Drug Pipeline & Clinical Update - September 2026

Judi Health closely monitors the drug landscape to provide our clients with timely information on newly FDA approved medications and products in the pipeline. Please find the September 2026 Monthly Drug Update below:

Key New Drug Approvals

Bixlenvo^TM (bictegravir; lenacapavir) oral tablet

Approval Date: 08/27/2026

Indication: Treatment of HIV-1 in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen

Cost*: $4,595 per month

Key Consideration:

• The smallest once-daily single tablet regiment (STR) for the treatment of HIV in virologically suppressed adults

• Received priority review by the FDA

Press Release: https://www.gilead.com/news/news-details/2026/u-s--fda-approves-gileads-bixlenvo-a-new-once-daily-single-tablet-option-for-virologically-suppressed-adults-with-hiv-including-those-on-complex-regimens  

‍

‍

Lisraya^TM (brepocitinib) oral tablet

Approval Date: 08/27/2026

Indication: Treatment of dermatomyositis in adult patients

Cost*: $420,000 annually

Key Consideration:

• First FDA approved oral treatment for dermatomyositis  

• Received priority review and orphan drug designation by the FDA  

Press Release: https://investor.roivant.com/news-releases/news-release-details/roivant-announces-fda-approval-lisrayatm-brepocitinib-adults  

‍

Mimrylo^TM (rusfertide) subcutaneous injection

Approval Date: 08/28/2026

Indication: Treatment of erythrocytosis in adults with polycythemia vera

Cost*: $4,200 per vial

Key Consideration:

• First in class hepcidin mimetic for erythrocytosis in polycythemia vera

• Received priority review and orphan drug designation by the FDA  

Press Release: https://www.takeda.com/newsroom/newsreleases/2026/fda-approval-mimrylo/  

‍

Etcamah® (camizestrant) oral tablet

Approval Date: 09/04/2026

Indication: Treatment of HR-positive, HER2-negative, locally advanced or metastatic breast cancer in adults

Cost*: TBD

Key Consideration:

• Received accelerated approval by the FDA

• Taken in combination with cyclin-dependent kinase (CDK) 4/6 inhibitor (abemaciclib, palbociclib or ribociclib)

• Black box warning for QTc prolongation

Press Release: https://www.astrazeneca.com/media-centre/press-releases/2026/etcamah-approved-us-for-hr-breast-cancer.html  

‍

Lyrfigtu^TM (lirafugratinib) oral capsule

Approval Date: 09/04/2026

Indication: Treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma harboring a FGFR2 fusion or other rearrangement

Cost*: TBD

Key Consideration:

• Second-line treatment option

• Received priority review and orphan drug designation by the FDA  

Press Release: https://elevartx.com/2026/09/23/elevar-fda-approval-lyrfigtu-2/  

‍

Notable Expanded Indications

• Ameluz® (aminolevulinic acid hydrochloride) – expanded to treat superficial basal cell carcinoma (sBCC) in adults

• Hyrnuo® (sevabertinib) – expanded to first-line treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors harbor HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutation

• Joenja® (leniolisib) – expanded to treat activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 4 years of age and older who weigh 27 kg or greater

• Inluriyo® (imlunestrant) – expanded to treat in ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer, in combination with abemaciclib, with disease progression following at least one line of endocrine therapy

• Aqneursa® (levacetylleucine) – expanded to treat ataxia in adults and pediatric patients with ataxia-telangiectasia (AT) weighing ≥15 kg

• Lenvima® (lenvatinib) – expanded to treat advanced renal cell carcinoma with a clear cell component (ccRCC) in adults, in combination with belzutifan

• Welireg® (belzutifan) – expanded to treat advanced renal cell carcinoma with a clear cell component (ccRCC) in adults, in combination with lenvatinib

• Olumiant® (baricitinib) – expanded to treat severe alopecia areata (AA) in patients 12 years of age and older

‍

*Cost: actual patient out-of-pocket costs may be lower, as the list price does not reflect insurance coverage, co-pay support for eligible patients, or financial assistance from patient support

‍