FDA gives Seattle Genetics’ bladder cancer drug important breakthrough designation

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Seattle Genetic

One of the best performing large-cap biotech stocks on the market is Seattle Genetics (NASDAQ: SGEN). This $19.7 billion market cap biotech has done very well for itself thanks to its strong portfolio of drug candidates, one of which made news on Thursday.

Specifically, Seattle Genetic’s main bladder cancer drug won a breakthrough therapy designation from the Food and Drug Administration (FDA). In response, shares of the company jumped a little, extending what’s been an impressive winning streak for the company since the beginning of 2019.

The news broke on late Wednesday night/early Thursday morning that the FDA approved Seattle Genetics’ Padcev drug as a treatment for metastatic urothelial cancer, one of the more common types of bladder cancer. This particular drug candidate, which was developed in partnership with another company, Astellas Pharma (NASDAQ: ALPMY), was first started back in 2007.

The FDA granted Padcev accelerated approval and a breakthrough therapy designation, an important distinction for drug candidates, based on earlier phase 2 clinical trial results which showed that Padcev patients had shown considerable improvement over a placebo in patients. At the moment, a phase 3 trial to confirm these results is underway.

The Breakthrough Therapy designation is meant to help promising drugs by prioritizing them for review by the agency. Normally, the review process can take a long time for a drug candidate, but in the case of conditions that are serious or life-threatening and lack serious treatments, drugs can earn the Breakthrough Therapy designation if they have strong results to back them up.

“The FDA approval of PADCEV is welcome news for patients with bladder cancer,” said Andrea Maddox-Smith, CEO of the Bladder Cancer Advocacy Network in an official Seattle Genetics press release. “Though new medicines for bladder cancer have been approved in recent years, most people living with advanced stages of this disease face a difficult journey with few treatment options.”

Shares of Seattle Genetics gained an extra 7% or so in response to this piece of news. Although this might not be that impressive, especially in light of other major double-digit jumps seen commonly in the biotech world, it is still pretty good considering Seattle Genetic’s large-cap size and the fact that it is already gained so much this year.

Many consider Seattle Genetics to be one of the most promising biotech stocks on the market. Out of the 19 Wall Street analysts covering the stock right now, 12 have a bullish “buy” rating while seven have a neutral “hold” rating. Going forward into 2020, Seattle Genetics is one of many promising biotech stocks out there that investors should pay attention to.

Seattle Genetics Company Profile

Seattle Genetics is a biotech firm focused on developing antibody-drug conjugates. The company’s lead product, Adcetris, has received approval for advanced front-line, relapsed/refractory and post-consolidation Hodgkin lymphoma, anaplastic large-cell lymphoma, and two other subtypes of cutaneous T-cell lymphoma. The company has several other oncology programs in pivotal trials, including enfortumab vedotin for bladder cancer. Seattle Genetics also licenses its antibody-drug conjugate technology to a number of leading biotechnology and pharmaceutical companies. – Warrior Trading News

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