Assertio Holdings Inc (ASRT) ニュース

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.

Hi dcaf7! We're still hanging in there on this company! What is your opinion about how this same day dosing will play out in terms of NCCN guideline possibility and sales with our without the NCCN guidelines? You sounded pessimistic in the past, but you apparently are still following this, so maybe you have not given up hope?

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

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

Interesting that they are presenting at a business summit, not scientific conference (which they have already done). What do they expect to gain? Is this for the insurance industry?

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.

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.

Now we have the PR.

I think you know the answer.

So no chance of Rolvedon '24 (and 25) sales being more than 175m to pay out the CVR from Spectrum?

Here is ChatGPT comparing Rolvedon same day with Neulasta next day..
https://media.stocktwits-cdn.com/api/3/media/510403/medium.png
https://media.stocktwits-cdn.com/api/3/media/509105/medium.png

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.

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"

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.

I'm referring to the same-day dosing of Rovedon. The full abstract from ASRT has been leaked on San Antonio Breast Cancer Conference website, which is definitely positive news. It has the potential to boost sales and is gaining attention, but the stock doesn't seem to be moving upward. Any thoughts on why that is?

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.

Hey guys, any idea why this stock isn't moving up? Rolvedon looks promising and definitely has long-term potential. The info seems to be out there, and the street is aware of it, but it’s not gaining any momentum. Any thoughts?

got it, thanks dcaf7!

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.

dcaf7, thanks for sharing this. I'm not an expert in this area, so I'm not sure if this study offers a significant advantage over existing ones. What’s your take on it?

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.

Thanks dcaf7 🙏

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

Hello Dcaf7, based on the full abstract being released on Nov 25th, can the experts evaluate whether same-day dosing is effective and works better?

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.

H.C. Wainwright starts Assertio at buy.
The investment bank said it believes Rolvedon could reach peak annual sales of around $140M in the early 2030s. It added that “long run positive traction” from products such as Rolvedon, Otrexup and Sympazan “ought to drive renewed interest from investors.”
The bank set its price target at $4.

ASRT.......................https://stockcharts.com/h-sc/ui?s=ASRT&p=W&b=5&g=0&id=p86431144783

ASRT................................https://stockcharts.com/h-sc/ui?s=ASRT&p=W&b=5&g=0&id=p86431144783

Heather Mason recently purchased 25K of ASRT shares.

A meta-analysis of the effect of pegfilgrastim biosimilars and eflapegrastim on DSN was presented at ASCO. "Additionally, eflapegrastim, another long-acting granulocyte-colony stimulating factor agent, significantly reduced DSN compared to conventional pegfilgrastim (WMD, n = –0.13 days; 95% CI –0.24 to –0.03; P = .01). The researchers recommended “exploring the impact of the drug in clinical settings on costs and patient-reported outcomes could provide valuable insights into optimizing the management of chemotherapy-related neutropenia.”
https://www.centerforbiosimilars.com/view/asco-2024-posters-showcase-positive-data-on-denosumab-pegfilgrastim-biosimilars

bought some shares today. Gaurantee the stock will tumble now!

Rolvedon/eflapegrastim is a new molecule. You cannot call it "novel formulation". Novel formulation of what? Neulasta? Nonsense.

dcaf7, please elaborate on what you mean?

Listened to yesterday ASRT presentation. They call Rolvedon a "novel formulation" (slide 5). Looks like these guys don't know what Rolvedon really is.

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”.

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!

ASRT.........................https://stockcharts.com/h-sc/ui?s=ASRT&p=W&b=5&g=0&id=p86431144783

ASRT 10Q due March 11

I don’t have an answer about what does it mean. I can explain why they will finish it earlier. Because they reduced the number of patients from 90 to 50. Good sign is that trial is still enrolling. It means they think that a positive outcome is still possible. What is next if the data is good? In my opinion, for approval they need to conduct a larger trial. Not sure if they want it.

The same day dosing trial for R has moved forward its study completion date from june 2025 to july 2024. Thoughts? Is this a good sign and if successful, what is next?

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)

ASRT new 52 week low

What is interesting, Coherus said their injector is more patient friendly than what is used in Onpro. So, it looks like a competition of injectors now. Is it possible to win Neulasta market by introducing a better injector? Unexpected twist.

Good question, dcaf7!

Shares of Coherus BioSciences (NASDAQ:CHRS) surged 36.4% after the FDA had approved an on-body injector version of the biosimilar – Udenyca for post-chemotherapy treatment Neulasta.
https://seekingalpha.com/news/4050413-biggest-stock-movers-today-coherus-biosciences-bit-digital
It will make more difficult for Rolvedon to compete. Why Spectrum or Assertio didn't start on-body injector program in addition to same day dosing?

Hi ATLcitizen! Good to see you here. I think physicians view Ryzneuta the same way as Rolvedon. No clear differentiation from Neulasta. Assertio should work on same day dosing. As for Poziotinib, I don't know. I don't see any new trials with Pozi but I see several drug candidates in development that are less toxic. I found interesting document describing what exactly Spectrum did to be acquired. It looks like Hanmi was considering to buy Spectrum.
https://www.sec.gov/Archives/edgar/data/1808665/000110465923071264/tm2315184-6_s4a.htm
This acquisition story is described on pp71-82 step by step. Board was interested to sell the company when TR became a CEO. "Following the appointment of Thomas J. Riga as Spectrum’s President and Chief Executive Officer effective January 1, 2022, the Spectrum board of directors engaged in discussions regarding potential strategic alternatives at each of its regularly scheduled meetings and authorized Mr. Riga and the Spectrum management team to explore potential strategic alternatives".