Scholar Rock Holdings Corporation (SRRK) 銘柄情報

super action

makes new highs consistently
Triple digits on the horizon

SRRK doing very well
almost two months since their "fake PR stunt" in SMA.
They believe this will go to market.

this is SMA not obesity.
Super news. Have some 50 shares left ---- to the finish line

$38 + 30% Nov 4 Obesity national crisis.. - Scholar Rock’s industry-leading anti-myostatin portfolio includes SRK-439 and apitegromab, the first investigational anti-myostatin therapy to show improved motor function in Spinal Muscular Atrophy (SMA) in a Phase 3 trial

SRRK under $30

see the share price this week.
The people behind the $ here.... dont get fooled by this.

over 60mn shares traded since the news were announced..... A lot of $$$. They are not "wrong"..
I really dont understand were you are coming from... Trial investigators are real and act independently.

This PR was NOT a fake stunt---- I suspect you just have a history with the stock?

that not science discussion, what SOC they compared against - standard palliative care or use of current therapeutics. they omitted the latter from inclusion. they know they are miles behind Spinraza Evyrsdi Zolgensma. compared against these SRRK is baby and need to go back to table and design the right Ph4 study. FDA won't look at current data for serious consideration. the PR was a fake stunt to raise two year worth of money cheaply but wolf cry won't work they did the same before. they fooled everyone again.

This beats the SOC and will likely replace it for years and thus generate billions in sales. 3 drugs are used for SMA, they generate 3.5bn in sales and one is for infants only. This might get 1bn in sales too.

do tell more on the science in complex high level - just wait for next 2 year till they do PH4 and show better efficacy -& less massaged data

SRRK Massive ????????????????? scheme

The next SRRK?
BFRI 2 Million floating 5 million market cap generating money from 2 FDA approved drugs deep pipeline 60% owned by tutes and insiders Roth gave $16.00 price target a few days ago.Cash flow positive in a few quarters. micro caps are flying lately.

$srrk

Why do you make all these claims if you dont understand the science?
The way this absorbed the offering..... should tell you a lot?

"Large bunch of lawsuits in the way" Why? You know trial investigators are real? You cant skew data in a PH3????

SRRK tricky pump raised 300M for 10.6M sh dilution in last two day. next going below 7 and a large bunch of lawsuits in the way

10.6M sh diluted by SRRK IN one day

holy crrrrraaaap
it was mistake to buy the otherday. selling it at a small loss before it goes back to 7s. it would be futile to hold here. obviously it was a institutional and insiders created hype and fraudulent propaganda event.

with the insiders cashing in in the high 20s like that, no one believes in new highs
They didnt believe in 30s in the first place?

I believe you are right about all that but the market potential.

Results are not optimal, yet this beats the SOC by a mile..... It will take many years (not sure exactly) until there will be another ph3 for SMA let alone we can judge the results.

Total SOC SMA drugs are 4bn in sales combined and this one is going to capture a large chunk of it, i dont know about the infants. This might go to 50 and beyond.

At least a year if at all approvable. srrk management stunt - questionable result and market potential.

getting disorderly now.....
enough with the arguing

SRRK: 'Monk' alerted this today --- if ya have WeBull --- at only $10. (WHO grabbed it then?? Did HE grab it??)

SOBR 200K Float Moving Fast SRRK Wow

300% is a nice gain take it no regrets but if doing a daytrade be a lot more careful

SRRK: And $80-per-share coming ANYWAY, despite what anyone on the Planet has to say!! (WOW!!!)



PS: And yet TRUTH-be-told, their "news" was pure STATISTICAL FLUFF!!!

SRRK: As usual, TW, MONSTER DD by ya!!! (And like you just noted, if they PR a little later today about DUMPING more shares to Market to pay their outrageous bills, whelp, TOILET FLUSH in price!!!)

short term, yes
longer term, with these results, someone will want to fund it and have a foot in the door.

A lot of offerings in issues with great data are absorbed fairly easily as in WVE as of late. It helps them finish the job.
(CADL might be a better comparison given the move)

SRRK they will need to do an offering so your ok .. The Company has incurred recurring losses since its inception, including net losses of $115.4 million and $77.3 million for the six months ended June 30, 2024 and 2023, respectively. In addition, the Company had an accumulated deficit of $791.8 million as of June 30, 2024. The Company anticipates that it will continue to incur significant operating losses for the next several years as it continues to develop its product candidates.

Good for you...I rode it years ago but have been out for a long time...🥳

SRRK: I avoided this puppy, Bro, and now it has just passed JUPITER!!! (Despite its outrageous price!!)

historical relief for patients
this EASILY beats Spinraza, Zolgensma(infants), and Evrysdi (1-1.5bn in sales each) in all the scenarios...

Early Barchart 100
https://www.barchart.com/stocks/performance/percent-change/advances?timeFrame=today&viewName=main&screener=overall&orderBy=percentChange&orderDir=desc

1 out of 3 patients aprox. saw some improvement.. current standard of care) at week 52
30.4% of patients receiving apitegromab had >3 point improvement in HFMSE versus 12.5% of patients on placebo

Open at $35 going to $20 and lower catch a dip .. Scholar Rock Reports Apitegromab Meets Primary Endpoint in Phase 3 SAPPHIRE Study in Patients with Spinal Muscular Atrophy (SMA)

Source: Business Wire
Apitegromab met primary endpoint with statistically significant and clinically meaningful improvement in motor function as measured by the gold standard Hammersmith Functional Motor Scale Expanded (HFMSE) for patients with SMA receiving apitegromab versus placebo (current standard of care) at week 52
30.4% of patients receiving apitegromab had >3 point improvement in HFMSE versus 12.5% of patients on placebo
Patients receiving apitegromab demonstrated early motor function improvement compared to placebo from the first measured time point at 8 weeks, benefit observed at 52 weeks as measured by HFMSE
Patients receiving apitegromab experienced clinically meaningful benefit in motor function across all age groups (ages 2-21)
Favorable safety profile in SAPPHIRE consistent with apitegromab’s long-term safety profile observed in the Phase 2 TOPAZ trial with >48 months of treatment experience in SMA patients
Scholar Rock plans to submit a U.S. Biologics License Application and European Union marketing authorisation application in Q1 2025
Scholar Rock to host Investor Call today at 8:00 AM ET
Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, today announced positive topline results from the Phase 3 SAPPHIRE clinical trial (NCT05156320) evaluating the efficacy and safety of apitegromab, an investigational muscle-targeted therapy, in patients with SMA.

The study achieved its primary endpoint demonstrating a statistically significant and clinically meaningful improvement for apitegromab versus placebo in motor function as measured by the gold standard HFMSE in SMA patients on chronic dosing of standard of care therapies (either nusinersen or risdiplam). Based upon the similar pharmacological profile of the 20 mg/kg and 10 mg/kg doses of apitegromab, the statistical analysis plan was prespecified to analyze both the combined dose (10 mg/kg and 20 mg/kg) compared to placebo, and 20 mg/kg dose each compared to placebo. Statistical significance is achieved per the prespecified statistical analysis plan (Hochberg multiplicity adjustment) where the p-value (≤0.025) is more rigorous if only one prespecified analysis crosses the statistical significance boundary of ≤ 0.05.

In the main efficacy population (ages 2-12), the mean difference in change from baseline in HFMSE was 1.8 points (p=0.0192) for all patients receiving apitegromab 10 mg/kg and 20 mg/kg (n=106) compared to placebo (n=50). Patients receiving 20 mg/kg of apitegromab (n=53) showed a 1.4 point mean difference compared to placebo (p=0.1149).

The prespecified analysis of the 10 mg/kg dose showed that patients receiving 10 mg/kg of apitegromab (n=53) showed an improvement of 2.2 points (nominal p=0.0121) compared to placebo.
Based upon PK/PD data from the SAPPHIRE trial, similar levels of target engagement were observed for the 10 mg/kg and 20 mg/kg dose groups.
Motor function outcomes were meaningful and consistent across the main efficacy population and in the ages 13-21 exploratory population, favored apitegromab (n=22) compared to placebo (n=10). Thirty percent of patients receiving apitegromab had >3 point improvement in HFMSE versus 12.5% of patients on placebo. Patients receiving apitegromab demonstrated early motor function improvement compared to placebo from the first measured time point at 8 weeks, benefit expanded at 52 weeks as measured by HFMSE. Following trial completion, 98 percent of SAPPHIRE patients (185/188) enrolled in the ongoing ONYX open-label expansion study.

“We are thrilled that apitegromab met the primary endpoint in our Phase 3 SAPPHIRE clinical study. The results clearly demonstrate robust and clinically meaningful improvement in motor function in patients with SMA,” said Jay Backstrom, M.D., MPH, President and Chief Executive Officer of Scholar Rock. “At Scholar Rock, we are working with urgency to deliver the potentially transformative benefits of apitegromab to children and adults with SMA in the US, Europe, and around the world.”

Treatment with apitegromab was well-tolerated across all age groups. There were no clinically relevant differences in the adverse event profile by dose, 10 mg/kg versus 20 mg/kg. No new safety findings were observed in the SAPPHIRE clinical trial; the profile was consistent with that observed in the Phase 2 TOPAZ clinical trial, including an extension study which had over four years of treatment as of the cut-off date. Serious adverse events (SAEs) were consistent with the underlying disease and current standard of care received by patients; no SAEs were assessed as related to apitegromab. There were no study drug discontinuations due to adverse events.

“We are grateful to the families and investigators who participated in our trials. The positive Phase 3 SAPPHIRE trial, along with over 4 years of TOPAZ clinical trial data, clearly demonstrate the potentially transformative benefit of apitegromab to drive clinically meaningful improvements in motor function as measured by HFMSE in a broad SMA population, where motor function would normally be expected to generally decline over time,” said Jing Marantz, M.D., Ph.D., Chief Medical Officer at Scholar Rock. “We look forward to submitting our applications to the FDA and the EMA in Q1 2025.”

The U.S. Food and Drug Administration (FDA) has granted Fast Track, Orphan Drug, and Rare Pediatric Disease designations, and the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) and Orphan Medicinal Product designations, to apitegromab for the treatment of SMA. The Company plans to submit a U.S. Biologics License Application (BLA) and a European Union marketing authorisation application (MAA) in Q1 2025.

“It’s a great day for people living with SMA and their families. These encouraging trial results mark a critical milestone for the SMA community,” said Kenneth Hobby, President of Cure SMA. “Declining motor function and hopes for reversing losses associated with muscle weakness are significant unmet needs, impacting activities of daily living, from breathing, eating, self-care, to working and social interactions. We need an approved therapy that can support motor function and further improve daily activities for people with SMA.”

Analyses of the full Phase 3 SAPPHIRE data are ongoing, and Scholar Rock plans to present detailed results at an upcoming medical conference in early 2025. Preliminary baseline characteristics from the trial will be presented during a poster presentation at the upcoming 29th Annual Congress of the World Muscle Society on Friday, October 11, 2024, being held in Prague, Czech Republic.

Conference Call Information

Scholar Rock will hold an investor confere

Um ..higher

Their is a God ! Thank You....yahooooo

SRRK under $10

SRRK under $10

SRRK under $10

Wow. Now a $7 stock

SRRK...$34.75...on the 100ma break...:party:
[11:57 AM]
georgie18 — 10/29/2021
SRRK...$27.34...Bullish Doji Star Reversal Pattern to the Upside as the Psar flipped Bullish...

Pincher Squeeze in play here...as the MACD Crosses Positive...Looking for a $40 Break/Hold...imo...we shall see...:party:

SRRK...$28.45...Lets see if we can Break/Hold the Upper Band today...as the Bollie Squeeze sets up here...imo...We shall see...:party:
[4:32 AM]
georgie18 — 10/29/2021
SRRK...$27.34...Bullish Doji Star Reversal Pattern to the Upside as the Psar flipped Bullish...

Pincher Squeeze in play here...as the MACD Crosses Positive...Looking for a $40 Break/Hold...imo...we shall see...:party:

SRRK...$27.34...Bullish Doji Star Reversal Pattern to the Upside as the Psar flipped Bullish...

Pincher Squeeze in play here...as the MACD Crosses Positive...Looking for a $40 Break/Hold...imo...we shall see...

Played this in the spring for nice profits...Back in again on this Pattern...

Chart... https://schrts.co/HtbEtPcc ...

SRRK...$31.62...on the 50ma Break to the Upside...:party:
[6:26 AM]
georgie18 — 05/24/2021
SRRK...$28.75...Took a starter on the Bullish Harami today...:party:

SRRK...$29.69...in the P/M...https://finance.yahoo.com/news/scholar-rock-presents-topaz-phase-113000823.html ...:party:

We`ll be back to higher highs soon.

SRRK...$28.75...Took a starter on the Bullish Harami today...CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for apitegromab, a selective inhibitor of myostatin activation, for the treatment of patients with Spinal Muscular Atrophy (SMA). Fast Track designation is intended to facilitate the development and expedite the review of drugs to treat serious conditions and get new drugs to patients earlier. Through Fast Track, Scholar Rock is eligible to submit a rolling Biologic License Application (BLA) for apitegromab if relevant criteria are met...

Scholar Rock Receives Fast Track Designation from the U.S. FDA for Apitegromab for the Treatment of Patients with Spinal Muscular Atrophy
https://www.businesswire.com/news/home/20210524005771/en/

Scholar Rock weakness overdone after TOPAZ results, says JPMorgan
JPMorgan analyst Anupam Rama noted that Scholar Rock shares are down about 15%, which Rama views as "overdone," after the company announced update 12-month results from the phase 2 TOPAZ study in the treatment of Type 2/3 Spinal Muscular Atrophy. The 12-month data showed relatively consistent functional benefit compared to six-month interim data reported in October, noted Rama, who added that "there were no major concerns" on the safety front. The analyst, who sees the "totality of data as a probability of success increase lever," reiterates an Overweight rating on Scholar Rock shares.

SRRK...$48.08...Back in on the Bullish Engulfing Candle on the Overbought Retrace...Psar will flip to a Bullish Buy Position this week...

Break/Hold $52 with no topside resistance and we make a run at $75/$100 range on this Blue Skies Chart...imo...we shall see...

Chart..https://schrts.co/wGhsGXPZ

georgie18 Wednesday, 10/28/20 06:38:13 AM
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SRRK...$34.85...in the PM...on this Blue Skies Chart set up...no topside resistance here...
[6:37 AM]
georgie1808/10/2020
SRRK...$14.22...Hod...just keeps gradually moving up off my $11.29 alert...I think $31 is coming here...we shall see...