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Something Has Happened to Zafgen, But What?

There’s a very strange situation going on today with Zafgen, the small biotech company that’s been developing a very unusual compound as an appetite/obesity therapy. I’ve mentioned them several times over the years (more links in that post), because it’s a very interesting story.

Unfortunately, it’s just gotten a lot more interesting, and not in a good way. The company has canceled two presentations on its progress, without warning or explanation. So far today, all attempts to get the company to comment have been futile, and investors are getting increasingly worried and impatient at the silence. The company’s stock spent yesterday sliding about 40%, and although it’s flat today (after a nasty open), it’s not because anything has come out to reassure anyone. You’d have to think that they’re getting ready to inform investors of some big hunk of material information, presumably something from the clinic, but when is that going to emerge?

Update: I spoke too soon. At 3:30 EST, with still no announcement of any kind, Zafgen stock is down about 27%.

Update 2: Today (October 14) the company has now disclosed a patient death in one of its clinical trial treatment groups. Cause unknown, and under investigation. Mystery (to one approximation) solved, but the bigger question remains.

12 comments on “Something Has Happened to Zafgen, But What?”

  1. Dr. Mindbender says:

    Maybe Shkreli bought it in an effort to “reinvest” his profits towards R&D.

  2. anon says:

    Is it even legal to with hold this type material information from investors? One may speculate that it’s positive because if it’s negative there are going to have to lawyer up.

  3. a. nonymaus says:

    Hmm. It could be positive news. It could be negative news. It could be that they need to quote the BBC news broadcast of April 18, 1930.

  4. Snark says:

    Funny to think of how those living in a pre-Twitter world would perceive this (Am I dating myself?).
    Whether one is managing a hedge fund or a IRA, if the timing of these sorts of things determine whether your investing year has been a success or not, you are doing it wrong,

  5. anchor says:

    As a practicing medicinal chemist for over 20+ years, I am not comfortable seeing an epoxide ring ( two in this case!) in my lead candidate. To me that was a clear and resounding No! As to how they shepherded this molecule to the clinical trial is beyond me for a difficult program (i.e. obesity). Score one for chemistry and zero for irrational and stupid MBA’s. I wish to be proved wrong.

    1. NVS Vet says:

      Tom Hughes, Zafgen CEO is not a MBA, is a discovery scientist that had a critical role in the development of Galvus. Could have done it better, but it got it approved in EU. How many drugs have you got approved in your 20+ carrer as a chemist?

  6. Ed says:

    They have a back up molecule that is almost as frightful, but which (IIRC) has no epoxides.

  7. anon II says:

    @anchor, that sentiment is what needs to change in pharma. we are starting to really understand reactivity and promiscuity and these decisions should be based on data, not gut. look at recent approvals of carfilzomib, ibrutinib et al. the suspicious natives (med chemists) need to let the data drive discovery, not what a molecule looks like.

  8. Lyle Langley says:

    @anon II:

    I agree with your statement about letting data drive discovery. Nothing more frustrating than someone’s opinion about what is and what is not a good drug. However, your examples are a bit misleading as well. Anyone in the field can recognize that drugs for cancer indications can be and are different (reactive groups, selectivity, etc.) than those for chronic indications. You can “get away” with dirtier drugs in some instances (short treatment regimens, etc.) than you can with others.

  9. in vivo veritas says:

    This will do it to you…..
    BOSTON, Oct. 14, 2015 (GLOBE NEWSWIRE) — Zafgen, Inc. (ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, today issued the following statement:

    “Zafgen recently learned of a patient death which occurred in the Company’s ongoing double-blind, randomized, placebo-controlled Phase 3 bestPWS study of beloranib in Prader-Willi Syndrome, a rare genetic disorder with a high rate of mortality linked to obesity and its co-morbidities. The cause of death remains unknown at this time. According to normal practice, the event was reported to the U.S. Food and Drug Administration, at which point the Agency initiated a discussion with the Company. The Company is working with the Agency to expedite a review and understanding of this event, and to determine implications of the event on the conduct of the trial, and anticipates providing an update as its discussions with the Agency progress. The thoughts of the Company are with the family of the patient at this time. Zafgen remains committed to ensuring the safety of all patients enrolled in its studies.”

  10. Hap says:

    It probably would have been better to have put this out when they had to perform public actions (canceling their presentations) then to have waited.

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