dcaf7
5 일 전
Raymond James Predicts Up to ~930% Rally for These 2 ‘Strong Buy’ Stocks
Jan 11, 2025, 06:05 AM
Heading Raymond James’ picks is Black Diamond Therapeutics, a biopharmaceutical company operating at the clinical stage and taking a novel precision oncology approach to developing oncological treatments. While most cancer drugs target specific mutations that cause or are found in tumors, Black Diamond targets families of oncogenic mutations through its MasterKey approach. This strategy has the potential to broaden the patient base and develop drug candidates with wide applications.
At the core of this innovation is Black Diamond’s flagship drug candidate, BDTX-1535, a brain-penetrant MasterKey inhibitor targeting the epidermal growth factor receptor (EGFR). Currently undergoing human clinical trials, BDTX-1535 is being developed for three key indications: second- and third-line non-small cell lung cancer (2L/3L NSCLC), first-line NSCLC, and glioblastoma multiforme (GBM).
In its 2L/3L NSCLC trial, the company delivered positive initial Phase 2 results in September of last year. The data was based on two patient cohorts; one with relapsed/refractory patients harboring non-classical EGFR mutations, and the other with C797S resistance mutations. Across both groups, BDTX-1535 demonstrated robust anti-tumor activity. The company anticipates providing a clinical update and obtaining regulatory feedback in the first quarter of 2025.
Black Diamond is also testing BDTX-1535 as a first-line therapy for NSCLC patients with non-classical EGFR mutations. Initial results from this ongoing trial are expected in the first quarter of 2025, and the company is optimistic that the encouraging activity observed in recurrent settings will translate into significant clinical benefits for newly diagnosed patients.
The potential doesn’t end there. Black Diamond is exploring the potential of BDTX-1535 in battling glioblastoma (GBM), one of the most aggressive brain cancers. Phase 1 data, presented last June, came from a dose-escalation trial in recurrent GBM patients and revealed promising signs. The drug not only demonstrated a strong safety and tolerability profile but also achieved significant anti-tumor activity. The drug was able to pass through the blood/brain barrier, and reached clinically meaningful levels in brain tumor tissues.
Considering the potential of BDTX-1535, the upcoming catalysts, and the company’s current share price of $1.93, Raymond James analyst Laura Prendergast views BDTX stock as deeply undervalued.
“We remain highly optimistic for 1Q25 clinical updates of BDTX-1535 in EGFRm NSCLC (2/3L updated data and first 1L data in patients with non-classical EGFR mutations)… [We] maintain our belief that numerous features of BDTX-1535 in NSCLC are being underappreciated by investors… We model BDTX-1535 hitting blockbuster status in FY31 and global peak sales of ~$1.8B in FY35. Based on our projections BDTX is significantly undervalued versus its smid-cap biotech peer group,” Prendergast opined.
Just how undervalued? Prendergast rates BDTX an Outperform (i.e., Buy), with a $20 price target implying a substantial one-year upside potential of ~930%. (To watch Prendergast’s track record, click here)
https://www.tipranks.com/news/raymond-james-predicts-up-to-930-rally-for-these-2-strong-buy-stocks
dcaf7
4 월 전
In PR from Sep 14, Elizabeth Buck said,
“BDTX-1535 was designed to address a broad spectrum of EGFR mutations, with emphasis on non-classical mutations that extend beyond PACC mutations”. This phrase caught my attention. Why? Because of Arrivent data presented at WCLC meeting on Sep 9, 2024. Their drug, firmonertinib, demonstrated pretty strong efficacy in NSCLC patients with EGFR non-classical mutations in Phase 1b trial. Possibly, it's why BDTX share price has been down lately. The difference between Arrivent and BDTX trials is in patient populations. Arrivent is recruiting patients with PACC mutations with no prior TKI exposure as 1st or 2nd-line treatment. BDTX is enrolling all patients after osimertinib/other TKI in 2nd/3d line in cohorts 1 and 2, and TKI-naïve patients in cohort 3. Cohorts 1 and 3 recruit patients with all non-classical mutations, including PACC mutations. Data from cohorts 1 and 2 will be released by the end of Q3 and I don’t think we should compare them with firmonertinib results. But data from cohort 3, expected in Q1 2025 might show which drug is better to treat patients with PACC mutations.
dcaf7
4 월 전
Abstract for poster presentation at ESMO 2024 was published.
Title: Real-world evidence of treatment practices and therapeutic outcomes for newly diagnosed NSCLC patients with non-classical EGFR mutations demonstrates high unmet medical need.
It is BDTX-sponsored study conducted by John Heymach lab. He is the first author of the abstract. They analyzed 11,434 sequenced cases of newly diagnosed and treatment naïve EGFRm NSCLC and found that 22% of patients have non-classical EGFR mutations (NCMs). They concluded that compared to NSCLC patients expressing classical EGFR mutations, patients expressing NCMs discontinue EGFR inhibitor treatment sooner, and chemotherapy remains the most common treatment, with poor patient outcomes. Moreover, the co-expression of osimertinib-resistant NCMs with L858R may contribute to inferior outcomes versus patients with L858R alone. These real-world data underscore the unmet medical need of patients expressing NCMs, and the opportunity for a 4th-generation TKI that potently inhibits NCMs in the newly diagnosed setting.
dcaf7
6 월 전
On Thursday, Piper Sandler reiterated its Overweight rating on Black Diamond Therapeutics stock, maintaining a $12.00 price target.
The firm's confidence in the company remains steadfast following a recent investor lunch with BDTX management. The discussions emphasized the potential of BDTX-1535 in the treatment spectrum of EGFR NSCLC (non-small cell lung cancer).
The management of Black Diamond Therapeutics presented their development strategies, focusing on the role BDTX-1535 could play following the use of osimertinib. They highlighted an expected objective response rate (ORR) of 30-40% for the upcoming third-quarter 2024 readout as a positive indicator.
Additionally, the company sees a potential for BDTX-1535 after adjuvant osimertinib and as a first-line therapy for non-classical mutations, with an ORR of over 50% in this group indicating a clear path for development.
The discussions also touched upon the possibility of BDTX-1535 competing against osimertinib in patients with the L858R mutation. Piper Sandler expressed optimism about the broad mutational coverage of BDTX-1535, considering it a significant aspect of the drug's profile within the EGFR NSCLC market.
The anticipation of Phase II data for BDTX-1535 in 2L+ EGFR NSCLC expected this quarter has been noted as a potential turning point. Should the forthcoming data validate the drug's profile, it could mark a significant inflection point for the company. Piper Sandler's outlook suggests that the upcoming clinical readouts could reinforce BDTX-1535’s standing in the treatment landscape for EGFR NSCLC.
dcaf7
6 월 전
Piper Sandler maintains Overweight on Black Diamond stock.
On Wednesday, Piper Sandler reaffirmed its Overweight rating on Black Diamond Therapeutics (NASDAQ:BDTX) with a steady price target of $12.00. The firm's focus was on the upcoming initial Phase II data for BDTX-1535 in treating EGFR+ NSCLC. The analyst highlighted the importance of the response rate to platinum chemotherapy, which is a current standard, as a benchmark for BDTX-1535's success.
The assessment of BDTX-1535's clinical efficacy during the dose-escalation stage was revisited, with expectations set on what would constitute a positive and clinically meaningful outcome. The response rate to platinum chemotherapy, which stands at 27%, was cited as a significant comparator, suggesting that an Objective Response Rate (ORR) of 37% or higher, along with signs of durability, would be favorable. Such results could solidify the drug's position for further development and positive implications for future first-line non-classical readouts.
Black Diamond Therapeutics is in the spotlight as it prepares to release its Phase II data for BDTX-1535. This data could potentially establish the drug as a next-generation EGFR tyrosine kinase inhibitor (TKI). The firm's anticipation is based on the Phase I data, which has shown promising results across various analyses.
The steadfast Overweight rating by Piper Sandler indicates confidence in Black Diamond Therapeutics' prospects. The $12.00 price target remains unchanged, reflecting the firm's positive outlook on the company's ongoing clinical trials and the potential of BDTX-1535 to advance in the development pipeline.
dcaf7
7 월 전
Piper Sandler reaffirms overweight rating on Black Diamond Therapeutics stock.
Published 03/06/2024
On Monday, Piper Sandler sustained its Overweight rating on Black Diamond Therapeutics (NASDAQ:BDTX), with a steady price target of $12.00. The firm's assessment follows recent presentations at the American Society of Clinical Oncology (ASCO) where Black Diamond Therapeutics showcased early clinical results for its drug BDTX-1535, particularly in recurrent glioblastoma multiforme (GBM).
At ASCO, the company revealed two sets of data concerning BDTX-1535. The highlight was the drug's confirmed ability to penetrate the central nervous system (CNS). In a window of opportunity study, 8 out of 9 GBM patients demonstrated CNS exposure levels surpassing the predefined pharmacokinetic thresholds, which are five times higher than the IC50 against relevant EGFR alterations in GBM. This included 6 of 7 patients at a 200 mg once-daily dosage, which is also the dose currently under evaluation for non-small cell lung cancer (NSCLC).
While plans for BDTX-1535 in GBM treatment remain to be determined, the data presented are considered significant for assessing the drug's clinical potential in NSCLC, especially for its intracranial efficacy. The anticipation for BDTX-1535's utility is further heightened by the expected release of initial Phase II data in third-line or later treatment for EGFR-positive NSCLC, which is slated for the third quarter of 2024.
The positive outlook on BDTX-1535's CNS penetration is key because it supports the drug's potential effectiveness in treating intracranial diseases, a critical factor for NSCLC patients with EGFR mutations. The upcoming Phase II data release is seen as a pivotal event that could substantially impact Black Diamond Therapeutics' drug development trajectory.
The company's focus now shifts to the anticipated Phase II results, which could serve as a major catalyst for BDTX-1535, especially if the data aligns with the promising outcomes observed in the GBM studies. The maintained price target by Piper Sandler reflects confidence in the drug's prospects and Black Diamond Therapeutics' ability to navigate the next stages of clinical trials.
dcaf7
9 월 전
The prevalence of non-classical EGFR mutations is approximately four times higher than that of EGFR Exon 20 insertions.
On Monday, Wedbush, a financial services firm, increased its price target for Black Diamond Therapeutics (NASDAQ:BDTX) shares to $16.00, rising from the previous target of $10.00. The firm has maintained an Outperform rating on the stock.
This adjustment follows Black Diamond's presentation at the American Association for Cancer Research (AACR) which highlighted the potential market for its drug candidate BDTX-1535 in the treatment of non-classical EGFR mutations and osimertinib-resistance mutations in non-small cell lung cancer (NSCLC).
According to the analysis presented by Black Diamond, non-classical EGFR mutations are highly prevalent, found in 22-30% of first-line treatment-naïve EGFR-mutated NSCLC cases. This prevalence is approximately four times higher than that of EGFR Exon 20 insertions. The firm noted that patients with these non-classical mutations often have a poor response to existing EGFR inhibitors.
Additionally, the mutations, along with C797S, represent a significant mechanism of resistance to current EGFR inhibitors. Wedbush believes that BDTX-1535 could be a leading therapy for patients with non-classical and C797S mutations. The firm sees promising development opportunities for the drug in various treatment settings, including post-adjuvant, first-line (1L), and second-line (2L) post-osimertinib.
Black Diamond Therapeutics has recently begun a Phase 2 cohort study of BDTX-1535 in a first-line treatment setting following feedback from the FDA, with initial data expected in 2025.
The company is also anticipating Phase 2 data from second and third-line (2L/3L) cohorts for patients with C797S and/or non-classical mutations, and non-classical mutations alone, which are expected to be released in the third quarter of 2024.
https://www.investing.com/news/company-news/wedbush-raises-black-diamond-stock-target-on-drug-potential-93CH-3369858
dcaf7
10 월 전
BDTX-1535 abstract for AACR presentation is released. There is no clinical data, it is about science. This study was conducted mostly by scientists from MD Anderson Cancer Center including John Heymach, who is an expert in EGFR/HER2 mutations in NSCLC. They discovered that treatment of two classical EGFR mutations, Exon 19 deletions and L858R, by Osimertinib results in two different resistance outcomes. Patients with Exon 19 deletions usually develop C797S resistance mutation whereas patients with L858R develop multiple non-classical resistance mutations. They also found that non-classical mutations often co-exist with L858R in first-line patients, making Osimertinib treatment less effective. For these patients BDTX-1535 should be a better option.
https://www.abstractsonline.com/pp8/#!/20272/presentation/8874
dcaf7
11 월 전
So far, I like what I see. 1535 has a nice PK profile and it definitely has activity for non-classical mutations and C797S. Therefore, it potentially has a place in the market for post Osimertinib patients. First line non-classical also looks reasonably promising. I am not sure about GBM. Their “Window of Opportunity” trial is unusual by design. I've never heard of other drugs being tested that way, but I guess it is the only way to get a clear answer. We’ll see the data at ASCO. If positive, the company will be in a unique position to address unmet medical needs of patients with EGFR mutated GBM. Cannot say much about their second drug, BDTX-4933. Pre-clinical data looks good, but I won’t speculate on drug activity until I see at least early clinical data.
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