Genmab to Acquire Merus in $8 Billion Deal, Strengthening Oncology Pipeline

Danish biotechnology company Genmab (Nasdaq: GMAB) has agreed to acquire Dutch oncology firm Merus (Nasdaq: MRUS) in an all-cash transaction valued at roughly $8 billion, a move that significantly expands Genmab’s late-stage pipeline and accelerates its push toward a fully owned operating model.

Under the terms of the deal, Genmab will pay $97.00 per share for all outstanding common shares of Merus, representing a premium of more than 40% over Merus’ most recent closing price. The boards of both companies have unanimously approved the transaction, which is expected to close by the first quarter of 2026 pending regulatory and shareholder approvals.

The acquisition brings Merus’ lead asset, petosemtamab, into Genmab’s pipeline. The bispecific antibody therapy, currently in Phase 3 clinical trials, has received two Breakthrough Therapy Designations from the U.S. Food and Drug Administration for treatment of head and neck cancers. Recent Phase 2 data presented at the 2025 ASCO meeting indicated promising efficacy, with outcomes surpassing standard of care benchmarks.

The addition of petosemtamab is expected to bolster Genmab’s transition to a fully owned model, reducing reliance on partnerships and collaborations. By 2027, Genmab anticipates four proprietary programs reaching the commercial stage, positioning the company for multiple new product launches within oncology.

Petosemtamab’s potential launch as early as 2027 could deliver significant commercial impact, with projections suggesting annual sales of $1 billion by 2029 and the possibility of multi-billion-dollar revenues in the longer term. Genmab expects the acquisition to become accretive to EBITDA before the end of the decade.

The $8 billion consideration will be financed through a combination of cash on hand and approximately $5.5 billion in debt, backed by commitments from Morgan Stanley Senior Funding. Genmab stated it remains committed to deleveraging, with a target of reducing gross leverage below three times within two years of closing.

A tender offer for Merus shares will launch in the coming weeks. If successful, the transaction will result in Merus becoming a wholly owned subsidiary of Genmab. Shareholders who do not tender their shares are expected to receive equivalent value through statutory buy-out proceedings in the Netherlands.

The deal highlights the intense competition among biotech companies to secure late-stage oncology assets with strong regulatory momentum. By integrating Merus’ multispecific antibody expertise, Genmab gains not only a promising drug candidate but also a platform that complements its own antibody development technologies.

For Merus, the acquisition provides the scale and resources of a global biotechnology leader to advance petosemtamab through late-stage development, regulatory review, and potential commercialization.

With a strong balance sheet, an expanded pipeline, and an emphasis on proprietary innovation, Genmab is positioning itself to compete more directly with larger global oncology players in the second half of the decade.

Release – The Oncology Institute Achieves $1.1 Million in Medicare Savings in CMS Enhancing Oncology Model Performance Period 2 through its California Professional Corporation

Research News and Market Data on TOI

Sep 22, 2025

PDF Version

Practice earns maximum quality points on avoidable ED visits and admissions, saving more than $3,500 per episode

CERRITOS, Calif., Sept. 22, 2025 (GLOBE NEWSWIRE) — The Oncology Institute of Hope and Innovation (NASDAQ: TOI), a leading value-based oncology practice, achieved $1.1 million in Medicare savings during Performance Period 2 of the Centers for Medicare & Medicaid Services’ Enhancing Oncology Model (EOM) through its California professional corporation, with savings equating to more than $3,500 per patient episode. TOI earned the maximum score on avoidable emergency department visits and hospital admissions. Results were driven by our High Value Cancer Care program conducted by Health Care Coaches and 24/7 symptom management support that helped patients stay on treatment and out of the hospital.

EOM is a voluntary total-cost-of-care model created by the CMS Innovation Center to advance high-quality, person-centered, and equitable cancer care for Medicare Fee-for-Service beneficiaries.

“These results again prove that our proactive navigation and real-time symptom management reduce unnecessary hospital visits and keep patients on treatment,” said Dr. Yale D. Podnos, Chief Medical Officer and President of Practice. “Patients across all our markets have access to these proven best practices to ensure each patient receives the right care at the right time.”

“This performance reinforces TOI’s leadership in value-based oncology,” said Dan Virnich, Chief Executive Officer. “By delivering measurable savings while improving quality, we continue to demonstrate that high-value cancer care is both clinically superior and financially sustainable.”

TOI’s success in EOM builds on its track record in CMS’s prior Oncology Care Model, where the organization exceeded quality standards and generated multi-million-dollar savings for Medicare.

About The Oncology Institute (www.theoncologyinstitute.com):
Founded in 2007, The Oncology Institute (NASDAQ: TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI offers cutting-edge, evidence-based cancer care to a population of approximately 1.9 million patients, including clinical trials, transfusions, and other care delivery models traditionally associated with the most advanced care delivery organizations. With over 180 employed and affiliate clinicians and over 100 clinics and affiliate locations of care across five states and growing, TOI is changing oncology for the better.

Media
The Oncology Institute, Inc.
marketing@theoncologyinstitute.com 

Investors
ICR Healthcare
TOI@icrhealthcare.com 

The Oncology Institute, Inc. (TOI) – Patient Additions And Pharmacy Division Drive 2Q25 Revenues Above Expectations


Thursday, August 14, 2025

TOI is an oncology practice management company that provides administrative services to oncology clinics. These clinics provide cancer care to a population of approximately 1.9 million patients. Services include cancer care, pharmacy and dispensary services, clinical trials, and services associated with oncology care. The company employs nearly 120 clinicians and over 700 teammates at over 70 clinic locations.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Revenues Were Driven By New Patients Under Contract. The Oncology Institute reported a loss for 2Q25 of $17.0 million or $(0.15) per share. Revenues of $119.8 million exceeded our estimate of $110.4 million. The company discussed newly active or pending contracts that will add covered lives during 2H25. It reiterated its guidance for Revenues, Gross Profit, Adjusted EBITDA, and Free Cash Flow. Cash on June 30, 2025 was $30.3 million.

Patient Services Were Close To Our Expectations. The Patient Services division reached $55.9 million. New payor contracts added patients during 1H25 that began generating revenues, although they have a period of higher cost during the transition to TOI management. We expect the patient mix to include more continuing patients during 2H25, improving margins while new contracts continue to drive growth.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

The Oncology Institute, Inc. (TOI) – Improving Oncology Treatment While Cutting Costs


Wednesday, July 23, 2025

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Initiating Coverage of The Oncology Institute With An Outperform Rating. The Oncology Institute of Hope & Innovation (TOI) is a medical practice management company specializing in community-based oncology practices. It manages and operates oncology clinics in five states using its proprietary, value-based methodology. These treatment regimens have improved outcomes for patients while reducing the cost of care.

TOI Uses Capitated Contracts To Control Costs. TOI enters into contracts with third-party payers to treat a specified number of health plan members based on the estimated per-member, per-month cost. This method of providing coverage based on population size is known as capitation. It also offers traditional fee-for-service as well as value-based oncology care.  This provides TOI with the flexibility to contract with more insurance plans.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Concentra Biosciences to Acquire Elevation Oncology in Strategic Biotech Merger

Key Points:
– Concentra Biosciences is acquiring Elevation Oncology for $0.36 per share in cash plus a CVR tied to future financial milestones.
– Elevation’s board supports the deal; insiders holding 5.1% have committed to tender their shares.
– Shareholders could earn additional payouts based on net cash reserves and proceeds from potential asset sales.

In a strategic move within the biotech sector, Concentra Biosciences has announced plans to acquire Elevation Oncology, a clinical-stage oncology firm known for its targeted cancer therapies. The transaction, which was unveiled Monday, values Elevation at $0.36 per share in cash. In addition to the upfront payment, shareholders will receive a contingent value right (CVR) tied to future financial outcomes.

This acquisition marks a significant shift for Elevation Oncology, which has focused its efforts on developing precision treatments for solid tumors with limited current treatment options. The deal aligns with Concentra’s expansion strategy in oncology innovation, particularly in addressing high-need patient populations.

Under the terms of the agreement, Elevation stockholders will receive a cash payout of $0.36 per share, with an additional CVR providing potential future compensation. The CVR includes two main components: shareholders could benefit from any closing cash above $26.4 million and from a share of future net proceeds related to the disposition of EO-1022, a clinical asset, if sold within a year of closing. The CVR will remain active for up to five years following the merger.

Elevation’s board of directors has unanimously backed the agreement, emphasizing that the proposed terms serve the best interest of shareholders. A wholly owned subsidiary of Concentra is expected to begin a formal tender offer by June 23, 2025. For the acquisition to proceed, a majority of Elevation’s outstanding shares must be tendered, and at least $26.4 million in net cash must remain on hand after deducting liabilities, transaction costs, and specific payments.

Support for the deal is already emerging. Elevation’s leadership and certain insiders, who collectively own about 5.1% of the company’s shares, have signed agreements to support and tender their holdings. If all conditions are met, the merger is expected to finalize by July 2025.

The acquisition arrives at a pivotal moment for Elevation Oncology. The company has faced challenges navigating the complex landscape of cancer drug development and commercialization. Partnering with Concentra provides a pathway to both secure value for current shareholders and potentially advance EO-1022 and other clinical assets under stronger financial and operational support.

Legal counsel for Elevation Oncology is being provided by Fenwick & West LLP, while Gibson, Dunn & Crutcher LLP is advising Concentra.

This merger is part of a broader trend in the biotech sector, where companies with innovative pipelines seek strategic partnerships or acquisitions to accelerate growth and mitigate risk. For Concentra, the deal expands its reach into solid tumor therapeutics—a market with both high clinical need and strong commercial potential.

As the healthcare sector continues to evolve, this acquisition underscores the importance of collaboration in bringing forward novel cancer treatments and delivering shareholder value in a highly competitive and capital-intensive industry.

Take a moment to take a look at Noble Capital Markets’ Biotechnology and Life Sciences Research Analyst Robert Leboyer’s coverage list.

Merck KGaA to Acquire SpringWorks Therapeutics in $3.9 Billion Deal to Expand Rare Tumor Treatments

Merck KGaA, Darmstadt, Germany, is making a significant move to bolster its healthcare division, announcing plans to acquire U.S.-based SpringWorks Therapeutics for approximately $3.9 billion. The definitive agreement will see Merck pay $47 per share in cash, representing a 26% premium to SpringWorks’ 20-day average stock price before news of the deal first surfaced.

This acquisition fits neatly into Merck’s long-term strategy to expand its global healthcare portfolio, particularly in the area of rare tumors and precision oncology. With this deal, Merck will not only add two groundbreaking FDA-approved therapies to its pipeline but also strengthen its commercial footprint in the United States—the largest pharmaceutical market in the world.

SpringWorks brings to the table a robust portfolio focused on rare diseases and oncology. Its leading products include OGSIVEO® (nirogacestat), the first systemic therapy approved for adults with progressing desmoid tumors, and GOMEKLI™ (mirdametinib), the first FDA-approved treatment for both adults and children with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN). Both therapies address underserved patient populations and are expected to drive immediate and sustainable revenue growth for Merck’s healthcare business.

“This acquisition marks a major step in our strategy to position Merck as a global powerhouse in science and technology,” said Belén Garijo, Chair of the Executive Board and CEO of Merck KGaA, Darmstadt, Germany. “It enhances our rare tumor portfolio, expands our presence in the U.S., and accelerates growth opportunities for our Healthcare sector.”

Financially, the acquisition is expected to be immediately revenue accretive and to contribute to earnings per share (EPS pre) by 2027. Merck plans to finance the acquisition through a combination of cash on hand and new debt while preserving its strong investment-grade credit rating.

SpringWorks’ CEO Saqib Islam expressed optimism about the deal, emphasizing that Merck’s resources and global reach will allow SpringWorks’ innovative therapies to benefit a broader population of patients worldwide. “We believe joining Merck will enable us to accelerate our mission to improve the lives of people affected by devastating rare tumors,” Islam said.

Regulatory approvals and SpringWorks shareholder approval are still pending, but both companies’ boards have unanimously supported the transaction. Closing is expected in the second half of 2025.

Beyond just two approved therapies, SpringWorks also brings a promising pipeline of additional programs targeting solid tumors and hematological cancers. Merck’s move to integrate this pipeline reflects its commitment to diversifying its portfolio while focusing on innovation-driven growth.

The acquisition also fits neatly into Merck’s wider portfolio strategy revealed during its 2024 Capital Markets Day: pursue external innovation through in-licensing and acquisitions that deliver early value. While healthcare remains a priority, Merck maintains ambitions to expand across its life sciences and electronics sectors as well.

For investors and the healthcare community, this deal signals that Merck is serious about building a leadership position in treating rare tumors and is willing to invest heavily to secure future growth. It also promises a significant expansion of treatment options for patients with limited existing therapies.

Take a moment to take a look at more emerging growth healthcare companies by taking a look at Noble Capital Markets’ Research Analyst Robert Leboyer’s coverage list.

Ligand Pharmaceuticals Expands Oncology Portfolio with $100 Million APEIRON Biologics Acquisition

In a strategic move to bolster its commercial-stage portfolio, Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) announced on July 8, 2024, its agreement to acquire APEIRON Biologics AG for $100 million in cash. This acquisition marks a significant expansion of Ligand’s oncology footprint, particularly in the realm of rare pediatric cancers.

The crown jewel of this acquisition is QARZIBA® (dinutuximab beta), a highly differentiated oncology drug used in the treatment of high-risk neuroblastoma in patients aged 12 months and above. QARZIBA, which received European Medicines Agency approval in 2017, is currently marketed in over 35 countries by global pharmaceutical company Recordati S.p.A.

Todd Davis, CEO of Ligand, emphasized the strategic importance of this acquisition, stating, “The addition of QARZIBA to our commercial royalty portfolio further supports our growth strategy to invest in high-value medicines that deliver significant clinical value and generate predictable and long-term revenue streams for our investors.”

The deal structure includes the initial $100 million cash payment, with the potential for up to an additional $28 million based on future commercial and regulatory milestones. Specifically, these additional payments are tied to QARZIBA royalties exceeding certain predetermined thresholds by either 2030 or 2034.

From a financial perspective, this acquisition is expected to make an immediate positive impact on Ligand’s bottom line. The company projects that the deal will be accretive to its earnings per share (EPS) by approximately $1.00 on an annualized basis, with a $0.50 impact expected for 2024 alone. In light of this, Ligand has increased its 2024 adjusted EPS guidance by 17% to a range of $5.00-$5.50.

The acquisition of APEIRON represents the sixth key asset added to Ligand’s commercial stage portfolio since the beginning of 2023, underscoring the company’s aggressive growth strategy. This diversification is expected to provide Ligand with a more stable and predictable revenue stream, a key consideration for investors in the volatile biotech sector.

QARZIBA’s unique position as the only immunotherapy for high-risk neuroblastoma marketed across Europe and other parts of the world makes it a particularly valuable addition to Ligand’s portfolio. Neuroblastoma, a rare cancer that primarily affects children, has limited treatment options, highlighting the potential impact of QARZIBA on patient outcomes.

In a parallel move, Ligand has also committed to investing up to $4 million in invIOs Holding AG, a privately held spin-off of APEIRON. This investment is aimed at financing the research and development of three innovative early-stage immuno-oncology assets, further expanding Ligand’s development stage portfolio.

Peter Llewellyn-Davies, CEO of APEIRON, expressed satisfaction with the deal, noting, “This transaction is an important milestone for our company and shareholders. We have spent more than 20 years translating academic research into therapeutic products for diseases with high unmet needs.”

The acquisition is expected to close in July 2024, subject to a 30-day shareholder objection period and other customary closing conditions. Upon completion, it will significantly reshape Ligand’s commercial portfolio and financial outlook.

As the biopharmaceutical industry continues to consolidate and seek ways to mitigate risk while maximizing potential returns, Ligand’s acquisition of APEIRON represents a strategic move to strengthen its position in the oncology market. By focusing on high-value, commercially available assets like QARZIBA, Ligand is positioning itself for sustained growth in the competitive and rapidly evolving pharmaceutical landscape.

Take a moment to take a look at emerging biotech companies by taking a look at Noble Capital Markets Research Analyst Robert LeBoyer’s coverage list.

Small Biotech Cullinan Goes All-In on Autoimmune CAR-T in $280M Pivot

In a bold strategic move, small-cap biotech Cullinan Oncology is transforming into an autoimmune disease company and rebranding as Cullinan Therapeutics. The Massachusetts company announced the major pivot alongside a $280 million private placement financing that extends its cash runway into 2028.

Cullinan is staking its future on the emerging potential of CAR-T cell therapies to treat autoimmune conditions like systemic lupus erythematosus (SLE). The company plans to advance its lead candidate CLN-978, a bispecific T cell engager originally developed for lymphoma, into SLE. An Investigational New Drug (IND) filing is targeted for the third quarter of 2024, with additional autoimmune indications likely to follow.

The strategic refocusing comes as preliminary data from small academic studies hint that CAR-T cells could induce durable remissions in autoimmune patients by depleting pathogenic B cells and modulating the immune system. In February, researchers reported that 8 out of 15 SLE patients achieved remission for over 1 year after CAR-T treatment, allowing them to discontinue all other medications.

“The unmet need in autoimmune diseases is vast, with most patients cycling through treatment after treatment without achieving remission,” said Cullinan CEO Alejandra Carvajal. “CAR-T cell therapy represents a potential paradigm shift, with an entirely novel mechanism to re-educate the immune system.”

Cullinan is one of the first movers in the autoimmune CAR-T space, but it won’t be alone for long. Peers like Kyverna, Cabaletta, Allogene and Arbor have all initiated programs or partnerships in the last year to develop similar cell therapies.

Cullinan has stopped enrolling patients in CLN-978’s lymphoma study to fully transition to autoimmune disorders. But the company is retaining its existing oncology pipeline, including lead asset zipalertinib in non-small cell lung cancer.

To fund the new autoimmune endeavors, Cullinan raised $280 million through the sale of shares and convertible securities to institutional investors. The private placement was led by venBio Partners and included Cullinan’s existing investors.

“This successful financing provides Cullinan with the resources to rapidly advance our CLN-978 program in SLE and beyond,” stated Carvajal. “We’re excited to lead the way into this new frontier at the intersection of cell therapy and autoimmune disease.”

Cullinan is making a high-risk, high-reward bet on still-unproven science. CAR-T’s efficacy in autoimmune conditions has only been explored in small patient numbers so far. But if the approach proves transformative, Cullinan could be at the vanguard of disrupting the large autoimmune drug market.

The hefty $280 million raise buys Cullinan plenty of runway to generate data from larger trials evaluating CLN-978 and shaping its future autoimmune portfolio. For autoimmune disease patients in need of new options, all eyes will be on Cullinan’s pioneering role in the promising CAR-T space.

Boundless Bio $100M IPO to Advance Novel Cancer Therapies

Boundless Bio, a biotech company pioneering a new approach to treating cancer, made its public debut on the Nasdaq stock exchange today in a $100 million initial public offering. The Cambridge, Massachusetts company is the latest biotech firm to go public in 2024 after last year’s IPO drought, pricing its shares at $16 each under the ticker symbol “BOLD.”

The $100 million capital raise will provide a major boost to Boundless Bio’s pipeline of experimental cancer therapies that target extrachromosomal DNA (ecDNA), double-stranded DNA molecules that exist outside of chromosomes and can contain amplified oncogenes driving tumor growth.

“EcDNA represents an exciting new frontier in cancer biology and a promising opportunity for therapeutic intervention,” said Zachary Hartman, CEO of Boundless Bio. “With this successful IPO, we are now well-capitalized to advance our novel ecDNA-targeted candidates through clinical trials and hopefully translate this cutting-edge science into meaningful treatments for patients.”

Leading the way for Boundless is BBI-355, the company’s most advanced program that inhibits checkpoint kinase 1, an enzyme involved in ecDNA replication and transcription. BBI-355 is currently being evaluated in the Phase 1/2 POTENTIATE study, with initial data from up to 90 patients expected in the second half of this year.

Not far behind is BBI-825, an oral ribonucleotide reductase inhibitor that targets a different mechanism related to ecDNA biology. This second clinical candidate entered Phase 1/2 testing just last month in the STARMAP trial, with early results anticipated in late 2025.

In addition to developing therapeutics, a portion of the $100 million IPO proceeds will fund Boundless Bio’s efforts to create a diagnostic test called ECHO to detect ecDNA levels in cancer patients’ tumors. The company believes this could enable more precise treatment by identifying patients most likely to respond to ecDNA-targeted therapies.

The successful Nasdaq listing bucks the trend of a biotech IPO market that was essentially frozen in 2023 amid volatile market conditions. But investor sentiment appears to have rebounded in 2024, with Boundless Bio becoming the seventh biotech to go public so far this year.

“This is an incredibly promising time for Boundless Bio and for companies working on novel modalities that could reshape cancer treatment,” said Tricia Lorida, a biotech analyst at SVB Securities. “While ecDNA therapies are still at an early stage, there is certainly excitement around targeting these unique DNA drivers of tumor growth and genomic instability.”

Boundless Bio’s IPO was led by Goldman Sachs, Guggenheim Securities, Piper Sandler, and Leerink Partners as joint book-running managers. The company granted underwriters a 30-day option to purchase up to an additional 937,500 shares at the IPO price, which could raise the total deal proceeds to $115 million if exercised in full.

With the $100 million-plus capital infusion, Boundless Bio is well-positioned to advance its pioneering work in the emerging field of ecDNA biology as the company aims to unlock new therapeutic options for cancer patients. The successful IPO marks an ambitious first step, but much will ride on the clinical data readouts expected over the next couple of years.

The successful $100 million IPO by Boundless Bio could pave the way for more biotech companies to tap the public markets in 2024 as investor appetite appears to be returning. After a dismal 2023 that saw very few biotechs go public, the new year has brought a flurry of IPO activity, with Boundless Bio becoming the seventh biotech to debut on the Nasdaq. Other drug developers waiting in the wings may seize the opportunity to join the IPO queue if market conditions remain favorable. An opening of the IPO window would provide a crucial capital infusion for biotech firms to continue advancing their R&D programs amid a challenging funding environment. While clinical data will ultimately determine the fates of these newly public companies, a reinvigorated IPO market bodes well for biotech innovation lingering in the pipeline.

Nuvation Bio Acquires AnHeart Therapeutics, Gains Promising Oncology Assets

In a strategic move to strengthen its oncology pipeline, Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company focused on developing novel cancer therapies, has announced its acquisition of AnHeart Therapeutics Ltd. in an all-stock transaction. This acquisition promises to transform Nuvation Bio into a late-stage global oncology company, positioning it as a potential commercial organization by the end of 2025.

The deal, which is subject to approval by AnHeart’s shareholders and other customary closing conditions, is expected to close in the second quarter of 2024. Upon completion, the former shareholders of AnHeart will own approximately 33% of Nuvation Bio on a fully diluted basis, while the current stockholders of Nuvation Bio will retain a 67% stake.

The primary asset driving this acquisition is taletrectinib, AnHeart’s lead investigational therapy and a next-generation ROS1 inhibitor for the treatment of ROS1-positive non-small cell lung cancer (NSCLC). Taletrectinib has already received Breakthrough Therapy Designations from both the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA).

Notably, taletrectinib is currently completing two pivotal Phase 2 studies, TRUST-I in China and TRUST-II, a global pivotal study, potentially positioning it as a best-in-class treatment option for patients with ROS1-positive NSCLC. The NMPA has also granted Priority Review Designation to New Drug Applications for taletrectinib, further underscoring its potential.

In addition to taletrectinib, the acquisition also brings safusidenib, a potentially best-in-class mutant IDH1 inhibitor, into Nuvation Bio’s pipeline. Safusidenib is currently being evaluated in a global Phase 2 study for the treatment of patients with grades 2 and 3 IDH1-mutant glioma.

“This transaction represents a significant milestone for our company and reflects Nuvation Bio’s continued commitment to developing therapies for patients with the most difficult-to-treat cancers,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “AnHeart’s lead asset, taletrectinib, which will become our lead asset as it completes two pivotal studies, is a differentiated, next-generation ROS1 inhibitor with a potentially best-in-class profile that may overcome the significant limitations of existing therapies.”

For Nuvation Bio, this all-stock acquisition preserves the company’s robust cash balance, enabling the development of both the newly acquired assets and its existing pipeline without the immediate need to raise additional capital. This financial strength positions Nuvation Bio to execute its development strategy effectively and advance its combined portfolio of differentiated oncology therapeutic candidates.

The acquisition also brings together the talented teams from both companies, with Nuvation Bio’s current management team, including Dr. Hung, remaining at the helm. Additionally, Min Cui, Ph.D., Founder and Managing Director of Decheng Capital, an investor in AnHeart, and Junyuan Jerry Wang, Ph.D., Co-Founder and Chief Executive Officer of AnHeart, will join Nuvation Bio’s board of directors.

As the demand for innovative cancer therapies continues to grow, Nuvation Bio’s acquisition of AnHeart Therapeutics represents a strategic move to bolster its oncology pipeline and position itself as a potential commercial organization in the near future. With taletrectinib and safusidenib as promising additions to its portfolio, Nuvation Bio is poised to make significant strides in addressing the unmet needs of patients with challenging forms of cancer.

AstraZeneca Makes $2.4 Billion Bet on Next-Gen Cancer Radioconjugates

In a bold move to fortify its oncology pipeline, pharmaceutical giant AstraZeneca (NASDAQ: AZN) has agreed to acquire clinical-stage biotech Fusion Pharmaceuticals (NASDAQ: FUSN) for up to $2.4 billion. The deal gives AstraZeneca full access to Fusion’s pioneering radioconjugate (RC) therapies and expertise as it aims to transform cancer treatment and unseat traditional chemotherapy and radiation regimens.

Fusion specializes in developing a promising new class of precision oncology drugs called RCs, which dispense powerful, targeted radiation directly to cancer cells via targeting molecules like antibodies. By delivering potent radioisotope payloads to tumors in this manner, RCs may improve upon external beam radiation’s limitations and indiscriminately toxic effects.

Under the agreed terms, AstraZeneca will pay $21 per share in cash upfront to acquire all outstanding Fusion shares, valuing the biotech at approximately $2 billion. This headline price represents a staggering 97% premium over Fusion’s closing price prior to deal announcement. AstraZeneca has also committed up to $3 per share in additional contingent value rights tied to a future regulatory milestone, which could push the total deal value to $2.4 billion if achieved.

For AstraZeneca, the acquisition paves the way for a major expansion into promising RC therapeutics, which could revolutionize how cancers are treated in the future. The crown jewel of the deal is FPI-2265, Fusion’s lead RC candidate that uses the alpha particle-emitting isotope actinium-225 to target PSMA proteins in metastatic castration-resistant prostate cancer. FPI-2265 is already in Phase 2 clinical trials with early data expected in 2024.

Beyond this advanced asset, AstraZeneca gains control of Fusion’s broader pipeline of RC programs and candidates across multiple solid tumor types. Just as importantly, the transaction provides AstraZeneca with Fusion’s specialized R&D capabilities, manufacturing infrastructure, and actinium-225 supply chain specifically tailored for developing these next-wave radiotherapeutics.

This strategic acquisition doubles down on AstraZeneca’s burgeoning radio-isotope therapy initiatives. The pharma giant already has a collaboration with Fusion exploring lung cancer applications using one of its RC molecules. By bringing Fusion’s RC therapy capabilities fully in-house, AstraZeneca can now swiftly integrate and scale up this cutting-edge treatment modality across its industry-leading oncology portfolio.

For Fusion investors, the buyout represents a lucrative exit at a substantial premium, especially compared to the company’s $300 million market cap prior to deal reports. While always bittersweet to see a promising biotech get absorbed, Fusion’s technology and team are now set to be fueled by abundant AstraZeneca resources in pursuing RC breakthroughs.

The transaction, expected to close in Q2 2024 pending customary approvals, foreshadows a future where RCs could potentially supplant chemotherapy and radiotherapy as more precise, less toxic foundational cancer regimens. While still an emerging field, AstraZeneca’s bold multi-billion dollar investment signals its confidence in harnessing RCs’ unique advantages over traditional oncology treatments.

As AstraZeneca executes an ambitious pivot toward next-generation RC therapies, biotech and pharma investors would be wise to monitor this rapidly evolving space. The acquisition of Fusion continues to position the pharma titan at the vanguard of replacing archaic cancer protocols with targeted radioconjugate precision medicines.

Novartis Scoops Up MorphoSys in $2.9B Bid to Expand in Oncology

Novartis made a big move this week to expand its oncology portfolio, announcing plans to acquire German biotech MorphoSys in an all-cash deal valued at approximately $2.9 billion. The proposed acquisition continues Novartis’ strategy of striking deals and partnerships to enhance its drug development capabilities, especially in cancer.

Under the terms of the agreement, Novartis will pay $73 per share to purchase all outstanding ordinary shares of MorphoSys, representing a premium of 37% over the biotech’s closing price on February 3rd. The deal has been unanimously approved by MorphoSys’ board and is expected to close in the first half of 2024, pending regulatory and shareholder approval.

Driving Novartis’ interest is MorphoSys’ lead pipeline candidate pelabresib, an investigational BET inhibitor being studied for myelofibrosis. Myelofibrosis is a type of bone marrow cancer that disrupts the body’s normal production of blood cells.

Pelabresib is currently in the Phase 3 MANIFEST-2 trial in combination with Incyte’s Jakafi for first-line myelofibrosis patients. While the trial posted mixed results in November, Novartis believes the data support a regulatory submission in the second half of 2024. The pharma giant sees pelabresib as having potential to be a “practice changing” myelofibrosis treatment.

Beyond pelabresib, MorphoSys brings other early-stage oncology assets that could strengthen Novartis’ position in blood cancers. However, the crown jewel of MorphoSys’ portfolio – its approved non-Hodgkin’s lymphoma drug Monjuvi – is not included in the acquisition. Just before the Novartis deal was announced, MorphoSys sold the global rights to Monjuvi to Incyte for $1.5 billion.

Novartis has been actively hunting for new drug programs and technology platforms to replenish its pipeline as patents expire over the next decade on blockbuster brands like Cosentyx and Entresto. The patent cliff threatens over 50% of Novartis’ current sales.

In 2022, the pharma giant established a $1 billion fund to invest in startups focused on potentially transformational medicines. It has also been open to large M&A, as seen last year with the $20.7 billion purchase of gene therapy biotech The Medicines Company.

The MorphoSys deal reinforces Novartis’ commitment to growing its oncology division, which accounted for over 30% of total sales in 2023. Earlier this year, Novartis acquired the oncology biotech Calypso for $335 million upfront.

From an investor perspective, the MorphoSys acquisition provides Novartis with multiple shots on goal in blood cancers. If pelabresib hits, it could generate peak sales above $1 billion annually according to analysts. And with MorphoSys trading at multi-year lows, Novartis appears to have struck at an opportune time.

However, the mixed clinical data keeps pelabresib’s commercial prospects uncertain. And with most of MorphoSys’ value residing in the newly divested Monjuvi, it remains to be seen if Novartis overpaid. Investors reacted with caution on Tuesday, with Novartis shares falling 1% on news of the acquisition.

But with MorphoSys providing additional expertise in hematology R&D and a foothold in the German biotech scene, Novartis can justify the deal as a strategic move to reinforce oncology leadership. The pharma giant has the resources to continue its shopping spree, with around $9 billion in annual free cash flow.

If Novartis can successfully integrate MorphoSys’ personnel and drug candidates into its pipeline, while achieving cost synergies, the acquisition could pay dividends over time as new oncology drugs emerge. But executing large M&A successfully is always challenging, and investors will watch closely how Novartis leverages its new MorphoSys assets.

Mark your calendars! Don’t miss Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference on April 17-18. This exclusive virtual event connects investors with 50 leading public biotech, healthcare services, and medical device companies. Presenting company slots are available…Read More

GC Oncology’s $380M IPO Kickstarts 2024 Biotech Market

The New Year has kicked off with a bang in biotech, as CG Oncology has completed the first initial public offering in the space for 2024. The cancer-focused biotech raised a whopping $380 million in its IPO on the Nasdaq, sailing past its initial target range of $181 million.

CG Oncology priced its shares at $19 apiece, above the $16-18 range it had set ahead of the IPO. The impressive deal is being viewed by many analysts and investors as a positive indicator that the biotech IPO market is rebounding in 2024 after a relatively slow 2023.

The robust demand for CG Oncology stock reflects renewed optimism and openness to investing in early-stage biotech companies, especially those with innovative science and strong leadership teams.

CG Oncology is developing a novel oncolytic virus therapy known as cretostimogene grenadenorepvec for the treatment of non-muscle invasive bladder cancer. Oncolytic viruses represent an exciting new approach in cancer treatment, wherein specially engineered viruses are able to infect and destroy cancer cells directly while also stimulating anti-tumor immune responses.

Cretostimogene grenadenorepvec is an adenovirus that has been engineered to replicate selectively in bladder cancer cells and stimulate the immune system by expressing granulocyte-macrophage colony-stimulating factor (GM-CSF). Early stage clinical data have shown promising signs of efficacy.

The company plans to use the IPO proceeds to fund a Phase 3 clinical trial of its lead candidate as well as earlier stage pipeline programs. Success in the Phase 3 study could support regulatory approval and commercialization.

CG Oncology was founded in 2018 by a veteran team of biotech entrepreneurs and scientists. The company pursued a pre-IPO crossover financing round in 2022, enabling it to build momentum heading into its public debut.

The IPO success places CG Oncology in a strong position to advance its pipeline. With the influx of capital, the company will be able to aggressively pursue its clinical development plans without relying heavily on external partners.

Moreover, the validation and visibility provided by being a public company can potentially help CG Oncology forge productive collaborations and access additional funding in the future.

Looking ahead, the positive investor response to CG Oncology seems likely to pave the way for more biotech IPOs in 2024. A robust IPO market provides fuel for innovation and discoveries that can transform patient lives.

The biotech sector sputtered in 2022, with only around 20 IPOs completed versus more than 50 in 2021. However, sentiment appears to be shifting, perhaps signaling sunnier days ahead.

In addition to favorable market conditions, biotech companies pursuing IPOs seem to be taking valuable lessons from 2022 by tightening focus on fundamentals like drug efficacy and visibility on clinical milestones.

Other than CG Oncology, a host of biotechs have already filed with SEC intentions to go public in 2024, spanning exciting areas like gene therapy, neurology, and synthetic biology.

With fresh capital and investor enthusiasm, the next generation of biotech companies can pursue ambitious goals to develop innovative medicines. More early-stage companies may also gain the funding needed to initiate or advance clinical trials.

CG Oncology’s big IPO pop reflects the right combination of cutting-edge science, unmet medical need, and strong leadership. This formula will likely be replicated by other emerging biotech stars in the making.

In all, the successful CG Oncology IPO kicks off 2024 as a promising year for biotech funding, innovation, and progress against once intractable diseases. Investors and industry observers will be tracking the IPO market closely through the year for signs of sustained momentum. If the appetite for compelling biotech stories persists, it could drive a much-needed renaissance helping to unlock new medical frontiers.

Mark your calendars! Don’t miss Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference April 17-18. This exclusive virtual event connects investors with 50 leading public biotech, healthcare services, and medical device companies.
Presenting company slots are available.