Top Stocks to Watch: IOVA Surges on Regulatory Approval, FDA Fast Tracks Aldeyra Drug.

Tuesday, Aug 19, 2025 9:57 am ET1min read

PainReform's solar analytics platform DeepSolar has been accepted into the NVIDIA Connect Program, while Iovance Biotherapeutics' Amtagvi has received Health Canada approval for unresectable or metastatic melanoma treatment. Aldeyra Therapeutics' ADX-2191 has been granted fast-track designation by the FDA for retinitis pigmentosa treatment. Delcath Systems' HEPZATO global Phase 2 Clinical Trial has dosed its first patient for liver-dominant metastatic colorectal cancer.

NVIDIA's Connect Program Accepts DeepSolar
NVIDIA's Connect Program has accepted PainReform's solar analytics platform DeepSolar, signaling a strategic partnership between the two companies. The acceptance marks a significant milestone for PainReform, as it leverages NVIDIA's cutting-edge AI and GPU technologies to enhance its solar analytics capabilities. This move is expected to boost the platform's efficiency and accuracy, potentially expanding its market reach and value [1].

Iovance Biotherapeutics' Amtagvi Approved by Health Canada
Iovance Biotherapeutics has received Health Canada approval for its Amtagvi, a tumor-derived autologous T cell immunotherapy. The approval marks a significant step forward for Iovance, as it is the first marketing authorization outside the U.S. for Amtagvi. The therapy is indicated for the treatment of adult patients with unresectable or metastatic melanoma that has progressed on or after at least one prior systemic therapy, including a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This approval comes on the heels of positive clinical trial results, which demonstrated promising efficacy and safety in treating advanced melanoma [2].

Aldeyra Therapeutics' ADX-2191 Granted Fast-Track Designation
Aldeyra Therapeutics' ADX-2191 has been granted fast-track designation by the FDA for the treatment of retinitis pigmentosa. The fast-track designation is a priority review program designed to expedite the development and review of drugs that treat serious or life-threatening conditions and fill unmet medical needs. This designation underscores the potential of ADX-2191 to address a significant unmet medical need, potentially accelerating its development and approval process [3].

Delcath Systems' HEPZATO Trial Begins
Delcath Systems has dosed its first patient in the global Phase 2 Clinical Trial for HEPZATO, a treatment for liver-dominant metastatic colorectal cancer. The trial aims to evaluate the safety and efficacy of HEPZATO in patients with liver-dominant metastatic colorectal cancer. The trial's success could pave the way for a new treatment option for patients with this challenging condition, highlighting Delcath Systems' commitment to advancing innovative therapies in oncology [4].

References:
[1] https://www.tradingview.com/news/gurufocus:2f38fb744094b:0-nvidia-stock-rises-as-cantor-fitzgerald-lifts-target-to-240-on-blackwell-ai-boom/
[2] https://www.biospace.com/press-releases/iovances-amtagvi-lifileucel-receives-health-canada-approval-for-advanced-melanoma
[3] [Aldeyra Therapeutics' Press Release on ADX-2191]
[4] [Delcath Systems' Press Release on HEPZATO Clinical Trial]

Top Stocks to Watch: IOVA Surges on Regulatory Approval, FDA Fast Tracks Aldeyra Drug.

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