The design of "REZILIENT3: randomized phase III study of first-line zipalertinib plus chemotherapy in patients with EGFR exon 20 insertion-mutated NSCLC" has been published. Notably, the first author is John Heymach, a world-renowned leader in NSCLC with EGFR mutations. https://www.tandfonline.com/doi/full/10.1080/14796694.2025.2457294

Interview with Nadim Ahmed, a CEO of CGEM.
https://www.biotechtv.com/post/cullinan-therapeutics-june-10-2025

Analysis of BDTX in Seeking Alpha, "Black Diamond Therapeutics: Targeted Approach And Early Efficacy Signals Create Potential For Significant Upside" by Galzus Research. https://seekingalpha.com/article/4793648-black-diamond-therapeutics-stock-targeted-approach-early-efficacy-signals-potential-upside

Dr. Helena Yu on REZILENT1 study

Expect BDTX-1535 to be acquired after Phase 2 readout.

We should see some Ph2 NSCLC data at ASCO.
Title: A phase II trial to evaluate the safety and efficacy of SSGJ-707, a bispecific antibody targeting PD-1 and VEGF, as a monotherapy in patients with advanced NSCLC.
The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT
https://meetings.asco.org/abstracts-presentations/251472

Pharmaceutical Manufacturer Assertio Therapeutics Inc. Agrees to Pay $3.6M to Resolve Allegations that It Violated the False Claims Act in Connection with Marketing its Fentanyl Product.
https://www.justice.gov/opa/pr/pharmaceutical-manufacturer-assertio-therapeutics-inc-agrees-pay-36m-resolve-allegations-it

In 2025 AACR Annual Meeting poster presentation on BDTX home page, https://blackdiamondtherapeutics.com/our-platform/presentations-publications

At the time of data cut off, Kaplan-Meier median overall survival was 5.8 months. From AACR 2025 poster "A Phase 0/1 ‘Trigger’ Trial of BDTX-1535 in Recurrent Glioblastoma (GBM) Patients with EGFR Alterations or Fusions".

Title of ASCO 2025 presentation: "Efficacy of zipalertinib in NSCLC patients with EGFR exon 20 insertion mutations who received prior platinum-based chemotherapy with or without amivantamab". Key catalyst for CGEM share price.

Title of BDTX-1535 presentation at AACR 2025.
A phase 0/1 ‘trigger’ trial of BDTX-1535 in recurrent glioblastoma (GBM) patients with EGFR alterations or fusions. Expect reporting OS data.

BDTX pipeline is updated. Besides licensing BDTX-4933, there are other changes, 1) 1L NSCLC data with BDTX-1535 are now expected in Q4 2025; 2) 2L/3L NSCLC data in H1 2026; 3) 1L GBM data at AACR in April 2025.
https://blackdiamondtherapeutics.com/pipeline-programs/pipeline

It means BDTX presented to Servier some promising Phase 1 data. I think, we'll see them soon.

Black Diamond stock target raised to $12 at H.C. Wainwright
Published 03/18/2025, 07:57 AM
Tuesday, H.C. Wainwright adjusted its price target on shares of Black Diamond Therapeutics (NASDAQ:BDTX), increasing it to $12.00 from the previous $11.00, while reiterating a Buy rating on the stock. The firm’s analysts highlighted upcoming catalysts for the company, specifically pointing to initial results for BDTX-1535 in the first-line (1L) setting for non-small cell lung cancer (NSCLC) patients with non-classical driver mutations expected in the second quarter of 2025. Further attention was drawn to updated Phase 2 results in the recurrent EGFR+ NSCLC setting anticipated in the second half of 2025.
Black Diamond (NASDAQ:CLAR) recently presented initial Phase 2 results for BDTX-1535, a fourth-generation, irreversible, brain-penetrant EGFR MasterKey inhibitor, in relapsed/refractory NSCLC patients with non-classical EGFR mutations and C797S resistance mutations. The treatment demonstrated a 36% objective response rate (ORR) in 22 response-evaluable patients, which improved to 42% after excluding patients without on-target resistance mutations. These findings were considered promising, with 74% of patients remaining on treatment as of the data cut, despite a relatively short follow-up period of 4.7 months.
The analysts at H.C. Wainwright noted the differences in patient populations when comparing BDTX-1535’s results with those of another candidate, firmonertinib, from ArriVent. They emphasized that unlike firmonertinib’s TKI-naive patient population, BDTX-1535’s study involved TKI-experienced patients.
https://www.investing.com/news/analyst-ratings/black-diamond-stock-target-raised-to-12-at-hc-wainwright-93CH-3933668

I think to estimate the effect of inclusion of same day dosing in NCCN guidelines on sales of Rolvedon, you need to look at what happened to Neulasta. A same day dosing of Neulasta was studied in 266-patient double-blind trial and it demonstrated non-inferiority. Amgen submitted data to NCCN and NCCN guidelines state that "Neulasta same day administered the day after myelosuppressive chemotherapy is supported by category one evidence, however FDA approved dosing schedule is still recommended". With that, why would they go for Onpro? On the other hand, "a survey of physicians who administer Neulasta reported that 31.6% of patients were treated on a “same-day” schedule because of patient/caregiver travel distance and practice related consideration". If same is applicable to Rolvedon after including it in NCCN guidelines, we may expect ~30% increase in treatable patient population.

On recently presented same day dosing data.
https://www.onclive.com/view/same-day-dosing-of-eflapegrastim-and-chemotherapy-is-safe-reduces-duration-of-severe-neutropenia-in-early-stage-breast-cancer

Three insiders including CEO bought ZNTL shares.

Is it a buying opportunity? Looks like a lot of uncertainty removed.

I don't know. Possibly, they want to focus on business aspects of same day dosing in this poster presentation.

Good watch.

Data from same day dosing trial will be presented at ACCC 51st Annual Meeting & Cancer Center Business Summit on March 5, 2025. Title: Eflapegrastim, a Long-Acting GCSF, Administered the Same Day as Chemotherapy in Patients with Early-Stage Breast Cancer: Results from a Multicenter, Open-Label, Study.

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

Maxim Group analyst Naz Rahman has reiterated their bullish stance on ASRT stock, giving a Buy rating today.
Dec 16, 2024, 01:45 PM
Naz Rahman has given his Buy rating due to a combination of factors related to Assertio Therapeutics’ recent clinical study results. The same-day dosing study of Rolvedon, presented at the San Antonio Breast Cancer Symposium, demonstrated favorable outcomes for patients, including rapid recovery of neutrophil counts and a very low incidence of febrile neutropenia. This aligns well with the results from the Phase 3 trial, reinforcing the drug’s safety and efficacy profile.
Furthermore, there were no new safety concerns, and the adverse event profile remained consistent with previous trials. The potential for Rolvedon to be incorporated into the National Comprehensive Cancer Network guidelines could also boost its market penetration and sales growth. With these positive indicators, Rahman perceives significant sales potential for Rolvedon, contributing to the Buy rating for Assertio Therapeutics.
https://www.tipranks.com/news/blurbs/positive-clinical-results-and-market-potential-drive-buy-rating-for-assertio-therapeutics

On Monday, H.C. Wainwright maintained its Buy rating and a price target of $4.00 for Assertio Therapeutics shares
The firm's stance follows Assertio Holdings' recent announcement of clinical trial results for ROLVEDON (eflapegrastim-xnst) injection. The trial focused on the drug's same-day dosing alongside chemotherapy in patients with early-stage breast cancer (ESBC).
The study, identified as NCT04187898, was an open-label, single-arm trial conducted at 13 U.S. sites. Participants were administered ROLVEDON 30 minutes after receiving chemotherapy for ESBC. Findings from the trial indicated a neutrophil count recovery time of 1.8 days and a febrile neutropenia rate of 2%.
The analyst from H.C. Wainwright highlighted the convenience and dosing flexibility of ROLVEDON, particularly its same-day dosing capability. This feature was seen as an incremental but potentially significant commercial differentiator.
https://www.investing.com/news/analyst-ratings/assertio-therapeutics-shares-get-buy-rating-on-clinical-trial-results-93CH-3774534

End of same day dosing hype.

I think you know the answer.

If the data had been outstanding, the company would have issued a PR on Nov 25. No need to wait until Dec 13. Most importing findings are already described in the abstract. Actual presentation won't add much.

The abstract is on SABCS website since Nov 25, 2024, not leaked. Data is OK, but Rolvedon won't be approved as same day injection. I don't think, it will boost sales much. Looks like market has same opinion. And ASRT doesn't even bother to issue a PR on these results.

Nothing really changed. Rolvedon doesn't look different from Neulasta and multiple biosimilars. Sales have remained flat over the last three quarters.

REDWOOD CITY, Calif., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus or the Company NASDAQ: CHRS,) today announced that it has entered into an asset purchase agreement (the Agreement) dated December 2, 2024, with Intas Pharmaceuticals Ltd. (Intas) for the divestiture of the UDENYCA (pegfilgrastim-cbqv) franchise for up to $558.4 million.

This trial was not design to demonstrate significant advantage. As you can read in the Conclusions, same day dosing "may be advantageous in reducing the time to ANC recovery". Just may be. This data will not result in label change, but it might be included in NCCN guidelines.

From the abstract
The primary endpoint was the time to recovery of absolute neutrophil counts (ANC) from nadir to ? 1.5×109/L in C1. Secondary endpoints included incidence of SN (ANC < 0.5×109/L) and FN (ANC < 1.0×109/L and temperature of > 38.3 oC or 2 consecutive readings ?
38.0 oC over 2 hours), duration of SN (DSN), and incidence of neutropenic complications, including use of antibiotics and/or hospitalizations.
Results: A total of 53 pts (mean [SD] age: 62.7 [11.9] years; female: 100%) from 13 sites across the US, were enrolled (White: 62.3%; Black or African American: 9.4%; others: 28.3%). Pts were relatively healthy (ECOG 0, 52.8% [n = 28] patients; ECOG 1, 47.2% [n =
25] patients). Efficacy in C1 was evaluable in 49 patients. Mean (SD) time to ANC recovery was 1.8 (1.1) days. Incidence of SN was 46.9% (n = 23) and mean (SD) DSN was 0.8 (1.0) days. Incidence of FN was 2% (n = 1). No neutropenic complications were observed during the study. Safety was assessed in all 53 patients who received at least 1 dose of eflapegrastim. Overall, 43 patients (81.1%) experienced any TEAE of musculoskeletal pain. Common musculoskeletal-related TEAEs experienced by ? 10% of patients were bone pain (52.8%; n = 28); back pain (26.4%; n = 14), arthralgia or pain in extremity (17.0%; n = 9 for each); and myalgia (13.2%; n = 7). No deaths were reported during the study.
Conclusions: These findings suggest that administration of eflapegrastim on the same day as TC chemotherapy may be advantageous in reducing the time to ANC recovery and related complications in pts with ESBC. The AEs observed in this study were consistent with those
generally observed in pts receiving TC and other GCSF products.

They will get info about efficacy and safety but they won't be able to conclude whether this regimen works better or not.

Same day dosing data will be presented at SABCS meeting by Lee Schwartzberg on December 13, 2024.
Abstract title is "Eflapegrastim, a long-acting GCSF, administered the same day as chemotherapy in patients with early-stage breast cancer: Results from a multicenter, open-label, study". Full abstract release date is November 25, 2024.

On earning call, they said that SPRIX might become an important asset due to NONPAIN act.
The NOPAIN Act expands patient and provider access to FDA-approved non-opioids in all outpatient surgical settings beginning in 2025 by providing separate Medicare reimbursement for non-opioid therapies.

Good analysis of today released data.
https://www.oncologypipeline.com/apexonco/black-diamond-joins-arrivent-pacc-pack

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.

The last paragraph in the PR is about NCM in newly diagnosed patients. Therefore, it makes sense to say about first line data first and second line data after it, even though expected data readout chronologically are in opposite order. But who knows. The recent share price decline looks suspicious.

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.

Raymond James initiated coverage of Black Diamond Therapeutics (BDTX) with an Outperform rating and $20 price target. The firm sees the potential for BDTX-1535 to potently target a broad spectrum of Estimated Glomerular Filtration Rate mutations in non-small cell lung cancer that are inadequately addressed by current standard of care, including non-classical EGFR mutations, osimertinib resistance mutations, and the L855R classical mutation, the firm tells investors in a research note.