Here's a roundup of top developments in the biotech space over the last 24 hours.
Stocks In Focus
Ampio Pharma Shares Fall As FDA Rejects Proposed Change In Knee Osteoarthritis Trial
Ampio Pharmaceuticals Inc (NYSE:AMPE) received written responses from the FDA under a Type C meeting request regarding the AP-013 Phase 3 trial results.
The FDA disagreed with the proposed change from the Intent-To-Treat population to the modified Intent-To-Treat population. FDA did not agree AP-013 could serve as a second pivotal trial for Ampion.
The stock closed 36.8% lower at $0.22 in after-market trading.
Vertex Pharma's Trikafta Approved In Canada For CF Patients Aged 6-11 Years
The approval covers patients who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator gene.
Additional dosage strength of Trikafta tablets is now available.
Codiak BioSciences's Pan Beta-Coronavirus Vaccine Shows Encouraging Action In Animal Studies
The data demonstrate the potential for the vaccine candidate to induce cross-neutralizing antibody protection against multiple strains.
Preclinical data showed a durable antibody response lasting at least eight months in a mouse model.
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Travere Therapeutics' CFO Resigns
Clague will step down from the CFO position in August and remain employed by the company in an advisory capacity into 2023 to facilitate a smooth transition.
Chris Cline, the company's current senior vice president of investor relations and corporate communications, will be the new CFO.
AstraZeneca's COVID-19 Antibody Provides Protection For At Least Six Months
The data showed that Evusheld reduced the risk of developing symptomatic COVID-19 by 77% in the primary analysis and 83% in the six-month follow-up analysis, compared to placebo.
There were no cases of severe disease or COVID-19-related deaths in the Evusheld group through the six-month follow-up.
CureVac-GSK's Bivalent COVID-19 Vaccine Shows Immune Responses, Protective Efficacy In Preclinical Studies
It's developing the vaccine, combining two mRNAs encoding the Beta and the Delta variant, in collaboration with GlaxoSmithKline Plc (NYSE:GSK).
In the vaccinated animals, the bivalent mRNA vaccine significantly reduced the viral load in the animals. The bivalent Beta /Delta vaccine candidate induced two-fold higher virus-neutralizing antibody titers against the Omicron variant than against the Delta variant in a rat model.
Kazia Completes Mid-Stage Brain Cancer Trial With Paxalisib
Kazia Therapeutics Limited (NASDAQ:KZIA) has completed a Phase 2 study of paxalisib in glioblastoma.
Median progression-free survival in the ITT population was 8.4 months, representing a substantial increment over the comparable figure of 5.3 months associated with temozolomide.
Cocrystal Pharma Collaborates With NIAID To Evaluate COVID-19 Protease Inhibitors
Under the NIAID collaboration, Cocrystal has provided its 3CL protease inhibitors, and the NIAID will be responsible for in vitro and in vivo studies evaluating the antiviral activity of the compounds.
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