Polycystic Ovary Syndrome

WALTHAM, Mass.--( BUSINESS WIRE )-- Revvity, Inc. (NYSE: RVTY), today announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for EUROIMMUN’s automated chemiluminescence-based immunoassay (ChLIA) test for free testosterone. This innovative test is the first of its kind to receive FDA clearance for direct quantitative measurement of free testosterone levels, marking a significant advancement in diagnostic capabilities for androgen disorders. Key features of the new test include: The only FDA-cleared ChLIA assay for direct quantitative measurement of free testosterone in human serum or plasma. Rapid results on EUROIMMUN’s ChLIA platforms with the first result available in just 48 minutes and an estimated throughput of nearly 60 tests per hour. Incorporation of monoclonal antibodies to ensure specificity and consistent performance across test batches. The state-of-the-art assay is processed on the Company’s random-access iSYS TM or i10 TM instruments to deliver quick turnaround times and high-throughput testing with minimal technician training and expertise, while maintaining superior accuracy and reliability. The assay provides direct measurement of free testosterone levels in a single test, enhancing diagnostic capabilities for conditions such as hypogonadism, impotence, polycystic ovarian syndrome (PCOS), and other androgenital syndromes. "Laboratory customers have been asking for a user-friendly FDA-cleared test, on a random-access platform, for direct measurement of free testosterone," said Jonathan Friend, general manager at Revvity’s EUROIMMUN US. "This clearance reinforces our commitment to expanding the FDA-cleared menu for the EUROIMMUN family of ChLIA automation solutions with assays that serve diverse patient populations across all demographics.” For more information about EUROIMMUN and its diagnostic solutions, please visit this webpage . About Revvity At Revvity, “impossible” is inspiration, and “can’t be done” is a call to action. Revvity provides health science solutions, technologies, expertise, and services that deliver complete workflows from discovery to development, and diagnosis to cure. Revvity is revolutionizing what’s possible in healthcare, with specialized focus areas in translational multi-omics technologies, biomarker identification, imaging, prediction, screening, detection and diagnosis, informatics and more. With 2023 revenue of more than $2.7 billion and over 11,000 employees, Revvity serves customers across pharmaceutical and biotech, diagnostic labs, academia and governments. It is part of the S&P 500 index and has customers in more than 190 countries. Stay updated by following our Newsroom , LinkedIn , X , YouTube , Facebook and Instagram .

NEW YORK--( BUSINESS WIRE )--Celmatix Therapeutics, a biotechnology company focused on advancing groundbreaking therapeutics for women’s health, has announced its latest drug program, a novel Jun-N-terminal kinase (JNK) inhibitor that targets pain and inflammation. The therapeutic drug candidate, developed using the DNA-Encoded Chemistry Technology (DEC-Tec) platform at the Center for Drug Discovery, Baylor College of Medicine (BCM), aims to address a critical unmet need in first-line treatments for a range of women’s health indications, starting with endometriosis and potentially extending to Polycystic Ovary Syndrome (PCOS) and ovarian aging. Endometriosis is a chronic disease impacting the quality of health and life for over 10% of girls and women between the ages of 15-45 worldwide. It is best known for causing pain during periods, sexual intercourse, bowel movements, and urination, but it may also lead to chronic pelvic pain, abdominal bloating, nausea, fatigue, infertility, mental health conditions, and increased risks for pregnancy complications, autoimmune diseases, cardiovascular disease, asthma, and cancer. Endometriosis-associated pain also negatively impacts women across their educational and career trajectories. In the US alone, endometriosis imposes an estimated $69 billion dollar burden on the health care system and over $119 billion dollars in lost productivity annually. While traditionally viewed as the presence of endometrial-like tissue outside the uterus, it is increasingly recognized as a chronic inflammatory condition, potentially explaining its numerous associated health issues. The standard of care involves surgical removal of lesions or affected organs, though recurrence often necessitates repeated procedures. Symptom management typically relies on pain medications and hormonal therapies, which provide the impetus for developing related treatments. Celmatix Therapeutics founder and CEO, Dr. Piraye Yurttas Beim, remarked, “Despite impacting one-in-ten women and girls, to date there have been no disease-altering, first-line medications brought to market to treat endometriosis. As someone who has been impacted by endometriosis since my first period, I can relate to the burden that this debilitating disease places on individuals, families, employers, and communities. Thanks to our decade-long multi-omics initiative, our research group was early in recognizing that inflammation is core to the pathophysiology of endometriosis and may explain why it predisposes women for so many other health conditions down the road. Long after their periods have ended, women pay the price for their period pain having been papered over with painkillers and birth control pills rather than truly addressed and cured. I dream of a better health trajectory for my daughter and her peers and believe that our new JNK immunotherapy will unlock that brighter future.” Dr. Stephen Palmer, Chief Scientific Officer of Celmatix Therapeutics, added, “Endometriosis represents an opportunity to address both one of the most significant areas of unmet clinical need and one of the biggest commercial opportunities in women’s health. Our evaluation process to find the right drug program to pursue involved a number of criteria, including target evaluation for anticipated safety, efficacy, and druggability. We also knew that we wanted to prioritize a biological target that was ideally involved in both the transmission of peripheral pain signals and inflammation. It rapidly became clear that a novel class of JNK inhibitors with greater specificity for JNK1 and 3 than for JNK 2 had the potential to meet our target product objectives. It was at that stage that we approached our colleagues at BCM to license lead compounds with many of the desired drug qualities. The promising JNK inhibitor scaffolds discovered at BCM have unique efficacy, potency, and safety signals achieved through novel interactions not previously addressed by other JNK inhibitors. The work on these compounds also confirmed reductions in inflammatory cytokines in models of endometriosis established for cell cultures and endometriosis lesion regression in rodent models. We are now rapidly progressing these licensed compounds through our internal lead optimization efforts and are optimistic to be able to nominate a development candidate soon.” Dr. Martin Matzuk, Director of the Center for Drug Discovery at BCM, who has dedicated over 30 years to discovering drug targets in women’s health, stated, “We are confident that Celmatix Therapeutics is the ideal partner for this innovative endometriosis treatment, with potential to expand into other women’s health indications. I have known members of the Celmatix team for over two decades, and they have a proven track record in research integrity and business acumen. The JNK project originated from screens using our sophisticated multi-billion compound DEC-Tec platform, and we are very pleased with the progress made by the Celmatix team.” Dr. Paul Klotman, President of BCM, praised the strategic collaboration between BCM and Celmatix, “Baylor College of Medicine always values the creation of knowledge and its application to further healthcare. Our collaboration on the JNK project for endometriosis reflects our mission to translate basic science into clinical treatments. This partnership exemplifies our commitment to innovative solutions that can directly impact patient care, and we are excited to see its potential for broader applications in women’s health and beyond.” Celmatix Therapeutics has previously announced its oral follicle stimulating hormone (FSH) small molecule program for women seeking infertility help in assisted reproductive technology (ART) clinics and its Anti-Mullerian Hormone (AMH) agonist biologics program for overcoming ovarian aging. About Celmatix Therapeutics Celmatix Therapeutics is a preclinical-stage women’s health biotech focused on advancing groundbreaking therapeutics for women’s health. With its growing pipeline of innovative drug programs including an AMHR2 agonist program focused on ovarian aging, an oral FSH for infertility, and a JNK inhibitor program for endometriosis, Celmatix Therapeutics is addressing areas of high unmet need by developing the next generation of interventions and pioneering advancements in women’s health. For more information, visit the company’s website at www.celmatix.com . About Baylor College of Medicine Baylor College of Medicine ( www.bcm.edu ) in Houston is recognized as a health sciences university and is known for excellence in education, research and patient care. Baylor is a top-ranked medical school and listed 20 th among all U.S. medical schools for National Institutes of Health funding and No. 1 in Texas. Located in the Texas Medical Center, Baylor has affiliations with seven teaching hospitals and jointly owns and operates Baylor St. Luke’s Medical Center, part of St. Luke’s Health. Currently, Baylor has more than 3,000 trainees in medical, graduate, nurse anesthesia, physician assistant, orthotics and genetic counseling as well as residents and postdoctoral fellows. The Center for Drug Discovery at BCM was created in 2012 with the goal to develop small-molecule probes, preclinical candidates, and drugs for researchers and clinicians. DEC-Tec, the major platform in the Center for Drug Discovery, contains an academic screening collection of over 7 billion drug-like molecules.

Pfizer has re-upped its drug discovery deal with AI startup PostEra to develop small molecule drugs and new warheads for antibody-drug conjugates, a major area of focus for the drugmaker following its $43 billion purchase of ADC developer Seagen. Pfizer will pay PostEra $12 million upfront for the ADC portion of the deal, according to the AI biotech, which declined to disclose the financial terms for the small molecule part of the deal. The total AI drug discovery pact with Pfizer is now worth up to $610 million, including the up to $260 million small molecule deal that the companies signed in 2022. PostEra first partnered with Pfizer in 2020 , though it did not disclose those financial details. Pfizer had nominated the maximum number of programs — “bigger than three, smaller than half a dozen,” PostEra CEO Aaron Morris said — in the small molecule partnership, and it then decided to expand the deal to add additional targets. As part of the updated deal, PostEra will also use its platform to optimize payloads used in ADCs, which consist of an antibody for targeting, a linker, and a payload — the part that kills the cancer cells once the ADC has reached its target. “The key innovation in the ADC side is precisely that approach of thinking about the payload design of ADC as a small molecule chemistry challenge,” PostEra CSO Alpha Lee said. “The payload part is a small molecule, but it’s canonically a cytotoxic natural product-like molecule. And the key innovation here is thinking about — well, can we do better in designing the payload to target specific mechanisms or specific targets, and to refine the design of the payload with AI?” Aside from its collaboration with Pfizer, PostEra signed a deal in 2023 with Amgen, and it is also working with the NIH to develop antivirals. Morris said that the startup has made $50 million in revenue since it was founded in 2019. The AI drug discovery startup has its own internal pipeline and is focusing on fertility as well as polycystic ovary syndrome, a hormone condition that impacts one in 10 women of childbearing age, according to the Office on Women’s Health . “We see a very chronic and systematic under-investment in that very important unmet medical need,” Lee said. “And we see a lot of opportunities where we can take this long body of scientific understanding which has not yet materialized into therapeutics yet, and in turn deploy our AI power in pursuing targets in that space.” The biotech expects to start IND-enabling studies for two programs this year.