Merck to Acquire US Biopharma Company SpringWorks Therapeutics to Accelerate Sustainable Growth of Healthcare Business

On April 28, 2025 Merck (DAX: MRK), a leading science and technology company, and SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a Stamford, Connecticut-based commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, reported the companies have entered into a definitive agreement for Merck to acquire SpringWorks (Press release, Merck KGaA, APR 28, 2025, View Source [SID1234654400]). The purchase price of $47 per share in cash represents an equity value of approximately $3.9 billion, or an enterprise value of $3.4 billion (€3.0 billion) based on SpringWorks’ cash balance as of December 31, 2024, and a premium of 26% to SpringWorks’ unaffected 20-day volume-weighted average price of $37.38 on February 7, 2025, the day prior to the first market speculation of a potential transaction between Merck and SpringWorks.

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"The agreed acquisition of SpringWorks is a major step in our active portfolio strategy to position Merck as a globally diversified, innovation and technology powerhouse. For our Healthcare sector, it sharpens the focus on rare tumors, accelerates growth, and strengthens our presence in the U.S.," said Belén Garijo, Chair of the Executive Board and CEO of Merck. "Beyond this planned transaction, we will continue to explore M&A opportunities across our three complementary business sectors, always with a firm focus on strategic fit, financial robustness, and long-term value creation."

The planned transaction is fully aligned with the business development/M&A priorities of Merck’s Healthcare business as outlined during the company’s Capital Markets Day in October 2024: to continue to pursue external innovation via in-licensing of high-quality compounds at various stages of development and focused acquisitions that promise early value creation. It also fits with the strategic objective of strengthening Merck’s Healthcare presence in the United States, the world’s largest pharmaceutical market.

Upon closing, the business combination will immediately contribute to Merck’s revenues and is expected to be accretive to Merck’s earnings per share pre (EPS pre) in 2027. The acquisition will be funded with available cash and new debt. Beyond this planned transaction, Merck will retain the ability to pursue larger transactions and continue to evaluate opportunities across its three sectors, with Life Science a priority. Merck is committed to preserving its strong investment grade credit rating.

SpringWorks’ rare tumor portfolio, including a marketed first-in-class, systemic standard-of-care therapy for adults with desmoid tumors and the first and only approved therapy for adults and children with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection, will accelerate immediate and sustainable revenue growth for Merck. SpringWorks’ portfolio complements Merck’s progress in rare tumors, with Merck recently exercising an option for worldwide commercialization rights for pimicotinib, an investigational therapy developed by Abbisko Therapeutics Co., Ltd. for patients with tenosynovial giant cell tumor (TGCT).

"We have the unique opportunity with SpringWorks to establish a leadership position in rare tumors and build a strong foundation for further investments in this area, where a large unmet medical need exists," said Peter Guenter, member of the Executive Board and CEO of Healthcare at Merck. "Together, Merck and SpringWorks are the perfect combination to improve outcomes for patients with rare tumors and bring therapeutic innovations to more patients worldwide while building on and reinforcing the early success of SpringWorks in the United States. For Merck, the planned acquisition will create long term, sustainable growth for our Healthcare business. Along with my successor Danny Bar-Zohar, we look forward to completing this strategic transaction and making a meaningful difference for patients whose lives are so profoundly affected by these complex and challenging tumors."

The agreed acquisition provides SpringWorks with an opportunity to expand its reach into markets beyond the U.S. and leverage the breadth of resources of Merck’s global Healthcare organization.

"From the outset, our focus at SpringWorks has been to create transformative solutions for patients suffering from serious diseases. We have successfully launched two best-in-class medicines in the United States, and with the aspiration to deliver our therapies worldwide, our journey is at a pivotal juncture. It became clear during our discussions with the Merck team that we share many core values, including a commitment to help more patients with rare tumors live longer, better lives," said Saqib Islam, CEO of SpringWorks Therapeutics. "We believe that by joining forces with Merck, we are not only creating significant, immediate value for our stakeholders, but we will also be able to leverage their resources and expertise to build a brighter future for the patient communities we seek to serve while also creating new opportunities for SpringWorks employees as part of a global organization."

SpringWorks’ U.S. Food and Drug Administration (FDA)-approved therapy, OGSIVEO (nirogacestat) is a first-in-class therapy that is the systemic standard of care for the treatment of adult patients with progressing desmoid tumors who require systemic treatment. SpringWorks’ marketing authorization application (MAA) for nirogacestat is under review with the European Medicines Agency (EMA), with a Committee for Medicinal Products for Human Use (CHMP) decision expected in Q2 2025.

GOMEKLI (mirdametinib) is the first and only FDA-approved therapy for the treatment of adult and pediatric patients 2 years of age and older with NF1-PN not amenable to complete resection. The FDA’s February 2025 approval of GOMEKLI was based on positive data from SpringWorks’ Phase 2b ReNeu trial, which showed GOMEKLI treatment resulted in a robust objective response rate, deep and durable reductions in tumor volume, and a manageable safety profile. With the approval, SpringWorks was granted a rare pediatric disease priority review voucher by the FDA. The marketing authorisation application for mirdametinib has been validated by the European Medicines Agency (EMA) with a potential approval in 2025. In addition, SpringWorks is advancing its pipeline with additional programs in other tumor settings that are currently underserved.

The transaction has been unanimously approved, by all those in attendance, by both the Merck and SpringWorks Boards of Directors and is expected to close in the second half of 2025, subject to satisfaction of customary closing conditions, including approval of SpringWorks’ shareholders and receipt of required regulatory approvals.

J.P. Morgan is acting as exclusive financial advisor and Sullivan & Cromwell LLP is acting as legal counsel to Merck. Centerview Partners LLC and Goldman Sachs & Co. LLC are acting as joint financial advisors to SpringWorks, and Goodwin Procter LLP is acting as SpringWorks’ legal counsel.

Alpha Tau Announces Closing of $36.9 Million Registered Direct Offering and Strategic Marketing Alliance with Oramed Pharmaceuticals

On April 28, 2025 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that it has successfully closed a registered direct offering (the "offering") whereby an affiliate of Oramed Pharmaceuticals Inc. ("Oramed") (Nasdaq: ORMP) (TASE: ORMP) purchased 14,110,121 of Alpha Tau’s ordinary shares, no par value, at a purchase price of $2.612 per ordinary share (Press release, Alpha Tau Medical, APR 28, 2025, View Source [SID1234652216]). The offering closed on April 28, 2025.

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The total gross proceeds of the offering were approximately $36.9 million, before deducting estimated offering expenses payable by Alpha Tau. Alpha Tau intends to use the net proceeds from the offering for general corporate purposes, including research and development-related purposes in connection with its product candidates, for expansion of its manufacturing capabilities and for potential commercialization of its product candidates.

In addition, the parties have entered into an agreement whereby an affiliate of Oramed will provide Alpha Tau with certain strategic services (investor relations and public relations) over the next three years in exchange for payments from Alpha Tau as well warrants to purchase additional Alpha Tau shares.

Alpha Tau CEO Uzi Sofer commented, "We are delighted to welcome Oramed as a strategic partner and to leverage their extensive expertise in navigating diverse capital markets channels. This investment comes at the perfect time for Alpha Tau given the rapid expansion of our business activities, including four parallel trial approvals in the U.S., expansion into trials in multiple internal organs, and continued expansion of our manufacturing capacity and pre-commercial preparations. We look forward to a long and fruitful relationship with Oramed."

Oramed CEO Nadav Kidron added, "We are incredibly excited about this alliance with Alpha Tau. We have tremendous conviction in the strength of the Alpha DaRT technology and the Alpha Tau management team. We anticipate significant advancements and milestone achievements as they execute their clinical and commercial roadmap."

A registration statement on Form F-3 relating to the securities to be sold in the registered direct offering has been filed with the U.S. Securities and Exchange Commission (the "SEC") and was declared effective on April 13, 2023. This registered direct offering was made only by means of a prospectus. A copy of the prospectus supplement and the accompanying prospectus relating to this offering was filed with the SEC and may be obtained for free by visiting EDGAR on the SEC’s website at www.sec.gov

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, 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 registration or qualification under the securities laws of any such state or jurisdiction.

SOPHiA GENETICS Announces Expanded Collaboration with AstraZeneca to Accelerate Liquid Biopsy Testing Globally from AACR

On April 28, 2025 SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native healthcare technology company and global leader in data-driven medicine, reported the expansion of its ongoing collaboration with AstraZeneca (LSE/STO/Nasdaq: AZN) to accelerate the deployment of MSK-ACCESS powered with SOPHiA DDM globally (Press release, AstraZeneca, APR 28, 2025, View Source [SID1234652267]). Building on the initial collaboration announced in October 2024, this new phase will extend the test’s reach to a total of 30 clinical institutions worldwide in 2025.

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Developed in collaboration with Memorial Sloan Kettering Cancer Center, MSK-ACCESS powered with SOPHiA DDM is an innovative liquid biopsy testing application designed to detect actionable genomic alterations from a single blood draw using proprietary, state-of-the-art algorithms which analyze circulating tumor DNA (ctDNA). The application supports real-time cancer monitoring and treatment selection when traditional tissue biopsies are not feasible due to cost, turnaround time, insufficient tissue, or the invasiveness of the procedure.

The expanded rollout will continue to contribute to AstraZeneca’s global real-world evidence initiatives and help further validate the clinical impact of decentralized liquid biopsy testing across diverse healthcare systems. By increasing the availability of MSK-ACCESS powered with SOPHiA DDM, SOPHiA GENETICS and AstraZeneca aim to understand further how liquid biopsy testing can complement solid tissue testing and, in some cases, provide greater benefit for labs and patients.

The announcement coincides with SOPHiA GENETICS’s presentation at AACR (Free AACR Whitepaper), in which the company presented data demonstrating the robust transferability of the decentralized MSK-ACCESS powered with SOPHiA DDMTM solution. Historically, site-to-site discordance has been a major barrier to the widespread adoption of liquid biopsy testing. SOPHiA GENETICS presented real-world data highlighting the consistent accuracy and precision of MSK-ACCESS powered with SOPHiA DDMTM across various laboratory settings. Interim results from the multi-center study demonstrated the high analytical performance of the decentralized test in line with the original single-site test at Memorial Sloan Kettering Cancer Center in New York.

"Our collaboration with AstraZeneca represents a significant step toward scaling next-generation oncology diagnostics globally," said Ross Muken, President, SOPHiA GENETICS. "This expanded deployment reflects the growing momentum behind liquid biopsy and our shared ambition to make these technologies more accessible and impactful worldwide."

Visit SOPHiA GENETICS at the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s Annual Meeting in Chicago, Illinois from April 25th–30th to learn more about how SOPHiA GENETICS is collaborating with AstraZeneca to transform patient care with data-driven medicine.

Kairos Pharma, Ltd. Announces Data to be Presented at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting

On April 28, 2025 Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical stage biopharmaceutical company, reported it will be presenting at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting to be held May 30-June 3, 2025 at McCormick Place, Chicago, Ill (Press release, Kairos Pharma, APR 28, 2025, View Source [SID1234652284]).

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The poster is titled, "Effect of KROS 101, a small molecule GITR ligand agonist, on T effector cells, T reg cells and intratumoral CD8 T cell cytotoxicity," and will be presented on June 2.

John Yu, M.D., Kairos CEO commented, "We look forward to the opportunity to continue to share data regarding our platform assets at one of the most prestigious oncology meetings in the world. We believe that KROS 101 has the potential to help optimize cancer treatment and we look forward to discussing our findings with the medical and scientific communities."

Arvinas Shares New Preclinical Combination Data for the PROTAC BCL6 Degrader, ARV-393, at the 2025 American Association for Cancer Research Annual Meeting

On April 28, 2025 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company working to develop a new class of drugs based on targeted protein degradation, reported data from preclinical combination studies of ARV-393, the company’s investigational PROteolysis TArgeting Chimera (PROTAC) B-cell lymphoma 6 protein (BCL6) degrader (Press release, Arvinas, APR 28, 2025, View Source [SID1234652219]). BCL6 is a transcriptional repressor protein and a known driver of B-cell lymphomas. Data demonstrated synergistic antitumor activity, including complete regressions, in combination with standard of care (SOC) chemotherapy, SOC biologics, and investigational oral small molecule inhibitors (SMIs) in high grade B-cell lymphoma (HGBCL) and aggressive diffuse large B-cell lymphoma (DLBCL) models. The results from these preclinical studies were shared in a poster presentation at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in Chicago, Illinois.

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Key findings from the studies included:

ARV-393 in combination with SOC chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]), induced significantly greater tumor growth inhibition compared with rituximab, CHOP, R-CHOP, or ARV-393 alone, with complete tumor regressions in all mice treated with the ARV-393 and R-CHOP combination.
ARV-393 in combination with SOC biologics targeting CD20 (rituximab), CD19 (tafasitamab), or CD79b (polatuzumab vedotin) resulted in tumor regressions and demonstrated significantly stronger tumor growth inhibition compared with each agent alone.
In preclinical models, ARV-393 increased CD20 expression, providing additional support for the exploration of combinations with CD20-targeted agents and in the context of low or loss of CD20 expression.
ARV-393 in combination with investigational small molecule inhibitors targeting clinically validated oncogenic drivers of lymphoma, such as BTK (acalabrutinib), BCL2 (venetoclax), or EZH2 (tazemetostat), resulted in superior tumor growth inhibition compared with each agent alone, with tumor regressions in all mice treated with the combinations.
"Given that combination regimens are the foundation of lymphoma treatment, we are encouraged by the strength of these preclinical combination data, which demonstrate complete tumor regressions in aggressive lymphoma models," said Noah Berkowitz, M.D., Ph.D., Chief Medical Officer at Arvinas. "We believe these preclinical data demonstrate potential for broad combinability of ARV-393 and provide a compelling rationale for considering combination strategies as we work to bring forward new therapeutic options for lymphoma patients."

A Phase 1 study of ARV-393 is enrolling patients with relapsed/refractory non-Hodgkin lymphoma, including DLBCL (NCT06393738).

Additional detail on the ARV-393 data presentation at AACR (Free AACR Whitepaper) 2025:

Poster Title: ARV-393, a PROteolysis TArgeting Chimera (PROTAC) BCL6 Degrader, Combined With Biologics or Small-Molecule Inhibitors Induces Tumor Regressions in Diffuse Large B-Cell Lymphoma Models
Abstract: 1655
Session Title: Degraders and Glues 2
Session Type: Experimental and Molecular Therapeutic
Location: Poster Section 18
Poster Board Number: 15
Date: Monday, April 28, 2025
Lecture Time: 9:00 a.m. – 12:00 p.m. CT

About ARV-393
ARV-393 is an investigational, orally bioavailable PROteolysis TArgeting Chimera (PROTAC) designed to degrade B-cell lymphoma 6 protein (BCL6), a transcriptional repressor and major driver of B-cell lymphomas. During B-cell development, tightly controlled BCL6 protein expression regulates >600 genes to facilitate rapid B-cell proliferation and tolerance of somatic hypermutation and gene recombination for antibody generation. Deregulated BCL6 expression is common in B-cell lymphoma and promotes cancer cell survival, proliferation, and genomic instability. PROTAC-mediated degradation has the potential to address the historically undruggable nature of BCL6. ARV-393 is currently in a Phase 1 clinical trial in patients with relapsed/refractory non-Hodgkin lymphoma.