Immunotherapy Breakthrough Could Help Some Cancer Patients Avoid Surgery and Chemotherapy
103 patients participated in the study, and 84 had 'all signs of their cancer' disappear
Researchers said that the immunotherapy drug appeared to only work well with patients who had mismatch repair-deficiency, a unique genetic mutation most often found in patients with colorectal cancer
A new immuno-based treatment could treat tumors without cancer patients undergoing surgery or chemotherapy, according to a new study.
The research, published in The New England Journal of Medicine and announced at the American Association of Cancer Research (AACR) Annual Meeting, suggested that 92% of patients who used the new immunotherapy drug, dostarlimab, to shrink their tumors ,continued to be cancer-free for at least two years.
Treating cancer usually involves a form of immunotherapy alongside chemotherapy and surgery to remove a tumor. However, the new immuno-based treatment would only require a single step — immunotherapy — to treat the cancer by teaching a person's immune system to recognize and attack cancer cells.
One hundred and three patients participated in the study, 54 with a variety of "solid tumor cancers," including stomach, endometrial and prostate, and 49 with rectal cancer.
Researchers shared in a press release from The Memorial Sloan Kettering Cancer Center that of the 54 patients with a 'variety of cancers," 35 had 'all signs of their cancer' disappear and were using the immuno-based treatment.
Related: This Refrigerator Staple Might Lower a Woman's Risk of Colorectal Cancer, New Study Says
Per the release, Dr. Andrea Cercek said, "Nearly 2 out of 3 patients with types of cancer other than rectal were able to preserve their organs and their quality of life."
'This is a very significant response, and the results were even better than we had hoped,' Dr. Cercek said. 'We found that some cancer types responded extremely well to the immunotherapy, including colon and stomach cancer.'
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Maureen Sideris, a patient who was diagnosed with gastroesophageal junction cancer in 2022 and participated in the study, said that the treatment had worked successfully for her, according to the Memorial Sloan Kettering Cancer Center release.
'My husband, Tommy, and I were preparing for the worst,' she recalled in a statement. 'But after being treated with only immunotherapy, I had no evidence of cancer and didn't have to undergo surgery or chemo or radiation. I felt like I won the lottery!'
Dr. Cerek reported that '20% of non-rectal cancer patients' who still had to undergo surgery 'saw lower rates of cancer recurrence." She said this suggests that 'even if the effect wasn't a home run, it helped most patients.'
Related: Radiation from CT Scans Performed in Just 1 Year Could Lead to Over 100,000 Future Cancer Diagnoses, Study Finds
As for all 49 patients with rectal cancer who participated in the study, 'there was no evidence of cancer after immunotherapy,' according to the Memorial Sloan Kettering Cancer Center release. Researchers said that one patient had a 'growth in a lymph node' that was surgically removed but they 'kept their rectum.'
However, researchers said that the new treatment comes with its own drawbacks as the immunotherapy drug appeared to only work well with patients who had mismatch repair-deficiency, which means certain cells have mutations when cancer cells separate, according to the National Cancer Institute (NCI).
Per the NCI, this mutation 'is most common' in 'colorectal cancer, other types of gastrointestinal cancer, and endometrial cancer" and can also be found in 'cancers of the breast, prostate, bladder and thyroid.' The immunotherapy drug works by targeting cells with this mutation, as the immunotherapy drug can more easily target the many mutations, per the study.
'We're really excited to help more people,' Dr. Cercek said. 'And we are already exploring why rectal tissue seems to have such an extraordinary response to immunotherapy and how we can use that knowledge to help with other cancer types.'
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Business Wire
5 days ago
- Business Wire
Bicycle Therapeutics Reports Recent Business Progress and Second Quarter 2025 Financial Results
CAMBRIDGE, England & BOSTON--(BUSINESS WIRE)--Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle ®) technology, today reported financial results for the second quarter ended June 30, 2025, and provided recent corporate updates. 'We continue to execute on our strategy, which is grounded in scientific rigor and focused on fulfilling our mission to develop next-generation precision-guided therapeutics that have the potential to help patients live longer and live well,' said Bicycle Therapeutics CEO Kevin Lee, Ph.D. 'We are energized by the progress we are making across our pipeline, and with this momentum, we are pleased to welcome our new Research and Innovation Advisory Board members, as well as new Board member Charles Swanton, to further our innovation and strategic growth.' Dr. Lee continued: 'As we advance our various pipeline programs that hold strong potential for changing the treatment paradigm for patients with cancer and creating value for shareholders, Bicycle remains committed to disciplined capital allocation. Today we announced organizational streamlining efforts that provide us with operational flexibility to deliver potentially value-generating datasets while strengthening our financial position in uncertain market conditions. Saying goodbye to talented team members is very difficult, and we sincerely thank them for their dedication to our company. We believe Bicycle is strongly positioned to realize our strategic priorities and milestones and look forward to providing key program updates over the second half of this year.' Second Quarter 2025 and Recent Events Presented additional human imaging data for an early Bicycle Radioconjugate ® (BRC ®) molecule targeting MT1-MMP at the American Association for Cancer Research (AACR) Annual Meeting 2025. A poster presentation included new data from a second patient who underwent MT1-MMP-PET/CT imaging that build on previously announced data. Altogether, the data continue to validate the potential of MT1-MMP as a novel cancer target and demonstrate the positive properties of BRC molecules for radiopharmaceutical imaging. Imaging data from these two patients are representative of the data generated to date in 12 out of 14 patients with various solid tumors. Bicycle Therapeutics continues to advance its emerging BRC pipeline, with initial EphA2 human imaging data expected in 2H 2025 and company-sponsored clinical trials planned for 2026. Presented two abstracts highlighting the development of Bicycle ® Drug Conjugate (BDC ®) zelenectide pevedotin for metastatic urothelial cancer (mUC) at the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting. The abstracts outlined previously disclosed topline combination data for zelenectide pevedotin plus pembrolizumab in first-line mUC from the Phase 1/2 Duravelo-1 trial and provided an overview of the ongoing Phase 2/3 Duravelo-2 registrational trial for zelenectide pevedotin in mUC. Bicycle Therapeutics is on track to provide an update on dose selection from the Duravelo-2 trial and the accelerated approval pathway for zelenectide pevedotin in mUC following a meeting with the U.S. Food and Drug Administration planned for 4Q 2025. Phase 1/2 Duravelo-4 trial for zelenectide pevedotin in NECTIN4-amplified non-small cell lung cancer (NSCLC) open and actively recruiting patients. Duravelo-4 is Bicycle Therapeutics' second trial to leverage NECTIN4 gene amplification as a biomarker for patient selection and to expand the development of zelenectide pevedotin for additional solid tumors. With several trials underway assessing the potential for zelenectide pevedotin to treat mUC, breast cancer and lung cancer, the company has decided to pause the previously announced Phase 1/2 Duravelo-5 trial in multiple tumors. Expanded Board of Directors with the addition of Charles Swanton, M.D., Ph.D., FRS, FMedSci, FRCP, current chair of Bicycle Therapeutics' Clinical Advisory Board. Dr. Swanton leads the Cancer Evolution and Genome Instability Laboratory at the Francis Crick Institute. His research focuses on how tumors evolve over space and time, developing an understanding of branching evolutionary histories of solid tumors, processes that drive cancer cell-to-cell variation and the impact of cancer diversity on effective immune surveillance and clinical outcomes. Dr. Swanton is a fellow of the Royal Society, a fellow of the Royal College of Physicians and a fellow of the Academy of Medical Sciences. He completed his M.D. and Ph.D. training at the Imperial Cancer Research Fund Laboratories. Formed Research and Innovation Advisory Board (RAB) to support scientific advancement and strategic growth across preclinical programs. The RAB replaces Bicycle's Scientific Advisory Board. Inaugural RAB members include: Jose-Carlos Gutierrez-Ramos, Ph.D., is a director on the Bicycle Therapeutics Board of Directors. He also serves as the chief science officer at Danaher Corporation, leading the Danaher Innovation Centers and the Danaher Scientific Advisory Board. Previously, Dr. Gutierrez-Ramos was head of global drug discovery at AbbVie Inc., group senior vice president of biotherapeutics research and development (R&D) at Pfizer Inc., and senior vice president and CEDD head of immuno-inflammation at GlaxoSmithKline plc. He was also the founding CEO and president of Repertoire Immune Medicine, where he built and led a team focused on decoding the human immunome. Prior to that, he served as president and CEO of Synlogic, Inc. Dr. Gutierrez-Ramos earned a Ph.D. from the immunology department of the Center for Molecular Biology at the Universidad Autonoma de Madrid, and a B.S., summa cum laude, in chemistry with a minor in biochemistry from the Universidad Complutense de Madrid. Jason Lewis, Ph.D., is the Emily Tow Chair at Memorial Sloan Kettering Cancer Center (MSKCC) and currently serves as the deputy director at the Sloan Kettering Institute, overseeing the Office of Scientific Education and Training. He is also the scientific director of the Radiochemistry and Molecular Imaging Probe Core Facility at MSKCC. Dr. Lewis is a laboratory head in Sloan-Kettering Institute's molecular pharmacology program and serves as a professor at the Gerstner Sloan-Kettering Graduate School of Biomedical Sciences and at Weill-Cornell Medical College. He earned a Ph.D. in biochemistry from the University of Kent and an M.S. and B.S. in chemistry from the University of Essex. Robert Lutz, Ph.D., is a consultant/advisor to biotech and pharma with more than 30 years of experience with a significant focus on the development of antibody-drug conjugates (ADCs). He currently serves as chief scientific officer of Iksuda Therapeutics and is a board member and chief development officer of Synthis Therapeutics. Prior to his consulting practice, Dr. Lutz was vice president of translational research and development at ImmunoGen, where he was responsible for the advancement of multiple ADC programs, including KADCYLA ® (ado-trastuzumab emtansine), the first ADC to be approved for solid tumor indications, and ELAHERE ® (mirvetuximab soravtansine). He earned a Ph.D. in biochemistry from Brandeis University and a B.S. in biochemistry from the University of New Hampshire. Michael Hofman, MBBS, FRACP, FAANMS, FICIS, GAICD, is a nuclear medicine physician and professor at the Sir Peter MacCallum Department of Oncology at the University of Melbourne in Australia. His research has been instrumental in advancing PSMA PET imaging and PSMA radioligand therapy, helping to revolutionize the diagnosis and treatment of prostate cancer. He was named Australia's top researcher in nuclear medicine, radiotherapy and molecular imaging in both 2024 and 2025. Professor Hofman leads the PET/CT program and the Prostate Cancer Theranostics and Imaging Centre of Excellence at Peter MacCallum Cancer Centre. He earned a degree in medicine and surgery from Monash University in Australia and undertook a PET/CT fellowship at St. Thomas' Hospital in London. Welcomed Michael Method, M.D., as senior vice president of clinical development. Dr. Method is an academic and clinical gynecologic oncologist with extensive drug development experience. He most recently served as a senior vice president of clinical development at Karyopharm Therapeutics, Inc., after his time as an executive medical director at ImmunoGen, Inc. where he led global clinical development for gynecologic and female malignancies. Previously, Dr. Method was a senior medical advisor for global medical affairs at Eli Lilly, focused on breast cancer. He earned his M.D. and MPH from Northwestern University, and his B.S. in biochemistry and MBA from the University of Notre Dame. Participation in Upcoming Investor Conferences Bicycle Therapeutics management will participate in the following investor conferences in September: Cantor Global Healthcare Conference on Thursday, Sept. 4; fireside chat at 3:55 p.m. ET Morgan Stanley 23 rd Annual Global Healthcare Conference on Tuesday, Sept. 9; fireside chat at 7:45 a.m. ET Live webcasts of the fireside chats will be accessible in the Investor section of the company's website at Archived replays of the webcasts will be available following the fireside chat dates. Second Quarter 2025 Financial Results Cash and cash equivalents were $721.5 million as of June 30, 2025, compared to $879.5 million as of December 31, 2024. The decrease in cash and cash equivalents is primarily due to cash used in operations, including increased cash payments for clinical program activities. R&D expenses were $71.0 million for the three months ended June 30, 2025, compared to $40.1 million for the three months ended June 30, 2024. The increase in expense of $30.9 million was primarily due to increased clinical program expenses for zelenectide pevedotin development, increased discovery, platform and other expenses, and increased personnel-related costs, offset by decreased clinical program expenses for Bicycle Tumor-Targeted Immune Cell Agonist ® (Bicycle TICA ®) molecules as well as higher U.K. R&D tax credits period over period. General and administrative expenses were $18.5 million for the three months ended June 30, 2025, compared to $15.9 million for the three months ended June 30, 2024. The increase in expense of $2.6 million was primarily due to increased personnel-related costs, as well as increased professional and consulting fees. Net loss was $79.0 million, or $(1.14) basic and diluted net loss per share, for the three months ended June 30, 2025, compared to net loss of $39.8 million, or $(0.77) basic and diluted net loss per share, for three months ended June 30, 2024. In recognition of the evolving macroeconomic environment and the importance of preserving capital, Bicycle Therapeutics is implementing a workforce reduction and taking other steps to optimize its operations and extend the company's expected financial runway. These strategic cost realignment efforts are being implemented to prioritize potentially high-impact, value-generating programs, which include the advancement of zelenectide pevedotin, BT5528, next-generation Bicycle ® Drug Conjugates and the company's wholly owned pipeline of Bicycle ® Radioconjugates. Bicycle Therapeutics anticipates total operational savings of approximately 30% over the course of the financial runway period. These actions are expected to extend the financial runway into 2028 and strengthen the company's ability to weather continued market uncertainty as it advances clinical programs through key milestones. About Bicycle Therapeutics Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle ® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle ® Drug Conjugate (BDC ®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BDC molecule targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist ® (Bicycle TICA ®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle ® Radioconjugates (BRC ®) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle ® technology to develop therapies for diseases beyond oncology. Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, Mass. For more information, visit Forward Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as 'aims,' 'anticipates,' 'believes,' 'could,' 'estimates,' 'expects,' 'forecasts,' 'goal,' 'intends,' 'may,' 'plans,' 'possible,' 'potential,' 'seeks,' 'will' and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the validation of MT1-MMP as a cancer target and BRC molecules having positive properties for radiopharmaceutical imaging; the initiation of new clinical trials, the progress of Bicycle's ongoing clinical trials and the timing of EphA2 human imaging data and updates on dose selection in the Duravelo-2 clinical trial and accelerated approval pathway; the outcome of Bicycle's strategic cost realignment efforts and Bicycle's expected financial runway; and the use of Bicycle Therapeutics' technology through various partnerships to develop therapies for diseases beyond oncology. Bicycle Therapeutics may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in research and development and in the initiation, progress and completion of clinical trials and clinical development of Bicycle Therapeutics' product candidates; the risk that Bicycle Therapeutics may not realize the intended benefits of its cost realignment efforts; the risk that Bicycle's projections regarding its expected cash runway are inaccurate or that its conduct of its business requires more cash than anticipated; and other important factors, any of which could cause Bicycle Therapeutics' actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled 'Risk Factors' in Bicycle Therapeutics' Annual Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 1, 2025, as well as in other filings Bicycle Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Bicycle Therapeutics expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Balance Sheets Data (In thousands) (Unaudited) June 30, December 31, 2025 2024 Cash and cash equivalents $ 721,451 $ 879,520 Working capital 726,840 861,375 Total assets 832,184 956,868 Total shareholders' equity 668,915 793,060 Expand
Associated Press
7 days ago
- Associated Press
Imfinzi approved in Canada as first and only perioperative immunotherapy for muscle invasive bladder cancer
MISSISSAUGA, ON, Aug. 6, 2025 /CNW/ - Health Canada has granted a Notice of Compliance (NOC) for Imfinzi® (durvalumab) for the treatment of patients with resectable muscle invasive bladder cancer (MIBC) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by adjuvant Imfinzi monotherapy treatment after radical cystectomy. The approval is based on results from the NIAGARA Phase III trial, which were published in The New England Journal of Medicine.1,2 In a planned interim analysis, the Imfinzi-based perioperative regimen demonstrated a statistically significant and clinically meaningful 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus neoadjuvant chemotherapy with radical cystectomy alone (based on event-free survival [EFS] hazard ratio [HR] of 0.68; 95% confidence interval [CI] 0.56-0.82; p<0.0001). Estimated median EFS was not yet reached for the Imfinzi plus gemcitabine and cisplatin arm versus 46.1 months for the comparator arm. An estimated 67.8% of patients treated with the regimen were event free at two years compared to 59.8% in the comparator arm.2 Results from the key secondary endpoint of overall survival (OS) showed that the Imfinzi-based perioperative regimen reduced the risk of death by 25% versus the comparator arm (based on OS HR of 0.75; 95% CI 0.59-0.93; p=0.011). Median survival was not yet reached for either arm. An estimated 82.2% of patients treated with the regimen were alive at two years compared to 75.2% in the comparator arm.2 Imfinzi was generally well tolerated, and no new safety signals were observed in the neoadjuvant and adjuvant settings. The most common adverse events (any Grade, occurring in ≥10% of patients) for the Imfinzi plus chemotherapy arm were nausea (53.6%), fatigue (51.5%), neutropenia (40.4%), anemia (38.7%), constipation (38.7%), decreased appetite (26.6%), rash (20.9%), pyrexia (20.8%), diarrhea (20.6%), abdominal pain (20.2%), vomiting (19.2%), blood creatine increased (18.5%), thrombocytopenia (17.2%), pruritus (15.1%), hypothyroidism (12.6%), neuropathy peripheral (12.5%), leukopenia (10.9%), and aspartate aminotransferase increased (10.4%).1 'Health Canada's approval of this durvalumab-based perioperative regimen represents a major advance for Canadians with muscle invasive bladder cancer, where nearly half will relapse despite curative treatment,' says Dr. Srikala Sridhar, Professor of Medicine at the University of Toronto, Genitourinary Medical Oncologist at the Princess Margaret Cancer Centre and NIAGARA trial investigator. 'Findings from the NIAGARA trial showed that this new regimen reduces risk of recurrence and significantly improves survival – which may offer new hope and potential to transform care in this setting.' 'The high rate of recurrence associated with muscle invasive bladder cancer is an ongoing challenge and source of concern for physicians and patients,' says Dr. Normand Blais, Medical Oncologist at the Centre hospitalier de l'Université de Montréal. 'The Health Canada approval based on results from the NIAGARA trial may now offer us the opportunity to increase the chance of better patient outcomes and long-term survival by the use of immunotherapy in this setting, which is very good news for patients and their families.' Bladder cancer is the 5th most common cancer in Canada, with more than 13,000 patients diagnosed each year.3 The most common type of bladder cancer is urothelial carcinoma, which begins in the urothelial cells of the urinary tract. Bladder cancer is considered muscle invasive when there is evidence of the tumour invading the muscle wall of the bladder but no distant metastases.4 In MIBC, approximately 50% of patients who undergo bladder removal surgery experience disease recurrence.5 Treatment options that prevent disease recurrence after surgery are critically needed in this curative-intent setting. 'This decision by Health Canada represents an important step forward for all Canadians affected by muscle invasive bladder cancer,' says Michelle Colero, Executive Director, Bladder Cancer Canada. 'For many patients and families, the fear of recurrence after surgery has been overwhelming. This new treatment option may offer renewed hope for longer, healthier lives.' About NIAGARA2 NIAGARA is a randomized, open-label, multi-centre, global Phase III trial evaluating perioperative Imfinzi as treatment for patients with MIBC before and after radical cystectomy. In the trial, 1,063 patients were randomized to receive four cycles of Imfinzi plus neoadjuvant chemotherapy prior to cystectomy followed by eight cycles of Imfinzi monotherapy, or neoadjuvant chemotherapy alone prior to cystectomy with no further treatment after surgery. NIAGARA is the largest global Phase III trial in this setting to date. The trial is being conducted at 192 centres in 22 countries across North America (including Canada), South America, Europe, Australia and Asia. Its dual primary endpoints are EFS and pathologic complete response at the time of cystectomy. Key secondary endpoints are OS and safety. About Imfinzi Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses. About AstraZeneca AstraZeneca is a global, science-led biopharmaceutical business whose innovative medicines are used by millions of patients worldwide. The company's core areas of scientific focus are Oncology; Cardiovascular, Renal and Metabolic (CVRM); Rare Disease; Respiratory & Immunology; and Vaccine & Immune Therapies. In Canada, the company employs more than 2,400 people and recently announced a major expansion of its research footprint in Mississauga – including the expansion of its AstraZeneca R&D Hub and the creation of a new Alexion Development Hub for Rare Diseases. AstraZeneca was recently recognized as one of Canada's Top 100 Employers, one of Canada's Most Admired Corporate Cultures, and a Greater Toronto Top Employer. AstraZeneca is committed to contributing to a more sustainable future for people, society and planet taking important steps to help tackle some of the most pressing sustainability challenges globally – from climate and biodiversity loss, to health equity and health system resilience. AstraZeneca was one of the first seven companies globally to have its net zero targets verified by the Science-Based Targets initiative (SBTi) Corporate Net-Zero Standard. For more information, please visit the company's website at Imfinzi® and the AstraZeneca logo are registered trademarks of AstraZeneca AB, used under license by AstraZeneca Canada Inc. References: SOURCE AstraZeneca Canada Inc.
Yahoo
31-07-2025
- Yahoo
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