Twist Bio launches new synthetic controls, including 1 for SARS mutation

Twist Bioscience (NASDAQ:TWST) announces the addition of 16 new synthetic controls for environmental testing, assay development, verification, and ongoing validation of diagnostic tests for a broad range of common respiratory diseases.

One of the controls detects D614G mutation-positive SARS-CoV-2, the most virulent strain of the coronavirus. The other controls detect other respiratory viruses including influenza H1N1, H3N2, influenza B, rhinovirus, enterovirus and several other human coronaviruses.

The company says researchers can pair all of its positive controls, including those launched today, with the Twist Respiratory Virus Research Panel for the detection of viruses that may cause respiratory symptoms identical to that of SARS-CoV-2. They can also be used as negative controls in qPCR and NGS-based tests for SARS-CoV-2 or positive controls for respiratory assays.

https://seekingalpha.com/news/3593558-twist-bio-launches-new-synthetic-controls-including-one-for-virulent-sars-mutation

Ultragenyx launches triheptanoin in U.S. for rare metabolic disorders

Ultragenyx Pharmaceutical (NASDAQ:RARE) commences the U.S. commercial launch of Dojolvi (triheptanoin), approved by the FDA on June 30, for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD), a group of rare chronic and life-threatening genetic disorders in which the body is unable to convert long-chain fatty acids into energy.

The product, designed to provide medium-chain odd-carbon fatty acids as an energy source and metabolic replacement, is the only approved therapy for LC-FAOD in the U.S.

https://seekingalpha.com/news/3593585-ultragenyx-launches-triheptanoin-in-u-s-for-rare-metabolic-disorders

XBiotech up on advancement of new anti-inflammatory antibody

Thinly traded micro cap XBiotech (XBIT +1.4%) is up modestly out of the gate this morning in reaction to its announcement that its R&D team has engineered a cell-based production system for the first of its new anti-IL-1⍺ antibodies for use in all areas of medicine except dermatology. It plans to advance the candidate into the clinic next year.

The new antibody will replace a previous generation True Human anti-IL-1⍺ antibody, bermekimab, that was sold in 2019 for $750 million in cash and up to $600 million in milestones to Johnson & Johnson (NYSE:JNJ) unit Janssen Biotech.

https://seekingalpha.com/news/3593614-xbiotech-in-green-on-advancement-of-new-anti-inflammatory-antibody

Astellas nabs NIH grant to fund studies of opioid addiction therapy

NIH’s National Institute on Drug Abuse has awarded a grant to Astellas Pharma (OTCPK:ALPMF) to help fund two Phase 1 clinical trials testing the safety and efficacy of ASP8062, an oral small molecule GABA_B receptor Positive Allosteric Modulator, as add-on maintenance therapy for opioid use disorder (OUD).

If the results are positive, a second phase of the grant may be awarded to help fund a randomized Phase 2 study in OUD patients on stable buprenorphine-based therapy.

https://seekingalpha.com/news/3593633-astellas-nabs-nih-grant-to-fund-studies-of-opioid-addiction-therapy

Novocure starts mid-stage study of electric field therapy for brain cancer

Novocure (NVCR +5.6%) has enrolled first patient in its Phase 2 pivotal (EF-33) trial of Tumor Treating Fields delivered utilizing high-intensity arrays in patients with recurrent glioblastoma (GBM).

Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division.

The 25-patient trial will test potential incremental survival benefit of Tumor Treating Fields delivered at 200 kHz to the brain using high-intensity arrays.

The primary endpoint is progression free survival, and final data is expected in 2022.

https://seekingalpha.com/news/3593642-novocure-initiates-mid-stage-study-of-electric-field-based-therapy-for-brain-cancer

COVID-19 vaccine makers have different plans on pricing

In a U.S. House Energy and Commerce Oversight and Investigations Subcommittee hearing yesterday conducted by remote video, representatives of COVID-19 vaccine developers disclosed a range of planned approaches to pricing.

AstraZeneca (NYSE:AZN) and Johnson & Johnson (NYSE:JNJ) indicated that they would price their offerings, if approved, at the cost of production, at least until the pandemic ebbs.

Moderna (NASDAQ:MRNA) and Merck (NYSE:MRK) said that they would set prices exceeding manufacturing costs, although Moderna added that it planned to price it “reasonably” to ensure broad access.

Pfizer (NYSE:PFE), developing its candidate with BioNTech (NASDAQ:BNTX), indicated that it expects to make a profit but it wouldn’t “charge too much” considering the “extraordinary times” of the pandemic. Individuals should not have to pay anything.

For comparison purposes, flu shots typically cost $16-25 per dose, according to the CDC. Jefferies’ Michael Yee believes that COVID-19 vaccines will cost $50-100 per course, adding that Moderna’s offering could generate up to $2B in sales in the first year.

https://seekingalpha.com/news/3593493-covidminus-19-vaccine-makers-different-plans-on-pricing

HCA Q2 earnings lift hospital group

Most hospital operators are enjoying a spike in buying after HCA Healthcare (HCA +12.7%) reported Q2 results this morning. Revenues were down 12% due to COVID-19 disruptions but earnings were up a tidy 38% helped by CARES Act relief.

Selected tickers: Universal Health Services (UHS +6.3%), Select Medical Holdings (SEM +4.5%), Tenet Healthcare (THC +7.8%), Community Health Systems (CYH +9.7%), Humana (HUM -0.6%)

https://seekingalpha.com/news/3593670-hca-q2-earnings-lift-hospital-group