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Tyra Biosciences, Inc. (Nasdaq: TYRA) is a clinical-stage biotechnology company based in Carlsbad, CA, focused on developing next-generation precision medicines that target significant opportunities in Fibroblast Growth Factor Receptor (FGFR) biology. The Company leverages its proprietary precision medicine platform, SNÅP, to enable rapid and precise drug design through iterative molecular SNÅPshots that predict genetic alterations likely to cause acquired resistance to existing therapies.
Tyra’s lead product candidate, TYRA-300, is an investigational oral FGFR3-selective inhibitor aimed at treating cancer and skeletal dysplasias, including achondroplasia. TYRA-300 is currently being evaluated in a multi-center, open-label Phase 1/2 clinical study, SURF301 (Study in Untreated and Resistant FGFR3+ Advanced Solid Tumors). SURF301 is designed to determine the optimal and maximal tolerated doses (MTD) and the recommended Phase 2 dose (RP2D) of TYRA-300, as well as to evaluate its preliminary antitumor activity. TYRA-300 has demonstrated positive preclinical results in skeletal dysplasias, and Tyra expects to submit an Investigational New Drug (IND) application to the FDA for a Phase 2 clinical study in pediatric achondroplasia in 2024.
Another key product in development is TYRA-200, an investigational oral FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations for the treatment of cancer. TYRA-200 is currently undergoing evaluation in a multi-center, open-label Phase 1 clinical study, SURF201 (Study in Previously treated and Resistant FGFR2+ Cholangiocarcinoma and Other Advanced Solid Tumors). SURF201 is designed to determine the optimal and MTD and RP2D of TYRA-200 and to evaluate its preliminary antitumor activity.
Tyra has recently achieved significant milestones, including the FDA granting Orphan Drug Designation (ODD) and Rare Pediatric Disease (RPD) Designation to TYRA-300 for treating achondroplasia. The Company is also actively presenting research findings at major scientific congresses such as the American Society for Bone and Mineral Research (ASBMR) and the American Society of Human Genetics (ASHG).
In 2024, Tyra secured approximately $200 million in funding via a securities purchase agreement with institutional and accredited investors, led by RA Capital Management. This financial boost strengthens Tyra's balance sheet as the company advances its clinical development programs and leverages the SNÅP platform for discovering new drug candidates.
Tyra Biosciences' vision is to provide novel therapeutic options for patients with unmet medical needs by developing best-in-class precision medicines. Their ongoing research, clinical trials, and financial stability position them well to achieve this goal.
Tyra Biosciences (Nasdaq: TYRA), a clinical-stage biotech company specializing in Fibroblast Growth Factor Receptor (FGFR) biology, has announced its participation in the 2024 Cantor Global Healthcare Conference. CEO Todd Harris will engage in a fireside chat on September 17, 2024, at 9:45 am ET. The company's management will also conduct one-on-one meetings with investors during the event.
A live and archived webcast of the fireside chat will be accessible through the Investor section of TYRA's website. This participation underscores TYRA's commitment to engaging with the investment community and showcasing its progress in developing next-generation precision medicines targeting significant opportunities in FGFR biology.
Tyra Biosciences (Nasdaq: TYRA) has appointed Doug Warner, M.D., as Chief Medical Officer. Dr. Warner brings over 20 years of clinical development leadership experience to TYRA. He will oversee the company's clinical portfolio and join the executive management team. TYRA is developing next-generation precision medicines targeting Fibroblast Growth Factor Receptor (FGFR) biology.
Dr. Warner's extensive experience includes 18 years at Amgen, where he led clinical development for oncology and bone disease programs. He was also recently the Chief Medical Officer at eFFECTOR Therapeutics. TYRA's CEO, Todd Harris, highlighted Dr. Warner's expertise in guiding programs from early development to global registrations as important for the company's current stage, with three potential best-in-class oncology candidates and a planned IND filing for achondroplasia later this year.
The Schall Law Firm, a national shareholder rights litigation firm, has announced an investigation into Tyra Biosciences, Inc. (NASDAQ:TYRA) for potential violations of securities laws. The inquiry focuses on whether Tyra issued false or misleading statements or failed to disclose important information to investors. Shareholders who have suffered losses are encouraged to participate in the investigation. The firm specializes in securities class action lawsuits and shareholder rights litigation.
Interested parties can contact Brian Schall of the Schall Law Firm at 310-301-3335 or through their website www.schallfirm.com for a free consultation about their rights. The press release notes that this announcement may be considered Attorney Advertising in some jurisdictions.
Tyra Biosciences (NASDAQ: TYRA) reported Q2 2024 financial results and corporate highlights. Key points include:
1. Initial results from SURF301 Phase 1 study for TYRA-300 expected in 2H 2024.
2. Preclinical proof-of-concept achieved for TYRA-300 in hypochondroplasia (HCH).
3. IND cleared for TYRA-430, an FGFR4/3 biased inhibitor for hepatocellular carcinoma.
4. Chief Medical Officer transition announced; search for external candidate underway.
5. Q2 2024 net loss of $18.7 million, compared to $13.3 million in Q2 2023.
6. Cash, cash equivalents, and marketable securities of $373.8 million as of Q2 2024, expected to fund operations through at least 2026.
Tyra Biosciences announced promising preclinical results for TYRA-300, an oral FGFR3 selective inhibitor, in treating hypochondroplasia (HCH).
Presented at the 6th Annual Achondroplasia & Skeletal Dysplasia Research Conference, the data showed TYRA-300 increased long bone lengths by up to 5.03% and skull size by 5.88% in mouse models, compared to vehicle-treated mice. The results support the potential of TYRA-300 as a best-in-class agent for FGFR3-related skeletal dysplasias like HCH.
The company plans to submit an Investigational New Drug (IND) application for achondroplasia (ACH) in the second half of 2024, aiming for a Phase 2 study in pediatric ACH.
Tyra Biosciences (Nasdaq: TYRA), a clinical-stage biotechnology firm specializing in precision medicines for FGFR biology, will participate in several investor conferences. On May 28-29, 2024, CEO Todd Harris will join a fireside chat at TD Cowen's Oncology Innovation Summit. The company will engage in one-on-one investor meetings at the Jefferies Global Healthcare Conference on June 5-6, 2024. Additionally, Harris will present on June 12, 2024, at the Goldman Sachs Global Healthcare Conference, with further investor meetings scheduled. Webcasts of these presentations will be available on Tyra's Investor page.
Tyra Biosciences, a clinical-stage biotechnology company, reported financial results for Q1 2024, with $382.5 million in cash and marketable securities. Recent highlights include progress on TYRA-300 in oncology and achondroplasia, new board appointments, and completion of a $200M private placement financing. The company continues to advance its pipeline and expects to report SURF301 Phase 1 initial results in 2H24.
Tyra Biosciences, a clinical-stage biotech company, appointed Susan Moran, M.D., M.S.C.E. and S. Michael Rothenberg, M.D., Ph.D. as independent directors, replacing Isan Chen, M.D. Both new directors bring extensive expertise in FGFR3 biology and oncology. Dr. Moran has a background in clinical trials and product development, while Dr. Rothenberg has experience in clinical care and drug development. The changes aim to advance the company's precision medicine candidates, particularly TYRA-300 for skeletal dysplasias and oncology.