The Daily Biotech Pulse: Ampio Falls On Knee Osteoarthritis Trial Update, AstraZeneca's COVID-19 Antibody Data, CureVac-GSK's Bivalent COVID-19 Vaccine Data

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 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

Health Canada approved the expanded use of Vertex Pharmaceuticals Incorporated's VRTX Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include children with cystic fibrosis ages 6 through 11.

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

Codiak BioSciences Inc CDAK announced new preclinical data from its pan beta-coronavirus vaccine program. 

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.

Click here to access Benzinga's FDA Calendar

Travere Therapeutics' CFO Resigns

Travere Therapeutics Inc's TVTX chief financial officer Laura Clague will retire after serving in this role for the past seven years. 

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

AstraZeneca plc AZN shared detailed results from the PROVENT Phase 3 pre-exposure prophylaxis (prevention) trial of Evusheld (tixagevimab and cilgavimab), formerly AZD7442.

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

CureVac N.V. CVAC announced preclinical data of bivalent second-generation COVID-19 vaccine candidate.

It's developing the vaccine, combining two mRNAs encoding the Beta and the Delta variant, in collaboration with GlaxoSmithKline Plc 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 KZIA has completed a Phase 2 study of paxalisib in glioblastoma. 

Final data exhibited median overall survival in the intent-to-treat (ITT) population (n=30) of 15.7 months, which compares very favorably to 12.7 months historically reported with temozolomide in this patient group.

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

Cocrystal Pharma Inc COCP announces a Non-Clinical Evaluation Agreement with the National Institute of Allergy and Infectious Diseases (NIAID) for exploratory preclinical studies to evaluate its 3CL protease inhibitors for COVID-19. 

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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