Daily Stock Watch: ISEE Stock's Eye Watering Rise

By Duncan Ferris

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Iveric Bio Inc (NASDAQ: ISEE) has seen its share price leap following a new FDA designation. However, with good news for a key competitor emerging too, is ISEE stock a good investment?

Photo by Amanda Dalbjörn on Unsplash

Iveric Bio Inc (NASDAQ: ISEE) received a boost this week after its lead treatment candidate won Breakthrough Therapy designation. The treatment, Zimura, gained the designation in relation to treatment of geographic atrophy (GA) secondary to Age Related Macular Degeneration (AMD).

The designation is designed to speed development and regulatory review of new medicines. It is offered to candidates with the potential to treat a serious condition and address an unmet medical need.

Zimura’s designation follows success in GATHER1 and GATHER2, two Phase 3 clinical trials.

Glenn P. Sblendorio, CEO of Iveric Bio Inc, said:

“We are now focused on the execution of our full NDA submission and launch preparation, with the possibility of being first to market. We look forward to working collaboratively with the FDA to expedite the review timeline for zimura and to potentially bringing a new therapy to AMD patients impacted by GA.”

But with a major competitor also receiving good news, is ISEE stock a good investment?

What is Iveric Bio?

Iveric Bio Inc is a biopharmaceutical company. Its focus is on novel treatments for retinal diseases with a focus on age related and orphan inherited retinal diseases (IRDs).

The company’s primary treatment candidate is Zimura. This therapy is believed to slow the chronic inflammation and cell death associated with retinal ageing. The company says the candidate has potential as a treatment for geographic atrophy or Stargadt Disease.

The treatment has finished Phase 3 clinical trials development for the former condition, and is in Phase 2 of development for the latter.  

The business has a slew of other treatment candidates too. However, these are all at the research or pre-clinical stage of development.

The company was formerly known as Ophthotech Corporation and changed its name to IVERIC Bio Inc in April 2019. The company was formed in 2007 and is based in Parsippany, New Jersey.

How Does Iveric Bio Inc Make Money?

With its most advanced treatment candidate still undergoing clinical trials, Iveric Bio Inc has yet to generate significant revenues.

ISEE Stock Financials

The year to date has seen Iveric Bio Inc’s share price climb by 4.04%. The last 12 months have seen the stock reach a high of $24.33 and a low of $8.85.

The company’s most recent earnings covered the quarter ended 30 September. These showed that the business had $321m in cash, cash equivalents and available for sale securities. This follows $50m of initial borrowing under its term loan debt financing facility with Hercules and SVB.

Iveric Bio Inc has estimated that its funding will be sufficient until at least mid-2024.

ISEE Growth Potential

With current funding giving the company a runway to mid-2024, it will soon have to start relying on its own revenues. This means it is heavily dependent on its treatment for GA.

GA is a leading contributor to blindness. It's estimated to affect more than 5 million patients worldwide and around 1 million in the United States. There are no currently approved treatments for the condition, though many businesses are attempting to develop therapies.

Additionally, Age-Related Macular Degeneration is expected to increase sharply in Asia, the region where it is currently most prevalent. As such, Iveric Bio Inc sees a significant commercial opportunity in developing an effective treatment for GA.

ISEE Stock Investment Risks

There are a slew of businesses currently attempting to bring treatments for geographic atrophy to market. These competitors include Apellis Pharmaceuticals (NASDAQ: APLS), Annexon Inc (NASDAQ: ANNX), Novartis (NYSE: NVS) and AstraZeneca (NASDAQ: AZN).

However, Iveric Bio Inc has progressed its treatment candidate further than any of these competitors, except Apellis. While Apellis had a hard start to the month as its stock fell on development delays, it received a boost on Friday.

The FDA accepted an amendment to its new drug application for intravitreal pegcetacoplan, which is its GA treatment. The amendment includes 24-month efficacy data from two Phase 3 trials.

The application now has a goal date of the end of February.

While Iveric Bio Inc is ahead of many of its competitors, it looks like Apellis could still make it to market first. This could give the business a valuable head-start and limit the potential impact of Zimura.

Is ISEE Stock a Good Investment?

Iveric Bio Inc finds itself in an interesting position. The business is well-funded and has a strong runway to market for its first treatment candidate.

However, competition in the space is strong, and it looks like the company will be beaten to the mark by Apellis. Additionally, there is no guarantee that Iveric’s zimura treatment will be approved by the FDA.

This means the company’s success could hinge on the effectiveness of its treatment and commercial strategy. On the one hand, zimura achieved a significant reduction in lesion size in both its Phase 3 trials. Apellis’ treatment did so in just one.

As such, Apellis could win the race to market, but there is a distinct possibility that Iveric has developed a more effective product. Even so, neither stock is nailed on for success, and investors should consider their appetite for risk before backing one of them.

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Topics:
Biotechnology
Pharmaceuticals
Industries:
Healthcare
Companies:
IVERIC bio
Apellis Pharmaceuticals
Annexon
Novartis AG
AstraZeneca

Author: Duncan Ferris

This article does not provide any financial advice and is not a recommendation to deal in any securities or product. Investments may fall in value and an investor may lose some or all of their investment. Past performance is not an indicator of future performance.

Duncan Ferris does not hold any position in the stock(s) and/or financial instrument(s) mentioned in the above article.

Duncan Ferris has not been paid to produce this piece by the company or companies mentioned above.

Digitonic Ltd, the owner of ValueTheMarkets.com, does not hold a position or positions in the stock(s) and/or financial instrument(s) mentioned in the above article.

Digitonic Ltd, the owner of ValueTheMarkets.com, has not been paid for the production of this piece by the company or companies mentioned above.

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