Assertio Holdings Inc (ASRT) Options

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".

What a shocker. I thought Pozi was dead. What do you think Hanmi is trying to do- get approval for 3rd line treatment? What about the whole dosing and side effects problem that FDA issued a CRL for--is Hanmi addressing that as far as you know? Do you know if MDA is still interested in investigating Pozi or have moved on? TIA.

Hi dcaf7! Found you again! What do you think of Ryzneuta?

Ryzneuta was approved 3 weeks ago. Second "novel" long-acting G-CSF. Acrotech is going to market it in the US. It is same company that markets five Spectrum drugs.
https://acrotechbiopharma.com/wp-content/uploads/2023/11/Evive-and-Acrotech-Announce-FDA-Approval-of-Ryzneuta.pdf

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.

Hanmi is ready to conduct a Phase 4 study "Reducing Neutropenia Incidence With Pegfilgrastim Administration on Day 3 After Chemotherapy (NEUTHREE)". Title is misleading since they are using Eflapegrastim (Rolvedon), not Pegfilgrastim (Neulasta). You can see it in official title, "Reducing Neutropenia Incidence by Changing the Date of Eflapegrastim Administration in Breast Cancer Patients Who Have Experienced Neutropenia After Chemotherapy". Here is a rationale for this study, "It is known that patients who experience neutropenia after the first round of chemotherapy are more likely to experience it again in subsequent rounds. The investigators aimed to see whether changing the pegfilgrastim administration date from day 1 to day 3 starting from the second round of chemotherapy for patients who experienced neutropenia after receiving pegfilgrastim on day 1 of the first round can reduce the incidence of neutropenia".
https://classic.clinicaltrials.gov/ct2/show/NCT05949333?term=eflapegrastim&draw=2&rank=2

very disappointing earnings release . . . . and the insiders all sold their stock to cover taxes on their options . . . . sure, whatever you say

wow that has been kept quiet. I presume it will be discussed in the quarterly earnings call

Hanmi posted 3dQ results. In their presentation you can find, "pan HER - preparing for global phase 3 trial" with Assertio as a partner.
http://www.hanmi.co.kr/upfile/ces/information/INFORMATION_PRESENTATIONS/90166507/127540fe-3519-4cb1-95bb-0ce29cb172ee.pdf

From VA Formulary Advisor.
Projected Place in Therapy/Conclusions
• In 2 phase III clinical trials in patients with early breast cancer receiving myelosuppressive chemotherapy for 4
cycles in the adjuvant setting, eflapegrastim was non-inferior to pegfilgrastim in reducing the duration of severe
neutropenia during cycle 1 (primary endpoint) and during cycles 2-4 (secondary endpoint). Pooled rates of febrile
neutropenia for this chemotherapy combination without G-CSF prophylaxis are 29.1%.
• Safety during the clinical trial (adverse reactions in ≥20%) was similar between eflapegrastim and pegfilgrastim
despite the fact that eflapegrastim provides a lower dose of G-CSF compared to pegfilgrastim. The package
labeling for both products contains the same contraindication and Warnings and Precautions.
• There is no clear place in therapy for eflapegrastim instead of pegfilgrastim.
https://www.va.gov/formularyadvisor/DOC/466

Ha ha. Good job. Posted by Defense World Staff on Aug 25th, 2023. Equities research analysts at StockNews.com began coverage on shares of Spectrum Pharmaceuticals (NASDAQ:SPPI – Get Free Report) in a note issued to investors on Friday. The firm set a “hold” rating on the biotechnology company’s stock.

Rolvedon vs biosimilars cost.
The final 2 articles highlighted in this issue of the Medical Letter address the question of cost. The first notes the recent approval of the new bone marrow stimulatory agent eflapegrastim-xnst (Rolvedon) for the prevention of chemotherapy-induced febrile neutropenia. The agent was FDA approved based on the results of 2 randomized trials in which it demonstrated noninferiority in one trial and possible superiority in the other trial vs pegfilgrastim (Neulasta).

Although there should always be interest in discovering novel, increasingly effective, less toxic approaches to supportive care measures in cancer management, the question here is the value of such agents vs less expensive biosimilar agents employed for this purpose. One dose of eflapegrastim is said to cost $4500 compared with pegfilgrastim biosimilar costing approximately $2500. This sum is not insignificant considering the common use of bone marrow stimulatory agents by oncology practices and health care systems, as well as the financial impact on third-party payers or as increasingly mandated insurance co-pay for individual patients.
https://www.onclive.com/view/unresolved-issues-in-antineoplastic-drug-therapy-is-it-finally-time-to-address-

A few quotes from the call from Dan Peisert

"We believe we can certainly accelerate the path to profitability, and possibly accelerate the trajectory to a broader reach than what the in-person team has been able to do to date to drive awareness to physicians as well as to purchasing managers."

"... should enhance our access to the capital markets at a lower cost of capital than either company had on a standalone basis and accelerate our future M&A strategies so we can leverage both our platforms with complementary assets..."

"...but the synergies will come largely from the contracting and the access teams that will be a tremendous benefit to rest of the Assertio portfolio"

Dan Peisert also noted that this accelerate their plans and be highly accretive in 2024 and that this is a blockbuster product. There was some mention of 600+ clinics that Spectrum had access to whereas ASRT had access to 2000+ clinics. So the Spectrum product will get advertised more broadly than before, ASRT will probably get access to new clinics and relationships with their non-contact platform.

The ASRT purchase conference call
https://events.q4inc.com/attendee/994427686/guest?t=1682444171300

WOOOOOOOOOOW 2-10K BUYS, ONE 5K BUYS. SMART MONEY BUYING NOT SELLING $$$$$$$$$$

well now..seems like this is the ground floor..saw it a while back and forgot about it so i could have gotten in earlier but im happy.. this is a real equity building event they will leverage some very important assets to shoot the moon.. the best part is the cash position and cfp of many milions a year.. a cash cow..,,enjoy while we can

i dont want to see the 5 dollar space anymore i want 50 but not today because i am doubling up tomorrow.. this is the one that gets me back in the game just need to be patient

221000 SHARE BUY ON THE CLOSE $$$$$$$$$$$$$$$$ OVER MIL $ BUY

shorts having a field day

Going up ~

$Assertio Holdings Inc This is a very smart move by the company, here is why and what it does. In short, buy the friking dip.
These transactions?? reduce our overall debt by $30M, or 42.9%, while consuming only $10.5M in cash (and issue ~$7M shares). In addition, the transactions will ??save the company $2M in annual interest payments, reduce the potential dilution from the exchanged convertible notes by 4.6%, and will be accretive to our diluted EPS by $0.02 in 2023," CEO Dan Peisert commented.

??????????????????????????????