The FDA clinical hold keeps Neumora Therapeutics from catching up to the field of biopharmaceutical companies pursuing the same target for schizophrenia. But Neumora remains on track with its lead program, a different drug in late-stage clinical testing for major depressive disorder.
The FDA clinical hold follows a a report of liver failure that may be associated with zelnecirnon, an experimental Rapt Therapeutics drug. The biotech notes that no other patient has experienced liver problems and this safety signal has not been seen in any other tests of the molecule.
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Arcellx attributes the death to limitations of the treatments that patients receive while their cell therapies are being manufactured. The company is working to expand these so-called bridging therapy options for patients.
For the second time in three months, Mersana Therapeutics is dealing with an FDA clinical hold. The partial hold on tests of its experimental ovarian cancer drug follows a full hold placed on an early-stage test of a different Mersana therapy in various types of solid tumors.
The FDA has asked for more information about cardiac complications reported last year in a Phase 1 study for the Molecular Templates cancer drug, MT-0169. The partial clinical hold comes as the biotech works through a corporate restructuring as well as a second Nasdaq de-listing notice.
Two fatalities were reported in an early-stage study testing a Gossamer Bio drug intended to treat a rare cancer affecting the central nervous system. Due to the adverse events and a partial FDA clinical hold, Gossamer has decided to stop work on the program.
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Astellas has become an active player in gene therapy. MedCity News caught up with company executive Richard Wilson, who explained Astellas’s strategy, the clinical holds on its two most advanced programs, and the rationale behind its recent gene therapy deals.
The lead cancer drug candidate of Foghorn Therapeutics is now under a partial clinical hold following a patient death. According to the biotech, the patient may have experienced a side effect that is a known complication of leukemia drugs.
The FDA placed a partial hold on a Curis drug in development for treating leukemia after a patient treated in a clinical trial died. The biotech company said the patient experienced a complication that is a known risk of the small molecule drug.
The FDA placed a partial clinical hold on a Phase 1 study testing experimental Alpine Immune Sciences cancer drug davoceticept in combination with Merck cancer immunotherapy Keytruda. The partial hold does not affect a separate study testing the Alpine drug as a monotherapy.
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The FDA has halted tests of a Pfizer gene therapy for Duchenne muscular dystrophy. The clinical hold is one of several placed on gene therapy tests in the past year due to safety concerns.
The FDA placed a partial clinical hold on a Kura Oncology leukemia drug following the death of one patient in the early-stage study. Kura executives said the death may be related to differentiation syndrome, a known complication of leukemia therapies.
For the second time in a week, the FDA placed a clinical hold on an Aprea Therapeutics cancer drug. The biotech said the agency cited safety and efficacy data from a prior failed clinical trial that tested the small molecule in a different form of cancer.
Two trials involving the drug MGD009 - a monotherapy study and one in combination with the company's PD-1 inhibitor - are barred from enrolling new patients pending FDA review and a planned protocol amendment.
The company's shares were down more than 40 percent in midday trading as the FDA placed a clinical hold on ZGN-1061, the second such hold the company has experienced in three years.