Rare disease drugmaker · part of HLB Group · based in Fort Lee, United States · elevartx.com
Elevar Therapeutics works on Cholangiocarcinoma, one of the rare diseases we track. It has 1 active clinical trial, and it is looking for volunteers now. It also has 1 FDA-approved rare disease drug.
Latest news, October 14, 2026. Elevar resubmitted its application for rivoceranib with camrelizumab in first-line liver cancer on October 9, 2026, after the FDA declined it in July over manufacturing site problems. No new FDA target date has been announced. The FDA approved Lyrfigtu (lirafugratinib), Elevar's first approved drug, on September 23, 2026. Elevar, October 14, 2026
Elevar Therapeutics is a Fort Lee, New Jersey biopharmaceutical company (formerly LSK BioPharma) and a majority-owned subsidiary of South Korea's HLB Group. Its lead programs are lirafugratinib, a selective FGFR2 inhibitor licensed globally from Relay Therapeutics in December 2024 for FGFR2 fusion-driven cholangiocarcinoma, approved by the FDA as Lyrfigtu on September 23, 2026, and rivoceranib, a VEGFR-2 inhibitor developed with camrelizumab for first-linehepatocellular carcinoma.
Elevar Therapeutics pipeline
Each row lists the diseases Elevar Therapeutics is studying at that stage, from the ones closest to approval down to the earliest work.
Mid-size studies that check whether a drug works and at what dose.
FGFR2 Gene Fusion/Rearrangement recruiting
Elevar Therapeutics clinical trials
These are Elevar Therapeutics trials for the rare diseases we track, from ClinicalTrials.gov. Statuses there can lag behind company news, so confirm with the study team before you plan around one.
1 trial looking for volunteers now
Looking for volunteersPhase 2Recently updatedNCT07359820
A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement
TestsLirafugratinib
For FGFR2 Gene Fusion/Rearrangement and Other Solid Tumors, Adult
The goal of this clinical trial is to evaluate if lirafugratinib is efficacious and safe to treat adult patients with previously treated, unresectable, locally advanced or metastatic solid tumors (excluding cholangiocarcinoma) harboring FGFR2 fusion or rearrangement.
Participants will:
* Take lirafugratinib regularly as instructed by their study doctor.
* Visit the clinic as instructed for checkups and tests.
* Keep a diary recording each time a dose of lirafugratinib is taken.
Follow a condition Elevar Therapeutics is studying
Pick a condition. One email when a new trial opens, a trial changes or the FDA decides, from any company, not only Elevar Therapeutics. Unsubscribe anytime.
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The FDA declined to approve that combination in July 2026 because of problems found at a manufacturing site inspection, and Elevar resubmitted the application on October 9, 2026.
Where Elevar Therapeutics trials take place
The trials above run at 19 study sites in 5 countries. Tap a country to see its states, cities and hospitals.
United States
8▼
France
4▼
Spain
3▼
South Korea
2▼
United Kingdom
2▼
Rare diseases Elevar Therapeutics works on
Each disease page lists every open trial, not only Elevar Therapeutics's, plus approved treatments.
Cholangiocarcinoma is a rare and aggressive cancer that forms in the bile ducts, the thin tubes that carry digestive fluid (bile) from the liver to the small intestine.
How common: About 8,000 new cases per year in the U.S.; rising incidence worldwide
Where to get support
Patient groups can explain a diagnosis, point you to specialists and tell you about trials before they open. Elevar Therapeutics's own site is elevartx.com, and our help paying for treatment page lists drugmaker programs and charity funds.
Lyrfigtu (lirafugratinib), approved by the FDA on September 23, 2026.
Who it is for: adults with previously treated cholangiocarcinoma, a bile duct cancer, whose tumor carries an FGFR2 fusion or other FGFR2 rearrangement.
What it is: a once-daily pill that Elevar describes as a selective FGFR2 inhibitor. Pemigatinib also blocks FGFR1 and FGFR3, and futibatinib blocks FGFR1, FGFR3 and FGFR4. The label still warns about high blood phosphate, eye problems and harm to an unborn baby.
Where it came from: licensed globally from Relay Therapeutics in December 2024; approved ahead of its target date, which Elevar gave as September 27th in March and as September 25th in September.
Not approved yet. Elevar resubmitted the application on October 9, 2026 and has not announced a new FDA target date.
The combination: rivoceranib, a VEGFR-2 inhibitor pill, with camrelizumab, a PD-1 antibody, as a first-line treatment for hepatocellular carcinoma, the most common liver cancer.
History: the FDA declined earlier applications in May 2024 and March 2025. Elevar announced on January 30, 2026 that the FDA had accepted a resubmission, with a July 23, 2026 target date. The FDA's Complete Response Letter, dated July 9, 2026 and announced by Elevar the next day, cited problems found when it inspected a manufacturing site.
Where to watch: the FDA calendar will carry a new date once Elevar discloses one.
HLB Group, a South Korean company, holds a majority stake.
Name: Elevar was formerly LSK BioPharma.
Where: Fort Lee, New Jersey.
Listing: not separately listed on a US exchange, which is why the ticker field on this page is empty.
Yes. Elevar's program is Elevar Care Connect, reachable at 1-833-804-3847, Monday through Friday from 8 AM to 8 PM ET. The Lyrfigtu site says it offers co-pay assistance and prescription assistance.
Still unpublished: eligibility rules and dollar amounts, as of October 18, 2026. Elevar said the drug is expected to be available in the US by the fourth quarter of 2026.
First step: call Care Connect, or ask the oncology team's financial counselor or the specialty pharmacy. The Lyrfigtu drug page will add the program's terms once Elevar publishes them.
Cholangiocarcinoma: Lyrfigtu targets the FGFR2 fusion found in roughly 10% to 20% of intrahepatic cases; the cholangiocarcinoma page lists the other FGFR drugs and every recruiting trial.
Liver cancer: the rivoceranib and camrelizumab program targets advanced hepatocellular carcinoma.
Elevar Therapeutics has active programs across 1 rare disease: Cholangiocarcinoma. Each disease page on Trial Friend shows the latest recruiting trials, FDA-approved treatments, and patient resources.
The clinical trials section on this page shows active and recruiting rare disease trials sponsored by Elevar Therapeutics, pulled live from ClinicalTrials.gov. Each trial card includes the study phase, recruitment status, conditions being studied, number of trial sites, and a direct link to the full study record. You can also explore individual disease pages to see trials from all sponsors for a specific condition.
To explore enrollment, find a recruiting trial in the clinical trials list on this page and click "View full study" to see the full ClinicalTrials.gov record, which includes eligibility criteria, study locations, and contact information for each trial site. Your doctor can also help determine if a specific trial is appropriate for your condition. Not all trials are open at every location, so check the site list for one near you.
Elevar Therapeutics has 1 FDA-approved drug with a rare disease use that we track, as of October 2026.
Source: the FDA's openFDA label database, matched to the rare diseases on Trial Friend; the list updates automatically and can include older products.
Yes, for 1 of its FDA-approved rare disease medicine that we track, each checked on Elevar Therapeutics' own website.
Lyrfigtu: Elevar Care Connect, 1-833-804-3847. Offers copay help with private insurance and a free medicine program. Checked October 5, 2026.
Medicare and Medicaid: drugmaker copay cards are limited to private insurance, so people with government coverage usually look to a free medicine program or a charity fund, both on the help paying page.
Eligibility is decided by each program, so call the number listed before a prescription is filled.