Exelixis, Inc. EXEL introduced that the FDA has notified it about an replace to its supplemental new drug software (sNDA) for cabozantinib.
The sNDA is in search of approval for cabozantinib for the therapy of adults with beforehand handled superior pancreatic neuroendocrine tumors (pNET) and superior extra-pancreatic (epNET).
In November 2024, the FDA notified the corporate that the sNDA for cabozantinib for the therapy of adults with beforehand handled superior pancreatic neuroendocrine tumors (pNET) and superior extra-pancreatic NET (epNET) could be mentioned at an Oncologic Medicine Advisory Committee (“ODAC”) assembly in March 2025.
The FDA has now notified the corporate that its sNDA will not be the topic of debate on the ODAC assembly. The sNDA is beneath FDA assessment and has a goal motion date of April 3, 2025.
Exelixis’ shares have gained 53.2% previously six months towards the industry’s decline of 10.1%.
Picture Supply: Zacks Funding Analysis
Extra on EXEL’s sNDA for Cabometyx
The sNDA relies on the ultimate outcomes of the part III CABINET pivotal trial, performed by the Nationwide Most cancers Institute’s Nationwide Medical Trials Community.
The trial evaluated cabozantinib vis-à-vis placebo in superior pNET and epNET.
In August 2023, the Alliance for Medical Trials in Oncology impartial Knowledge and Security Monitoring Board unanimously beneficial that enrollment within the CABINET trial be stopped and randomized sufferers be unblinded to remedy with the allowance for crossover from placebo to cabozantinib because of the substantial enchancment in progression-free survival (PFS) noticed at this interim evaluation.
Last outcomes from the enrolled affected person inhabitants confirmed statistically important and clinically significant enhancements with cabozantinib versus placebo within the main endpoint of PFS by blinded impartial central assessment.
Cabozantinib is authorised beneath the model identify Cabometyx as monotherapy for the therapy of sufferers with superior renal cell carcinoma (RCC) and together with Opdivo (nivolumab) as a first-line therapy for sufferers with superior RCC.
The drug is authorised for the therapy of sufferers with hepatocellular carcinoma who’ve been beforehand handled with sorafenib, and for grownup and pediatric sufferers aged 12 years and above with regionally superior or metastatic differentiated thyroid most cancers (DTC) that has progressed following prior VEGFR-targeted remedy and who’re radioactive iodine-refractory or ineligible.
In August 2024, the FDA granted cabozantinib orphan drug designation for the therapy of pNET and assigned a goal motion date of April 3, 2025.
EXEL’s Efforts to Increase Cabometyx Label, Diversify Portfolio
Exelixis generated $1.3 billion in product revenues within the first 9 months of 2024, primarily from Cabometyx gross sales.
A possible label enlargement ought to enhance gross sales additional.
The pipeline progress has additionally been spectacular as Exelixis appears to increase its oncology portfolio past Cabometyx.
One other promising candidate in Exelixis’ pipeline is zanzalintinib, a next-generation oral TKI. Enrollment has been accomplished within the late-stage STELLAR-303 research evaluating zanzalintinib, together with Tecentriq, in contrast with regorafenib in sufferers with metastatic refractory colorectal most cancers that’s not microsatellite instability-high or mismatch repair-deficient. Preliminary outcomes from the research are anticipated in 2025.
Exelixis has additionally collaborated with pharma big Merck MRK to guage zanzalintinib together with Merck’s blockbuster anti-PD-1 remedy Keytruda (pembrolizumab) in a late-stage research for treating sufferers with head and neck squamous cell carcinoma (HNSCC).
Each the businesses can even consider zanzalintinib with Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor Welireg (belzutifan) in a part I/II research and two part III research for the therapy of sufferers with RCC.
Per the settlement, Merck will provide Keytruda for the continued, Exelixis-sponsored part III STELLAR-305 research in beforehand untreated PD-L1-positive recurrent or metastatic HNSCC.
The profitable improvement of further medication ought to broaden its portfolio and scale back its dependence on its lead drug, Cabometyx.
Zacks Rank & Different Key Picks
EXEL at the moment carries a Zacks Rank #2 (Purchase).
Another top-ranked shares within the biotech sector are Immunocore Holdings plc IMCR and Citadel Biosciences, Inc. CSTL, each carrying a Zacks Rank #1 (Sturdy Purchase) at current. You’ll be able to see the complete list of today’s Zacks #1 Rank stocks here.
Up to now 60 days, estimates for Immunocore’s 2024 loss per share have narrowed from $1.18 to 94 cents. Loss per share estimates for 2025 have narrowed from $1.70 to $1.57 throughout the identical time-frame.
IMCR’s earnings beat estimates in two of the trailing 4 quarters and missed the identical on the remaining two events, the common shock being 25.57%.
Up to now 90 days, estimates for Citadel Biosciences’ 2024 loss per share have narrowed from 58 cents to eight cents. Loss per share estimates for 2025 have narrowed from $1.88 to $1.84 throughout the identical time-frame.
CSTL’s earnings beat estimates in every of the trailing 4 quarters, the common shock being 172.72%.
Solely $1 to See All Zacks’ Buys and Sells
We’re not kidding.
A number of years in the past, we shocked our members by providing them 30-day entry to all our picks for the entire sum of solely $1. No obligation to spend one other cent.
Hundreds have taken benefit of this chance. Hundreds didn’t – they thought there have to be a catch. Sure, we do have a purpose. We wish you to get acquainted with our portfolio companies like Shock Dealer, Shares Below $10, Know-how Innovators,and extra, that closed 228 positions with double- and triple-digit good points in 2023 alone.
Merck & Co., Inc. (MRK) : Free Stock Analysis Report
Exelixis, Inc. (EXEL) : Free Stock Analysis Report
Castle Biosciences, Inc. (CSTL) : Free Stock Analysis Report
Immunocore Holdings PLC Sponsored ADR (IMCR) : Free Stock Analysis Report
To read this article on Zacks.com click here.
The views and opinions expressed herein are the views and opinions of the writer and don’t essentially mirror these of Nasdaq, Inc.
