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It was a busy week in the biotech sector, with many regulatory and pipeline updates. Neumora Therapeutics NMRA plummeted on the announcement of a study failure, while Hoth Therapeutics HOTH gained on study data.
Recap of the Week’s Most Important Stories:
NMRA Stock Crashes on Study Failure
Neumora Therapeutics announced the failure of its lead pipeline candidate, navacaprant, in a late-stage study for major depressive disorder (MDD). Shares of the company plummeted on the same.
The phase III KOASTAL-1 study evaluated the efficacy and safety of navacaprant against placebo in adults with moderate-to-severe MDD over a six-week treatment period. The study failed to achieve its primary endpoint. Treatment with the drug failed to demonstrate a significant improvement over placebo in alleviating depression symptoms, as measured by the Montgomery-Asberg Depression Rating Scale.
The study also failed to show statistically significant improvement in the reduction of anhedonia (the inability to feel pleasure), as assessed by the Snaith-Hamilton Pleasure Scale.
The KOASTAL-1 study is one of the three late-stage studies in the KOASTAL program evaluating navacaprant in the MDD indication. Management continues to analyze the study results further, as it claimed that the drug showed an efficacy signal in female patients.
HOTH Stock Soars on Study Data
Hoth Therapeutics announced positive interim safety and efficacy results from a mid-stage study of its lead candidate, HT-001, which is being developed to address skin toxicities linked to cancer patients undergoing treatment with EGFR inhibitors. Shares of HOTH surged on the data announcement.
Per the data readout from the ongoing phase IIa study, all patients treated with the candidate achieved the primary efficacy endpoint of an ARIGA score ≤1, showing significant skin toxicity improvement by the six-week mark.
Additionally, 66% of patients treated with HT-001 reported reduced pain and itching scores, which significantly improved their quality of life. Importantly, all patients retained their full EGFR inhibitor dosage, ensuring the cancer treatment's complete therapeutic efficacy. This is a significant improvement over previous reports that highlighted frequent dose reductions or treatment interruptions caused by skin-related side effects.
HOTH currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
CPRX Stock Gains on Patent Litigation With Teva
Catalyst Pharmaceuticals CPRX and its licensor, SERB, announced entering into a settlement agreement with Teva Pharmaceuticals TEVA. The agreement resolves the patent litigation brought by Catalyst and SERB on Teva for submitting an abbreviated new drug application to the FDA seeking marketing approval for a generic version of Firdapse 10 mg tablets before applicable patents expire.
