Shares of Iovance Biotherapeutics (IOVA - Free Report) fell 6.8% on Nov 18 after management announced that it expects a delay in completing the ongoing rolling submission of the biologics license application (“BLA”) to the FDA for its TIL therapy, lifileucel, in heavily pre-treated melanoma patients.
The rolling BLA, initiated this August, seeks the FDA’s approval for lifileucel to treat patients with advanced unresectable or metastatic melanoma, which has progressed on or after prior anti-PD-1/L1 therapy. If the melanoma is BRAF mutation-positive, it should have also been treated with prior BRAF or BRAF/MEK inhibitor therapy.
This delay is due to the FDA’s comments regarding supplemental assay validation information and comparability data for lifileucel. Per management, the company can promptly address the regulatory body’s comments, which will result in an extension of its anticipated BLA filing timeline. Iovance expects the rolling submission to be completed in first-quarter 2023. Management had announced that it expected the filing to be completed this year in the fourth quarter.
Shares were down due to the delay in the filing timeline. In the year-to-date period, shares of Iovance have plunged 65.3% year to date compared with the industry’s 19.2% decline.
If the BLA is approved, lifileucel will be the first FDA-approved individualized, one-time cell therapy for melanoma patients. It willalso be Iovance’s first-ever therapy to receive FDA approval. An approval to lifileucel will help cater to the needs of melanoma patients who have already been treated with standard-of-care medications and have limited treatment options.
Lifileucel is also being evaluated in other clinical studies. Iovance intends to start a phase III study by this year’s end to evaluate lifileucel in combination with Merck’s (MRK - Free Report) blockbuster PD-1 inhibitor Keytruda (pembrolizumab). The late-stage study will evaluate the lifileucel-Merck’s Keytruda combo as apotential treatment for immune checkpoint inhibitor naïve frontline metastatic melanoma. IOVA already evaluated this combination for the given indication in a cohort of the phase II study (IOV-COM-202). Data from the cohort demonstrated an overall response rate of 67%.
A multi-center study, IOV-COM-202 is composed of seven cohorts evaluating Iovance’s TIL therapies in multiple settings and for several indications, as a monotherapy and in combination with Merck’s Keytruda or Bristol-Myers’ (BMY - Free Report) Opdivo/Yervoy.
Opdivo and Yervoy are two of the many blockbuster drugs marketed by Bristol Myers. Both drugs are key top-line drivers for Bristol Myers. In the first nine months of 2022, Bristol Myers generated $6.0 billion from Opdivo sales and recorded $1.6 billion as product revenues from Yervoy.
Zacks Rank & Stocks to Consider
Iovance currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the overall healthcare sector is Angion Biomedica , which has 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 Angion Biomedica’s 2022 loss per share have narrowed from $1.64 to $1.54. During the same period, the loss estimates per share for 2023 have narrowed from $1.54 to $1.48. Shares of Angion Biomedica have plunged 70.3% in the year-to-date period.
Earnings of Angion Biomedica beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 66.42%, on average. In the last reported quarter, ANGN delivered an earnings surprise of 41.67%.
Where Will Stocks Go…
If Biden Wins? If Trump Wins?
The answers may surprise you.
Since 1950, even after negative midterm years, the market has never had a lower presidential election year. With voters energized and engaged, the market has been almost unrelentingly bullish no matter which party wins!
Now is the time to download Zacks' free Special Report with 5 stocks that offer extreme upside for both Democrats and Republicans…
1. Medical manufacturer has gained +11,000% in the last 15 years.
2. Rental company is absolutely crushing its sector.
3. Energy powerhouse plans to grow its already large dividend by 25%.
4. Aerospace and defense standout just landed a potentially $80 billion contract.
5. Giant Chipmaker is building huge plants in the U.S.
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Shares of Iovance Biotherapeutics (IOVA - Free Report) fell 6.8% on Nov 18 after management announced that it expects a delay in completing the ongoing rolling submission of the biologics license application (“BLA”) to the FDA for its TIL therapy, lifileucel, in heavily pre-treated melanoma patients.
The rolling BLA, initiated this August, seeks the FDA’s approval for lifileucel to treat patients with advanced unresectable or metastatic melanoma, which has progressed on or after prior anti-PD-1/L1 therapy. If the melanoma is BRAF mutation-positive, it should have also been treated with prior BRAF or BRAF/MEK inhibitor therapy.
This delay is due to the FDA’s comments regarding supplemental assay validation information and comparability data for lifileucel. Per management, the company can promptly address the regulatory body’s comments, which will result in an extension of its anticipated BLA filing timeline. Iovance expects the rolling submission to be completed in first-quarter 2023. Management had announced that it expected the filing to be completed this year in the fourth quarter.
Shares were down due to the delay in the filing timeline. In the year-to-date period, shares of Iovance have plunged 65.3% year to date compared with the industry’s 19.2% decline.
If the BLA is approved, lifileucel will be the first FDA-approved individualized, one-time cell therapy for melanoma patients. It willalso be Iovance’s first-ever therapy to receive FDA approval. An approval to lifileucel will help cater to the needs of melanoma patients who have already been treated with standard-of-care medications and have limited treatment options.
Lifileucel is also being evaluated in other clinical studies. Iovance intends to start a phase III study by this year’s end to evaluate lifileucel in combination with Merck’s (MRK - Free Report) blockbuster PD-1 inhibitor Keytruda (pembrolizumab). The late-stage study will evaluate the lifileucel-Merck’s Keytruda combo as apotential treatment for immune checkpoint inhibitor naïve frontline metastatic melanoma. IOVA already evaluated this combination for the given indication in a cohort of the phase II study (IOV-COM-202). Data from the cohort demonstrated an overall response rate of 67%.
A multi-center study, IOV-COM-202 is composed of seven cohorts evaluating Iovance’s TIL therapies in multiple settings and for several indications, as a monotherapy and in combination with Merck’s Keytruda or Bristol-Myers’ (BMY - Free Report) Opdivo/Yervoy.
Opdivo and Yervoy are two of the many blockbuster drugs marketed by Bristol Myers. Both drugs are key top-line drivers for Bristol Myers. In the first nine months of 2022, Bristol Myers generated $6.0 billion from Opdivo sales and recorded $1.6 billion as product revenues from Yervoy.
Zacks Rank & Stocks to Consider
Iovance currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the overall healthcare sector is Angion Biomedica , which has 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 Angion Biomedica’s 2022 loss per share have narrowed from $1.64 to $1.54. During the same period, the loss estimates per share for 2023 have narrowed from $1.54 to $1.48. Shares of Angion Biomedica have plunged 70.3% in the year-to-date period.
Earnings of Angion Biomedica beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 66.42%, on average. In the last reported quarter, ANGN delivered an earnings surprise of 41.67%.
Where Will Stocks Go…
If Biden Wins? If Trump Wins?
The answers may surprise you.
Since 1950, even after negative midterm years, the market has never had a lower presidential election year. With voters energized and engaged, the market has been almost unrelentingly bullish no matter which party wins!
Now is the time to download Zacks' free Special Report with 5 stocks that offer extreme upside for both Democrats and Republicans…
1. Medical manufacturer has gained +11,000% in the last 15 years.
2. Rental company is absolutely crushing its sector.
3. Energy powerhouse plans to grow its already large dividend by 25%.
4. Aerospace and defense standout just landed a potentially $80 billion contract.
5. Giant Chipmaker is building huge plants in the U.S.
Hurry, Download Special Report FREE >>
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