Shares of Paris-based Abivax SA fell 25.4% to €21 (US$25.07) on Monday after the company said it would halt a phase IIb/III trial of its lead candidate, ABX-464, in high-risk COVID-19 patients for lack of efficacy. Development of the drug in chronic inflammatory indications continues. Shares of Cytodyn Inc. also fell Monday, declining about 25.7% by midday as the company reported summary findings of a phase III trial of Vyrologix (leronlimab-PRO 140) in severe to critically ill COVID-19 patients. Researchers at Rokote Laboratories Finland Ltd., meanwhile, said that within a few months they would start a trial for a nasal spray COVID-19 vaccine they're developing.

Anaptysbio’s phase III of imsidolimab misses primary endpoint

The phase II study of imsidolimab, from Anaptysbio Inc., for treating moderate to severe palmoplantar pustulosis failed to hit its primary endpoint. Top-line data showed the antibody that inhibits interleukin-36-receptor function failed to show a statistically significant improvement over placebo at week 16. The company is calling it quits for developing imsidolimab in the indication but said it would continue development for five other indications, including a phase III trial in treating generalized pustular psoriasis that’s set to begin in mid-2021. The San Diego-based company stock (NASDAQ:ANAB) was taking a pounding at midday, with shares sagging 35% from the opening bell.

Three-way contest in alopecia areata pits big, little players

A race is shaping up in alopecia areata, with Concert Pharmaceuticals Inc., Eli Lilly and Co. and Pfizer Inc. developing late-stage prospects for the hair-loss condition. Each company is advancing a JAK inhibitor with unique properties. But not every contender has disclosed much data in the disorder, which afflicts more than 700,000 people in the U.S.

Despite its price, Zolgensma gets NICE nod

Novartis AG’s Zolgensma (onasemnogene abeparvovec) is set to become the most expensive treatment ever approved by the U.K.’s National Institute for Health and Care Excellence (NICE). The agency issued draft guidance March 8 recommending the £1.79 million (US$2.47 million) therapy for babies, up to a year old, with type 1 spinal muscular atrophy (SMA), a rare inherited condition that leads to a life expectancy of less than two years. The high cost of the “potentially curative one-off gene therapy” is offset by the evidence of “exceptional benefit to young babies, potentially allowing them to reach normal childhood developmental milestones,” NICE said. The guidance also recommends the gene therapy for pre-symptomatic babies with SMA as part of a managed access arrangement while more data is collected.

After phase III failure, Bio-Thera drops batansine technology in favor of new ADC platform

Days after taking the unusual step, for a Chinese company, of terminating a couple of clinical programs, Bio-Thera Solutions Ltd. said it still plans to continue R&D in antibody-drug conjugates (ADC) with a new technology platform, the company told BioWorld. Bio-Thera ended the development of phase III-stage HER2-ADC candidate BAT-8001 and Trop2 ADC BAT-8003 due to the flawed drug-linker batansine. “Bio-Thera is committed to working on ADCs, but we decided to abandon the batansine technology,” Bert Thomas, Bio-Thera's senior vice president of business development, told BioWorld. “We plan to advance multiple new candidates from our new ADC platform into clinical studies in 2022.”

$1.9T stimulus could trigger 4% Medicare sequester

The voluminous American Rescue Plan – the second largest stimulus package in American history – has something for everyone. Almost. The $1.9 trillion package that passed the Senate March 6 and is expected to be passed by the House this week failed to extend the moratorium that is set to expire at the end of the month on the 2% Medicare sequestration. That means Medicare reimbursement for Part B drugs and other covered services will be subject to the 2% cut once again beginning April 1. Next year, that cut could go up to 4% under the current pay-go statute intended to help offset the federal debt, the Congressional Budget Office predicted.

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