Biotech Stock Roundup: NMRA Plunges on Study Failure, HOTH, VIR Soar on Study Data & More

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 FailureNeumora 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 DataHoth 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 TevaCatalyst 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.Per the terms, Teva has agreed not to market its generic version of Firdapse in the United States, subject to approval, before Feb. 25, 2035, unless specific exceptions outlined in the agreement arise. Additionally, Catalyst/SERB and Teva will end all ongoing patent litigation over Firdapse patents in the U.S. District Court in New Jersey.However, litigation against the remaining defendants continues. While Hetero faces claims for all Orange Book-listed patents for the drug, Lupin does the same for the Catalyst Firdapse patent expiring in 2037.VIR Stock Gains on Study DataVir Biotechnology VIR presented encouraging safety and efficacy data in ongoing dose escalation studies for two of its dual-masked T-cell engagers (TCEs) — VIR-5818, targeting a variety of HER2-expressing solid tumors, and VIR-5500, targeting PSMA in metastatic castration-resistant prostate cancer (mCRPC).VIR-5818 is being evaluated in a phase I study for safety and pharmacokinetics alone, and in combination with pembrolizumab, in participants with a variety of HER2-expressing cancers, including breast and colorectal cancer. Early efficacy data indicate that 50% (10/20) of participants receiving VIR-5818 doses ≥400 µg/kg experienced dose-dependent tumor shrinkage across multiple HER2-positive tumor types.A phase I study is assessing the safety, pharmacokinetics, and preliminary efficacy of VIR-5500 in mCRPC patients. Early efficacy data show encouraging signs of prostate-specific antigen (PSA) responses. PSA reductions were observed in 100% of participants after an initial dose ≥120 µg/kg.Data show encouraging preliminary safety and efficacy profiles with no dose-limiting cytokine release syndrome. The maximum tolerated dose has not been reached as dose escalation continues, and early clinical response signals are observed in heavily pretreated participants.PerformanceThe Nasdaq Biotechnology Index has gained 0.85% in the past four trading sessions and Regeneron’s shares have gained 2.57%. In the past six months, shares of MRNA have lost 62.93%. (See the last biotech stock roundup here: Biotech Stock Roundup: Updates From GILD, REGN, GSK, ANAB Down on Study Data, EWTX Gains)Image Source: Zacks Investment ResearchWhat's Next in Biotech?Stay tuned for more pipeline updates. Research Chief Names "Single Best Pick to Double"From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.This company targets millennial and Gen Z audiences, generating nearly $1 billion in revenue last quarter alone. A recent pullback makes now an ideal time to jump aboard. Of course, all our elite picks aren’t winners but this one could far surpass earlier Zacks’ Stocks Set to Double like Nano-X Imaging which shot up +129.6% in little more than 9 months.Free: See Our Top Stock And 4 Runners UpWant the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Teva Pharmaceutical Industries Ltd. (TEVA): Free Stock Analysis Report Catalyst Pharmaceuticals, Inc. (CPRX): Free Stock Analysis Report Hoth Therapeutics, Inc. (HOTH): Free Stock Analysis Report Vir Biotechnology, Inc. (VIR): Free Stock Analysis Report Neumora Therapeutics, Inc. (NMRA): Free Stock Analysis ReportTo read this article on Zacks.com click here.Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks