Biotech Stock Roundup: BHVN, WVE, ZVRA Stocks Up on Updates, BIIB & UCBs Study Data & More

Zacks Equity Research
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The biotech sector was in focus last week, with regular pipeline and regulatory updates. Drug approvals were in the spotlight as well.

Here's a recap of the week’s most important stories:

Biogen, UCB Lupus Study Data

Biogen BIIB and partner UCB announced that the phase III PHOENYCS GO study, which evaluated the investigational drug candidate, dapirolizumab pegol, for the treatment of moderate-to-severe systemic lupus erythematosus (SLE), met the primary endpoint by demonstrating clinical improvement in moderate-to-severe SLE.

The double-blind, placebo-controlled phase III PHOENYCS GO study evaluated dapirolizumab pegol as an add-on therapy to standard-of-care (SOC) versus placebo with SOC for treating SLE. Data from the study showed that dapirolizumab pegol, in combination with SOC, led to greater improvement in moderate-to-severe disease activity after 48 weeks compared with placebo in addition to SOC.

The study also demonstrated clinical improvements in key secondary endpoints measuring disease activity and flares. The safety profile of dapirolizumab pegol was similar to that seen in the previous studies.

Following the PHOENYCS GO study's success, BIIB and UCB plan to initiate a second phase III study, PHOENYCS FLY, on dapirolizumab pegol in 2024.

FDA Rejects VNDA’s NDA

Shares of Vanda Pharmaceuticals Inc. VNDA were down after the FDA issued a complete response letter (CRL) to its new drug application (NDA) seeking approval for its pipeline candidate, tradipitant, for the treatment of symptoms in gastroparesis.

The NDA included evidence of the candidate’s efficacy from two placebo-controlled studies. However, per the CRL, the FDA called for Vanda to conduct additional studies on tradipitant with a design that was inconsistent with the advice of key experts in the field and not appropriate based on the scientific understanding of the disease.

Also, per management, the FDA delayed its decision by more than 185 days and failed to meet the requirements specified by the Food Drug and Cosmetic Act (“FDCA”). Notably, the FDCA requires the FDA to review an NDA and provide either an approval or a possible hearing within 180 days of the filing. The FDA failed to do either. VNDA also stated that it had repeatedly asked the FDA to hold an advisory committee meeting to discuss the NDA for tradipitant that the regulatory body declined.

Despite the FDA declining to approve tradipitant for treating symptoms in gastroparesis, the company will continue to pursue the marketing approval for tradipitant in the given indication.

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