AbbVie Secures FDA Nod for New ADC Drug Emrelis in Lung Cancer

AbbVie ABBV announced that the FDA has granted accelerated approval to its antibody-drug conjugate (ADC), telisotuzumab vedotin (or Teliso-V), for treating certain patients with non-small cell lung cancer (NSCLC). The drug will be marketed under the brand name Emrelis.

Under this approval, Emrelis is approved to treat adult patients with locally advanced or metastatic, non-squamous NSCLC with high c-Met protein overexpression (OE) who have received a prior systemic therapy. This makes it the first FDA-approved therapy for this patient population.

The drug is designed to target the c-Met protein, which is overexpressed in many solid tumors, including NSCLC. Per AbbVie, c-Met OE is found in 25% of advanced EGFR wild-type NSCLC patients and is associated with a poor prognosis. Approximately half of these patients have high c-Met OE, defined as at least 50% of tumor cells with strong (3+) staining, as determined by an FDA-approved test.

Emrelis’ approval also marks a significant milestone for AbbVie, marking the company's first internally developed solid tumor drug and its first solid tumor therapy to receive FDA approval for lung cancer.

The accelerated approval is supported by data from the phase II LUMINOSITY study, which showed that patients with high c-Met protein OE treated with the drug achieved an overall response rate of 35%. To convert this approval into a full one, AbbVie is conducting a phase III confirmatory study called TeliMET NSCLC-01, evaluating the drug in patients with previously treated c-Met-overexpressing NSCLC.

ABBV Stock Performance

Shares of the company have outperformed the industry year to date, as seen in the chart below.

ABBV’s Growing Oncology Portfolio

AbbVie has significantly broadened its oncology portfolio over recent years. Initially anchored by Imbruvica and Venclexta, the company has expanded its offerings to include Epkinly, Elahere, and most recently, Emrelis, bringing the total to five oncology therapies.

ABBV also has an exciting and diverse pipeline of promising new therapies in both blood cancers and solid tumors. Notably, etentamig (formerly ABBV-383), a BCMA x CD3 bispecific antibody, is currently being evaluated in a late-stage study for relapsed/refractory multiple myeloma.

The company is also developing another c-Met targeting ADC called Temab-A (formerly ABBV-400). This drug is being evaluated in a late-stage study for metastatic colorectal cancer and in mid-stage development for gastroesophageal cancer.

ABBV Inks Deal With ADARx Pharma to Develop siRNA Therapies

In a separate press release, AbbVie announced a collaboration and license option agreement with ADARx Pharmaceuticals to develop small interfering RNA (siRNA) therapeutics across multiple disease areas, including neuroscience, immunology and oncology.

The partnership leverages ADARx's proprietary siRNA discovery technology, which enables sustained and precise mRNA silencing. AbbVie will contribute its expertise in antibody engineering, ADCs and targeted tissue delivery to enhance the therapeutic potential and precision of the siRNA candidates.

Per the deal terms, AbbVie will make an upfront payment of $335 million to ADARx. In addition, ADARx will be eligible to receive ‘several billion dollars’ in milestone payments as well as tiered royalties on any resulting product.

ABBV’s Zacks Rank

AbbVie currently carries a Zacks Rank #3 (Hold).

AbbVie Inc. Price

AbbVie Inc. price | AbbVie Inc. Quote

Our Key Picks Among Biotech Stocks

A couple of better-ranked stocks from the industry are Adaptive Biotechnologies ADPT and Agenus AGEN, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for Adaptive Biotechnologies’ 2025 loss per share have improved from 92 to 87 cents. During the same timeframe, estimates for 2026 loss per share have narrowed from 69 to 65 cents.

Adaptive Biotechnologies’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.38%. Shares of ADPT have surged 51% year to date.

Estimates for Agenus’ 2025 loss per share have narrowed from $7.05 to $5.85 over the past 60 days, and the same for 2026 loss has improved from $7.14 to $5.74.

Agenus’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 22.71%. Year to date, its shares have gained 27%.

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This article originally published on Zacks Investment Research (zacks.com).

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