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions. MALIGNANCY
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.

Consider the risks and benefits of HADLIMA treatment prior to initiating or continuing therapy in a patient with known malignancy. In clinical trials, more cases of malignancies were observed among adalimumab-treated subjects compared to control subjects. Non-melanoma skin cancer (NMSC) was reported during clinical trials for adalimumab-treated subjects. Examine all patients, particularly those with a history of prolonged immunosuppressant or psoralen and ultraviolet A (PUVA) therapy, for the presence of NMSC prior to and during treatment with HADLIMA. In adalimumab clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers. Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents. HYPERSENSITIVITY
Anaphylaxis and angioneurotic edema have been reported following adalimumab administration. If a serious allergic reaction occurs, stop HADLIMA and institute appropriate therapy.

HEPATITIS B VIRUS REACTIVATION
Use of TNF blockers, including HADLIMA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.

Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.

Exercise caution in patients who are carriers of HBV and monitor them during and after HADLIMA treatment.

Discontinue HADLIMA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming HADLIMA after HBV treatment.

NEUROLOGIC REACTIONS
TNF blockers, including adalimumab products, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome.

Exercise caution when considering HADLIMA for patients with these disorders; discontinuation of HADLIMA should be considered if any of these disorders develop.

HEMATOLOGIC REACTIONS
Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with adalimumab products.

Consider stopping HADLIMA if significant hematologic abnormalities occur.

CONGESTIVE HEART FAILURE
Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with adalimumab products; exercise caution and monitor carefully.

AUTOIMMUNITY
Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome or autoimmune hepatitis. Discontinue treatment if symptoms of a lupus-like syndrome or autoimmune hepatitis develop.

IMMUNIZATIONS
Patients on HADLIMA should not receive live vaccines.

Pediatric patients, if possible, should be brought up to date with all immunizations before initiating HADLIMA therapy.

Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero-exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab products in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.

ADVERSE REACTIONS
The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (eg, upper respiratory, sinusitis), injection site reactions, headache, and rash.

Before prescribing HADLIMA, please read the Prescribing Information, including the Boxed Warning about serious infections and malignancies. The Medication Guide and Instructions for Use also are 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 www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook.

Cautionary Note Regarding Forward-Looking Statements
The information above reflects management’s current intentions and expectations for the future with respect to Organon’s expectations regarding milestone expenses, which constitute “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are subject to a number of risks, assumptions, uncertainties and other factors, such as the completion of Organon’s quarter-end closing process, including review by management and the audit committee of the Organon’s board of directors, which could result in material changes to the preliminary estimates described herein. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the Securities and Exchange Commission ("SEC"), including Organon’s most recent Annual Report on Form 10-K and subsequent SEC filings (as amended, where applicable), available at the SEC’s Internet site (www.sec.gov).

View source version on businesswire.com: https://www.businesswire.com/news/home/20260515139840/en/

Shin Hae-gon (right), Head of Overseas Sales at Hanmi Pharmaceutical, and Andreas Daugaard Jørgensen (left), Managing Director, Organon Asia Pacific Cluster, met at Organon’s Malaysia office to discuss the expansion of Hanmi’s combination therapies into the Southeast Asian market.

SEOUL, South Korea, May 21, 2026 (GLOBE NEWSWIRE) -- Hanmi Pharmaceutical announced that it has signed a supply agreement with global healthcare company Organon to export three combination medicines for the Malaysian and Philippine markets, expanding the companies’ partnership in Southeast Asia.

Under the agreement, Hanmi will supply three finished combination products in the cardiovascular and respiratory therapeutic areas, while Organon will be responsible for marketing, distribution, and sales in the local markets. The two companies plan to pursue phased regulatory approvals and product launches in Malaysia and the Philippines, with the potential to expand their collaboration over the mid to long term.

Organon, established in 2021 is a global healthcare company with a portfolio of over 70 products across a range of therapeutic areas. Through a deep commercial ability and trusted manufacturing network, Organon brings these important medicines and devices to patients when and where they need them in over 140 markets, including Southeast Asia.

Hanmi Pharmaceutical has previously expanded its global presence through partnerships with multinational pharmaceutical companies. The current agreement with Organon builds on Hanmi’s experience in global collaborations and is expected to support the company’s commercial expansion in the Southeast Asian market.

Southeast Asia is widely regarded as a rapidly growing pharmaceutical market driven by population growth and the increasing prevalence of chronic diseases. In particular, demand for combination therapies is rising as the number of patients with chronic conditions such as hypertension continues to increase.

“At Organon, we are committed to improving access to medicines that address the greatest health needs in the communities we serve,” said Mazen Altaruti, President, Organon Emerging Markets. “This partnership with Hanmi reflects our shared focus on expanding treatment options for patients in Malaysia and the Philippines and advancing more equitable access to care across the region.”

Sean Hwang, CEO of Hanmi Pharmaceutical, said, “Hanmi will continue accelerating its global expansion with our diverse portfolio of combination therapies, which represent one of the company’s core strengths. Through our collaboration with Organon, we aim to improve treatment accessibility for patients in Southeast Asia.”

■ Contact info:

Official Websites: www.hanmipharm.com, www.linkedin.com/company/hanmipharm
[email protected], +82-02-410-0467

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b62e29c9-0e09-4dad-9cb8-6e47fb8415db

Organon (OGN - Free Report) is one of the stocks most watched by Zacks.com visitors lately. So, it might be a good idea to review some of the factors that might affect the near-term performance of the stock.

Shares of this pharmaceutical company have returned +0.8% over the past month versus the Zacks S&P 500 composite's +6% change. The Zacks Medical Services industry, to which Organon belongs, has gained 3.2% over this period. Now the key question is: Where could the stock be headed in the near term?

Although media reports or rumors about a significant change in a company's business prospects usually cause its stock to trend and lead to an immediate price change, there are always certain fundamental factors that ultimately drive the buy-and-hold decision.

Earnings Estimate RevisionsHere at Zacks, we prioritize appraising the change in the projection of a company's future earnings over anything else. That's because we believe the present value of its future stream of earnings is what determines the fair value for its stock.

Our analysis is essentially based on how sell-side analysts covering the stock are revising their earnings estimates to take the latest business trends into account. When earnings estimates for a company go up, the fair value for its stock goes up as well. And when a stock's fair value is higher than its current market price, investors tend to buy the stock, resulting in its price moving upward. Because of this, empirical studies indicate a strong correlation between trends in earnings estimate revisions and short-term stock price movements.

Organon is expected to post earnings of $0.87 per share for the current quarter, representing a year-over-year change of -13%. Over the last 30 days, the Zacks Consensus Estimate remained unchanged.

The consensus earnings estimate of $3.37 for the current fiscal year indicates a year-over-year change of -7.9%. This estimate has remained unchanged over the last 30 days.

For the next fiscal year, the consensus earnings estimate of $3.61 indicates a change of +7% from what Organon is expected to report a year ago. Over the past month, the estimate has remained unchanged.

Having a strong externally audited track record, our proprietary stock rating tool, the Zacks Rank, offers a more conclusive picture of a stock's price direction in the near term, since it effectively harnesses the power of earnings estimate revisions. Due to the size of the recent change in the consensus estimate, along with three other factors related to earnings estimates, Organon is rated Zacks Rank #3 (Hold).

The chart below shows the evolution of the company's forward 12-month consensus EPS estimate:

12 Month EPS

Revenue Growth ForecastEven though a company's earnings growth is arguably the best indicator of its financial health, nothing much happens if it cannot raise its revenues. It's almost impossible for a company to grow its earnings without growing its revenue for long periods. Therefore, knowing a company's potential revenue growth is crucial.

For Organon, the consensus sales estimate for the current quarter of $1.54 billion indicates a year-over-year change of -3.3%. For the current and next fiscal years, $6.11 billion and $6.14 billion estimates indicate -1.6% and +0.4% changes, respectively.

Last Reported Results and Surprise HistoryOrganon reported revenues of $1.46 billion in the last reported quarter, representing a year-over-year change of -3.5%. EPS of $0.71 for the same period compares with $1.02 a year ago.

Compared to the Zacks Consensus Estimate of $1.47 billion, the reported revenues represent a surprise of -0.48%. The EPS surprise was -14.46%.

Over the last four quarters, Organon surpassed consensus EPS estimates two times. The company topped consensus revenue estimates two times over this period.

ValuationWithout considering a stock's valuation, no investment decision can be efficient. In predicting a stock's future price performance, it's crucial to determine whether its current price correctly reflects the intrinsic value of the underlying business and the company's growth prospects.

While comparing the current values of a company's valuation multiples, such as price-to-earnings (P/E), price-to-sales (P/S), and price-to-cash flow (P/CF), with its own historical values helps determine whether its stock is fairly valued, overvalued, or undervalued, comparing the company relative to its peers on these parameters gives a good sense of the reasonability of the stock's price.

As part of the Zacks Style Scores system, the Zacks Value Style Score (which evaluates both traditional and unconventional valuation metrics) organizes stocks into five groups ranging from A to F (A is better than B; B is better than C; and so on), making it helpful in identifying whether a stock is overvalued, rightly valued, or temporarily undervalued.

Organon is graded A on this front, indicating that it is trading at a discount to its peers. Click here to see the values of some of the valuation metrics that have driven this grade.

ConclusionThe facts discussed here and much other information on Zacks.com might help determine whether or not it's worthwhile paying attention to the market buzz about Organon. However, its Zacks Rank #3 does suggest that it may perform in line with the broader market in the near term.

Organon (OGN - Free Report) has been one of the most searched-for stocks on Zacks.com lately. So, you might want to look at some of the facts that could shape the stock's performance in the near term.

Shares of this pharmaceutical company have returned +0.5% over the past month versus the Zacks S&P 500 composite's +0.2% change. The Zacks Medical Services industry, to which Organon belongs, has gained 3.3% over this period. Now the key question is: Where could the stock be headed in the near term?

Although media reports or rumors about a significant change in a company's business prospects usually cause its stock to trend and lead to an immediate price change, there are always certain fundamental factors that ultimately drive the buy-and-hold decision.

Revisions to Earnings EstimatesHere at Zacks, we prioritize appraising the change in the projection of a company's future earnings over anything else. That's because we believe the present value of its future stream of earnings is what determines the fair value for its stock.

Our analysis is essentially based on how sell-side analysts covering the stock are revising their earnings estimates to take the latest business trends into account. When earnings estimates for a company go up, the fair value for its stock goes up as well. And when a stock's fair value is higher than its current market price, investors tend to buy the stock, resulting in its price moving upward. Because of this, empirical studies indicate a strong correlation between trends in earnings estimate revisions and short-term stock price movements.

For the current quarter, Organon is expected to post earnings of $0.87 per share, indicating a change of -13% from the year-ago quarter. The Zacks Consensus Estimate remained unchanged over the last 30 days.

For the current fiscal year, the consensus earnings estimate of $3.37 points to a change of -7.9% from the prior year. Over the last 30 days, this estimate has remained unchanged.

For the next fiscal year, the consensus earnings estimate of $3.61 indicates a change of +7% from what Organon is expected to report a year ago. Over the past month, the estimate has remained unchanged.

Having a strong externally audited track record, our proprietary stock rating tool, the Zacks Rank, offers a more conclusive picture of a stock's price direction in the near term, since it effectively harnesses the power of earnings estimate revisions. Due to the size of the recent change in the consensus estimate, along with three other factors related to earnings estimates, Organon is rated Zacks Rank #3 (Hold).

The chart below shows the evolution of the company's forward 12-month consensus EPS estimate:

12 Month EPS

Projected Revenue GrowthEven though a company's earnings growth is arguably the best indicator of its financial health, nothing much happens if it cannot raise its revenues. It's almost impossible for a company to grow its earnings without growing its revenue for long periods. Therefore, knowing a company's potential revenue growth is crucial.

In the case of Organon, the consensus sales estimate of $1.54 billion for the current quarter points to a year-over-year change of -3.3%. The $6.11 billion and $6.14 billion estimates for the current and next fiscal years indicate changes of -1.6% and +0.4%, respectively.

Last Reported Results and Surprise HistoryOrganon reported revenues of $1.46 billion in the last reported quarter, representing a year-over-year change of -3.5%. EPS of $0.71 for the same period compares with $1.02 a year ago.

Compared to the Zacks Consensus Estimate of $1.47 billion, the reported revenues represent a surprise of -0.48%. The EPS surprise was -14.46%.

Over the last four quarters, Organon surpassed consensus EPS estimates two times. The company topped consensus revenue estimates two times over this period.

ValuationNo investment decision can be efficient without considering a stock's valuation. Whether a stock's current price rightly reflects the intrinsic value of the underlying business and the company's growth prospects is an essential determinant of its future price performance.

While comparing the current values of a company's valuation multiples, such as price-to-earnings (P/E), price-to-sales (P/S), and price-to-cash flow (P/CF), with its own historical values helps determine whether its stock is fairly valued, overvalued, or undervalued, comparing the company relative to its peers on these parameters gives a good sense of the reasonability of the stock's price.

As part of the Zacks Style Scores system, the Zacks Value Style Score (which evaluates both traditional and unconventional valuation metrics) organizes stocks into five groups ranging from A to F (A is better than B; B is better than C; and so on), making it helpful in identifying whether a stock is overvalued, rightly valued, or temporarily undervalued.

Organon is graded A on this front, indicating that it is trading at a discount to its peers. Click here to see the values of some of the valuation metrics that have driven this grade.

ConclusionThe facts discussed here and much other information on Zacks.com might help determine whether or not it's worthwhile paying attention to the market buzz about Organon. However, its Zacks Rank #3 does suggest that it may perform in line with the broader market in the near term.