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Tuesday, December 19, 2023

Aldeyra Therapeutics' skin disease drug succeeds in mid-stage study

 Aldeyra Therapeutics said on Tuesday its experimental drug to treat a type of chronic skin disease was safe and well tolerated in a mid-stage study.

The drug, ADX-629, also helped reduce the severity of eczema symptoms in adult patients with mild to moderate atopic dermatitis, the Lexington, Massachusetts-based company said.

ADX-629 belongs to a class of medicines called RASP modulators designed to reduce levels of specific inflammation-causing chemical compounds.

Atopic dermatitis is characterized by itchy, dry, and inflamed skin and affects about 16.5 million adults and more than 9.6 million children in the United States, according to Aldeyra.

https://finance.yahoo.com/news/1-aldeyra-therapeutics-skin-disease-122735153.html

immunome started at Outperform by Wedbush

 Target $12

https://finviz.com/quote.ashx?t=IMNM&ty=c&ta=1&p=d

Why Is COVID-19 Vaccine Player CureVac Stock Plummeting

A German court has invalidated a patent central to CureVac N.V's (NASDAQ: CVAC) lawsuit against BioNTech SE (NASDAQ: BNTX) related to seeking fair compensation for infringement of a portfolio of CureVac's intellectual property rights utilized in Comirnaty, BioNTech, and Pfizer Inc's (NYSE: PFEmRNA COVID-19 vaccine.

The ruling represents the first decision on validity in ongoing patent litigation between CureVac and BioNTech in Germany, involving eight CureVac intellectual property rights.

Proceedings continue regarding the seven remaining rights, for which validity, infringement, and potential damages will be decided individually.

Following the decision, a ruling on infringement of the German part of EP 1 857 122 B1, scheduled for December 28, 2023, before the Regional Court Düsseldorf, will likely be postponed.

The stakes remain high for CureVac in this legal conflict, Reuters highlighted, citing analysts, the potential transformation of its financial status if even a fraction of the revenues were awarded.

Earlier, a regional German court halted a separate patent infringement trial brought by CureVac against BioNTech, awaiting decisions from German and European patent offices regarding the validity of CureVac's intellectual property rights, indicating the complexities and delays in the legal proceedings.

CureVac and Pfizer/BioNTech are in a legal tussle over the vaccine patent in the U.S. as well.

In May, CureVac was granted to transfer the ongoing patent litigation filed by Pfizer/BioNTech in the federal district court of Massachusetts to the Eastern District of Virginia. The transfer is expected to significantly accelerate the progress of the litigation, allowing for a likely 2024 trial date.

Last month,  Acuitas Therapeutics filed a lawsuit in Virginia federal court against Germany-based CureVac, accusing it of failing to credit Acuitas on patents related to COVID-19 vaccines.

Lantheus cut to Market Perform by Blair

 from Outperform

https://finviz.com/quote.ashx?t=LNTH&ty=c&ta=1&p=d

Guardant: Tentative Date of FDA Advisory Panel Review of Shield™ Blood Test

 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is tentatively scheduled to review the premarket approval application (PMA) for the company’s Shield™ blood test to screen for colorectal cancer on March 28, 2024. The date and details of the meeting are subject to confirmation by the FDA and publication in the Federal Register.

https://www.businesswire.com/news/home/20231219982476/en/

Veru Eyes Development of Combo Treatment to Prevent Muscle Loss, Up Fat Loss with GLP-1 Drugs

 Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of obesity, oncology, and viral induced acute respiratory distress syndrome, today announced it will host an investor conference call and audio webcast on Thursday, January 4, 2024, at 8:00 a.m. ET to discuss the recent financing and the Company’s strategy to prioritize the development of enobosarm for weight loss as well as provide an update on the Company’s drug pipeline.

The audio webcast will be accessible under “Investor Kit” in the Investors page of the Company’s website at www.verupharma.com. To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call. An archived version of the audio webcast will be available for replay on the Company’s website for approximately three months. A telephonic replay will be available on January 4, 2024 at approximately 12:00 p.m. ET by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international), passcode 7752713, for one week.

https://www.biospace.com/article/releases/veru-to-host-investor-call-on-january-4th-2024-to-discuss-recent-financing-and-strategy-to-prioritize-the-development-of-enobosarm-as-a-combination-treatment-to-prevent-muscle-loss-and-augment-fat-loss-associated-with-weight-loss-glp-1-drugs/

Quest: New 88-Compound Novel Psychoactive Substance Test Panel

 Quest Diagnostics (NYSE: DGX), the nation's leading provider of diagnostic information services, today unveiled its new confirmatory testing service for novel psychoactive substances (NPS). The new panel, which tests for 88 compounds, covers a broad array of drug classes, such as designer opioids, designer benzodiazepines, designer stimulants, fentanyl analogs, synthetic cannabinoids, and other illicit additives. Two of these classes are rapidly accelerating America's overdose crisis: other illicit additives (xylazine) and fentanyl analogs (acetyl fentanyl). The new test panel is designed to help healthcare providers detect potential drug misuse in patients prescribed controlled medications, such as opioids and other substances, amid a proliferation of synthetic or "designer" drugs in the nation's drug supply.

NPS are versions of established prescription and illicit drugs that are routinely chemically altered to enhance drug effects and evade tracking by law enforcement. As their chemical composition frequently evolves, conventional point-of-care and laboratory test methods may fail to detect NPS, increasing risks for individual patients and challenging efforts to understand their long-term health effects or prevalence in communities.

The Quest panel uses definitive liquid chromatography with advanced tandem mass spectrometry-based testing to establish NPS misuse. Quest's team of toxicologists, medical experts and data analysts will periodically review and update the panel to include the most relevant and prevalent substances present in communities, as reflected by trends in the company's nationally representative Health Trends® dataset and the latest reports from public health, academic research and law enforcement organizations.

Quest developed the panel to address the changing drug epidemic, as revealed by its nationally representatives Health Trends® report, "Drug Misuse in America 2023: The Growing Crisis of Novel Psychoactive Substances." Based on more than 3.6 million clinical laboratory drug tests performed by Quest Diagnostics in 2022, the report provides insights into the drug crisis and its shifts from misuse of prescription opioids and fentanyl to NPS. The report also includes analysis of 3,730 randomly selected "remnant" specimens tested using a pilot version of the new NPS test panel.

Approximately 13.1% of remnant specimens tested were positive for at least one NPS. Of these, the animal tranquilizer xylazine was found in 8.1%, or nearly 1 in 12 specimens tested, making it the most prevalent single NPS. Yet, non-xylazine substances, including fentanyl analogs and designer benzodiazepines, were found in 5% of remnant specimens tested, or roughly 40% of all NPS-positive test results.

These findings align with a recent report from the U.S. Centers for Disease Control and Prevention (CDC) highlighting the increasing connection between xylazine and opioid overdose deaths while also revealing growing misuse of other NPS.

https://www.prnewswire.com/news-releases/quest-diagnostics-launches-new-88-compound-novel-psychoactive-substance-test-panel-302019063.html