PR Newswire
CARLSBAD, Calif.
, Dec. 1, 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 two key members of its leadership team: Bhavesh Ashar as Chief Operating Officer and Heather Faulds as Chief Regulatory Officer. Together, Mr. Ashar and Ms. Faulds will be essential in advancing oral dabogratinib through global Phase 2 studies in skeletal dysplasia and urologic cancers and preparing for potential future pivotal Phase 3 studies. Mr. Ashar’s appointment is effective immediately and Ms. Faulds’s appointment is effective December 8, 2025.
Mr. Ashar has more than 25 years of global pharmaceutical and biotechnology experience, most recently serving as Chief Commercial Officer at SpringWorks Therapeutics, Inc. from 2021 through its acquisition by Merck KGaA in 2025. Ms. Faulds brings more than 20 years of experience leading global regulatory strategies across all phases of development, including the approvals of several important medicines like SPINRAZA® and LYBALVI®. Most recently, Ms. Faulds served as SVP, Global Regulatory Sciences at Blueprint Medicines.
“Bhavesh and Heather are joining TYRA at a defining moment, as what we are building carries profound significance,” said Todd Harris, CEO of TYRA. “Our team is united by a shared belief that patients are counting on us to deliver the precision medicines of the future — oral therapies that are thoughtfully engineered, clinically meaningful, and capable of changing lives. Bhavesh and Heather bring not only deep expertise across oncology and rare disease development, regulatory strategy and commercialization, but also a genuine commitment to that mission. I’m grateful to welcome them to TYRA and excited for what we will accomplish together for patients.”
Prior to joining TYRA, Mr. Ashar served as Chief Commercial Officer at SpringWorks Therapeutics, Inc., where he built the commercial infrastructure and successfully launched two rare oncology products, OGSIVEO® (nirogacestat) and GOMEKLI™ (mirdametinib) in the U.S. and drove readiness for the E.U. launches. Previously, he served as Senior Vice President, General Manager of U.S. Oncology at Bayer, where he was responsible for a broad portfolio in prostate, liver, colorectal, gastrointestinal stroma tumor, hematologic and tumor-agnostic biomarker driven cancers. Before joining Bayer, he held roles of increasing responsibility at Sanofi Genzyme over a 15-year tenure, including Vice President, General Manager of U.S. Oncology and Vice President, Global Head of Transplant (Oncology Division). Prior to Sanofi Genzyme, Mr. Ashar was a consultant with McKinsey & Company where he served clients in the biopharmaceutical space. Mr. Ashar received an MBA from the University of Chicago and a BS in Mathematics from Imperial College in London.
“I am excited to join TYRA at this pivotal time to help shape the next phase of growth for the company,” said Bhavesh Ashar, Chief Operating Officer. “Throughout my career in oncology and rare disease, I’ve seen how targeted medicines can profoundly impact patients’ lives. I believe we have a tremendous opportunity with oral dabogratinib to deliver best-in-class medicines in both skeletal dysplasias and urologic cancers by selectively targeting FGFR3. I look forward to partnering with this talented team to build a world-class organization capable of delivering transformative therapies to patients who need them most.”
Ms. Faulds brings more than 20 years of experience leading global regulatory strategies across all phases of development, as well as multiple therapeutic areas and modalities to TYRA. Most recently, Ms. Faulds served as SVP, Global Regulatory Sciences at Blueprint Medicines through its acquisition by Sanofi, where she led global regulatory affairs. Prior to that, Ms. Faulds was the Chief Regulatory Affairs and Quality Assurance Officer at Fulcrum Therapeutics, where she led multiple functions, including global regulatory affairs, quality assurance and medical writing across the company. Prior to Fulcrum, she was SVP, Regulatory Affairs at Alkermes, where she led the team that achieved FDA approval for LYBALVI® (olanzapine and samidorphan) for the treatment of schizophrenia and bipolar disease. Previously, Ms. Faulds served as SVP, Regulatory Affairs at Scholar Rock where she led multiple functions spanning regulatory affairs, GxP compliance, pharmacovigilance, and medical writing, and was responsible for regulatory strategies across clinical programs for rare diseases and immuno-oncology. Prior to Scholar Rock, Ms. Faulds spent 12 years at Biogen in roles of increasing responsibility across CMC regulatory and global regulatory strategy. While at Biogen, she led the global approval of PLEGRIDY® (peginterferon beta-1a) for the treatment of multiple sclerosis and her leadership paved the way for several novel health authority approvals including SPINRAZA® (nusinersen), the first treatment for spinal muscular atrophy, which was approved by the FDA in 90 days following NDA submission. Ms. Faulds also led regulatory activities for programs in Alzheimer’s.
“My career has been driven by a deep commitment to advancing therapies for patients with serious unmet needs, and I’m excited to bring that passion to TYRA,” said Heather Faulds, incoming Chief Regulatory Officer. “TYRA’s mission to develop thoughtfully engineered therapies and their commitment to patients and families resonate deeply with me. I am looking forward to partnering with this talented team to move oral dabogratinib forward with urgency, precision, and the shared goal of improving outcomes for people who are counting on us.”
About Oral Dabogratinib (formerly TYRA-300)
Oral dabogratinib is TYRA’s lead precision medicine candidate stemming from its in-house SNÅP platform. Oral dabogratinib is an investigational, FGFR3-selective inhibitor currently in development for the treatment of skeletal dysplasia and urologic cancers that has demonstrated interim clinical proof-of-concept results in metastatic urothelial carcinoma (mUC, SURF301). The current planned clinical development for oral dabogratinib includes global Phase 2 clinical trials for pediatric achondroplasia (ACH, BEACH301), intermediate risk (IR) non-muscle invasive bladder cancer (NMIBC, SURF302), low-grade upper tract urothelial carcinoma (LG-UTUC, SURF303) and potentially future mUC clinical trials. The FDA has granted Orphan Drug Designation (ODD) and Rare Pediatric Disease (RPD) Designation to dabogratinib for the treatment of achondroplasia.
Please visit the Patients page of our website for more information on our clinical trials.
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. TYRA’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 clinical-stage programs in targeted oncology and genetically defined conditions. TYRA’s lead precision medicine stemming from SNÅP, oral dabogratinib, is a potential first-in-class selective FGFR3 inhibitor. Dabogratinib’s current planned clinical development includes BEACH301 for pediatric ACH, SURF302 for IR NMIBC, SURF303 for LG-UTUC and potentially mUC. TYRA is also developing TYRA-430, an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers, in the SURF431 study for advanced hepatocellular carcinoma, and TYRA-200, an oral, investigational, FGFR1/2/3 inhibitor, in the SURF201 study for metastatic intrahepatic cholangiocarcinoma. TYRA is based in Carlsbad, CA.
For more information about our science, pipeline and people, please visit www.tyra.bio 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 potential for global Phase 2 studies and pivotal Phase 3 studies of oral dabogratinib in skeletal dysplasia and urologic cancers and the timing thereof; the significance of Tyra’s product candidates; the expected advancement of our pipeline and our growth; the potential to develop next-generation precision medicines and their potential to be best-in-class or first-in-class; the potential safety and therapeutic benefits of, and market opportunities for, our product candidates; 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: 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 or final data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the potential for proof-of-concept results to fail to result in successful subsequent development of dabogratinib; later developments with the FDA may be inconsistent with prior feedback from the FDA; we are early in our development efforts, 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, recruitment, 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; our dependence on third parties in connection with manufacturing, research and preclinical testing; we may expend our limited resources to pursue a particular product candidate and/or indication and fail to capitalize on product candidates or indications with greater development or commercial potential; acceptance by the FDA of INDs or of similar regulatory submissions by comparable foreign regulatory authorities for the conduct of clinical trials of our product candidates; an accelerated development or approval pathway may not be available for dabogratinib or other product candidates and any such pathway may not lead to a faster development process; 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; risks associated with and uncertainties related to management changes and transitions; regulatory developments in the United States and foreign countries; our ability to obtain and maintain intellectual property protection for our product candidates and proprietary technologies; 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]
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