On January 13, 2025 Syndax Pharmaceuticals (Nasdaq: SNDX) reported that it will present at the 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14th at 10:30 a.m. PT/1:30 p.m. ET (Press release, Syndax, JAN 13, 2025, View Source [SID1234649678]). Ahead of the presentation, Syndax highlighted its recent accomplishments and anticipated 2025 milestones.

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"Building on a transformative 2024 with the FDA approvals of Revuforj and Niktimvo, we are focused on executing two outstanding U.S. launches for these first-in-class, practice-changing medicines," said Michael A. Metzger, Chief Executive Officer. "Syndax is well-positioned for continued success and long-term growth with two approved drugs launching into multi-billion-dollar markets, a clear strategy to expand into additional indications, and a strong cash position expected to fund operations through profitability."

2024 Key Accomplishments

Revumenib:

Launched Revuforj (revumenib), the first and only U.S. Food and Drug Administration (FDA) approved menin inhibitor, in late November 2024. Revuforj was approved by the FDA under the Agency’s Real-Time Oncology Review (RTOR) program for the treatment of relapsed or refractory (R/R) acute leukemia with a KMT2A translocation in adult and pediatric patients one year and older.
Revumenib was added to the latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) as a category 2A recommendation for R/R acute leukemia with a KMT2A rearrangement.1
Announced that the primary endpoint was met in the protocol-defined efficacy population of 64 adults with R/R mNPM1 AML in the Phase 2 cohort of the AUGMENT-101 trial of revumenib.
Reported additional positive results from a post-hoc efficacy analysis of all 77 R/R mNPM1 AML patients who met the efficacy evaluable criteria in the Phase 2 cohort of AUGMENT-101.
Published data from the pivotal Phase 2 portion of the AUGMENT-101 trial of revumenib in adult and pediatric patients with R/R KMT2A-rearranged (KMT2Ar) acute leukemia in the Journal of Clinical Oncology.
Presented a larger data set with longer follow-up from the pivotal Phase 2 portion of the AUGMENT-101 trial of revumenib in R/R KMT2Ar acute leukemia at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.
Presented data from multiple ongoing trials evaluating revumenib in mNPM1 and KMT2Ar acute leukemia across the treatment landscape. These trials include:
BEAT AML: A Phase 1 trial evaluating the combination of revumenib with venetoclax and azacitidine in newly diagnosed mNPM1 or KMT2Ar AML patients. The trial is being conducted as part of the Leukemia & Lymphoma Society’s Beat AML Master Clinical Trial. Updated data from the trial showed an overall response rate (ORR)2 of 100% (37/37) and a composite complete remission (CRc) rate of 95% (35/37).
SAVE: A Phase 1/2 trial evaluating an all-oral combination of revumenib with venetoclax and decitabine/cedazuridine in pediatric and adult patients with R/R AML or mixed-lineage acute leukemia (MPAL) harboring either mNPM1, KMT2Ar, or NUP98r alterations. The trial is being conducted by investigators from MD Anderson Cancer Center. Updated data that showed an ORR of 82% (27/33) and a CR/CRh rate of 48% (16/33) were presented at the 66th ASH (Free ASH Whitepaper) Annual Meeting.
Axatilimab:

Received U.S. Food and Drug Administration (FDA) approval for Niktimvo (axatilimab-csfr) for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs).
Announced axatilimab-csfr was added to the latest NCCN Guidelines as a category 2A recommendation for the treatment of GVHD after the failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.
Published results from the pivotal Phase 2 AGAVE-201 trial of axatilimab in adult and pediatric patients with recurrent/refractory active chronic GVHD in the New England Journal of Medicine.
Presented a secondary analysis of overall and organ-specific responses from the pivotal Phase 2 AGAVE-201 trial of axatilimab in adult and pediatric patients with recurrent/refractory active chronic GVHD who had received at least two prior lines of systemic therapy at the 66th ASH (Free ASH Whitepaper) Annual Meeting.
Initiated enrollment in the MAXPIRe trial, a 26-week randomized, double-blinded, placebo-controlled Phase 2 trial of axatilimab on top of standard of care in patients with idiopathic pulmonary fibrosis (IPF).
The Company’s partner, Incyte, initiated a Phase 2, open-label, randomized, multicenter trial of axatilimab in combination with ruxolitinib in patients ≥12 years of age with newly diagnosed chronic GVHD.
The Company’s partner, Incyte, initiated a Phase 3, randomized, double-blind, placebo-controlled, multi-center trial that will investigate the use of axatilimab in combination with corticosteroids as initial treatment for chronic GVHD.
Corporate:

Announced a $350 million royalty funding agreement with Royalty Pharma based on U.S. net sales of Niktimvo. Syndax expects that its cash, cash equivalents and marketable securities, together with the $350 million from the royalty funding agreement and anticipated product revenue and interest income, will enable the company to reach profitability.
Expected 2025 Key Milestones

Revumenib:

Maximize U.S. adoption of Revuforj as the preferred menin inhibitor, leveraging our first mover advantage and robust clinical data.
Submit a supplemental NDA (sNDA) filing for revumenib in R/R mNPM1 AML in the first half of 2025, followed by a potential FDA approval around year-end 2025.
Publish pivotal data from AUGMENT-101 trial in R/R mNPM1 AML in the first half of 2025.
Initiate a pivotal trial of revumenib in combination with venetoclax and azacitidine in newly diagnosed mNPM1 or KMT2Ar acute leukemia patients unfit to receive intensive chemotherapy in the first quarter of 2025.
Report Phase 1 data from a trial evaluating the combination of revumenib with intensive chemotherapy (7+3) followed by revumenib maintenance treatment in newly diagnosed patients with mNPM1 or KMT2Ar acute leukemias in the second half of 2025.
Initiate multiple frontline trials evaluating revumenib in combination with intensive chemotherapy, starting in 2025.
Present additional data at medical congresses from ongoing trials of revumenib in combination with standard-of-care agents.
Axatilimab:

Launch Niktimvo in the U.S. in early first quarter of 2025. In the U.S., Niktimvo will be co-commercialized by Syndax and Incyte.
Complete enrollment in MAXPIRe Phase 2 IPF trial in 2025 with topline data expected in 2026.
Presentation at the 43rd Annual J.P. Morgan Healthcare Conference

Syndax will webcast its presentation from the 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2025 at 10:30 a.m. PT (1:30 p.m. ET). A live webcast of the fireside chat can be accessed from the Investor section of the Company’s website at www.syndax.com, where a replay of the event will also be available for a limited time.

On January 13, 2025 First Ascent Biomedical, a pioneer in personalized cancer treatment, reported a $6 million investment from Vidal Duart Enterprises, Inc., with an additional co-investment from Techstars (Press release, First Ascent Biomedical, JAN 13, 2025, View Source [SID1234649694]). The funding will accelerate First Ascent Biomedical’s mission to transform medical oncology with highly individualized, prospective treatment planning technologies that improve patient survival.

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First Ascent Biomedical’s technology represents a shift from a one-size-fits-all approach to a tailored strategy, offering hope to cancer patients who have exhausted traditional options. The company’s functional precision medicine platform integrates drug testing, DNA/RNA sequencing and AI-guided tumor weakness mapping to test hundreds of FDA-approved drugs against a patient’s unique cancer profile. The platform delivers a highly personalized, actionable plan to a patient’s physician in an average of 10 days. Results show that First Ascent Biomedical’s technology has significantly improved patient outcomes. Patients treated with decisions guided by the platform demonstrated an 83% greater benefit than those treated with the standard of care of a doctor’s choice.

The platform’s technology was developed by Dr. Noah Berlow, co-founder and CTO, and Dr. Diana Azzam, First Ascent Biomedical’s co-founder and scientific advisor. Dr. Berlow designed the company’s AI framework. Dr. Azzan brings years of cancer research and a wealth of functional precision medicine expertise to First Ascent Biomedical, currently serving as an assistant professor of environmental health sciences at the Florida International University Robert Stempel College of Public Health and Social Work.

The capital raised will support the expansion of First Ascent Biomedical’s operations, including the establishment of a state-of-the-art lab in Florida, where the company will continue its mission to transform cancer care for all patients, especially those in underserved communities.

"The funding we have raised is a defining moment for First Ascent Biomedical and for cancer care," said Jim Foote, Co-founder and CEO of First Ascent Biomedical. "As someone who tragically lost my son to cancer, I know the devastating toll this disease takes on families. With this fresh capital, we are not just advancing technology—we are giving patients and their families hope. Florida is where our technology was invented, so we are excited to open our first commercial lab here as we charge forward in making personalized cancer care widely accessible."

"First Ascent Biomedical is at the forefront of a new era in cancer treatment. Their groundbreaking technology has already proven its potential to save lives and change the trajectory of this disease," said Carlos Duart, Owner of Vidal Duart Enterprises. "This investment is not just a business decision—it’s a commitment to improving outcomes for cancer patients everywhere."

Tina Vidal Duart, Co-owner of Vidal Duart Enterprises, added: "We are proud to support a company that combines innovation with compassion. The work First Ascent Biomedical is doing will have a ripple effect far beyond Florida, giving patients personalized care that improves their chances of survival. We are honored to help bring this vision to life."

"First Ascent Biomedical represents the future of cancer care, where innovation and personalization come together to save lives," said Andrew Cleland, Chief Investment Officer at Techstars. "The opportunity to transform medical oncology through precision medicine is immense, and First Ascent Biomedical is paving the way to make customized cancer treatment a reality with its drug prediction technologies."

On January 13, 2025 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases, reported key objectives and anticipated milestones for 2025, which will be the subject of Nurix’s corporate update at the 43rd Annual J.P. Morgan Healthcare Conference today at 3:00 p.m. PT, in San Francisco (Press release, Nurix Therapeutics, JAN 13, 2025, View Source [SID1234649629]).

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"Nurix had an exciting year of successful execution of our clinical trials and significant progress in several key business areas," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "We recently presented impressive clinical responses from our NX-5948 Phase 1a/1b clinical trial both in patients with relapsed or refractory chronic lymphocytic leukemia and in patients with Waldenstrom’s macroglobulinemia. We received Fast Track Designation from the U.S. Food and Drug Administration for both of these indications as well as PRIME designation for CLL from the European Medicines Agency. Nurix is positioned to initiate a suite of late-stage clinical studies of NX-5948 in 2025, including pivotal studies in CLL. We also anticipate significant advances in our portfolio of wholly owned and partnered programs in the area of inflammation and immunology, including degraders of IRAK4 and STAT6."

"2024 was a year of significant advancement in our research and discovery organization," said Gwenn M. Hansen, Ph.D., chief scientific officer of Nurix. "We not only advanced several preclinical programs that are approaching key development milestones within our wholly owned and partnered portfolios, but we also expanded our discovery platform to include AI-powered drug discovery that leverages our early investments in E3 ligase research, DEL discovery, chemistry automation and machine learning. Nurix has developed a suite of AI tools applicable across the breadth of our technical workflows, but with a specific focus on prospective ligand discovery informed by our years of accumulated DEL know-how and screening data, which we are calling DEL-AI."

2024 Accomplishments and Business Highlights

Clinical Development Pipeline

Advanced NX-5948 and presented positive clinical data at oncology-focused medical meetings throughout 2024. New positive clinical data were presented at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH2024) in December 2024 and at the 12th International Workshop on Waldenstrom’s Macroglobulinemia (IWWM-12) in October 2024, from patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (r/r CLL/SLL) and patients with Waldenstrom’s macroglobulinemia (WM) treated in the Phase 1a/1b clinical trial of NX-5948. NX-5948 is an orally bioavailable, brain penetrant degrader of Bruton’s tyrosine kinase (BTK). At ASH (Free ASH Whitepaper)2024, Nurix reported a robust objective response rate (ORR) of 75.5% among the 49 efficacy-evaluable r/r CLL patients across all doses tested, with the majority of responses occurring at the first assessment (Week 8). With longer time on treatment, the ORR increased to 84.2% based on an exploratory efficacy analysis of patients who had at least two response assessments (Week 16). Responses and robust BTK degradation were observed across all populations regardless of prior treatment, baseline mutations including those with BTK mutations associated with treatment resistance to both covalent and non-covalent BTK inhibitors, high-risk molecular features, or central nervous system (CNS) involvement. NX-5948 was well-tolerated in all patient populations and across all doses tested from 50 to 600 mg daily. In the nine efficacy-evaluable WM patients treated with NX-5948 an ORR of 77.8% was observed with increasing depth of response over time, supporting continued development of NX-5948 for this indication. Additional information on the ongoing clinical trial can be accessed at www.clinicaltrials.gov (NCT05131022). A webcast of Nurix’s ASH (Free ASH Whitepaper)2024 presentation and additional discussion on the company’s programs and plans is available in the Investors section of the Nurix website.
Successfully executed on regulatory strategy for global development of NX-5948 with U.S. FDA Fast Track and European Medicines Agency PRIME designations: In 2024, NX-5948 received two separate Fast Track designations from the U.S. Food and Drug Administration (FDA): the first for the treatment of adult patients with r/r CLL/SLL after at least two lines of therapy, including a BTK inhibitor and a B-cell lymphoma 2 (BCL2) inhibitor, and the second for the treatment of adult patients with r/r WM after at least two lines of therapy, including a BTK inhibitor. In Europe, NX-5948 received PRIME designation for the treatment patients with r/r CLL/SLL after treatment with at least a BTK inhibitor and a BCL2 inhibitor. Regulatory clearance for clinical site initiations was received in several countries and clinical trial expansion is ongoing in France, Poland, Italy and Spain. Additional countries are anticipated to come online in 2025.
Re-initiated enrollment in NX-2127 Phase 1a/b trial: Following a decision in March 2024 in which the FDA lifted a manufacturing-related, partial clinical hold on the NX-2127 clinical trial, Nurix reinitiated enrollment in a dose escalation study within the current Phase 1a/1b trial, using its new chirally controlled drug product of NX-2127, a novel orally bioavailable bifunctional molecule that degrades BTK and the cereblon neosubstrates Ikaros (IKZF1) and Aiolos (IKZF3). Nurix is focusing development on aggressive lymphomas where the combination of BTK degradation and IKZF1/3 degradation have the potential for synergy and significant therapeutic benefit. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT04830137).
Advanced Phase 1a dose escalation trial of NX-1607 in monotherapy and in a combination cohort with paclitaxel in adults in a range of oncology indications. Nurix’s lead drug candidate from its E3 ligase inhibitor portfolio, NX-1607, is an orally bioavailable inhibitor of Casitas B-lineage lymphoma proto-oncogene (CBL-B) for immuno-oncology indications, including a range of solid tumor types. The company has evaluated dosing and scheduling regimens to optimize tolerability and maximize pharmacodynamic effects. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT05107674).
Research and Discovery

Advanced a pipeline of wholly owned and partnered programs in inflammation and immunology: At ACR Convergence 2024, the annual meeting of the American College of Rheumatology, Nurix presented preclinical data, including mechanism of action and activity in relevant disease models of inflammation and autoimmune diseases, from NX-5948. Nurix announced plans to initiate clinical testing of NX-5948 in autoimmune cytopenias such as warm autoimmune hemolytic anemia (wAIHA) in 2025, initially as an addition to its ongoing Phase 1b trial in patients with B-cell malignancies. At ACR Convergence 2024, positive preclinical data were also presented from Nurix’s collaboration with Gilead to develop GS-6791/NX-0479, an IRAK4 degrader, that has potential applications in the treatment of rheumatoid arthritis and other inflammatory diseases. In addition, Nurix’s ongoing research program with Sanofi was extended for the development of a degrader of STAT6 (signal transducer and activator of transcription 6), a key drug target in type 2 inflammation, with the goal of nominating a development candidate in the first half of 2025.
Expanded Nurix’s portfolio of brain penetrant degraders: At the annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in April 2024, Nurix presented the first clinical evidence of brain penetration and clinical activity in the CNS for its BTK degrader NX-5948. In addition, data from Nurix’s previously undisclosed program to develop an orally available, brain penetrant pan-mutant B-RAF degrader for the treatment of mutant B-RAF driven solid tumors were presented at the 7th Annual TPD & Induced Proximity Summit. These programs, along with other scientific presentations throughout 2024, clearly demonstrate Nurix’s ability to achieve brain penetrant and CNS active degraders.
Published the first description of BTK’s clinically important scaffolding function: Nurix scientists and clinical collaborators published a manuscript in the journal Science titled "Kinase Impaired BTK Mutations Are Susceptible to Clinical Stage BTK and IKZF1/3 Degrader NX-2127" that elucidates a previously unappreciated oncogenic scaffold function of BTK responsible for clinical resistance to enzymatic inhibitors and shows that NX-2127, a potent targeted protein degrader with differentiated activity against BTK and IKZF1/3, can overcome this resistance across a broad range of acquired mutations. The elimination of BTK’s scaffolding function is a critical attribute of both NX-2127 and NX-5948, with potential clinical relevance in both B-cell malignancies and inflammation.
Demonstrated cellular proof of concept for its degrader antibody conjugate (DAC) platform: Early preclinical data from Nurix’s ongoing collaboration with Pfizer to develop DACs were presented at the ADC & Radiopharmaceuticals Pharma & Biotech Partnering Summit. The data from two separate DACs demonstrated cell-type selective degradation of targeted proteins by DACs and highlighted the potential advantages of this new drug class and Nurix’s novel approach to DAC optimization.
Achieved significant milestones in collaborations with Gilead, Sanofi and Pfizer: In April 2024, Nurix announced that Gilead elected to extend the research term of the companies’ ongoing collaboration, originally established in 2019, by an additional two years, which resulted in a payment of $15 million to Nurix. In April 2024, Nurix also announced the extension of its research term with Sanofi for its previously undisclosed STAT6 degrader program. In 2024, Nurix also achieved its first milestone in its ongoing Pfizer collaboration and received a $5 million payment. In total, in 2024, Nurix earned milestones and fees in these ongoing strategic collaborations totaling $22 million through the third fiscal quarter of 2024 (August 31, 2024).
Corporate and Leadership

Strengthened leadership team with C-suite appointments and new Board of Directors member with drug commercialization expertise: In 2024, Nurix announced the promotions of Paula G. O’Connor, M.D., as chief medical officer and Pasit Phiasivongsa, Ph.D., as chief technical officer of Nurix. These appointments strengthen leadership in clinical operations and CMC ahead of planned pivotal studies for NX-5948 in 2025. In addition, Anil Kapur, a senior leader in commercial operations in hematology and oncology with over 25 years of executive experience in pharmaceutical and biotech companies across both U.S. and international markets joined the Nurix board of directors.
Strengthened balance sheet to support development of pipeline: Nurix ended its fiscal year with an estimated, unaudited $609.6 million in cash and investments as of November 30, 2024.* Based on its operating plan, Nurix anticipates that the company will be able to fund its operating activities into the first half of 2027.
2025 Goals and Catalysts

NX-5948
Initiate pivotal studies for NX-5948: Nurix is evaluating NX-5948 in an ongoing Phase 1b clinical trial in adults with relapsed or refractory B-cell malignancies and expects to initiate a suite of clinical trials in 2025 intended to support global registration of NX-5948 for the treatment of patients with CLL.
Expand the development of NX-5948 in additional cancer indications and inflammatory diseases: Nurix expects to complete the ongoing Phase 1b clinical trial in patients with WM and determine Phase 2 dose(s) as well as to continue to explore regulatory paths for this indication. In inflammation and immunology (I&I), Nurix plans to implement a sequenced, multi-organ system approach to evaluating NX-5948 to generate the greatest opportunity for patients and value creation, seeking first proof of concept through the study of CLL patients with secondary autoimmune-mediated hemolytic anemia with plans to explore non-malignant cytopenias, such as warm autoimmune hemolytic anemia (wAIHA), before potentially moving to dermatologic indications, such as hidradenitis suppurativa (HS), and neurologic indications, such as multiple sclerosis (MS).
NX-2127
Drive NX-2127 to proof-of-concept data: Nurix is focusing development on aggressive lymphomas where the combination of BTK degradation and IKZF1/3 degradation have the potential for synergy and significant therapeutic benefit. The company plans to complete dose escalation with new chirally controlled drug product and select recommended Phase 1b dose for selected indications and expects to share additional clinical data after selection of a Phase 1b expansion dose(s) and indication(s).
NX-1607:
Drive NX-1607 to proof-of-concept data: Nurix is testing both once daily (QD) and twice daily (BID) dosing of NX-1607. With additional patients in the BID dosing arms, Nurix plans to establish a Phase 1b monotherapy dose and expects to share additional clinical data after selection of a Phase 1b expansion dose(s) and indication(s).
Preclinical-development pipeline:
Advance IRAK4 degrader program into Phase 1: GS-6791 (previously NX-0479) is a potent, selective, oral IRAK4 degrader. Nurix’s partner Gilead exercised its option to exclusively license GS-6791 in March 2023 and is responsible for conducting IND-enabling studies and advancing this program to clinical development, which Nurix anticipates in 2025. Nurix retains its option to co-develop and co-promote in the United States, splitting U.S profits and losses evenly and receiving royalties on ex-U.S. sales.
Nominate a STAT6 degrader development candidate: Nurix anticipates nominating a STAT6 degrader development candidate in the first half of 2025. Under its collaboration with Sanofi, delivery of a development candidate data package triggers a licensing option decision for Sanofi. If licensed by Sanofi, Nurix retains its option to co-develop and co-promote in the United States, splitting U.S profits and losses evenly and receiving royalties on ex-U.S. sales.
Nominate a development candidate within Nurix’s wholly owned degrader pipeline: Nurix is advancing several preclinical programs within its wholly owned pipeline. In 2025, Nurix anticipates nominating at least one development candidate to advance to IND-enabling studies.

On January 13, 2025 Crescent Biopharma presented its corporate presentation (Press release, Crescent Biopharma, JAN 13, 2025, View Source [SID1234649647]).

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On January 13, 2025 Jazz Pharmaceutical presented its corporate presentation (Presentation, Jazz Pharmaceuticals, JAN 13, 2025, View Source [SID1234649663]).

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