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PHIO's Skin Cancer Candidate to Enter Clinical Study, Stock Up

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Phio Pharmaceuticals (PHIO - Free Report) recently received an investigational new drug (IND) application clearance from the FDA to initiate clinical study on skin cancer indications. Shares of the company surged almost 22% following the announcement.

Phio will evaluate PH-762 for patients with cutaneous squamous cell carcinoma, melanoma, and merkel cell carcinoma. It plans to initiate phase Ib study of the candidate by the second half of 2023.

Cutaneous malignancies, such as melanoma and squamous cell carcinoma, can be locally destructive and systemically devastating, posing a significant challenge in cancer treatment.

The FDA's clearance of the IND application for PH-762 marks a significant step toward the company's evolution from drug discovery to clinical development.

The upcoming phase Ib clinical study will be a multi-center, dose-escalating assessment to evaluate the safety and tolerability of neoadjuvant use of intratumorally injected PH-762. In addition to safety evaluation, researchers will also examine the tumor response to PH-762 and determine the optimal dosage or dose range for further investigation.

This study holds tremendous potential for advancing the understanding of PH-762's effectiveness against these challenging forms of skin cancer.

Shares of Phio have fallen 8.4% year to date compared with the industry’s 0.7% decline.

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With the FDA's clearance, Phio will concentrate its efforts on U.S. clinical study. The company plans to wind down its first in-human clinical study for PH-762 in France, which is focused on treating patients with metastatic melanoma.

PH-762 also received clearance for an IND application sponsored by AgonOx, Inc. This clinical study will explore the treatment of "double positive" CD8 tumor-infiltrating lymphocytes in patients with melanoma and other advanced solid tumors.

Phio’s other pipeline candidate, PH-894, is in the development stage. It is being studied for treating viral infections. The company has completed the IND-enabling studies for the same and is in the process of finalizing the reports required for an IND submission.

Zacks Rank and Stocks to Consider

Currently, Phio carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the same sector are Ocuphire Pharma (OCUP - Free Report) , Allogene Therapeutics (ALLO - Free Report) and Halozyme Therapeutics (HALO - Free Report) , 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

Loss per share estimates for Ocuphire Pharma have narrowed from 29 cents to 24 cents for 2023 and from 86 cents to 81 cents for 2024, in the past 60 days. 

The company’s shares have surged 38.6% in the year-to-date period. Ocuphire’s earnings beat estimates in three of the last four quarters and missed the mark in one, the average surprise being 21.19%.

Loss per share estimates for Allogene have narrowed from $2.50 to $2.31 for 2023 and from $2.48 to $2.20 for 2024, in the past 60 days. Shares of ALLO have declined 2.6% in the year-to-date period. 

Allogene’s earnings beat estimates in three of the last four quarters and missed the mark in one, the average surprise being 5.08%.

The Zacks Consensus Estimate for Halozyme Therapeutics’ earnings has increased from $3.75 per share to $3.76 for 2024, in the past 60 days. Shares of HALO have plunged 41.5% in the year-to-date period. 

Halozyme Therapeutics’ earnings beat estimates in three of the last four quarters and missed the mark in one, the average surprise being 12.09%.

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