dcaf7
3週前
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
dcaf7
3週前
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
KRISGO
1月前
It looks like the company will be presenting these results at a conference on December 13th. The following message is from a poster named "D_S" on StockTwits.
"D_S: Nov 29, 2024 9:44 AM : $ASRT The abstract link showed back up again on the San Antonio Breast Conference website. ASRT's abstract is there. As such there is not an "embargo" on them releasing a pr. However, that pr can only discuss the abstract information, not fully discuss the research. It's part of the requirement to have research presented at this conference----they want the research discussed first there. So here is my opinion.....if same-day dosing results are only to be about the convenience of patients not having to go to a 2nd day visit, then ASRT puts out a simple pr on day of poster presentation (after market closes). If same-day dosing results are showing (as we think from analysis of abstract) that giving the infection on day of chemo reduces severe neutropenia vs next day dosing, then I think there could be chance of cc call (on top of pr) to discuss implications. CEO needs the stock price up to give him options for future large acquisition potentially, but at least to give investors confidence"
dcaf7
1月前
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.
dcaf7
1月前
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.
dcaf7
2月前
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.
dcaf7
10月前
Rolvedon pediatric study is a postmarketing requirement from FDA. If it was up to Spectrum, they wouldn’t run it because of small commercial opportunity and approved Neulasta. I think completion of Phase 2 is what ASRT needs to accomplish. I doubt phase 3 will be required but they need to complete current study and to show the results to FDA that can happen 3-4 years away from now. As for Neulasta you can find that “no overall differences in safety were identified between adult and pediatric patients based on postmarketing surveillance”. As for same day dosing, I think, nobody knows what the next step looks like. Depends on data. Three years ago, JT said “If data is good, we would engage in a discussion with the FDA to path forward”. About a year ago, TR said the same, “whether that be going to chat with FDA about a regulatory path forward, whether it is publication, it is really contingent upon what we see in that data”.
ATLcitizen
10月前
A couple questions. A few days ago, a phase 2 study showed pediatric patients tolerated Rolvedon without requiring dose reduction. I could not copy link, but can find on Stocktwits ASRT from poster Avedesian. What is the significance? Does this mean Assertio may market to pediatric patients now, or phase 3 required? Also, this poster says that Neulasta and biosimilars required dose reduction for pediatric patients. Does this mean R is safer? How does this differentiate R from Neulasta and biosimilars? Next question: Hanmi recently said in interview with a Korean biopharma news that they expect R to be successful in their same day dosing trial to get a 'competitive edge'. IMO this appears to be a sign that they will continue with another study if the current study is successful. Another poster on X, claiming to be a doctor (this was copied on Stocktwits) said that they expect it to be short study due to requiring only one cycle of treatment. Any ideas of how long to complete another study, including enrollment? Should this be a quicker study? TIA!
dcaf7
11月前
Hanmi Pharma said it has signed a strategic agreement with its U.S. partner company, Assertio Holdings, which previously acquired Spectrum Pharmaceuticals, to re-acquire the rights to Rolontis, a long-acting neutropenia treatment and Korea's 33rd novel drug, for the Asian and African markets.
Published 2024.02.02
?? : KBR(https://www.koreabiomed.com)
dcaf7
1年前
On Hanmi. Brokerages raise stock price targets for Korean traditional pharma citing licensing deals, export gains.
Daishin Securities set the target prices for Hanmi Pharm and Yuhan Corp. from the current 315,500 won and 63,300 won to 420,000 won and 92,000 won, respectively. Hanmi has strengths in the continued steady profit growth through the sales of key products like Rosuzet, Amozaltan family, and Rolvedon.
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