Relugolix

The National Institute for Health and Care Excellence (NICE) has recommended Gideon Richter’s Ryeqo (relugolix, estradiol and norethisterone) as the first long-term daily pill for endometriosis. NICE has recommended in final draft guidance that the relugolix combination therapy be used on the NHS in England to treat the symptoms of endometriosis in adults of reproductive age who have had medical or surgical treatment for the chronic condition. The health technology assessment agency’s decision follows an earlier negative recommendation and comes after Gideon provided new evidence on the Ryeqo’s effectiveness and value for money. Affecting approximately 1.5 million women in the UK, endometriosis occurs when tissue similar to the lining of the uterus grows elsewhere in the body. Patients can experience a range of symptoms, including dysmenorrhoea (painful cramping, usually in the lower abdomen), heavy bleeding and pelvic pain. Ryeqo is designed to block the specific hormones that contribute to endometriosis while also providing necessary hormone replacement in a single daily tablet. NICE estimates that around 1,000 patients per year could benefit from the therapy. Helen Knight, director of medicines evaluation at NICE, said Ryeqo “marks a potential step-change in how we manage endometriosis”. She continued: “Instead of travelling to clinics for injections, there is now a daily tablet that can be taken at home. The treatment can also be stopped and started more easily, which is particularly important for those planning to have children and for managing side effects.” Among the clinical evidence supporting NICE’s recommendation were positive results from the late-stage SPIRIT programme, in which significantly more patients achieved pain reduction with Ryeqo versus placebo at 24 weeks. In the SPIRIT 1 study, 75% of patients responded to Ryeqo for their dysmenorrhoea compared to 27% in the placebo arm. The same result was seen in SPIRIT 2, with 75% of dysmenorrhoea responders in the Ryeqo cohort compared to 30% for placebo. Additionally, 59% and 66% of patients responded to Ryeqo for their non-menstrual pelvic pain (NMPP) in SPIRIT 1 and 2, respectively, compared to 40% and 43% of those receiving placebo. Positive long-term efficacy data from the SPIRIT open-label extension study, which showed that dysmenorrhoea and NMPP reduction was sustained over two years with Ryeqo treatment, also supported the agency’s decision.

CARLSBAD, Calif., Jan. 29, 2025 /PRNewswire/ -- Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, announced today the appointment of Adele Gulfo to its Board of Directors. Ms. Gulfo brings nearly three decades of executive leadership experience to the TYRA board, with a strong track record in developing and commercializing some of the world's best-selling medicines at Pfizer, AstraZeneca, Viatris and Sumitomo Pharma. "Adele is one of the most accomplished drug developers in our industry, with nearly thirty years of global expertise in product commercialization. She has been instrumental in the development and approval of multiple drugs across several therapeutic areas, including blockbuster medicines like LIPITOR® and CRESTOR®," said Todd Harris, CEO of TYRA. "Adele has a diversified background both as a pharmaceutical executive and board member, with a wealth of knowledge in growing oncology business units. Her experience in launching ORGOVYX® for prostate cancer will be particularly valuable as we plan for late-stage development of TYRA-300 in non-muscle invasive bladder cancer. We look forward to Adele's insights as we advance our precision medicine pipeline and continue to grow TYRA." Most recently, Ms. Gulfo served as Chief Executive Officer, Biopharma Commercial Unit, for Sumitomo Pharma America, Inc. where she led the commercial and development portfolio for multiple therapeutic areas including oncology, rare disease, urology, CNS and Women's Health. Previously, Ms. Gulfo served as chief commercial and business development officer at Sumitovant Biopharma from 2020 to 2023. Previously, she served as chief commercial development officer at Roivant Sciences, where she was influential in the formation of Sumitovant and in preparations for the launches of key brands, including ORGOVYX® (prostate cancer), GEMTESA (overactive bladder), RETHYMIC (congenital athymia), and MYFEMBREE (women's health). Adele was the president and general manager of Pfizer's $12B+ U.S. primary care business unit, as well as country manager for Pfizer's U.S. Biopharma business, including specialty and oncology business units. Earlier in her career at Pfizer, Adele was instrumental in the development, launch, and commercial success of LIPITOR®, which became the world's best-selling medicine. Prior to Pfizer, Adele held vice president roles within AstraZeneca, including business development and innovation and commercial readiness, as well as the multi-billion-dollar cardiovascular business unit. She oversaw the launch of Crestor® and its growth into a $2 billion medicine. Ms. Gulfo received a BS in biology from Seton Hall University and an MBA in marketing with highest honors from Fairleigh Dickinson University. She studied post-graduate molecular biology at the University of Medicine and Dentistry of New Jersey where she began her career. Ms. Gulfo has been awarded several patents over her career and has extensive public company board experience. Currently, Ms. Gulfo serves on the board of directors of Enpro, a publicly traded industrial engineering firm, and the Innovation Growth Board for Mass General Brigham, the largest hospital-based research enterprise in the United States. "TYRA has great potential to develop best-in-class precision medicines in therapeutic areas like non-muscle invasive bladder cancer and skeletal dysplasia, which represent large market opportunities where innovation is desperately needed," said Ms. Gulfo. "I look forward to partnering with the executive leadership team and other members of the board and leveraging my experience to advance and grow TYRA's pipeline." About Tyra Biosciences Tyra Biosciences, Inc. (Nasdaq: TYRA) is a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in FGFR biology. The Company's in-house precision medicine platform, SNÅP, enables rapid and precise drug design through iterative molecular SNÅPshots that help predict genetic alterations most likely to cause acquired resistance to existing therapies. TYRA's expertise in FGFR biology has created a differentiated pipeline with three clinical-stage programs in targeted oncology and genetically defined conditions. The Company's lead precision medicine stemming from SNÅP, TYRA-300, is a potential first-in-class selective FGFR3 inhibitor that is designed to avoid the toxicities associated with inhibition of FGFR1, FGFR2 and FGFR4, while being agnostic for the FGFR3 gatekeeper mutations. TYRA-300 is expected to be evaluated in three Phase 2 studies: SURF302 for IR NMIBC, BEACH301 for pediatric achondroplasia and SURF301 for metastatic urothelial cancer. TYRA is also developing TYRA-200, an oral, investigational, FGFR1/2/3 inhibitor, in the SURF201 study for metastatic intrahepatic cholangiocarcinoma, and TYRA-430, an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. TYRA is based in Carlsbad, CA. For more information about our science, pipeline and people, please visit and engage with us on LinkedIn. Forward-Looking Statements TYRA cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: the expected advancement of our pipeline and our growth; the potential to develop next-generation precision medicines and their potential to be first-in-class and/or best-in-class; the potential safety and therapeutic benefits of, and market opportunities for, our product candidates; the expected timing and phase of development of TYRA-300; and the potential for SNÅP to develop therapies. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: later developments with the FDA may be inconsistent with prior feedback from the FDA; we are early in our development efforts, have only recently begun testing TYRA-300 and TYRA-200 for oncology in clinical trials and the approach we are taking to discover and develop drugs based on our SNÅP platform is novel and unproven and it may never lead to product candidates that are successful in clinical development or approved products of commercial value; potential delays in the commencement, enrollment, data readouts and completion of preclinical studies and clinical trials; results from preclinical studies or early clinical trials not necessarily being predictive of future results; interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, as follow-up on the outcome of any particular patient continues and as more patient data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval, and/or commercialization; the potential for our programs and prospects to be negatively impacted by developments relating to our competitors, including the results of studies or regulatory determinations relating to our competitors; and other risks described in our prior filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in our annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact: Amy Conrad [email protected] SOURCE Tyra Biosciences WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED