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3 Things In Biotech, April 3: Alkermes Gets Into Trouble, Puma Gets Into Your Head, Myriad Gets Into Japan

Apr. 04, 2018 8:00 AM ETALKS, AZN, MYGN, PBYI7 Comments
Zach Hartman profile picture
Zach Hartman


  • Alkermes has a major setback in depression.
  • Puma gets into the guidelines.
  • Myriad proceeds to Japan with BRCA testing kit.

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Welcome to another edition of "3 Things In Biotech You Should Learn Today," a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research.

Alkermes has a major setback in depression

Company: Alkermes (ALKS)

Therapy: ALKS 5461

Disease: Major depressive disorder

News: ALKS disclosed the receipt of a refusal to file letter from the FDA regarding their application for approval for ALKS 5461 to treat major depressive disorder. The company had hoped to market this agent for patients with depression who were not seeing an adequate response to current antidepressant therapy. The FDA felt that the evidence presented is insufficient to decide on the approval. They want to see another efficacy study, as well as a bioavailability study.

Looking forward: ALKS indicated that they do not agree with this assessment, and that they plan to appeal the refusal to file. However, I have to say that this does not bode well at all for the application in its current form. But at least we can say that the program is not dead in the water. This could, however, set the ALKS 5461 program back by a year or more, so it makes sense to try and appeal.

For now, though, I would treat buying on this drug's promise as an extremely high risk proposition.

Puma gets into the guidelines

Company: Puma Biotechnology (PBYI)

Therapy: Neratinib

Disease: HER2-positive breast cancer

News: PBYI announced that neratinib is now being included in the NCCN's guidelines for breast cancer. More specifically, the use of this agent in patients with brain metastases secondary to their breast cancer is now given a category 2A recommendation, when

This article was written by

Zach Hartman profile picture
I am a former PhD scientist-turned-writer focused on cancer education. My writings in Seeking Alpha have been devoted to helping people identify promising investment opportunities in cancer research through commentary of recent events. Readers can learn more about other aspects of cancer research by visiting my site Invest Against Cancer.I also collaborate with Avisol Capital Partners on their Marketplace service known as the Total Pharma Tracker (TPT). Some of my work will be available to TPT subscribers either exclusively, or in advance. If you are interested, please click the link above!

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