Vertex Pharmaceuticals has just won enormous approval from the FDA. Is biotechnology stock obviousness?

Green Pharmaceuticals (VRTX 5.31%)) I just got his second approval from the Food and Drug Administration of the United States (FDA) in just 41 days. On December 20, 2024, the FDA gave a boost to Alyftrek in the treatment of cystic fibrosis (see). Last Thursday, the agency approved Jouravx from the summit at the top in the treatment of adults with moderate to severe acute pain.

Unsurprisingly, investors reacted positively to the last regulatory victory, the actions of Vertex jumping on Friday. Is this stock of biotechnology a purchase of the purchase now after its enormous approval from the FDA?

What is the importance of Approval of the FDA of Jouravx for the summit?

The CEO of Vertex, Reshma Kewalramani, described the approval of the FDA of Journavx as “a historic step for the 80 million people in America which prescribe a medication for moderate to severe acute pain each year”. Is it just a media threshing of a business manager? I don’t think.

Journavx is the first new class of pain drugs approved in more than two decades. It is a highly selective pain signal inhibitor for a sodium channel called NAV1.8, a similar action mechanism of lidocaine of local pain. In clinical trials at an advanced stage, the drug has reduced the scores of the average digital evaluation scale (NPRS) by around 50%.

The summit drug is about to meet a major medical need. Anti-inflammatory drugs and pain relievers such as ibuprofen are often not strong enough to fully relieve acute pain. Opioids can be very addictive. Journavx is not an opioid and has no observed addictive potential.

As Kewelramani mentioned, the acute pain medication market is important to around 80 million patients. Vertex plans to charge a wholesale price of $ 15.50 per pill of 50 mg for daytime, and the American approval of the FDA in the indication of acute pain could also increase the right future approval of the drug in the treatment of peripheral neuropathic pain. This new therapy could easily become another successful drug for the summit.

Good additional news – and more potentially on the way

One day after the FDA approved Jouravx, Vertex received good additional news. The company announced that it had signed a reimbursement agreement with NHS England for CASGEVY in the treatment of sickle cell anemia. Vertex and NHS in England previously concluded an agreement to make genetic publishing therapy available to patients with transfusion beta-talemia in August 2024.

The large biotechnology company assesses Povetacicept in a global study at an advanced stage to treat IGA nephropathy, a chronic kidney disease. He hopes to be able to request accelerated approval in the United States for the medication once a provisional analysis cohort has reached 36 weeks of treatment. Registration for this cohort should conclude this year.

Another pipeline candidate could also be a possibility of accelerated approval. The summit assesses Inaxaplin in a phase 3 study to treat renal disease mediated by APOL1 (AMKD). He plans to complete the registration for the provisional analysis cohort this year, with a decision on a potential accelerated approval file after the cohort reached 48 weeks of treatment.

Is the title of summit an obvious buy?

As we say about infopublicities, “but wait! There is more!” Vertex is also busy working on a potential remedy for type 1 diabetes. He tests Zimiscel in a phase 3 study to treat T1D patients with serious hypoglycemic events. A second T1D program, VX-264, is in a phase 1/2 study.

In the meantime, the summit enjoys a monopoly to treat the underlying cause of cystic fibrosis. Newly approved Alyftrek will probably become the most successful FC therapy of the company to date.

Vertex seems to be on a solid path for more than double of its income with its current products and its candidates. The company has also proven that it can invest judiciously in research and development and intelligent commercial development. So, is this stock of biotechnology an obvious purchase? I think yes.

Keith Speights has positions in Vertex Pharmaceuticals. The Motley Fool has positions and recommends Vertex Pharmaceuticals. The Motley Fool has a policy of disclosure.