dcaf7
6 months ago
Rolvedon pediatric study is a postmarketing requirement from FDA. If it was up to Spectrum, they wouldnβt 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 βno overall differences in safety were identified between adult and pediatric patients based on postmarketing surveillanceβ. As for same day dosing, I think, nobody knows what the next step looks like. Depends on data. Three years ago, JT said βIf data is good, we would engage in a discussion with the FDA to path forwardβ. About a year ago, TR said the same, βwhether 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 dataβ.
ATLcitizen
6 months ago
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
7 months ago
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
10 months ago
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.
crawford2012
2 years ago
$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.
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yankee2
3 years ago
ASRT $3.00 Looking good so far
https://www.barchart.com/stocks/quotes/ASRT/technical-chart?plot=CANDLE&volume=total&data=DO&density=X&pricesOn=1&asPctChange=0&logscale=1&indicators=BBANDS(20,2);SMA(13);PTP(50);SRSI(14,14);WILLR(14,40);ADX(14);ACCUM;MACD(12,26,9);RSI(14,100);SMA(50)&sym=ASRT&grid=1&height=500&studyheight=100
glta