Tyra Biosciences, Inc. Stock Price, News & Analysis

Tyra Biosciences (Nasdaq: TYRA), a clinical-stage biotechnology company, reported its Q3 2024 financial results and corporate highlights. Key points include positive interim clinical proof-of-concept results for TYRA-300 in metastatic urothelial cancer (mUC) from the SURF301 Phase 1/2 study. The company received IND clearance for a Phase 2 study of TYRA-300 in pediatric achondroplasia (BEACH301) and plans to submit an IND for a Phase 2 study in non-muscle invasive bladder cancer (NMIBC) by year-end 2024.

Tyra also advanced its TYRA-200 and TYRA-430 programs and appointed Dr. Doug Warner as Chief Medical Officer. Financially, Tyra reported a net loss of $24.0 million for Q3 2024, with increased R&D and administrative expenses. The company holds $360.1 million in cash and equivalents, expected to fund operations through 2026.

Tyra Biosciences received FDA clearance for its IND application to proceed with BEACH301, a Phase 2 clinical trial of TYRA-300 in pediatric achondroplasia. TYRA-300 is the first oral FGFR3-selective inhibitor well-tolerated in clinical studies. The trial will evaluate children ages 3-10 with achondroplasia, enrolling up to 10 participants per dose level in treatment-naïve and previously treated cohorts. The study aims to assess safety, tolerability, and changes in growth velocity. First patient dosing is expected in Q1 2025. TYRA-300 received both Orphan Drug and Rare Pediatric Designations from the FDA for achondroplasia treatment.

Tyra Biosciences announced promising interim clinical data for TYRA-300, their investigational oral FGFR3-selective inhibitor, in treating metastatic urothelial cancer (mUC). In patients receiving ≥90mg daily doses, 6 out of 11 (54.5%) achieved confirmed partial response, with 100% disease control rate. The study included 41 heavily pre-treated patients, with 44% receiving ≥3 prior therapies. TYRA-300 demonstrated favorable safety results across all doses, showing infrequent FGFR2/FGFR1-associated toxicities. Only 4 serious adverse events (10%) were reported, with one dose-limiting toxicity of grade 3 diarrhea at 90mg daily.

Tyra Biosciences (Nasdaq: TYRA) announced it will host a conference call and webcast on October 25, 2024 at 8:00 am ET to present interim clinical results of TYRA-300 from the SURF301 Phase 1/2 study in metastatic urothelial cancer (mUC). The data will be presented at the 36th EORTC-NCI-AACR Symposium in Barcelona, Spain. Dr. Gary Steinberg from Rush University Medical Center will join TYRA's management team for the presentation and Q&A. The webcast will be accessible through TYRA's investor relations website, with telephone participation available through pre-registration.

Tyra Biosciences (Nasdaq: TYRA) announced three abstracts for presentation at the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (ENA 2024) in Barcelona, Spain, from October 23-25, 2024. The presentations include:

1. A late-breaking oral presentation on the preliminary safety and anti-tumor activity of TYRA-300, a highly selective FGFR3 inhibitor, in participants with advanced solid tumors with activating FGFR3 mutations/fusions (SURF301).

2. A poster on the preliminary pharmacokinetic and pharmacodynamic analysis of TYRA-300 from the SURF301 study.

3. A poster on the multicenter, open-label Phase 1/2 study of TYRA-300 in advanced urothelial carcinoma and other solid tumors with activating FGFR3 gene alterations (SURF301).

The abstracts are embargoed until 00.01 hrs CEST on Friday, October 25, 2024.

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.