Immunomedics (IMMU) Stock Rockets On FDA Approval

Immunomedics IMMU Stock News

Immunomedics, Inc. (NASDAQ: IMMU) is running for the top in the premarket hours this morning. The more than 30% gains come after the company announced FDA approval in the oncology space. Here’s what’s happening:

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IMMU Stock Heads Up On FDA Approval

In a press release issued late yesterday, Immunomedics said that the United States Food and Drug Administration, or FDA, has approved Trodelvy. The treatment has been approved for adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease.

Importantly, Trodelvy is the first ADC approved by the FDA for relapsed or refractory metastatic TNBC. The drug is also the first FDA-approved anti-Trop-2 ADC.

In the release, IMMU reminded investors that prior to approval, the drug was granted Breakthrough Therapy Designation and Priority Review. In fact, the drug was approved under the FDA’s Accelerated Approval Program.

The approval was based on both the objective response rate and duration of response seen in a multicenter Phase 2 clinical trial. Of course, given the accelerated nature of the approval, continued approval is contingent uppon the vrification of clinical benefit in the confirmatory Phase 3 clinical trial.

Importantly, this clinical trial was recently halted by the IDSMC as a result of compelling evidence of efficacy across multiple endpoints.

In a statement, Dr. Loretta M. Itri, CMO at IMMU, had the following to offer:

We are proud to bring Trodelvy to patients with metastatic TNBC who are in dire need of new options. Trodelvy has the potential to become a standard of care in in the management of TNBC, and we anxiously await the results of ongoing studies in other types of metastatic breast cancer. This approval highlights the potential of our unique ADC platform and strengthens the premise that the Trop-2 antigen found in many solid cancers is an important target for drug delivery. We are committed to broadening the potential use of Trodelvy in other Trop-2-expressing cancers, especially those with unmet need.

The above statement was followed up by Dr. Behzad Aghazadeh, Executive Chairman at IMMU. Here’s what he had to say:

Trodelvy’s approval is a major milestone in our transformation from a research-based organization to a fully-integrated biopharmaceutical company, underscoring our commitment to bring innovative therapies to patients with hard-to-treat cancers. We are grateful to all of the patients, their families, physicians, and nurses who participated in our clinical trials and played a significant role in making this moment possible.

Why Investors Are So Excited Here

There’s definitely good reason to be excited about Immunomedics today. First and foremost, the accelerated approval means that the company can now start selling the drug and generating revenue. This is great news in and of itself.

Nonetheless, there’s more to be excited about here.

The breast cancer market is a massive one. In fact, by the year 2025, the market is expected to grow to be worth $38.4 billion annually. Now, it would be foolish to think that IMMU will get all of, or even the majority of this market with the new drug, but it doesn’t have to. Tapping into just a small percentage of this vast market has the potential to yield meaningful revenues.

All in all, if you’re not watching IMMU yet, now is the time to start!

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