CUMBERLAND PHARMACEUTICALS REPORTS Q1 2026 FINANCIAL RESULTS & COMPANY UPDATE

On May 5, 2026 Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, reported that its product portfolio of FDA-approved brands delivered combined net revenues of $9.1 million during the first quarter of 2026. Cumberland ended the quarter with $71.0 million in total assets, $49.7 million in liabilities and $21.6 million of shareholders’ equity.

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"We entered 2026 with strong momentum following an outstanding 2025, which featured double-digit revenue growth, the addition of a new product to our portfolio, new international approvals and breakthrough clinical study results," said A.J. Kazimi, Cumberland Pharmaceuticals CEO. "We have built on that momentum through our recently announced Strategic Transaction, which represents an important next step in our Company’s evolution, enabling us to sharpen our focus on developing high-value product candidates, while unlocking significant value for our shareholders."

RECENT COMPANY DEVELOPMENTS INCLUDE:

Strategic Transaction
Cumberland recently announced a Strategic Transaction with Apotex Inc., the largest Canadian-based pharmaceutical company, to integrate the branded U.S. commercial businesses. Under the terms of the agreement, Apotex will acquire Cumberland’s portfolio of FDA-approved brands for $100 million in cash consideration, subject to Cumberland shareholders’ approval and certain other customary closing conditions.
This transaction is designed to unlock value and sharpen Cumberland’s focus on advancing its pipeline of differentiated product candidates designed to address unmet medical needs. The integration of Cumberland’s products will create more critical mass to support patient care and expand product distribution.
Following the closing of the transaction, Cumberland will retain its development programs, as well as its majority ownership in Cumberland Emerging Technologies. This positions Cumberland to operate with the profile of an innovative, development-stage biopharmaceutical organization devoted to new medicines for the future.

Development Pipeline

In addition to its portfolio of FDA-approved brands involved in the transaction with Apotex, Cumberland is developing ifetroban, a potent thromboxane antagonist, through a series of clinical programs designed to address unmet medical needs with significant market potential.
Cumberland has announced breakthrough results in a Phase II clinical study of ifetroban in patients with cardiomyopathy associated with Duchenne muscular dystrophy ("DMD"). This rare, fatal genetic neuromuscular disease results in deterioration of the skeletal, heart and lung muscles. Discussions with the FDA are underway regarding the study results and remaining requirements for approval.
During the first quarter of 2026, the FDA granted Fast Track Designation for Cumberland’s ifetroban candidate product for DMD patients.
This designation is intended to accelerate the development and review of therapies that address serious conditions with unmet medical needs. Importantly, it allows for more frequent FDA interaction, rolling data submissions and earlier guidance throughout the approval process. The program previously received both Orphan Drug and Rare Pediatric Disease designations from the FDA.
In addition, Cumberland has a Phase II clinical program evaluating its ifetroban product candidate in patients with Systemic Sclerosis ("SSc") or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs. Enrollment in the study is completed and the next milestone will be announcing its top-line study results.
Cumberland’s third development program involves the use of ifetroban in patients with Idiopathic Pulmonary Fibrosis ("IPF"), the most common form of progressive fibrosing interstitial lung disease. Enrollment in the study is well underway at medical centers across the U.S., with interim safety and interim efficacy results pending.

FINANCIAL RESULTS:

Net Revenue: For first quarter of 2026, the Company’s net revenues of $9.1 million, which represented a 5% increase compared to the first quarter of 2025 after removing the $3 million milestone payment last year associated with the approval of Vibativ in China. Cumberland’s branded portfolio revenue included $1.0 million for Kristalose, $2.9 million for Sancuso, $2.1 million for Vibativ, $1.0 million for Caldolor and $1.9 million for Talicia.
Operating Expenses: Total operating expenses for the quarter were $12.3 million.
Net Income (Loss): The net loss for the first quarter of 2026 was approximately $3.3 million.
Adjusted Earnings (Loss): Adjusted loss for the quarter was $1.9 million, or $0.13 per share.
Balance Sheet: At March 31, 2026, Cumberland had approximately $71.0 million in total assets, including $11.0 million in cash and cash equivalents. Liabilities totaled $49.7 million, including $5.2 million on the company’s credit facility. Total shareholders’ equity was $21.6 million on March 31, 2026.

EARNINGS REPORT CALL:
A conference call will be held today, May 5, 2026, at 4:30 p.m. Eastern Time to provide a company update and discuss the financial results.
The link to register is View Source
Registered participants can dial in from their phone using a dial-in and PIN number that will be provided to them. Alternatively, they can choose a "Call Me" option to have the system automatically call them at the start of the conference.

A replay of the call will be available for one year and can be accessed via Cumberland’s website or by visiting: View Source

(Press release, Cumberland Pharmaceuticals, MAY 5, 2026, View Source [SID1234665113])

Rigel Reports First Quarter 2026 Financial Results

On May 5, 2026 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported financial results for the first quarter ended March 31, 2026, including sales of TAVALISSE (fostamatinib disodium hexahydrate), GAVRETO (pralsetinib) and REZLIDHIA (olutasidenib), and recent business progress.

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"Rigel entered 2026 with continued year-over-year growth from our commercial portfolio and financial discipline, driving another quarter of profitability. We are operating from a position of financial strength with a solid cash balance that can fund our development plans and allows for financial flexibility to pursue potential in-license opportunities," said Raul Rodriguez, Rigel’s president and CEO. "During the first quarter we also continued to advance our development pipeline, including our ongoing Phase 1b study of R289 in patients with lower-risk MDS, which may be a transformational opportunity for Rigel."

First Quarter 2026 Business Update

Commercial

First quarter net product sales were $54.9 million, an increase of 26% from the same period of 2025.
Corporate

In February, Michael P. Miller joined Rigel’s Board of Directors as an independent director and member of the Compensation Committee.
In April, Rigel received notification from Eli Lilly and Company that it will terminate the collaboration agreement with Rigel, which included the development of ocadusertib (previously R552 or LY3871801), an investigational, potent and selective receptor-interacting protein kinase 1 (RIPK1) inhibitor. The termination will become effective on June 15, 2026.
In early May, Rigel restructured its credit relationship with MidCap Financial to replace its existing term loan credit facility with a revolving credit facility for $40.0 million, with an option to increase to $60.0 million, subject to customary conditions. As part of the transaction, Rigel repaid the remaining outstanding term loan balance of $40.0 million and drew down $8.0 million on the new revolving credit facility.
Clinical Development

Rigel continues to advance its Phase 1b clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of R2891, a potent and selective dual inhibitor of interleukin receptor-associated kinases 1 and 4 (IRAK1/4), in patients with relapsed or refractory (R/R) lower-risk myelodysplastic syndrome (MDS). Enrollment in the dose expansion phase of the study is ongoing.
Rigel is on track to complete enrollment of the dose expansion phase of the Phase 1b study and select the recommended Phase 2 dose for future clinical studies in the second half of 2026. The company anticipates sharing preliminary data from the dose expansion phase of the study by the end of 2026.
The first data release for pralsetinib from the TAPISTRY study (NCT04589845) was presented in a poster presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) – Gastrointestinal Cancers Symposium (ASCO-GI) in January. The analysis reported results from the Phase 2 global, open-label, multicohort study, in which the efficacy and safety of pralsetinib was evaluated in a cohort of patients with rearranged during transfection (RET) fusion-positive solid tumors, including pancreatic, colorectal, and hepatobiliary cancers. Pralsetinib demonstrated robust and durable activity against RET fusion-positive solid tumors, including gastrointestinal (GI) tumors, and in the efficacy evaluable population showed an overall response rate (ORR) of 67% (26/39). These data supports RET fusions as a tissue-agnostic target with sensitivity to RET inhibition, suggesting the potential therapeutic utility of pralsetinib in these patients.
Key Publications

A paper titled "Matching-Adjusted Indirect Comparison of Olutasidenib and Ivosidenib in Isocitrate Dehydrogenase 1-Mutated Relapsed/Refractory Acute Myeloid Leukemia," was published in Advances in Therapy in February. The publication analysis used a well-accepted methodology called matching-adjusted indirect comparison (MAIC), which adjusts for between study differences in baseline characteristics to better estimate comparative efficacy. The analysis suggests that olutasidenib and ivosidenib achieve similar response rates in R/R isocitrate dehydrogenase-1 (IDH1)-mutated acute myeloid leukemia (AML), but responses achieved with olutasidenib may be more durable. The longer duration of complete remission (CR) plus CR with partial hematologic recovery (CR+CRh) observed with olutasidenib may be clinically meaningful in a setting where sustained remissions are difficult to achieve. While indirect and non-confirmatory, these findings may provide important comparative context for clinicians, medical affairs, and health-policy stakeholders in the absence of head-to-head data.
A paper titled "Final Efficacy and Safety Data From the Phase 1/2 ARROW Study of Pralsetinib in Patients With Advanced RET Fusion-Positive Non-Small Cell Lung Cancer (NSCLC)," was published in the Journal of Clinical Oncology in March. The publication reports the final data from the registrational trial evaluating pralsetinib for the treatment of patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC). The final data, which includes an additional 42 months of follow-up from data previously published, further support the robust, durable responses with a manageable toxicity profile seen in patients with RET fusion-positive NSCLC, and are consistent with previous reports from the ARROW study NSCLC cohort.
First Quarter 2026 Financial Update
For the first quarter ended March 31, 2026, total revenues were $58.8 million, consisting of $54.9 million in net product sales and $3.9 million in contract revenues from collaborations. Net product sales increased 26% compared to $43.6 million in the same period of 2025. TAVALISSE net product sales were $37.3 million, an increase of 31% compared to $28.5 million in the same period of 2025. GAVRETO net product sales were $9.6 million, an increase of 7% compared to $9.0 million in the same period of 2025. REZLIDHIA net product sales were $8.0 million, an increase of 31% compared to $6.1 million in the same period of 2025. Contract revenues from collaborations primarily consisted of $1.8 million of revenue from Grifols S.A. related to earned royalties, $1.8 million of revenue from Kissei Pharmaceutical Co., Ltd. related to delivery of drug supplies and $0.3 million of revenue from Medison Pharma related to earned royalties and delivery of drug supplies. Contract revenues from collaborations in the prior year period included a one-time $3.0 million regulatory milestone in connection with the approval of TAVALISSE in the Republic of Korea.

Total costs and expenses were $46.9 million compared to $40.6 million for the same period of 2025. The increase in costs and expenses was primarily driven by increased research and development costs driven by the timing of clinical activities, including continued progress in our R289 program, as well as increased commercial-related expenses and personnel-related costs.

Income before income taxes was $11.7 million.

Rigel reported net income of $8.7 million, or $0.47 basic and $0.44 diluted per share, compared to $11.4 million, or $0.64 basic and $0.63 diluted per share, for the same period of 2025.

Cash, cash equivalents and short-term investments as of March 31, 2026 was $146.7 million, compared to $155.0 million as of December 31, 2025.

2026 Outlook
Rigel reaffirms its 2026 total revenues guidance of approximately $275 to $290 million, including:

Net product sales of approximately $255 to $265 million.
Contract revenues of approximately $20 to $25 million.
The company also continues to anticipate it will report positive net income for the full year 2026, while funding existing and new clinical development programs.

Conference Call and Webcast with Slides Today at 4:30 p.m. Eastern Time
Rigel will hold a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time).

Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call will also be webcast live and can be accessed from the Investor Relations section of the company’s website at www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.

About ITP
In patients with immune thrombocytopenia (ITP), the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. Patients suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs), and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

About NSCLC
It is estimated that over 229,000 adults in the U.S. will be diagnosed with lung cancer in 2026. Lung cancer is the leading cause of cancer death in the U.S., with non-small cell lung cancer (NSCLC) being the most common type accounting for 77% of all lung cancer diagnoses.2 RET fusions are implicated in approximately 1-2% of patients with NSCLC.3

About AML
Acute myeloid leukemia (AML) is a rapidly progressing cancer of the blood and bone marrow that affects myeloid cells, which normally develop into various types of mature blood cells. AML occurs primarily in adults and accounts for about 1 percent of all adult cancers. The American Cancer Society estimates that there will be about 22,720 new cases in the United States, most in adults, in 2026.4

Relapsed AML affects about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow. 5,6 Refractory AML, which affects between 10 and 40 percent of newly diagnosed patients, occurs when a patient fails to achieve remission even after intensive treatment.7 Quality of life declines for patients with each successive line of treatment for AML, and well-tolerated treatments in relapsed or refractory disease remain an unmet need.

About TAVALISSE
TAVALISSE (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Please click here for Important Safety Information and Full Prescribing Information for TAVALISSE.

About GAVRETO
GAVRETO is indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test and adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).*

*Thyroid indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Please click here for Important Safety Information and Full Prescribing Information, including Boxed WARNING, for GAVRETO.

About REZLIDHIA
REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

Please click here for Important Safety Information and Full Prescribing Information, including Boxed WARNING, for REZLIDHIA.

To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

TAVALISSE, GAVRETO and REZLIDHIA are registered trademarks of Rigel Pharmaceuticals, Inc.

(Press release, Rigel, MAY 5, 2026, View Source [SID1234665129])

AVEO Oncology, an LG Chem company, Announces Two Poster Presentations at ASCO 2026 Annual Meeting

On May 5, 2026 AVEO Oncology, an LG Chem company ("AVEO"), reported that two abstracts were accepted for presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 annual meeting this May 29-June 2, 2026, in Chicago, IL.

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Presentation Details

Title: Final analysis of the TiNivo-2 phase 3 trial: Long-term outcome of tivozanib (Tivo) in patients with metastatic renal cell carcinoma (mRCC)
First Author: Robert Motzer, MD, Memorial Sloan Kettering Cancer Center
Abstract Number: 4555
Poster Session: Genitourinary Cancer—Kidney and Bladder
Poster Board: 34
Date and Time: Sunday, May 31, 2026, 9:00am – 12:00 PM CDT

Title: FIERCE-HN: A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of ficlatuzumab (HGF/cMET mAb) in combination with cetuximab in participants with recurrent or metastatic (R/M) HPV negative head and neck squamous cell carcinoma (HNSCC)
First Author: Julie E. Bauman, MD, MPH, George Washington University Cancer Center
Abstract Number: TPS6132
Poster Session: Head and Neck Cancer
Poster Board: 585b
Date and Time: Saturday, May 30, 2026, 1:30 PM – 4:30 PM CDT

(Press release, AVEO, MAY 5, 2026, View Source [SID1234665148])

MacroGenics and Sagard Healthcare Partners Enter into Expanded ZYNYZ® Royalty Purchase Agreement

On May 4, 2026 MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, reported that it entered into an expanded royalty purchase agreement with Sagard in exchange for a capped royalty interest on future global net sales of ZYNYZ (retifanlimab-dlwr). MacroGenics and Sagard entered into the initial ZYNYZ royalty purchase agreement in June 2025.

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ZYNYZ is a PD-1 inhibitor originally developed by MacroGenics and licensed to Incyte Corporation pursuant to an exclusive global collaboration and license agreement in October 2017. MacroGenics retains its other economic interests related to ZYNYZ, including future potential development, regulatory and commercial milestones.

Under the terms of the amended royalty purchase agreement, MacroGenics receives a $60 million upfront payment from Sagard and is eligible to receive an additional 2026 sales-based milestone of up to $20 million for the sale of its royalty rights on global net sales of ZYNYZ. All royalty rights will revert back to MacroGenics once Sagard has received total payments of either 1.7x its investment by September 30, 2032, or 2.0x its investment at any time thereafter.

Additional information regarding the expanded royalty purchase agreement is provided in a Current Report on Form 8-K filed by MacroGenics with the U.S. Securities and Exchange Commission.

About ZYNYZ

Zynyz (retifanlimab) is a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), indicated in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) in the U.S, Europe and Japan and as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression or intolerance to platinum-based chemotherapy in the U.S.

Zynyz is also indicated as monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in the U.S., EU, Canada and Switzerland.

Zynyz is marketed by Incyte in the U.S.

Zynyz is a registered trademark of Incyte.

(Press release, MacroGenics, MAY 4, 2026, View Source [SID1234665057])

Aktis Oncology Initiates Phase 1b Clinical Trial for AKY-2519, a B7-H3 Miniprotein Radioconjugate, in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

On May 4, 2026 Aktis Oncology, Inc. (NASDAQ:AKTS) (Aktis or the Company), a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large populations, reported the initiation of a Phase 1b clinical trial of AKY-25191 in patients with metastatic castration-resistant prostate cancer (mCRPC). The mCRPC-dedicated Phase 1b trial is part of Aktis’ clinical development strategy to develop AKY-2519 broadly in B7-H3 expressing tumors. Aktis plans to initiate a Phase 1b basket trial in lung, colorectal, and other high B7-H3 expressing solid tumors in the second half of 2026.

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"We see an opportunity to advance broad clinical development of AKY-2519 given the high expression of B7-H3 across multiple solid tumor types and associated poor prognosis. We are excited to advance a two-trial strategy, which enables us to evaluate AKY-2519 broadly in multiple patient subsets and to efficiently generate indication-relevant data for actionable, data-driven decision-making," said Akos Czibere, MD, PhD, Chief Medical Officer at Aktis. "This strategy was informed by insights from our clinical advisory boards and reflects the distinct treatment patterns and clinical needs of patients with mCRPC compared to other solid tumor patients. Importantly, this allows us to generate data in mCRPC in both PLUVICTO-naïve and -experienced patients to maximize the potential impact of AKY-2519."

"Prostate cancer is one of the most important indications for therapeutic radiopharmaceuticals; however, many unmet needs persist," said Oliver Sartor, MD, LCMC Health, Director, Transformational Prostate Cancer Research Center, New Orleans, LA. "A substantial number of mCRPC patients are ineligible for PSMA-targeted therapy due to low target expression and even more importantly, many patients have a sub-optimal response to PSMA targeted therapy. We all agree that further improvements are needed. Given high expression in mCRPC, B7-H3 represents a promising new target. The Phase 1b mCRPC AKY-2519 clinical study is a critical step in learning more about the safety and efficacy of a promising new next-generation B7-H3 targeted radiopharmaceutical. We look forward to learning more from these investigations."

The first Phase 1b open label trial will enroll patients with mCRPC, including both PLUVICTO-naïve and PLUVICTO-experienced cohorts, at multiple prostate-specific radioligand therapy centers in the U.S. The study will explore three dose levels in each cohort. Following dose escalation, the trial will expand enrollment at selected dose levels to generate additional clinical data. Preliminary data are expected in 2027. The second Phase 1b multi-center, open label trial will enroll patients in the U.S. with lung, colorectal, and other high B7-H3 expressing solid tumors. The protocol for this basket trial has been finalized and is currently under regulatory review.

AKY-2519 is the second miniprotein Aktis has advanced to the clinic in the past 12 months. Aktis’ lead program, AKY-1189, a miniprotein radioconjugate protein targeting Nectin-4 expressing tumors, is currently enrolling patients in an ongoing Phase 1b trial, with preliminary data anticipated in the first quarter of 2027.

Conference Call and Webcast Information
Aktis will host a live conference call and webcast tomorrow, Tuesday, May 5, 2026, at 8 a.m. ET to discuss its clinical development strategy for AKY-2519. To access the conference call, please register here. Registrants will receive the dial-in number and unique PIN. A live webcast of the call will be available under "Events" in the Investors section of the Aktis Oncology website at investors.aktisoncology.com. The archived webcast will be available for 90 days following the call.

PLUVICTO (lutetium Lu 177 vipivotide tetraxetan) is a registered trademark of Novartis Pharmaceuticals Corporation.

About Aktis’ miniprotein radioconjugate platform
Aktis has developed a proprietary, isotope-agnostic miniprotein radioconjugate platform to selectively deliver the tumor-killing properties of radioisotopes to targeted tumors. Aktis’ therapeutic miniprotein radioconjugates are designed to maximize anti-cancer activity through high tumor penetration coupled with internalization and retention in cancer cells, while rapidly clearing from normal organs and tissues. The Aktis platform further enables clinicians to visualize and verify target engagement with imaging isotopes prior to exposure to therapeutic radioisotopes. Leveraging this platform, and its patient-first end-to-end supply chain, Aktis is advancing a pipeline of next-generation targeted radiopharmaceuticals to address the unmet needs of patients across a broad spectrum of solid tumors.

(Press release, Aktis Oncology, MAY 4, 2026, View Source [SID1234665074])