Merck Completes Acquisition of Terns Pharmaceuticals, Inc.

On May 5, 2026 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported the successful completion of the acquisition of Terns Pharmaceuticals, Inc. ("Terns") (Nasdaq: TERN).

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"The Terns acquisition reflects Merck’s continued focus on science‑driven, value‑enhancing business development aimed at bringing meaningful innovation to patients," said Robert M. Davis, chairman and chief executive officer, Merck. "We believe TERN‑701 has the potential to become a differentiated treatment option for certain patients with chronic myeloid leukemia, and we look forward to working with the Terns team to advance its clinical development."

TERN-701 was recently granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia (CML) in the chronic phase without the T315I mutation previously treated with two or more tyrosine kinase inhibitors (TKIs). The BTD designation for TERN-701 is based on data from the ongoing Phase 1/2 CARDINAL trial (NCT06163430).

Transaction details

Merck completed the cash tender offer, through a subsidiary, for all the outstanding shares of common stock of Terns at a purchase price of $53.00 per share, without interest and subject to any applicable tax withholding. As of the tender offer expiration at one minute after 11:59 p.m., Eastern Time, on May 4, 2026, 100,091,794 shares of Terns common stock were validly tendered and not validly withdrawn, representing approximately 86.36% of the total number of Terns’ issued and outstanding shares of common stock as of such date and time. All such shares have been accepted for payment in accordance with the terms of the tender offer, and Merck, on behalf of its subsidiary, will promptly pay for such shares.

Following the completion of the tender offer, Merck completed the acquisition of Terns through a merger of Merck’s wholly-owned subsidiary with and into Terns, with Terns being the surviving corporation, in which all shares of Terns common stock issued and outstanding at the effective time of the merger were converted into the right to receive cash equal to the $53.00 offer price per share, without interest and subject to any applicable tax withholding. At the completion of the merger, Terns became a wholly-owned subsidiary of Merck and Terns’ common stock will no longer be listed or traded on the Nasdaq Global Select Market.

The transaction is expected to be accounted for as an asset acquisition, resulting in a charge to research and development expense of approximately $5.8 billion, or approximately $2.35 per share, included in both second quarter and full year 2026 GAAP and non-GAAP results. Additionally, GAAP and non-GAAP EPS are expected to be negatively impacted by approximately $0.12 per share in 2026, representing costs associated with advancing TERN-701 and costs of financing.

About TERN-701

TERN-701 is a novel investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor (TKI) designed to bind to the ABL myristoyl pocket, with a potentially best-in-disease profile that could improve upon existing treatments for certain patients with chronic myeloid leukemia (CML).

About chronic myeloid leukemia

Chronic myeloid leukemia (CML) is a slow growing type of blood cancer that leads to an overproduction of white blood cells that accumulate in the blood and bone marrow, disrupting the production of healthy blood cells. CML is commonly associated with the Philadelphia chromosome, a translocation between chromosomes 9 and 22 that results in constitutive activation of the BCR::ABL1 fusion protein, which fuels cancer growth.

(Press release, Merck & Co, MAY 5, 2026, View Source [SID1234665144])

Cellectar Biosciences Reports Positive 12-Month Follow-Up Data from Phase 2b CLOVER WaM Study Demonstrating Durable Responses and Efficacy of Iopofosine I 131 in r/r Waldenström Macroglobulinemia

On May 5, 2026 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of targeted oncology therapies, reported updated and mature 12-month follow-up data from its Phase 2b CLOVER WaM clinical trial evaluating iopofosine I 131 in patients with relapsed or refractory (r/r) Waldenström macroglobulinemia (WM). The updated dataset includes a minimum of 12 months of follow-up for all enrolled patients, as requested by the U.S. Food and Drug Administration (FDA), and the durability data presented here, further strengthen the previously reported efficacy results. The Company also reports subset analyses from CLOVER WaM showing iopofosine I 131 demonstrated strong and consistent efficacy in both BTKi-exposed and BTKi-refractory patients.

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"The depth, durability, and consistency of responses observed across both the total population and BTKi-treated subsets underscore iopofosine’s potential as a meaningful new treatment option in WM and differentiate it from currently available therapies," said Jarrod Longcor, chief operating officer of Cellectar Biosciences. "With the completion of at least 12-month follow-up on all patients, we believe this dataset meets key regulatory expectations for an accelerated approval submission and positions us well as we advance toward initiating our confirmatory study."

Patients enrolled in the CLOVER WaM clinical trial had a median of four prior lines of therapy (range 2-15), with refractory rates running from 77% in Bruton tyrosine kinase inhibitors (BTKi)-exposed patients to 60% in chemotherapy-exposed patients and 58% in patients exposed to both BTKi and rituximab, making this one of the most heavily pretreated and refractory WM populations studied to date. Updated 12-month data demonstrated high response rates and sustained durability, supporting its accelerated regulatory pathway and potential role as a differentiated treatment option.

Summary of Efficacy Results in per Protocol Study Population (n=55):

Overall Response Rate (ORR): 83.6%
Major Response Rate (MRR): 61.8% (primary endpoint achieved)
Median Duration of Response (DoR): 17.8 months (secondary endpoint achieved)
Median Progression-Free Survival (PFS): 13.5 months
Very Good Partial Response/Complete Response Rate (VGPR/CR): 14.5%
Disease Control Rate (DCR): 98.2%
During the follow-up period, responses deepened and remained durable, underscoring the strength of the data, especially considering that treatment with iopofosine I 131 is a fixed-dosed regimen containing four ~30-minute infusions. This further highlights its potential for meaningful clinical benefit without the need for continuous therapy.

"These mature 12-month follow-up data, as required by the FDA, further strengthen the compelling clinical profile of iopofosine I 131," said James Caruso, president and chief executive officer. "Importantly, the durability of response continues to improve over time, and the consistency of activity in post-BTKi patients reinforces the potential of iopofosine to address a critical unmet need in the second line setting and beyond. We remain committed to providing iopofosine I 131 to the thousands of patients who can benefit from treatment and plan to initiate our confirmatory study in fourth quarter of this year."

Iopofosine I 131 continues to demonstrate a predictable and manageable safety profile:

Adverse events were transient and unlike other therapies approved for WM there were no significant bleeding events and low rates of infection (<10%)
Cytopenias were the most common treatment-emergent adverse events
Non-hematologic toxicities were primarily low grade (Grade <2)
Compelling Activity in BTKi-Exposed and Refractory Patients
BTKi therapies have become the standard of care in frontline treatment of WM, outcomes in post-BTKi patients are of increasing importance. Iopofosine I 131 demonstrated strong and consistent efficacy in both BTKi-exposed and BTKi-refractory patients, populations that are among the most difficult to treat.

Summary of Efficacy Results in BTKi-Exposed Patients (n=39):

MRR: 64.1%
Median DoR: 18.2 months
Median PFS: 15.9 months
Summary of Efficacy Results in BTKi-Refractory Patients (n=33):

MRR: 63.6%
Median DoR: 18.2 months
Median PFS: 14.8 months
These results demonstrate durability and depth of response comparable to, or exceeding, the overall study population, reinforcing the consistency of iopofosine’s activity across treatment-resistant subgroups. Furthermore, comparative assessments with published datasets suggest that iopofosine I 131 delivers superior efficacy across key endpoints relative to currently available salvage therapies in similar patient populations.

Efficacy and safety results from r/r WM patients treated with iopofosine I 131 immediately following BTKi therapy have been accepted for presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place from May 29-June 2, 2026 in Chicago, Illinois.

The company also plans to present the full data sets at upcoming medical congresses or scientific meetings.

About Accelerated Approval and Confirmatory Study Initiation
The CLOVER WaM dataset incorporates key elements aligned with regulatory expectations for accelerated approval, including:

Use of surrogate endpoints (MRR supported by DoR) reasonably likely to predict clinical benefit
Demonstration of durable responses in a high unmet need population
Completion of ≥12-month follow-up across all patients, as requested by the FDA
Cellectar is advancing plans to initiate a confirmatory randomized study in a post-first line, post-BTKi population. The study is expected to evaluate progression-free survival (PFS) as the primary endpoint, consistent with regulatory guidance.

The company is also preparing for potential regulatory submissions in the United States and Europe, supported by the strength and maturity of the CLOVER WaM dataset.

About Waldenstrom’s Macroglobulinemia
Waldenstrom’s Macroglobulinemia (WM) is a B-cell malignancy characterized by bone marrow infiltration with clonal lymphoplasmacytic cells that produce a monoclonal immunoglobulin M (IgM) that remains incurable with available treatments. The prevalence in the U.S. is approximately 26,000 with 1,500–1,900 patients being diagnosed annually. Approximately 11,500 patients require treatment in the relapsed or refractory setting and there are an estimated 4,700 patients requiring third line or greater therapy. There are also approximately 1,000 patients that have exhausted all current treatment options by third line because they are ineligible or intolerant to those existing therapies. Therefore, the total addressable market for third line or greater therapy is approximately 5,700 patients. There are no FDA- approved treatment options for patients progressing on BTKi therapy. BTKi therapies do not demonstrate complete response rates and require continuous treatment.

Non-FDA approved salvage treatments are used in more than 60% of patients. Over 50% of patients are treated with the same or similar treatment from prior lines of therapy. There is an established unmet need for new FDA-approved treatments, such as iopofosine I 131, that may provide a novel mechanism of action, increased deep durable responses, and time-limited treatment, especially in heavily pretreated WM patients.

(Press release, Cellectar Biosciences, MAY 5, 2026, View Source [SID1234665109])

Nuvectis Pharma, Inc. Reports First Quarter 2026 Financial Results and Business Highlights

On May 5, 2026 Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, reported its financial results for the first quarter of 2026 and provided an update on recent business progress.

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Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "2026 is off to a good start for Nuvectis as we advance the NXP900 Phase 1b clinical program which continues to enroll patients at top sites in the US in both the monotherapy and combination arms of the program." Mr. Bentsur added, "At this year’s AACR (Free AACR Whitepaper) conference held last month, we provided preclinical data supporting the use of NXP900 in combination with sotorasib, a RAS inhibitor, in non-small cell lung cancer (NSCLC). The combination demonstrated clear synergy both in sotorasib-sensitive and sotorasib-resistant NSCLC models."

Mr. Bentsur concluded, "We are excited for what’s ahead in 2026 and expect a preliminary data readout from the NXP900 Phase 1b study in the summer. We continue to operate with financial discipline and remain focused on achieving key clinical development milestones in our NXP900 program in 2026 and beyond."

First Quarter 2026 Financial Results

Cash and cash equivalents were $25.1 million as of March 31, 2026, compared to $31.6 million as of December 31, 2025.

The Company’s net loss was $6.1 million for the three months ended March 31, 2026, compared to $5.3 million for the three months ended March 31, 2025, an increase of $0.8 million. Non-cash stock-based compensation was $1.9 million for the three months ended March 31, 2026 compared to $1.4 million for the three months ended March 31, 2025.

Research and development expenses were $4.1 million for the three months ended March 31, 2026, compared to $3.7 million for the three months ended March 31, 2025, an increase of $0.4 million. The increase was primarily driven by a $0.4 million increase in manufacturing costs, a $0.3 million increase in employee compensation and benefits, and a $0.2 million increase in clinical trial expenses, partially offset by a $0.5 million reduction in license fees and other professional services.

General and administrative expenses were $2.2 million for the three months ended March 31, 2026, compared to $1.9 million for the three months ended March 31, 2025, an increase of $0.3 million. The increase was primarily driven by a $0.2 million increase in professional and consulting services related to public company expenses and a $0.1 million increase in employee compensation and benefits.

Finance income was $0.2 million for the three months ended March 31, 2026 and 2025.

(Press release, Nuvectis Pharma, MAY 5, 2026, View Source [SID1234665125])

Citius Oncology, Inc. Secures Up to $36.5 Million in Debt and Equity Capital to Accelerate LYMPHIR® Commercialization

On May 5, 2026 Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), a specialty biopharmaceutical company focused on the development and commercialization of novel targeted oncology therapies, reported that it has entered into a senior secured term loan credit facility (the "Credit Facility") with Avenue Venture Opportunities Fund II, L.P., a fund of Avenue Capital Group ("Avenue"), providing for up to $25 million in capital to support the ongoing commercialization of LYMPHIR (denileukin diftitox-cxdl), approved by the Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy, and has also entered into a definitive agreement for the immediate exercise of certain outstanding warrants, with expected gross proceeds to the Company of approximately $11.5 million. The combined financings are expected to provide enhanced financial flexibility to support commercial execution, working capital, and general corporate purposes.

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"This Credit Facility strengthens our ability to continue to execute on the LYMPHIR launch, aligning capital access with commercial performance, and underscoring the confidence that a global investment firm like Avenue Capital has in our commercial trajectory and the long-term potential of LYMPHIR. In parallel, the warrant exercise financing provides additional near-term capital to further support our commercial efforts Collectively, this provides the company with meaningful financial flexibility as we continue to scale our commercial infrastructure, drive adoption of LYMPHIR among treating physicians, and expand patient access to this important therapy for relapsed or refractory cutaneous T-cell lymphoma. We are pleased to have Avenue as a capital partner as we advance our mission to improve outcomes for patients with limited treatment options," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology and Citius Pharmaceuticals.

"Citius Oncology has a differentiated, FDA-approved therapy with a targeted commercial opportunity. We are excited to support the Citius team as they execute on their commercialization strategy and work to realize the full value of their first FDA-approved asset," said Chad Norman, Senior Portfolio Manager of Avenue Capital Group.

H.C. Wainwright & Co. is acting as the exclusive origination, structuring and placement agent to Citius Oncology for the financings.

Financings Summary

The Credit Facility has a term of 3.5 years and includes an initial tranche of $10 million, to be fully funded at closing, plus two additional tranches of up to an aggregate of $15 million, subject to achievement of predefined revenue milestones and liquidity conditions. The Company has agreed to issue to Avenue warrants to purchase up to 11,111,111 shares of the Company’s common stock, at an exercise price of $0.90 per share, exercisable for a period of five years following the effective date of stockholder approval of the issuance of the shares issuable upon exercise of the warrants. The Company will also issue to Avenue warrants to purchase shares of common stock equal to 10% of the amount funded in each future tranche, divided by the exercise price of $0.90 per share. Additionally, Avenue will have the right, at any time while any loan is outstanding, to convert up to $4.0 million of the outstanding principal under the credit facility into shares of the Company’s common stock at a price per share equal to 120% of the exercise price of the warrant, subject to certain terms and conditions, including beneficial ownership limitations.

Concurrently, the Company entered into definitive agreements with a single healthcare-focused institutional investor for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 12,777,778 shares of common stock, originally issued in July 2025, September 2025, and December 2025, at a reduced exercise price of $0.90 per share, with expected gross proceeds to the Company of approximately $11.5 million prior to deduction of placement agent fees and other offering expenses. In consideration for the immediate exercise of these warrants for cash, the Company will issue new unregistered warrants to purchase up to 25,555,556 shares of common stock. The new warrants will have an exercise price of $0.90 per share, will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares issuable upon exercise of the new warrants and will expire five years after the later of (i) the date of stockholder approval and (ii) the effective date of the Resale Registration Statement (as defined below). The new warrant offering is expected to close on or about May 6, 2026, subject to satisfaction of customary closing conditions.

The Company intends to use the net proceeds from the financings primarily to fund ongoing LYMPHIR commercialization efforts such as sales force expansion, market access initiatives, medical affairs activities, and manufacturing supply chain support, with the remainder to be used for working capital and general corporate purposes.

Warrant Offering Disclosure

The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "1933 Act") and, along with the shares of common stock issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the new warrants (the "Resale Registration Statement").

The Company also has agreed to amend certain existing warrants to purchase up to an aggregate of 15,697,024 shares of the Company’s common stock that were previously issued to the investor in December 2025, with an exercise price of $1.09 per share, effective upon the closing of the offering, such that the amended warrants will have a reduced exercise price of $0.90 per share, will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares upon exercise of the warrants and will expire five years after the date of stockholder approval.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

About LYMPHIR (denileukin diftitox‑cxdl)

LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin (DT) fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors.

In 2021, denileukin diftitox received regulatory approval in Japan for the treatment of relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize denileukin diftitox in all markets except for India, Japan and certain parts of Asia. LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA and subsequently launched in the U.S. in December 2025.

(Press release, Citius Oncology, MAY 5, 2026, View Source [SID1234665145])

Pfizer Reports Strong First-Quarter Results And Reaffirms 2026 Guidance

On May 5, 2026 Pfizer reported Strong First-Quarter Results And Reaffirms 2026 Guidance.

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(Press release, Pfizer, MAY 5, 2026, View Source [SID1234665407])