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Positive Outlook for Tyra Bioscience Following FDA Clearance and Promising Clinical Data

H.C. Wainwright analyst Mitchell Kapoor reiterates a Buy rating for Tyra Bioscience, citing FDA clearance for TYRA-300 Phase 2 trial and promising clinical data in non-muscle-invasive bladder cancer, with a 12-month price target of $30 per share.

H.C. Wainwright analyst Mitchell Kapoor has reiterated their bullish stance on TYRA stock, giving a Buy rating on January 7.
Mitchell Kapoor’s rating is based on the recent FDA clearance for Tyra Bioscience’s TYRA-300 Phase 2 trial in non-muscle-invasive bladder cancer (NMIBC), which he views as a risk-mitigated step due to promising previous data in metastatic urothelial carcinoma (mUC). The earlier trial demonstrated significant tumor regression in patients, with a notable percentage achieving partial responses at therapeutic doses, coupled with a favorable safety profile.
Additionally, Kapoor utilizes a discounted cash flow valuation method to assess Tyra Bioscience, focusing on TYRA-300 and TYRA-200. His analysis considers a range of probabilities for regulatory approval across various indications based on preclinical evidence and the established efficacy of FGFR inhibition. Despite potential risks such as delays or setbacks in clinical development, Kapoor sets a 12-month price target of $30 per share, underscoring his confidence in the company’s growth prospects.
In another report released on January 7, UBS also initiated coverage with a Buy rating on the stock with a $28.00 price target.
Tyra Bioscience (TYRA) Company Description: Tyra Biosciences Inc is a precision oncology company focused on developing purpose-built therapies to overcome tumor resistance and improve outcomes for patients with cancer.
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TYRA-300 Phase 2 Trial for Non-Muscle Invasive Bladder Cancer Gets FDA Green Light

The FDA has cleared Tyra Biosciences' IND application for TYRA-300, allowing a Phase 2 trial in low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC).
The SURF302 trial will evaluate the safety and efficacy of TYRA-300, an oral FGFR3-selective inhibitor, in patients with FGFR3-altered NMIBC.

Tyra Biosciences' TYRA-300 Shows Promise in Bladder Cancer and Achondroplasia

Tyra Biosciences reported positive interim Phase 1/2 data for TYRA-300 in metastatic urothelial cancer (mUC), with a 54.5% confirmed partial response rate in FGFR3+ patients.
The FDA cleared the IND for TYRA-300's Phase 2 study in pediatric achondroplasia (BEACH301), with the first patient expected to be dosed in Q1 2025.

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Tyra Biosciences Stock Target Adjusted Following Clinical Data Review

H.C. Wainwright has adjusted Tyra Biosciences' stock price target to $30 from $32 while maintaining a Buy rating, following a review of clinical data for its lead compound, TYRA-300. The drug showed promising results in treating non-muscle-invasive bladder cancer and metastatic urothelial carcinoma, with a favorable safety profile.

Protara Therapeutics' TARA-002 Shows Promise in Bladder Cancer Trial

Protara Therapeutics' TARA-002 achieved an 80% complete response rate (CRR) in non-muscle invasive bladder cancer (NMIBC) patients.
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Tyra Biosciences' TYRA-300 Shows Promise in Metastatic Urothelial Cancer

TYRA Biosciences reported positive interim results for TYRA-300 in metastatic urothelial cancer (mUC) from the SURF301 Phase 1/2 study, demonstrating notable anti-tumor activity.
The company's IND was cleared for a Phase 2 study of TYRA-300 in pediatric achondroplasia (BEACH301), with plans to initiate the study in Q1 2025.

FDA Clears Tyra Biosciences' Phase 2 Trial of TYRA-300 for Achondroplasia

The FDA has cleared Tyra Biosciences' Investigational New Drug (IND) application for TYRA-300, an oral FGFR3-selective inhibitor, to treat achondroplasia in children.
The Phase 2 BEACH301 study will evaluate TYRA-300's safety, tolerability, and impact on growth velocity in children aged 3 to 10 with achondroplasia.

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Reference News

[1]
Positive Outlook for Tyra Bioscience Following FDA Clearance and Promising Clinical Data
markets.businessinsider.com · Jan 13, 2025

H.C. Wainwright's Mitchell Kapoor reiterates a Buy rating for TYRA stock, citing FDA clearance for TYRA-300's Phase 2 tr...

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