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Here’s a roundup of top developments in the biotech space over the last 24 hours:

Atara Biotherapeutics Inc ATRA completed the planned Interim Analysis of the ATA188 Phase 2 study (EMBOLD) in progressive multiple sclerosis patients.

The analysis’ primary focus was on expanded disability status scale (EDSS) improvement at six months and overall safety.

The safety monitoring committee believes the six-month interim endpoint may be an inaccurate measure. It recommended continuing the study without sample size adjustment until the final analysis.

The final read-out is planned for October 2023.

Shares are down 43% to $4.94 during the premarket session.

Also Read: Which COVID-19 Vaccine(s) Significantly Prevented Deaths – Read To Find Out

Humanigen Inc HGEN has been informed of preliminary topline results from the ACTIV-5/BET-B trial evaluating lenzilumab plus remdesivir versus placebo plus remdesivir in hospitalized COVID-19 patients. 

The trial did not achieve statistical significance on the primary endpoint, defined as the proportion of patients alive and without mechanical ventilation through Day 29. 

The data also showed a non-significant trend toward a reduction in mortality in the overall patient population.

An expert review of data from 79 real-world studies showed that AstraZeneca plc’s AZN COVID-19 vaccine and the available mRNA COVID-19 vaccines provide equally effective protection against hospitalization and death following two doses.

The data available at the review time relates to the Delta SARS-Cov-2 and earlier variants.

Emerging data on third dose boosting from the UK Health Security Agency and Brazil indicates similar findings on serious COVID-19 outcomes resulting from the Omicron variant.

Hoth Therapeutics Inc HOTH has announced proof-of-concept data generated using cognitive and behavioral assessments in an Alzheimer’s disease mouse model.

All behavioral tests performed after >5 weeks of treatment showed a significant improvement in the HT-ALZ treated groups compared to the vehicle-treated groups, with similar cognitive and behavioral trends in the HT-ALZ-treated groups compared to the wild-type (non-AD) animals. 

The other behavioral assessments are repeated after longer HT-ALZ dosing periods (e.g., six weeks).

Agios Pharmaceuticals Inc AGIO announced that effective August 8, Jackie Fouse, will transition to the chair of the board of directors, and Brian Goff will assume the role of chief executive officer. The current chairman, David Schenkein, M.D., will remain on the board as a director.

Renovacor Inc RCOR has entered into a research collaboration with the University of Utah’s Nora Eccles Harrison Cardiovascular Research and Training Institute to expand its pipeline to advance an AAV gene therapy program for three genetic segments of arrhythmogenic cardiomyopathy (ACM). 

ACM is a heritable heart muscle disorder that can affect the left and right ventricle.

In the research agreement terms, Renovacor has an option for an exclusive license to inventions generated from the collaboration.

SIGA Technologies Inc SIGA announced approximately $28 million in procurement orders for oral TPOXX (tecovirimat), including approximately $2 million for initial procurement by two new international jurisdictions and approximately $26 million for procurement by Canada.

Canada has ordered approximately $39 million of oral TPOXX this year. 

This year, SIGA has received approximately $56 million of international orders for oral TPOXX (tecovirimat) from six jurisdictions, of which five are new customers.

Offerings

Applied Genetic Technologies Corporation AGTC priced its previously announced underwritten public offering of 16.7 million shares and accompanying warrants to purchase up to 16.7 million shares at $0.60.

The gross proceeds are expected to be approximately $10 million.

Shares are slipping 46% at 46 cents during the premarket session.

Pliant Therapeutics Inc PLRX priced the upsized underwritten public offering of 10.8 million at $18.50 per share, with gross proceeds of approximately $200 million.

Gossamer Bio Inc GOSS has announced a private placement of approximately 16.6 million shares at $7.21/share, with gross proceeds of approximately $120 million.

On The Radar

PDUFA Dates

Regeneron Pharmaceuticals Inc REGN: REGEN-COV (casirivimab and imdevimab) for non-hospitalized COVID-19 patients and as prophylaxis in certain individuals.

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