Iovance Biotherapeutics Inc (IOVA)

Iovance Biotherapeutics Inc (IOVA) stock dropped by 18.67% due to the FDA placed a clinical hold on its IOV-LUN-202 trial studying LN-145 as a treatment for non-small cell lung cancer. This was due to a recently reported fatal adverse event related to the pre-conditioning regimen. In details,

• FDA Clinical Hold: The primary driver behind the stock drop was the FDA's decision to impose a clinical hold on Iovance's IOV-LUN-202 trial, which was assessing LN-145 as a potential treatment for non-small cell lung cancer (NSCLC). This action was taken in response to a fatal adverse event that had been recently reported and was linked to the pre-conditioning regimen associated with the therapy.
• Trial Enrollment Pause: As a result of the FDA's clinical hold, the company had to pause the enrollment of new patients in the NSCLC trial. While this halt occurred, patients who had previously undergone treatment with the therapy continued to be monitored.
• Potential Delay: Analysts estimated that the FDA's clinical hold could potentially lead to a delay of several months in the therapy trial. This setback represented a significant obstacle to Iovance's efforts to develop an innovative treatment for NSCLC, a prevalent form of cancer.
• LN-145 TIL Therapy: The therapy in question, known as LN-145 TIL, was also being developed for the treatment of melanoma. It involved the extraction and modification of white blood cells from a patient's tumor, which were then reintroduced into the patient to bolster the immune system's ability to combat cancer cells.
• Recruitment Momentum Concerns: The clinical hold had the potential to not only prolong the resolution process but also impede the recruitment of patients for the trial, exacerbating data delay concerns, according to Truist analyst Asthika Goonewardene.
• Pre-Conditioning Regimen: The patient's death was linked to the pre-conditioning regimen, wherein a brief course of chemotherapy was administered to eliminate immune cells before the Iovance therapy infusion.
• Limited Impact on Other Trials: While the clinical hold affected the NSCLC trial, Iovance clarified that it had no impact on its other ongoing trials, including those related to melanoma. However, concerns were raised about the potential implications for the marketing application in melanoma.
• Extended FDA Review: Notably, the FDA had previously extended the review timeline for Iovance's skin cancer therapy used for melanoma, citing resource constraints, which added to the uncertainties surrounding the company's future prospects.

Iovance Biotherapeutics Stock (IOVA) declined 8.43% to $5.43 after the company had its price target cut by Barclays from $40.00 to $18.00 in a research note issued to investors.

https://www.americanbankingnews.com/2023/09/19/iovance-biotherapeutics-nasdaqiova-price-target-lowered-to-18-00-at-barclays.html

Iovance Biotherapeutics (IOVA) shares tumbled over 14.54%to reach $4.64 after competitors Seagen and Genmab reported positive phase 3 trial data for a cervical cancer treatment. This development may affect the approval prospects of Iovance's Lifileucel therapy for the same condition, despite its potential for advanced melanoma approval with an FDA priority review.

https://www.fool.com/investing/2023/09/14/why-shares-of-iovance-biotherapeutics-dropped-thur/

Iovance Biotherapeutics, Inc. (IOVA) fell 9.78% to $7.93 as the company priced its underwritten public offering of 20,000,000 shares at $7.50 per share. The stock is up more than 26% so far this year.

https://www.fool.com/investing/2023/07/11/why-these-2-nasdaq-biotech-stocks-fell-hard-tuesda/