ImmunoGen (IMGN) Stock: Tanking On Regulatory Update

ImmunoGen, Inc. (NASDAQ: IMGN) is having an incredibly rough start to the trading session this morning, and for good reason. The company announced an update with regard to a clinical candidate, upsetting investors and sending the stock tumbling. Today, we’ll talk about:

  • The update;
  • what we’re seeing from IMGN stock as a result; and
  • what we’ll be watching for ahead.

IMGN Announces Update

As mentioned above, ImmunoGen is having a rough day in the market today after providing a regulatory update. The update came by way of press release early this morning.

In the release, the company announced that the FDA has recommended that it conduct a new Phase 3 randomized trial to evaluate the safety and efficacy of mirvetuximab soravtansine in patients with high folate receptor alpha (FRa)-positive, platinum-resistant ovarian cancer. The recommendation came as part of a Type C meeting with the FDA.

The meeting came after the results of the Phase 3 FORWARD I trial became available. Unfortunately, IMGN and investors were hoping that the meeting would lead to an approval without the need for additional studies. This simply wasn’t the case.

In a statement, Anna Berkenblit, MD, SVP and CMO at IMGN, had the following to offer:

We are encouraged by the consistent signal of anti-tumor activity and the favorable benefit-risk profile in patients with high FRĪ± expression in our Phase 3 FORWARD I trial.

We appreciate the constructive engagement with FDA and look forward to aligning with the agency on the design of a new registration trial in this population.

The above statement was followed up by Mark Enyedy, President and CEO at IMGN. Here’s what he had to say:

Our meeting with FDA enabled us to clarify a regulatory path forward for mirvetuximab and we are evaluating all avenues to bring this promising therapy to ovarian cancer patients.

The mirvetuximab combination cohorts continue to advance and, with approximately $270 million on the balance sheet as of the end of Q1, we remain focused on developing innovative ADC therapeutics and delivering more good days to people with cancer.

What We’re Seeing From The Stock 

One of the first lessons that we learn when we start to work in the market is that the news leads to moves. When it comes to ImmunoGen, the news proved to be negative.

After all, with the need for an additional Phase 3 trial comes a new, yet unexpected expense. This also means that there may have been problems with the data in the inital Phase 3 trial that could keep the treatment from being approved. So, it’s not surprising to see that upset investors are sending the stock tumbling down.

As is just about always the case, our partners at Trade Ideas were the first to alert us to the declines. Currently (9:22), IMGN is trading at $2.17 per share after a loss of $0.98 per share or 31.11% thus far today.

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to keep a close eye on IMGN. In particular, we’re interested in following the story surrounding the company’s continued work to bring mirvetuximab soravtansine to market and provide value to shareholders. Nonetheless, we’ll keep a close eye on the story and bring the news to you as it breaks!

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