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Biotech Stock Roundup: ICPT's Study Data, NVAX Vaccine Gets EUA, VERU Up on Data

·4 min read

The biotech sector has been in the spotlight in the past week with important pipeline and regulatory updates. Acquisitions and collaborations have also taken center stage in this space.

Recap of the Week’s Most Important Stories:

Intercept Reports NASH Study Data:   Intercept Pharmaceuticals, Inc. ICPT announced positive top-line results from a new interim analysis of its ongoing phase III REGENERATE study of obeticholic acid (OCA) in patients with liver fibrosis due to nonalcoholic steatohepatitis (NASH). OCA 25 mg met the agreed primary endpoint of improvement in liver fibrosis without worsening of NASH at 18 months, consistent with the original REGENERATE analysis. OCA 25 mg demonstrated double the response rate in reduction of liver fibrosis without worsening of NASH versus placebo.

The safety was evaluated in 2,477 subjects who took at least one dose of the study drug. The safety population in this new interim analysis had significantly longer exposure to the study drug, yielding more than 8,000 total patient-years and 3.4 times more exposure than the original analysis.  Intercept expects to resubmit its new drug application (NDA) for OCA in liver fibrosis due to NASH following a pre-submission meeting scheduled with the FDA later this month.

Intercept currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Novavax Gets Authorization for VaccineNovavax NVAX announced that the FDA has granted emergency use authorization (EUA) to its COVID-19 vaccine, NVX-CoV2373. The EUA was based on data from the phase III study PREVENT-19, which enrolled approximately 30,000 participants aged 18 years and over in the United States and Mexico. The vaccine demonstrated 90.4% efficacy with a reassuring safety profile.  The two dose vaccine has received conditional authorization for use in individuals aged 18 and over from multiple regulatory agencies worldwide, including the European Commission. Per the company, Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the United States.

Vertex to Acquire ViaCyteVertex Pharmaceuticals Incorporated VRTX announced that it will acquire privately held biotechnology company ViaCyte for $320 million in cash. ViaCyte is focused on delivering novel stem cell-derived cell replacement therapies as a functional cure for type 1 diabetes (T1D). Vertex has a candidate, VX-880, an investigational allogeneic stem cell-derived, fully differentiated, insulin-producing islet cell therapy for T1D, in its pipeline. The acquisition is expected to accelerate the development of the VX-880 program in type I diabetes. The deal is expected to close later this year, subject to certain customary closing conditions. A phase I/II study is ongoing on VX-880.

VERU’s Shares Surge on Study Results:  Shares of Veru, Inc. VERU have surged following the release of successful results from the late-stage study for COVID-19. The rise is attributed to the publication of positive results from a phase III study evaluating the efficacy and safety of oral sabizabulin 9 mg versus placebo in approximately 210 hospitalized moderate to severe COVID-19 patients. Sabizabulin is a novel dual antiviral and anti-inflammatory agent for the treatment of hospitalized moderate-severe COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS) and death. The study met primary and key secondary endpoints.

A planned interim analysis was conducted on the first 150 patients randomized into the study. The Independent Data Safety Monitoring Committee unanimously recommended that the phase III study be halted early due to clear efficacy benefit. Treatment with sabizabulin showed a statistically significant and clinically meaningful 55.2% reduction in deaths compared to placebo in moderate to severe hospitalized COVID-19 patients, thereby achieving the primary endpoint. Sabizabulin treatment had a significant and clinically meaningful reduction in days in ICU, days on mechanical ventilation and in the hospital, hence meeting the key secondary endpoints.  The drug was well tolerated with a more favorable safety profile compared to placebo.

Performance

The Nasdaq Biotechnology Index has gained 0.79% in the past five trading sessions. Among the biotech giants, Moderna has gained 7.32% during the period. Over the past six months, shares of Vertex have gained 27.43%. (See the last biotech stock roundup here: Biotech Stock Roundup: VRTXs Regulatory Update, TYME Gains on Acquisition & More)

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What's Next in Biotech?

Stay tuned for more pipeline and regulatory updates.


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Vertex Pharmaceuticals Incorporated (VRTX) : Free Stock Analysis Report
 
Novavax, Inc. (NVAX) : Free Stock Analysis Report
 
Intercept Pharmaceuticals, Inc. (ICPT) : Free Stock Analysis Report
 
Veru Inc. (VERU) : Free Stock Analysis Report
 
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