Iovance Biotherapeutics (IOVA Quick QuoteIOVA - Free Report) is a commercial-stage pharmaceutical company primarily focused on developing and marketing novel T cell-based cancer immunotherapies.

Currently, Iovance has two cancer drugs in its portfolio — Amtagvi and Proleukin. While Proleukin is approved to treat two cancer indications, namely metastatic renal cell carcinoma (mRCC) and metastatic melanoma, Amtagvi is approved for advanced melanoma indication.

The company is developing its pipeline candidates, consisting of tumor-infiltrating lymphocyte (TIL), across multiple oncology indications.

Year to date, Iovance’s shares have soared 66.4% against the industry’s 5.7% fall.

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This upside is attributable to the recent FDA approval for Amtagvi, granted under the accelerated pathway to treat advanced melanoma in patients previously treated with a PD-1 and targeted therapy. Following this approval, the drug is the first individualized, one-time cell therapy for melanoma patients.

Prior to Amtagvi’s accelerated approval, there were no FDA-approved therapies for advanced melanoma, which progressed on or after prior anti-PD-1/L1 therapy. Management estimates that around 8,000 people in the U.S. die from melanoma every year. Hence, the approval of the drug will help address the needs of melanoma patients who have already been treated with standard-of-care medications and have limited treatment options. A commercial launch of the drug is currently underway.

This regulatory approval also makes the company a likely candidate for acquisition by big cancer drugmakers. Regulatory filings in Canada and Europe are currently under review, with final decisions expected later this year.

The company is also evaluating Amtagvi, combined with Merck’s PD-L1 inhibitor, Keytruda, in the phase III TILVANCE-301 study as a potential treatment for frontline advanced melanoma. This study will also serve as a confirmatory study for the drug in the approved indication.

Iovance has also been engaged in discussions with the FDA for developing Amtagvi in cervical cancer. Based on these discussions, management plans to reopen enrolment in cohort 2 of the phase II C-145-04 study. The study will enroll patients who have previously received anti-PD-1 therapy. The company expects this study to support a potential regulatory filing for the drug in cervical cancer indication.

Apart from Amtagvi, Iovance is also evaluating some other pipeline candidates in clinical development. This includes LN-145, an investigational TIL therapy being evaluated in separate mid-stage studies for head and neck squamous cell carcinoma (HNSCC) and non-small cell lung cancer (NSCLC).

Last month, Iovance announced that the FDA removed the clinical hold placed on the registrational phase II IOV-LUN-202 study evaluating LN-145 in certain NSCLC patients. The agency lifted this hold after reviewing the company’s proposal for additional safety measures and monitoring. To develop these measures, management worked closely with the agency officials and an independent data monitoring committee.

This clinical hold was placed by the FDA last December following a grade 5 (fatal) adverse effect, potentially related to the non-myeloablative lymphodepletion pre-conditioning regimen observed in the study.

Owing to the clinical hold, IOVA paused the enrollment of new patients in the IOV-LUN-202 study. Following the removal of this hold, management restarted enrolling patients in the study and intends to enroll a total of around 120 patients by the following year.

Iovance Biotherapeutics, Inc. Price

 

Iovance Biotherapeutics, Inc. price | Iovance Biotherapeutics, Inc. Quote

Zacks Rank & Key Picks

Iovance currently carries a Zacks Rank #3 (Buy). Some better-ranked stocks in the overall healthcare sector include ADMA Biologics (ADMA Quick QuoteADMA - Free Report) , ANI Pharmaceuticals (ANIP Quick QuoteANIP - Free Report) and Ligand Pharmaceuticals , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share (EPS) have risen from 22 cents to 30 cents. During the same period, EPS estimates for 2025 have improved from 32 cents to 50 cents. Year to date, shares of ADMA have surged 41.4%.

Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same on one occasion. ADMA delivered a four-quarter average earnings surprise of 85.00%.

In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 EPS have risen from $4.06 to $4.43. Meanwhile, during the same period, EPS estimates for 2025 have improved from $4.80 to $5.04. Year to date, shares of ANIP have risen 22.7%.

Earnings of ANI Pharmaceuticals beat estimates in each of the last four quarters. ANI delivered a four-quarter average earnings surprise of 109.06%.

In the past 60 days, Ligand Pharmaceuticals’ earnings estimates per share for 2024 have increased from $4.42 to $4.56. During the same period, earnings estimates for 2025 have risen from $5.11 to $5.27. Year to date, shares of Ligand Pharmaceuticals have gained 9.2%.

Ligand Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters. On average, LGND’s four-quarter earnings surprise was 84.81%.