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.
Net Income Was Within Expectations. Gyre Therapeutics reported 4Q24 Net Income Attributable to Common Shareholders of $(0.1) million or $(0.00) per share and FY2024 Net Income of $12.1 million, or $0.14 per basic share and $0.05 per fully diluted share. Revenues were $105.8 million in FY2024 with gross margins of 96.3%, consistent with our revenue estimates of $101.4 million and 96.2% gross margins. As of December 31, 2024, cash on hand was $51.2 million. Separately, results of the Phase 3 clinical trial for Hydronidone will be announced in 2Q25.
Hydronidone Data Announcement Pushed To 2Q25. In its quarterly press release, the company stated that data from the Phase 3 clinical trial for Hydronidone will be announced in 2Q25, although we had expected the data in 1Q25. We do not see this as a significant delay, as it extends the timeframe by 2 to 14 weeks. We believe this can still allow for regulatory filing in China during FY2025.
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Key Points: – AstraZeneca is acquiring Belgium-based EsoBiotec for $425 million upfront, with an additional $575 million contingent on milestones. – The deal enhances AstraZeneca’s cell therapy capabilities through EsoBiotec’s ENaBL platform, which enables in vivo immune cell engineering. – The acquisition aligns with AstraZeneca’s broader strategy of leveraging cell therapies, gene editing, and radioconjugates for oncology and immune disorders.
AstraZeneca has announced a significant expansion of its cell therapy pipeline with the planned acquisition of EsoBiotec, a Belgium-based biotech firm specializing in immune cell engineering. The deal, valued at up to $1 billion, consists of a $425 million upfront payment with the potential for an additional $575 million based on development and regulatory milestones. The acquisition is expected to close in the second quarter of 2025.
EsoBiotec’s ENaBL platform represents a transformative approach to cell therapy. Unlike conventional ex vivo cell therapies that require the extraction, modification, and reinfusion of patient cells, ENaBL allows for direct genetic programming of immune cells within the body. This eliminates the need for invasive lymphodepletion procedures and could significantly lower costs while improving accessibility for patients.
AstraZeneca has not yet disclosed specific target indications for EsoBiotec’s platform but has emphasized its potential applications in oncology and immune-mediated diseases. The ENaBL technology could help develop novel cancer treatments or autoreactive cell therapies for conditions such as autoimmune disorders.
This acquisition marks another step in AstraZeneca’s aggressive expansion into the cell therapy space. The pharmaceutical giant has been actively pursuing high-value deals to strengthen its pipeline in this emerging field. In 2022, AstraZeneca acquired TeneoTwo for up to $1.27 billion, securing its T cell engager TNB-486, now renamed AZD0486, which is in Phase III trials for follicular lymphoma and Phase II trials for B cell non-Hodgkin lymphoma.
Further reinforcing its position, AstraZeneca made another major investment in December 2023 with the $1 billion purchase of Gracell Biotechnologies. This deal added GC012F, now known as AZD0120, an investigational CAR T therapy targeting CD19 and BCMA for multiple myeloma and systemic lupus erythematosus.
Beyond acquisitions, AstraZeneca has formed strategic collaborations in cell therapy, including a $245 million agreement with Cellectis in November 2023 and a potential $2 billion partnership with Quell Therapeutics in June 2023. These investments highlight the company’s commitment to leveraging cutting-edge biotechnologies to expand its capabilities in immune modulation and oncology.
As a relative latecomer to the cell therapy market, AstraZeneca is rapidly scaling its presence through acquisitions and partnerships. By integrating EsoBiotec’s ENaBL platform into its pipeline, AstraZeneca positions itself to compete with industry leaders in the race to develop next-generation cell therapies that offer improved efficacy, lower costs, and enhanced patient accessibility.
With this latest acquisition, AstraZeneca continues to build a robust portfolio of cell therapies that could redefine treatment approaches for cancer and immune-related diseases. Investors and industry analysts will be closely monitoring how effectively AstraZeneca integrates these new technologies and translates them into viable commercial therapies.
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.
Product Sales Drove Revenue Growth. Zomedica reported 4Q24 revenues of $7.9 million and FY2024 revenues $27.3 million, in line with our estimates of $8.0 million and $27.5 million. Gross Margins were 70.0% as expected, with a loss for FY2024 of $46.9 million or $(0.05) per share. Cash and equivalents on December 31 was $71.4 million.
CEO Addressed Recent Stock Delisting. At the beginning of the quarterly conference call, CEO Larry Heaton spoke about the events leading to the delisting from the New York American Exchange earlier this month. As discussed in our Research Note on March 11, the recent market weakness brought the stock below the threshold for continued listing. This weakness led to a move to the OTCQB Venture Market, causing further weakness.
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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.
FY2024 Was A Productive Year. Cadrenal reported a 4Q24 loss of $4.2 million or $(2.55) per share and FY2024 loss of $10.7 million or $(8.73) per share. An important development discussed in our Research Note on March 5 was Cadrenal’s announcement of a collaborative agreement with Abbott (ABT, Not Rated) for support of its pivotal trial testing tecarfarin in patients with left ventricular assist (LVAD) devices. Cash and equivalents on December 31 were $10.0 million.
Tecarfarin Is In Development For Several Patient Populations With Coagulation Needs. Many patients that are at risk for cardiovascular events (stroke, embolism, deep vein thrombosis) take anticoagulants in the direct oral anticoagulant class (DOACs, such as Eliquis or Xarelto). However, there are several patient populations that must take warfarin, an older drug, due to lack of efficacy or high bleeding risk. Tecarfarin is being developed to replace warfarin in these populations. Cadrenal has Orphan Drug designation from the FDA for implanted mechanical devices (LVADs) and prevention of systemic thromboembolism in end-stage kidney disease (ESKD) and atrial fibrillation (AFib).
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Key Points: – Mallinckrodt and Endo will combine to form a diversified pharmaceutical powerhouse. – The merger will create a company with $3.6 billion in projected 2025 revenue and $1.2 billion in adjusted EBITDA. – The new entity will focus on branded specialty pharmaceuticals while planning to separate its generics and sterile injectables business.
Pharmaceutical companies Mallinckrodt and Endo have agreed to merge in a $6.7 billion deal that will create a new powerhouse in the specialty medication market, the companies announced Thursday.
The stock-and-cash transaction, expected to close in the second half of 2025, combines Mallinckrodt’s rare disease portfolio with Endo’s sterile injectables business, positioning the merged entity to compete more effectively in high-margin specialty pharmaceutical segments.
Shares of both companies jumped on the news, with Mallinckrodt stock up 7.2% and Endo shares surging 12.3% in morning trading.
Under the terms of the agreement, Endo shareholders will receive $80 million in cash while maintaining a 49.9% stake in the combined company. Mallinckrodt shareholders will hold the remaining 50.1% interest, with Mallinckrodt serving as the parent company.
The merged firm projects $3.6 billion in revenue for 2025 with $1.2 billion in adjusted EBITDA. Management expects to achieve $150 million in annual cost synergies by the third year post-merger, with $75 million realized in the first year.
Goldman Sachs is providing $900 million in committed financing to support the transaction. The combined company will operate with a net leverage ratio of approximately 2.3x, giving it significant financial flexibility for future growth initiatives.
Siggi Olafsson, CEO of Mallinckrodt, will lead the combined entity. The companies emphasized that the complementary nature of their businesses would maximize operational efficiencies while maintaining focus on innovation.
A key component of the merger strategy involves the eventual separation of the combined sterile injectables and generics businesses. While these operations will initially be integrated, management plans to spin off this unit as a standalone company, pending board approval and market conditions.
The core branded specialty pharmaceuticals business will focus on rare diseases and hospital-based therapies, areas where both companies have established market positions. With 17 manufacturing facilities and 30 distribution centers predominantly in the United States, the company will employ approximately 5,700 people worldwide.
According to Endo’s interim CEO Scott Hirsch, the merger will leverage complementary strengths and create immediate scale advantages in key therapeutic areas. The planned separation of the generics business aims to further sharpen focus on high-growth specialty markets.
The Mallinckrodt-Endo merger comes amid increasing consolidation in the pharmaceutical sector as companies look to gain scale and portfolio diversification.
Analysts at Morgan Stanley noted that the deal makes strategic sense for both companies, particularly given the challenges they’ve faced individually in recent years. The combined entity will have greater resources to invest in R&D and a stronger position in negotiations with payers and hospital systems.
However, some analysts expressed caution about integration risks and the ambitious timeline for the planned business separation. Healthcare analysts at JP Morgan pointed out that executing a merger of this scale while simultaneously preparing for a business spinoff creates significant operational complexity. The management team will need to carefully balance these priorities to deliver the promised synergies.
The combined company will be listed on the New York Stock Exchange following the transaction’s completion.
Key Points: – BMS is acquiring 2seventy bio for $5.00 per share, an 88% premium to its last closing price. – The deal strengthens BMS’s cell and gene therapy portfolio, particularly in multiple myeloma treatment. – The acquisition comes amid increased M&A activity in biotech, signaling confidence in the sector’s long-term potential.
Bristol Myers Squibb (BMY) has announced a definitive agreement to acquire 2seventy bio (TSVT) in an all-cash deal valued at approximately $286 million. This acquisition further strengthens BMS’s foothold in the oncology space, particularly through its access to Abecma, an FDA-approved CAR T-cell therapy for multiple myeloma. The deal is expected to close in the second quarter of 2025, pending regulatory approvals and shareholder consent.
BMS’s acquisition of 2seventy bio aligns with its broader strategy to expand its presence in the high-growth cell and gene therapy market. 2seventy bio has focused exclusively on Abecma, a treatment developed in collaboration with BMS, to extend and improve the lives of patients with relapsed or refractory multiple myeloma. With this acquisition, BMS will take full control of Abecma’s commercialization and development, streamlining operations and potentially accelerating future advancements.
Chip Baird, CEO of 2seventy bio, emphasized the significance of the transaction, stating: “This acquisition ensures Abecma continues to reach patients in need while maximizing value for our stakeholders.” BMS, with its expansive resources and global reach, is well-positioned to drive further innovation in the cell therapy space.
The biotech sector has seen a resurgence in M&A activity, with pharmaceutical giants seeking to bolster their pipelines amid ongoing scientific advancements and a challenging regulatory landscape. The acquisition of 2seventy bio comes at a time when investors are looking for signs of stability in biotech, and deals like this reinforce confidence in the sector’s long-term growth potential.
The broader biotechnology sector, as measured by the iShares Biotechnology ETF (IBB), has posted gains year-to-date, reflecting renewed investor interest in the space. As larger pharmaceutical companies look to capitalize on cutting-edge therapies, small and mid-cap biotech firms with promising assets are becoming increasingly attractive acquisition targets. The deal values 2seventy bio at a significant premium, rewarding shareholders with an 88% increase from its prior trading price. However, it also raises questions about the long-term independence of innovative biotech firms. While consolidation can lead to greater efficiency and resource allocation, it may also reduce competition and limit the number of standalone biotech companies driving early-stage innovation.
For BMS, the acquisition is a strategic move to reinforce its oncology pipeline amid growing competition in the CAR T-cell therapy space. With this deal, BMS is betting on continued demand for personalized cell-based therapies and positioning itself to lead in this evolving field. Biotech acquisitions are often driven by the need for pharmaceutical companies to secure new revenue streams as patents on existing drugs expire. By acquiring 2seventy bio, BMS gains a competitive advantage in the high-value oncology segment, ensuring its ability to remain a dominant force in the industry.
Bristol Myers Squibb’s acquisition of 2seventy bio represents a significant development in the biotech sector. As M&A activity accelerates, the deal underscores the importance of targeted therapies in oncology and highlights the ongoing push by pharmaceutical giants to secure cutting-edge treatments. For investors, this acquisition may serve as a signal that biotech remains a strong sector, with potential for both innovation and consolidation in the years ahead.
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.
Recent Price Weakness Forces Move To The OTC Bulletin Board. As the recent decline in the overall markets was affecting companies in many sectors, the closing price of Zomedica stock fell below $0.10 per share on March 3. This crossed a threshold set by the New York American exchange, forcing the delisting of ZOM shares. Zomedica shares began trading on the OTCQB Venture Market under the symbol ZOMDF. There were no other events or crisis that caused the delisting.
During 2024, Zomedica Has Met All Of The Product Goals We Expected. Over the past year, Zomedica has introduced several new assays for use with its TRUFORMA diagnostics platform. These assays are sold to veterinary practices for use with TRUFORMA diagnostic instruments, allowing the veterinarian to run tests without sending samples to an outside lab. This allows the diagnosis in a few minutes and allows the practice to capture the profit from the tests. The TRUFORMA assays, reported as diagnostic consumables, have been one of the sources of sales growth over the past year.
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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.
We Are Initiating Coverage Of Gyre Therapeutics With An Outperform Rating. Gyre Therapeutics is a pharmaceutical company developing drugs for inflammatory diseases that lead to fibrosis. It currently markets Etuary (pirfenidone) in China for idiopathic pulmonary fibrosis. The lead drug in the pipeline is Hydronidone, a new molecule derived from pirfenidone, that is in a Phase 3 clinical trial in China. The data announcement is expected to report Phase 3 clinical trial results in March 2025.
Hydronidone Was Developed To Improve Efficacy and Side Effects. Hydronidone is a structural analogue of pirfenidone that was developed to improve efficacy with a more tolerable side effect profile. It is in Phase 3 trial in China for fibrosis of the liver after hepatitis B (HBV) infections. Hydronidone targets steps in the Transforming Growth Factor (TGF)-ß1 pathway as well as the downstream genes and liver cells it activates to produce fibrotic tissue. Data from the Phase 3 in China will be used to design a Phase 2a trial in the US, expected to begin in late FY2025.
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Key Points: – Sun Pharma announced a $355 million acquisition of Checkpoint Therapeutics to expand its oncology portfolio. -The biotech sector is showing strength, with the IBB ETF up 3.5% year-to-date. – The acquisition brings FDA-approved cancer treatment UNLOXCYT™ to Sun Pharma’s global portfolio.
Sun Pharmaceutical Industries has announced its acquisition of Checkpoint Therapeutics in a $355 million deal aimed at strengthening its presence in the oncology sector. Checkpoint, a commercial-stage biotech company, has developed UNLOXCYT™ (cosibelimab-ipdl), the first and only FDA-approved anti-PD-L1 treatment for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC). This acquisition is expected to accelerate global access to this innovative cancer treatment and expand Sun Pharma’s onco-dermatology portfolio.
The broader biotech sector is emerging as a bright spot in an otherwise volatile market. The iShares Biotechnology ETF (IBB) is up 3.5% year-to-date, reflecting increased investor confidence in the sector’s growth potential. Unlike other areas of the stock market that have struggled amid rising interest rates and economic uncertainty, biotech has benefited from continued innovation, regulatory approvals, and M&A activity.
The deal provides Sun Pharma with immediate access to a groundbreaking cancer treatment, allowing the company to leverage its global footprint to scale distribution. With approximately 1.8 million new cSCC cases diagnosed annually in the U.S. alone, there is a substantial market opportunity for UNLOXCYT™. Sun Pharma expects to enhance Checkpoint’s commercialization efforts and drive greater adoption of the therapy in key markets worldwide.
In addition to the $4.10 per share cash payment, Checkpoint shareholders will receive a contingent value right (CVR) of up to $0.70 per share if UNLOXCYT™ secures approval in major European markets by specific deadlines. This structure incentivizes timely regulatory approvals and ensures continued development efforts.
The Sun Pharma-Checkpoint deal is the latest in a wave of biotech acquisitions, reflecting growing interest from larger pharmaceutical firms seeking to expand their specialty drug pipelines. Given the sector’s recent performance and ongoing medical advancements, further consolidation in biotech could be on the horizon.
For investors, the strong performance of biotech stocks and M&A activity suggest that the sector could be positioned for continued growth. As traditional sectors face headwinds, biotech’s mix of innovation, regulatory catalysts, and strategic acquisitions make it an attractive space to watch.
Key Points: – Kestra Medical Technologies has priced its upsized initial public offering (IPO) of 11,882,352 common shares at $17.00 per share, aiming to raise approximately $202 million. – Shares are set to begin trading on the Nasdaq Global Select Market on March 6, 2025, under the ticker symbol “KMTS.” – Kestra specializes in wearable medical devices and digital healthcare solutions, particularly for cardiovascular disease monitoring and intervention.
Kestra Medical Technologies, a Kirkland, Washington-based company specializing in wearable medical devices and digital healthcare solutions, has announced the pricing of its upsized initial public offering (IPO). The company is offering 11,882,352 common shares at a public offering price of $17.00 per share, with gross proceeds expected to be approximately $202 million, excluding any exercise of the underwriters’ option to purchase additional shares. This option allows underwriters a 30-day period to acquire up to 1,782,352 additional common shares at the IPO price, less underwriting discounts and commissions.
Trading of Kestra’s common shares is scheduled to commence on March 6, 2025, on the Nasdaq Global Select Market under the ticker symbol “KMTS.” The closing of the offering is anticipated to occur on March 7, 2025, contingent upon the fulfillment of customary closing conditions.
The IPO is being led by prominent financial institutions, with BofA Securities, Goldman Sachs & Co. LLC, and Piper Sandler acting as lead bookrunners. Wells Fargo Securities and Stifel are serving as bookrunners, while Wolfe | Nomura Alliance is participating as co-manager for the offering.
Kestra Medical Technologies is a commercial-stage company focused on transforming patient outcomes in cardiovascular disease through intuitive, intelligent, and connected monitoring and therapeutic intervention technologies. Their flagship product, the ASSURE® Wearable Cardioverter Defibrillator (WCD) system, is designed to provide automatic detection and defibrillation for ventricular arrhythmias, offering a modern approach to sudden cardiac arrest protection. The ASSURE system integrates with the Kestra CareStation™ remote patient data platform, enabling configurable notifications for clinical events and trending of physiological and device data at any time.
The company’s decision to go public comes amid increasing demand for wearable medical technology, particularly in the cardiovascular sector. As heart disease remains one of the leading causes of death globally, there is a growing market for advanced monitoring and intervention solutions. Kestra’s innovative approach to real-time monitoring and emergency response through connected devices positions it as a competitive player in this expanding industry. The funds raised through the IPO will likely support further research and development, product expansion, and potential strategic partnerships to enhance its market presence.
Investors will be closely watching the stock’s performance following its debut on the Nasdaq. Given the strong interest in digital healthcare and the increasing adoption of wearable medical devices, Kestra’s IPO could attract significant attention from both institutional and retail investors. The success of this offering could also signal broader investor confidence in the future of digital health solutions, particularly those that leverage artificial intelligence and real-time data tracking to improve patient outcomes.
Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.
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.
Clinical Progress Expected To Lead To Filings For Three Product Approvals. Ocugen reported a 4Q24 loss of $13.9 million or $(0.05) per share and FY2024 loss of $54.1 million or $(0.20) per share. The company made significant progress in its clinical trials during the quarter and since the start of FY2025. It has also received regulatory designations that accelerate product approval. The company had $58.5 million in cash on December 31, sufficient to fund operations through 1Q26.
Clinical Trial Advances Point To Three BLAs In 3 Years. Ocugen has made significant progress with three products for three diseases that lead to vision loss. The three ongoing trials are Phase 3 for OCU400, the Phase 2/3 for OCU410ST in Stargardt disease, and the Phase 1/2 trial for GA. These trials are on schedule for filing applications for approval in 2026, 2027, and 2028 respectively. OCU400 and OCU410ST have Orphan Drug designations that can accelerate approval, while GA is a large market of over 10 million patients in the US alone.
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Key Points: – Jazz Pharmaceuticals expands oncology pipeline with the $935 million acquisition of Chimerix, gaining dordaviprone, a potential treatment for rare brain tumors. – Dordaviprone targets a critical unmet need for H3 K27M-mutant diffuse glioma, with an FDA Priority Review and a PDUFA decision expected by August 18, 2025. – The deal strengthens Jazz’s rare disease focus and could provide durable revenue growth with patent protection extending to 2037.
Jazz Pharmaceuticals (NASDAQ: JAZZ) has announced its acquisition of Chimerix (NASDAQ: CMRX) for approximately $935 million in an all-cash transaction. The deal, expected to close in the second quarter of 2025, will bolster Jazz’s oncology portfolio by adding Chimerix’s lead asset, dordaviprone, a promising treatment for rare brain tumors.
Dordaviprone is a novel small-molecule therapy in development for H3 K27M-mutant diffuse glioma, an aggressive brain tumor that primarily affects children and young adults. Currently, there are no FDA-approved treatments specifically for this patient group, with radiation being the standard approach. The drug has been granted Priority Review by the FDA, with a target decision date set for August 18, 2025. If approved, dordaviprone could become a breakthrough treatment and may qualify for a Rare Pediatric Disease Priority Review Voucher (PRV).
Jazz Pharmaceuticals’ Chairman and CEO, Bruce Cozadd, emphasized the strategic importance of the acquisition. “Dordaviprone has the potential to become a standard of care for a rare oncology disease with no current FDA-approved treatments,” said Cozadd. “This deal reinforces our commitment to patients with rare diseases and adds a near-term commercial opportunity to our pipeline.”
Chimerix CEO Mike Andriole echoed this sentiment, highlighting the benefits of Jazz’s global commercial scale in expanding access to dordaviprone. “This agreement enables us to reach more patients globally while delivering significant value to our shareholders,” he stated.
Dordaviprone is currently being studied in a Phase 3 ACTION trial, evaluating its use in newly diagnosed, non-recurrent H3 K27M-mutant diffuse glioma patients following radiation. If successful, this could expand its use beyond recurrent cases.
The acquisition price of $8.55 per share represents a 72% premium over Chimerix’s closing stock price on March 4, 2025. Jazz will finance the transaction using its existing cash and investments.
The deal strengthens Jazz’s position in rare oncology and provides a potential long-term revenue stream, with patent protection for dordaviprone extending to 2037. If approved, the drug could see a rapid commercial launch in the U.S. in the second half of 2025.
Jazz expects to leverage its development and commercialization expertise to execute a strong launch strategy, positioning dordaviprone as a new standard of care for H3 K27M-mutant diffuse glioma. The acquisition is subject to customary closing conditions, including regulatory approvals and the tendering of a majority of Chimerix’s shares.
With this move, Jazz Pharmaceuticals reinforces its commitment to oncology innovation and its mission to address significant unmet medical needs. If the FDA grants approval, dordaviprone could be a game-changer for brain tumor treatment, offering hope to patients with limited options.
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.
Cadrenal and Abbott Announce The LVAD Collaboration We’ve Been Waiting For. Cadrenal announced a development agreement with Abbott (ABT, Not Rated) to develop Tecarfarin in patients with Abbott’s HeartMate3 LVAD (left ventricle assist device). Under the agreement, Abbott will support Cadrenal’s pivotal TECH-VLAD (TECarfarin Anticoagulation and Hemocompatibility with Left Ventricular Assist Devices) trial in its design, site selection, recruitment, and its HeartMate3 experience.
LVAD Patients Have An Unmet Need For A New Anticoagulant. While Direct Oral Anticoagulation Drug (DOAC) category has been highly successful, there are several populations where they are not effective or have safety risks. Patients with LVAD devices can only use warfarin, a drug that has variable efficacy with several drawbacks, including a requirement for frequent patient monitoring. LVAD patients have less effective anticoagulation and remain at high risk for coagulation events (bleeding, stroke, myocardial infarct).
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