Patient diagnosis in Covid-19 vaccine trial still pending: AstraZeneca

To review, AstraZeneca yesterday suspended its Phase 3 trial of Covid-19 vaccine candidate AZD1222 after one U.K. participant suffered a serious adverse reaction.

It was reported today that the reaction was a rare inflammatory condition affecting the spinal cord called transverse myelitis, that is caused by infections or immune system disorders.

The company a short time ago said those reports are incorrect, and that there’s been no final diagnosis of yet. The company also confirms that there was a short pause in the trial in July after one volunteer was confirmed to have an undiagnosed case of multiple sclerosis, unrelated to the vaccine.

https://seekingalpha.com/news/3612712-patient-diagnosis-in-covidminus-19-vaccine-trial-still-pending-says-astrazeneca

Review extended for BioMarin hemophilia A gene therapy Euro application

BioMarin Pharmaceutical (BMRN -0.3%) discloses that the European Medicines Agency (EMA) has requested complete 52-week data from the 134 participants in its ongoing Phase 3 clinical trial, BMN 270-301, evaluating gene therapy valoctocogene roxaparvovec in patients with severe hemophilia A.

The last follow-up visit should happen in November which will enable the company to submit the data by the end of Q1 2021. As a result, the EMA’s accelerated review of the marketing application will revert to standard review.

The company encountered a similar issue in the U.S. Last month, it received a CRL from the FDA citing the need for two-year data from the trial to confirm the duration of the treatment effect. The timeline for submitting the requested results will be late 2021/early 2022 since the last follow-up visit will not be completed until November of next year. The agency’s previous action date was August 21.

https://seekingalpha.com/news/3612577-review-period-extended-for-biomarin-application-in-europe-for-hemophilia-gene-therapy

New York City indoor dining to resume at 25% capacity

Governor Andrew Cuomo is allowing indoor dining at New York City restaurants to resume at 25% capacity on September 30. Cuomo says he will re-assess the guidelines again on November 1.

The decision will be a boost to chains with a higher mix of dine-in business traditionally.

Sector watch: Shake Shack (SHAK +3.0%), Ruth’s Hospitality Group (RUTH +1.8%), Starbucks (SBUX +1.6%), Darden Restaurants (DRI +0.6%), Potbelly (PBPB +0.3%), Cheesecake Factory (CAKE -1.4%) and Dine Brands Global (DIN -2.8%).

Compare restaurant stocks side by side.

https://seekingalpha.com/news/3612611-new-york-city-indoor-dining-to-resume-25-capacity

Metacrine sets IPO terms

NASH biotech, Metacrine (MTCR) to raise $85M by offering 6.5M shares at a price range of $12 – $14.

Metacrine is a clinical-stage biopharmaceutical company focused on discovering and developing differentiated therapies for patients with liver and gastrointestinal, or GI, diseases. Most advanced program targets the farnesoid X receptor, or FXR, which is central to modulating liver and GI diseases.

https://seekingalpha.com/news/3612642-metacrine-sets-ipo-terms

Sinovac COVID-19 vaccine shows positive effect in elderly volunteers

Sinovac Biotech Ltd. (SVA) announces positive preliminary results from a Phase 1/2 clinical trial evaluating the safety and immunogenicity of Coronavac, its COVID-19 vaccine candidate, in healthy adults at least 60 years old.

421 volunteers aged between 60 and 89 were recruited. They received two shots of the vaccine 28 days apart.

Low, medium and high doses were well-tolerated with no vaccine-related serious adverse events reported.

The seroconversion (generation of antibodies) rate and geometric mean titers (GMT) (average level of antibodies in a group) were comparable to those observed in younger adults (aged 18-59) who participated in earlier studies.  Specifically, the seroconversion rate in elderly subjects was 98.0% compared to 97.4% in younger adults. GMTs in the medium dose groups were 42.2 and 44.1, respectively.

Detailed results will be submitted for publication.

The medium dose has been selected for a Phase 3 trial.

https://seekingalpha.com/news/3612627-sinovac-covidminus-19-vaccine-shows-positive-effect-in-elderly-volunteers

Illumina Backed Healthcare Company Grail Inc. Files for IPO

Healthcare company Grail Inc. on Wednesday filed with the U.S. Securities and Exchange Commission for a proposed initial public offering.

Grail’s filing indicates it plans to raise $100 million, although that figure is often used as a placeholder to calculate filing fees.

The Menlo Park, Calif., company, which focuses on the early detection of cancer, said it has applied to list its shares on the Nasdaq Global Select Market under the symbol GRAL.

Grail’s backers include Illumina Inc., which currently holds a 14.6% stake, and Johnson & Johnson, which owns a 7.6% interest.

Illumina launched Grail in 2016 with a group of other investors aiming to develop and market a test to detect genetic evidence of cancer in the blood.

Grail in May said it had raised $390 million in a Series D funding round.

https://www.marketscreener.com/quote/stock/ILLUMINA-INC-9659/news/Illumina-Backed-Healthcare-Company-Grail-Inc-Files-for-IPO-31257460/

Regeneron sees reporting biomarker data for COVID-19 therapy by September end

Regeneron Pharmaceuticals said on Wednesday it expects to report biomarker data for its COVID-19 antibody cocktail by the end of this month.

The drugmaker last month struck a partnership with Roche AG to make and supply the COVID-19 antibody cocktail, which is being tested on several hundreds of patients after it prevented and treated the respiratory disease in animals.

Regeneron has already signed a $450 million deal for the cocktail with the U.S. government, under the Trump administration’s “Operation Warp Speed” program that is aimed at the faster distribution of vaccines and treatments to fight the new coronavirus when trials are successful.

The company said on Wednesday it was moving manufacturing of some of its products to Ireland to increase the production capacity of the cocktail and might look for other supply partners if there is a lot of demand.

Regeneron’s cocktail, REGN-COV2, contains an antibody made by the company and another isolated from recovered COVID-19 patients. Rivals Eli Lilly and AbbVie are also pursuing antibody therapies for the respiratory illness.

https://www.reuters.com/article/us-health-coronavirus-regeneron-pharms-idUSKBN2602EP