Shares of $SGEN are getting clown-raped this morning after receiving notice from the FDA telling them their drugs were total shit and needed to pause their clinical trials for their leukemia treatments.
Four people have been killed by their experimental treatments.
The clinical holds were initiated to evaluate the potential risk of hepatotoxicity in patients who were treated with SGN-CD33A and received allogeneic stem cell transplant either before or after treatment. Six patients have been identified with hepatotoxicity, including several cases of veno-occlusive disease, with four fatal events.
Overall, more than 300 patients have been treated with SGN-CD33A in clinical trials across multiple treatment settings.
Seattle Genetics says it is working diligently with the FDA to determine whether there is any association between hepatotoxicity and treatment with SGN-CD33A, to promptly identify appropriate protocol amendments for patient safety and to enable continuation of these trials.
The phase 1/2 trial of SGN-CD33A monotherapy in pre- and post-allogeneic transplant AML patients has been placed on full clinical hold. Two phase 1 trials have been placed on partial clinical hold (no new enrollment, existing patients may continue treatment with re-consent).
These studies are SGN-CD33A monotherapy, including a subset of older AML patients in combination with hypomethylating agents, and SGN-CD33A combination treatment with 7+3 chemotherapy in newly diagnosed younger AML patients. No new studies will be initiated until the clinical holds are lifted.
Seattle Genetics’ other ongoing trials of SGN-CD33A, including the phase 3 CASCADE trial in older AML patients and phase 1/2 trial in myelodysplastic syndrome, are proceeding with enrollment.
Shares of SGEN were hot, coming into today’s buzz saw. They aren’t anymore — off by 14%.
Another biotech name, $ELGX, was completely blown to smithereens after announcing they were halting shipments of their endovascular AAA systems of complete and total shit.
Apparently, they were having some minor ‘sizing issues.’
Co states, “The temporary hold on AFX is not related to any reported events from physicians and we continue to see very good commercial clinical results with the latest versions of AFX and AFX2. The manufacturing issue was identified through our on-going product testing and we are proactively implementing the hold to ensure we always provide the safest possible products for patients… In addition, the AFX manufacturing issue is unrelated to the manufacturing process for Nellix and Ovation, which continue to be available in approved markets.”
Shares are down 15%.
