[BuckeyeStocks]

U.S. approves first gene-editing treatment, Casgevy, for sickle cell disease https://www.cnbc.com/2023/12/08/casgevy-first-crispr-gene-editing-treatment-approved-in-us.html?__source=iosappshare%7Ccom.apple.UIKit.activity.CopyToPasteboard

[Monksdream]

What are the bleep are you talking about without pasting a chart to back up your assertion

[JJ8]

CRSP share price Spread Triple Top Breakout today on 06-Dec-2023. GLTA

[jondoeuk]

Smart move. Don't waste resources, learn from the clinical data and improve the pipeline https://finance.yahoo.com/news/crispr-therapeutics-announces-updates-immuno-211500451.html

[rayank]

Is the 12/8 FDA approval in the price already?

[JJ8]

CRSP share price Low Pole Reversal today on 04-Dec-2023. We had 3 sessions of trading in Dailies that was in Downtrend while the Weeklies are in Uptrend. It seems the Weeklies more likely to continue should this week the trend in Dailies continue to keep support of the Weekly Uptrend. We shall see. GLTA

[Monksdream]

UR welcome
I came across CRSP three years ago and learned about the discoverers of the technology, Jennifer Doudna and Emmanuelle Charpentier who shared the 2020 Nobel for chemistry
I have been following the technology since, including Jennifer Doudna’s Nobel lecture
Clustered
Regularly
Interspersed
Short
Palindromic
Repeats

[JJ8]

Interesting and informative analysis. Thanks for posting. GLTY & GLTA

[Monksdream]

Older YouTube interview with Sam Kulkarni CRSP CEO

[Monksdream]

Good capsule analysis by a YouTuber
Not all of them are shills

[JJ8]

CRSP share price Double Bottom Breakdown today on 30-Nov-2023. The Daily turned Downtrend in this trading session while the Weeklies are still in Uptrend as of this week. We shall see what path it may choose to follow. I am optimistic for the long term at this time.

[jondoeuk]

We should get data from the VCTX210 and VCTX211 trials next year https://news.ubc.ca/2023/11/27/stem-cell-based-treatment-for-type-1-diabetes/

[rayank]

9:10 am ET November 29, 2023 (Benzinga) Print
On CNBC’s "Mad Money Lightning Round," Jim Cramer said he would not buy CRISPR Therapeutics AG (NASDAQ: CRSP) stock "all the way up here. I think it’s got to come down a little because the stock is losing a lot of money."

[rayank]

Ok so maybe the FDA approval on Dec. 8th is already built into the price of CRSP during it's recent surge? That is kind of what I am thinking that if they do get the approval, that maybe it doesn't go up much more if any at all? But VRTX going down on the UK day of approval seems to me a puzzle?

[rayank]

The Wall Street Journal: https://apis.mail.aol.com/ws/v3/mailboxes/@.id==VjN-hiBNZAcI-lM8ByCu6y6Fx8t6dU8_Ph3pmNGylKIWMjCXfC_x8h62mmwyIcmu_FBw/messages/@.id==AKCdX-kLfEQZZWTGCgS3CFXbnrk/content/parts/@.id==2/thumbnail?appid=AolMailNorrin&downloadWhenThumbnailFails=true&pid=2

[YankeMike]

Yes, it has a bright future, and it will help so many patients along the way!

[rayank]

Wall Street Analysts Believe CRISPR Therapeutics AG (CRSP) Could Rally 33.75%: Here's is How to Trade
9:55 am ET November 20, 2023 (Zacks) Print
CRISPR Therapeutics AG (CRSP) closed the last trading session at $67.89, gaining 75.8% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $90.80 indicates a 33.8% upside potential.

The mean estimate comprises 20 short-term price targets with a standard deviation of $46.01. While the lowest estimate of $42 indicates a 38.1% decline from the current price level, the most optimistic analyst expects the stock to surge 224.1% to reach $220. It's very important to note the standard deviation here, as it helps understand the variability of the estimates. The smaller the standard deviation, the greater the agreement among analysts.

While the consensus price target is a much-coveted metric for investors, solely banking on this metric to make an investment decision may not be wise at all. That's because the ability and unbiasedness of analysts in setting price targets have long been questionable.

But, for CRSP, an impressive average price target is not the only indicator of a potential upside. Strong agreement among analysts about the company's ability to report better earnings than they predicted earlier strengthens this view. While a positive trend in earnings estimate revisions doesn't gauge how much a stock could gain, it has proven to be powerful in predicting an upside.

Here's What You Should Know About Analysts' Price Targets

According to researchers at several universities across the globe, a price target is one of many pieces of information about a stock that misleads investors far more often than it guides. In fact, empirical research shows that price targets set by several analysts, irrespective of the extent of agreement, rarely indicate where the price of a stock could actually be heading.

While Wall Street analysts have deep knowledge of a company's fundamentals and the sensitivity of its business to economic and industry issues, many of them tend to set overly optimistic price targets. Are you wondering why?

They usually do that to drum up interest in shares of companies that their firms either have existing business relationships with or are looking to be associated with. In other words, business incentives of firms covering a stock often result in inflated price targets set by analysts.

However, a tight clustering of price targets, which is represented by a low standard deviation, indicates that analysts have a high degree of agreement about the direction and magnitude of a stock's price movement. While that doesn't necessarily mean the stock will hit the average price target, it could be a good starting point for further research aimed at identifying the potential fundamental driving forces.

That said, while investors should not entirely ignore price targets, making an investment decision solely based on them could lead to disappointing ROI. So, price targets should always be treated with a high degree of skepticism.

Here's Why There Could be Plenty of Upside Left in CRSP

Analysts' growing optimism over the company's earnings prospects, as indicated by strong agreement among them in revising EPS estimates higher, could be a legitimate reason to expect an upside in the stock. That's because empirical research shows a strong correlation between trends in earnings estimate revisions and near-term stock price movements.

For the current year, 11 estimates have moved higher over the last 30 days while one has gone lower. As a result, the Zacks Consensus Estimate has increased 26.2%.

Moreover, CRSP currently has a Zacks Rank #2 (Buy), which means it is in the top 20% of more than the 4,000 stocks that we rank based on four factors related to earnings estimates. Given an impressive externally-audited track record, this is a more conclusive indication of the stock's potential upside in the near term. You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here >>>>

Therefore, while the consensus price target may not be a reliable indicator of how much CRSP could gain, the direction of price movement it implies does appear to be a good guide.

[rayank]

https://www.fool.com/investing/2023/11/14/2-stocks-to-buy-hand-over-fist-as-market-rallies/?source=eptyholnk0000202&utm_source=yahoo-host&utm_medium=feed&utm_campaign=article&yptr=yahoo

[YankeMike]

Yes, exciting times!

[rayank]

Yes that would be huge.

[YankeMike]

Nice, Dad! Yeah, December 8th is when we expect FDA approval...

-Exa-cel PDUFA target action date is December 8, 2023 for severe sickle cell disease (SCD)-

ZUG, Switzerland and BOSTON, Oct. 31, 2023 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP) today announced the completion of the U.S. Food and Drug Administration’s (FDA) Cellular, Tissue, and Gene Therapies Advisory Committee meeting for exagamglogene autotemcel (exa-cel) for the treatment of SCD in people ages 12 and older with recurrent vaso-occlusive crises (VOCs). Exa-cel is the first potential therapy to emerge from a strategic partnership between CRISPR Therapeutics and Vertex Pharmaceuticals.

If approved, exa-cel could be the first genetic therapy available to approximately twenty thousand people with severe SCD in the U.S. The FDA granted priority review for exa-cel in the treatment of people with SCD and assigned a Prescription Drug User Fee Act (PDUFA) action date of December 8, 2023. Exa-cel’s Biologics License Application (BLA) for transfusion-dependent beta-thalassemia (TDT) was assigned a PDUFA date of March 30, 2024.

[rayank]

Yes son I bought some at $67.96.

[JJ8]

CRSP appears to be in a strong bullish trend. Its 200-day moving average is upwards sloping and the MACD histogram is above 0. Comparative Relative Strength analysis shows that this issue is outperforming the S&P 500.

Momentum for CRSP is strongly bullish. The 14-period Slow Stochastic oscillator is above 80, the level which many analysts call overbought. This means that investors have been actively purchasing shares and driving the price higher.

The last 10-days have seen significant volume in CRSP, with average daily volume above the average for the last year. Today's volume is no exception; with 5,294,492 shares having been traded already. The On Balance Volume indicator (OBV) is bullish. The slope of the indicator is positive and suggests that buyers are presently more active than sellers. As of 12:09 PM ET Monday, 11/20/2023

[OldAIMGuy]

Since adding CRSP to my portfolio in May of 2022, there have been a few moments of hand wringing. However, trading around the core position has helped the overall cause. Currently, including the cash reserve, the position is up in value over 50%. Share price is up roughly 36%, so the opportunistic trading has added nicely to total return.



Best wishes,
OAG

[rayank]

[OldAIMGuy]

Nice response to today's news on product. It looks like there's been some good cost control going on as well.
OAG

[jondoeuk]

Q3 results https://uk.finance.yahoo.com/news/crispr-therapeutics-provides-business-reports-211500077.html

[jondoeuk]

The UK's MHRA has approved exa-cel. The therapy will be marketed as Casvegy in the UK for the treatment of sickle cell disease and transfusion-dependent beta thalassemia in patients 12 years or older. This marks the first regulatory approval of a CRISPR-based gene-editing therapy in the world https://www.businesswire.com/news/home/20231115290500/en/%C2%A0Vertex-and-CRISPR-Therapeutics-Announce-Authorization-of-the-First-CRISPRCas9-Gene-Edited-Therapy-CASGEVY%E2%84%A2-exagamglogene-autotemcel-by-the-United-Kingdom-MHRA-for-the-Treatment-of-Sickle-Cell-Disease-and-Transfusion-Dependent-Beta-Thalassemia

[JJ8]

CRSP share price Double Top Breakout today on 16-Nov-2023. Added more shares at $59.14 GLTA

PS: The Dailies and Weeklies are both in Uptrend in sync.

[Monksdream]

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

[Monksdream]

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

[jondoeuk]

Update https://www.fiercebiotech.com/biotech/fda-advisers-give-first-crispr-based-therapy-wave-through-satisfied-site-editing

[Monksdream]

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

[YankeMike]

Thanks for the info!!

[jondoeuk]

Briefing document https://www.fda.gov/media/173415/download

[jondoeuk]

Live feed (I think)

[jondoeuk]

FDA reviewers have reportedly raised questions about possible side-effects of the novel gene therapy for SCD developed by VRTX and CRSP that is currently being reviewed for approval by the agency. The reviewers have asked the FDA advisory committee set to discuss the therapy to consider requiring additional studies about potential side-effects of the therapy. The FDA panel is scheduled to discuss exa-cel's application next Tuesday, according to Reuters https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-advisers-consider-need-more-studies-vertexcrispr-gene-therapy-2023-10-27/

Reuters said the FDA reviewers did not appear to question the efficacy of the treatment. While the FDA is not bound to the recommendations of its advisory committees, it generally follows them. The agency's target date for deciding on whether to approve exa-cel is Dec. 8. RBC analyst Luca Issi told Reuters that reviewers' concerns seemed ''benign'' and expects additional studies only after the therapy is approved.

[jondoeuk]

Upcoming https://www.globenewswire.com/news-release/2023/09/27/2750466/0/en/CRISPR-Therapeutics-to-Present-at-the-Society-for-Immunotherapy-of-Cancer-SITC-38th-Annual-Meeting.html

[jondoeuk]

https://twitter.com/adamfeuerstein/status/1699413363623710803

[jondoeuk]

A new assessment released by the Institute for Clinical and Economic Review found that VRTX/CRSP's exa-cel and BLUE's lovo-cel would be cost-effective if priced between $1.35M and $2.05M https://icer.org/wp-content/uploads/2023/08/SCD_-RAAG_AUG-2023.pdf

Exa-cel has an FDA action date of Dec. 8, while lovo-cel's in Dec. 20. Regarding evidence of efficacy, ICER gave exa-cel a C++ rating, saying it would result in incremental net benefit, or result in substantial net benefit when evaluated against standard of care. For lovo-cell, the grade was B+, noting the treatment would provide at least an incremental benefit.

An independent appraisal committee overwhelmingly voted (13-1 for each therapy) that current evidence is adequate that both therapies provide a net benefit compared to the standard of care. ICER is also recommending that manufacturers and payers work together on alternative payment models for gene therapies. This is to address both the significant short-term budget impact of the treatments and the uncertainty surrounding their longer-term safety and benefits.

[jondoeuk]

2Q results https://uk.finance.yahoo.com/news/crispr-therapeutics-provides-business-reports-200100760.html

[jondoeuk]

No, but some anticipate a CHMP this year. As for the MHRA, I haven't heard anything.

[Monksdream]

CRSP bounced off the 200 day SMA