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Friday, August 5, 2022

List of Core Symptoms to Better Define Long COVID Proposed

 Researchers proposed a list of core symptoms that could offer a better working definition of long COVID, based on an observational cohort study from the Netherlands.

Among over 1,700 COVID patients, 21.4% had at least one core symptom -- including chest pain, breathing difficulties, painful muscles, ageusia or anosmia, tingling or heavy extremities, lump in throat, feeling alternately hot and cold, dizziness, headache, nausea, and general fatigue -- that worsened 90 to 150 days after diagnosis compared with 8.7% (361 of 4,130) of controls without COVID at a matched time point, reported Judith Rosmalen, PhD, of University Medical Center Groningen, and colleagues.

This suggests that 12.7% of these patients experienced persistent somatic symptoms as a result of their infection, they noted in The Lancet.

"After recovery from acute COVID-19, a substantial proportion of patients continue to experience symptoms of a physical, psychological, or cognitive nature," Rosmalen and team wrote. "These long-term sequelae of COVID-19 have been described as the next public health disaster in the making, and there is an urgent need for empirical data informing on the scale and scope of the problem to support the development of an adequate health-care response."

Of note, for certain symptoms, the researchers noted differences between men and women, with women showing longer persistence of increased symptom severity after COVID-19 than men.

In addition, "research shows that COVID-19 might also affect brain functioning and mental health. Therefore, future research should not overlook mental health symptoms (e.g., depression and anxiety symptoms), nor additional post-infectious symptoms that were not assessed in this study (e.g., brain fog, insomnia, and postexertional malaise)," Rosmalen and team concluded. "Additionally, future intersectional research should assess how ethnicity, gender, age, socioeconomic status, other social identities, and the presence of underlying chronic diseases are associated with symptom dynamics surrounding COVID-19 and risk of post-COVID-19 condition."

In an accompanying comment, Christopher Brightling, PhD, and Rachael Evans, MBChB, PhD, of the NIHR Biomedical Research Centre at the University of Leicester in England, noted that this study "does not provide new mechanistic insights, which are key to uncovering new therapeutic targets. In other studies, clustering of patient-reported outcomes has identified different severity groups of long COVID and identified increased systemic inflammation in people with very severe long COVID. How patient-centered outcomes, together with biomarkers, can further refine long COVID diagnosis and inform precision medicine approaches warrants further consideration."

For this study, data were taken from the Lifelines COVID-19 and Dutch Lifelines cohort studies, which examine the health and health-related behaviors of people living in the north of the Netherlands. All participants (mean age 53.7 years, 60.8% women) were sent digital questionnaires regarding their symptoms, which were assessed using 24 repeated measurements from March 31, 2020 to Aug. 2, 2021.

Rosmalen and colleagues matched participants with COVID-19 (a positive test or a physician's diagnosis) by age, sex, and time to COVID-negative controls, and recorded symptom severity before and after infections in participants with COVID and compared that with matched controls.

The authors noted that serological assays were used to detect SARS-CoV-2 infection, but patients with long COVID might have lower antibody responses, which was a study limitation. In addition, the cross-sectional nature of the study may have led to recall bias. Furthermore, nearly all participants were white, which may affect the generalizability of these results.


Disclosures

This study was supported by the ZonMw Gender and Health Program and the ZonMw COVID-19 Program. The Lifelines initiative has been made possible by subsidy from the Dutch Ministry of Health, Welfare, and Sport, the Dutch Ministry of Economic Affairs, the University Medical Center Groningen, University of Groningen, and the Provinces in the north of the Netherlands.

The study authors reported no conflicts of interest.

Brightling reported relationships with GlaxoSmithKline, AstraZeneca, Boehringer Ingelheim, Novartis, Chiesi, Genentech, Roche, Sanofi, Regeneron, Mologic, and 4DPharma. Evans reported relationships with AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim, and the National Institute for Health and Care Research.

Aerie results, business update

 Second Quarter Glaucoma Franchise Net Revenues of $33.3 Million, up 23% over Second Quarter 2021

Outlook for Net Cash Used Expected to Be Less Than $20 Million per Quarter, on Average, for the Remainder of 2022

Aerie Expects to be Cash Flow Break Even During 2024

https://finance.yahoo.com/news/aerie-pharmaceuticals-reports-second-quarter-200100214.html

Amgen takes BiTEs out of pipeline, dropping BCMA, PSMA assets

 Amgen is bowing out (PDF) of the congested BCMA race. With a who’s who of drug developers going after the multiple myeloma target, the big biotech has decided to stop work on its bispecific contender as part of a cull that also saw it pick between its two PSMA prospects. 

The BCMA candidate, pavurutamab, entered the clinic in 2017 but suffered a setback last year when Amgen hit pause on the phase 1 study to discuss “protocol modifications to optimize safety monitoring and mitigation with the FDA.” Work resumed later in 2021 but, with other modalities against BCMA now on the market, Amgen has decided to stop development and focus its R&D dollars on other candidates. 

“Multiple myeloma is a very crowded space and our decision with respect to 701 had a lot to do with our ability to get the market ahead of the competition or not. So we're prioritizing on those medicines where we think we can be best-in-class and first-in-class and we have other programs underway that may be useful in multiple myeloma,” Amgen CEO Bob Bradway said on a quarterly results conference call. 

David Reese, EVP of R&D at Amgen, went on to highlight the DLL3 program, tarlatamab, as a BiTE that remains a focus because of the “substantial lead” the company enjoys in the space. “I think you'll see this kind of prioritization going forward,” Reese said.

In PSMA, Amgen has a direct replacement for the dropped asset. Buying Teneobio for $900 million upfront last year gave Amgen two bispecifics targeting PSMA, its own acapatamab and the newly acquired TNB-585. Amgen let more data trickle in before making a decision on which candidate to stick with, ultimately deciding to drop acapatamab and take TNB-585, now known as AMG 340, forward.  

Teneobio designed AMG 340 to have a low-affinity anti-CD3 arm, reflecting evidence that the approach can reduce cytokine secretion compared to molecules with a strongly activating CD3 domain without sacrificing efficacy. Amgen’s selection of the molecule over its own acapatamab suggests the theory is holding up in the clinic so far.

https://www.fiercebiotech.com/biotech/amgen-takes-bites-out-pipeline-dropping-bcma-and-psma-assets-light-data-and-competition

Neurocrine axes in-licensed tremor program on phase 2 data

 Two years after licensing the asset for $45 million upfront, Neurocrine Biosciences has pulled the plug on the development of NBI-827104 in essential tremor after the failure of a phase 2a clinical trial to make the case for further investment. 

Neurocrine put down $5 million to secure an option on the T-type calcium channel blocker, then known as ACT-709478, in 2019. The following year, the biotech paid Idorsia $45 million to exercise the option, putting it on the hook for up to $365 million in development and regulatory milestone payments. Neurocrine moved the candidate into a phase 2 essential tremor trial last year.

Now, management has data from the phase 2 study—and the signs are bad. With the phase 2a missing its specified endpoints, including on the TETRAS essential tremor scale, Neurocrine has concluded the totality of the data fail to make the case for more development in essential tremor. No further work is planned in the indication.

“It was not a failed trial, it was a negative trial,” Eiry Roberts, M.D., chief medical officer at Neurocrine, said in a conference call with investors. “We saw some evidence of activity, but the signal was not sufficiently robust to hit statistical significance or to hit clinical relevance, either on the accelerometer or on the TETRAS endpoints that we looked at.”

“We had central assessments as well as local assessments on the TETRAS and there was high concordance between the two sets of assessments,” Roberts added. “So it was a robust data set.” 

The news comes months after Praxis hailed the success of its T-type calcium channel blocker in a phase 2a essential tremor study. Jazz also has a runner in the race, suvecaltamide, that it moved into a phase 2b study late last year.

Neurocrine is pushing ahead with a phase 2 clinical trial of NBI-827104 in epilepsy with continuous spike-and-wave during sleep. Enrollment is complete and top-line data are due by the end of the year. Because of the differences between the two patient populations, Roberts sees little readthrough from the essential tremor results to the epilepsy readout.

https://www.fiercebiotech.com/biotech/it-was-not-failed-trial-it-was-negative-trial-neurocrine-axes-licensed-essential-tremor

Sensus Healthcare Second Quarter 2022 Financial Results Feature Revenue Growth of 124%

 Diluted EPS of $0.21 compares with $(0.02) for the year-ago quarter 

Affirms expectations for full-year profitability

Conference call begins at 4:30 p.m. Eastern time today

Sensus Healthcare, Inc. (Nasdaq: SRTS), a medical device company specializing in highly effective, non-invasive, minimally-invasive and cost-effective treatments for oncological and non-oncological conditions, announces financial results for the three and six months ended June 30, 2022.

Highlights from the second quarter of 2022 and recent weeks include the following (all comparisons are with the second quarter of 2021, unless otherwise indicated):

  • Revenues were $12.1 million, up 124% from $5.4 million

  • Net income was $3.5 million, or $0.21 per diluted share, compared with a net loss of $(0.3) million, or $(0.02) per share

  • Adjusted EBITDA, a non-GAAP financial measure, was $4.7 million, compared with $(0.1) million

  • Exited the quarter with $33.7 million in cash and cash equivalents

  • Received orders for 10 TransDermal Infusion Systems™ from Hair Enhancement Centers to provide needleless injections of U.SK Under Skin’s hair-growth serum Skin Savers Hair™

  • Shipped 5 units to Asia

  • Shipped a second SRT System to Colorado State University College of Veterinary Medicine and Biomedical Sciences

  • Expects continued growth in the third quarter and affirms expectations for full-year profitability

Sensus Healthcare will host an investment community conference call today beginning at 4:30 p.m. Eastern time, during which management will discuss financial results for the second quarter of 2022, provide a business update and answer questions. To access the conference call, please dial 888-390-3967 (U.S. and Canada) or 862-298-0702 (International). Please direct the operator to be connected to the Sensus Healthcare conference call. The call will be webcast live and can be accessed at the following link, which also may be found in the Investor Relations section of the Company’s website at www.sensushealthcare.com.

Following the conclusion of the conference call, a replay will be available by dialing 888-539-4649 (U.S. and Canada Toll Free) or 754-333-7735 (International). At the system prompt, dial the replay code 157325 followed by the # sign. Playback will begin automatically. An archived webcast of the call will also be available in the Investor Relations section of the Company’s website for a period of time.

https://finance.yahoo.com/news/sensus-healthcare-second-quarter-2022-200500881.html

Health Catalyst cut at Stifel, JPMorgan

 

Aug-05-22DowngradeStifelBuy → Hold$27 → $16
Aug-05-22DowngradeJP MorganOverweight → Neutral$20 → $16

Twist Bioscience Reports Fiscal Third Quarter 2022 Financial Results

  Record revenue of $56.1M in 3QFY22; Increase of 60% over $35.0M in Fiscal 2021 --

-- Orders increased 53% in 3QFY22 over fiscal 2021 to $59.7M --

-- Increases revenue guidance to $203 million for full year fiscal 2022 --

https://www.biospace.com/article/releases/twist-bioscience-reports-fiscal-third-quarter-2022-financial-results/