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I'd prefer a 129% gain instead of a 0.69% gain...but I'm weird though.
;)
Someone on a different thread mentioned that it's because Oramed didn't provide any details. Maybe Nadav will go into depth about the results today at the H.C. Wainwright 24th Annual Global Investment Conference. The stream starts in about two hours.
If Oramed got the same gains today as Akero, our stock price would be over $11 bucks.
I just was about to post the same thing.
Why the huge price jump for Akero Therapeutics today while Oramed is in red territory for essentially the same positive news for its Nash drug? I don't understand the reason why there is a huge difference.
BTIG analyst Ryan Zimmerman reiterated a Buy rating on Avita Medical (RCEL – Research Report) today and set a price target of $16.00.
Oramed Reports Positive Top-Line Results from Phase 2 NASH Trial with its ORMD-0801, Oral Insulin Candidate
https://seekingalpha.com/pr/18936923-oramed-reports-positive-top-line-results-from-phase-2-nash-trial-ormdminus-0801-oral-insulin?source=content_type%3Aall%7Cfirst_level_url%3Aportfolio%7Csection%3Aportfolio_content_unit%7Csection_asset%3ApressReleases%7Cline%3A1
AVITA Medical Achieves Positive Topline Pivotal Trial Results for Treatment of Stable Vitiligo Using the RECELL® System
https://seekingalpha.com/pr/18935815-avita-medical-achieves-positive-topline-pivotal-trial-results-for-treatment-of-stable?source=content_type%3Aall%7Cfirst_level_url%3Aportfolio%7Csection%3Aportfolio_content_unit%7Csection_asset%3ApressReleases%7Cline%3A1
AMLX is up 77% in pre-market and as expected and is pushing up BCLI as well (+10.25% in pre-market). If my guess is right, I would expect to see Brainstorm stock up 20+% by the closing bell today.
I'm really curious to see what their stock price will jump to tomorrow. I assume that it will be similar to Brainstorm stock if they get the same kind of good news.
AMLX passed the FDA committee vote 7 yes, 2 no, 0 abstain.
I wonder how much that news improves Nurown's odds for FDA approval.
Well, if Oramed gets FDA approval, all of us here will be great investors!
;)
The potential of this product is a factor but getting rich from choosing the stock is also a big factor. For example, me buying Apple and turning my $7,000 investment to over $325,000 is friggin' awesome. I'm hoping for that awesome feeling again if Oramed gets FDA approval.
;)
This is what stood out to me from that article:
The results for the Phase 2 Nash trial and the Phase 1 (cohort A) covid pill trial are supposed to be released between now and the end of September.
Then, the next big news will be the Phase 3 Diabetes clinical trial results in January.
ORMP: Upcoming data from ORA-D-013-1 & NASH studies could be catalysts
https://finance.yahoo.com/news/ormp-upcoming-data-ora-d-131500205.html
Watching Oramed Pharmaceuticals; Zack's Small-Cap Research Sets $38 Valuation
https://www.benzinga.com/analyst-ratings/price-target/22/08/28637202/watching-oramed-pharmaceuticals-zacks-small-cap-research-sets-38-valuation
I just read this on the HotCopper boards:
BCLI: Filing a BLA for NurOwn® for the Treatment of ALS…
https://finance.yahoo.com/news/bcli-filing-bla-nurown-treatment-141600304.html
This stood out to me:
RECELL® System Data to be Presented at the Controversies and Conversations in Laser & Cosmetic Surgery Annual Meeting
https://seekingalpha.com/pr/18908998-recell-system-data-to-be-presented-controversies-and-conversations-in-laser-and-cosmetic?source=content_type%3Aall%7Cfirst_level_url%3Aportfolio%7Csection%3Aportfolio_content_unit%7Csection_asset%3ApressReleases%7Cline%3A1
Brainstorm Cell Therapeutics (BCLI) Receives a Buy from Maxim Group
https://www.tipranks.com/news/blurbs/brainstorm-cell-therapeutics-bcli-receives-a-buy-from-maxim-group?mod=mw_quote_news
I don't have a Facebook account so can someone go to the No More Excuses! ALS Watch Dog Group - Facebook page and put up a posting informing them that Brainstorm is running low on cash and that they should do a fundraising event for Nurown. If the FDA approves the Nurown BLA, No More Excuses can use that money to help Brainstorm get up and running as fast as possible.
The one thing that I'm wooried about:
Brainstorm Cell Therapeutics Inc.'s (BCLI) CEO Chaim Lebovits on Q2 2022 Results - Earnings Call Transcript
https://seekingalpha.com/article/4534421-brainstorm-cell-therapeutics-inc-s-bcli-ceo-chaim-lebovits-on-q2-2022-results-earnings-call?source=content_type%3Aall%7Cfirst_level_url%3Aportfolio%7Csection%3Aportfolio_content_unit%7Csection_asset%3Alatest%7Cline%3A1
I'm confused about what happened to the stock price today.
It shoots up to $4.70 with the announcement of the FDA filing and then gets pushed down to where it started by the closing bell. Was that pullback caused by shorters? I was expecting a huge bump to the stock price after that great news...weird.
ABOUT FRIGGIN' TIME!!!
That is fantastic news! Does anyone know approximately how long it would take for the FDA to approve Nurown after Brainstorm's BLA filing?
Just a reminder that Brainstorm's 2nd quarter earnings call is on Monday morning @ 7am central time.
https://www.webcaster4.com/Webcast/Page/2354/46290
Just noticed that too. I wonder what caused that spike.
Monday, August 15, 2022
8:00 AM Eastern Time
AVITA Medical GAAP EPS of -$0.25 beats by $0.15, revenue of $8.34M beats by $1.18M
AVITA Medical (AVHHL) plans to submit PMA supplement for this new indication to FDA by the end of 2022
VALENCIA, Calif. and MELBOURNE, Australia, Aug. 11, 2022 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) (Company), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, today announced topline results from its pivotal randomized, controlled trial evaluating the safety and effectiveness of the RECELL System combined with meshed autograft for reduction of donor skin harvesting in soft tissue reconstruction. Injuries considered for the clinical trial included any full-thickness acute skin defect, such as degloving or peeled back skin injuries, road rash, surgical wounds, and flesh-eating disease.
“Soft-tissue injuries can be challenging to treat and I am very pleased with the outcomes using RECELL – especially the use of less donor skin when treating a variety of injuries,” said Dr. Steven E. Mapula, Assistant Professor of Surgery TCU and Division Chief of Plastic Surgery at John Peter Smith Hospital. “Following FDA approval, I look forward to utilizing RECELL broadly to help patients with a wide variety of soft-tissue injuries.”
The study design included co-primary endpoints, based on pairwise comparisons where each subject received both RECELL used in combination with widely-meshed skin grafting and the Control treatment of conventional skin grafting; one endpoint had a hypothesis of superiority for donor skin sparing and the other co-primary endpoint had a hypothesis of non-inferiority for healing. Preliminary review of adverse events shows consistency with our years of prior RECELL experience, reinforcing the product’s compelling safety profile. The primary study outcomes are as follows:
The donor sparing endpoint was met, showing a superior ratio of treated injury area to donor site area (p<0.001) with RECELL versus Control
The healing endpoint did not reach pre-specified statistical non-inferiority, however, observed values for healing with RECELL were the same or slightly better than Control
“Our study has shown statistically superior donor sparing and comparable healing rates for RECELL treatment of soft tissue injuries and we are confident in moving forward with our plan for a PMA submission later this year,” said Dr. Mike Perry, Chief Executive Officer of AVITA Medical. “The RECELL System has been used to effectively treat serious burn injuries and we anticipate that the RECELL System will be well-positioned to treat patients with soft-tissue injuries, pending FDA review and approval.”
The Company also plans to submit detailed results from the trial for peer-reviewed publication.
Skin grafting is the standard of care for soft tissue reconstruction, including post-trauma and post-surgical skin reconstruction. Skin grafting requires the harvesting of donor skin, resulting in an additional wound to the patient. Significant pain, delayed healing, risk of infection, the need for multiple procedures, discoloration and scarring are associated with donor site wounds. The total addressable market (“TAM”) for soft tissue repair is approximately $1 billion and more than twice as large as the TAM for burns. Further, if FDA approved, the existing reimbursement codes utilized for burn treatment with the RECELL System will apply to this indication.
AVITA Medical, Inc. Second Quarter 2022 Earnings Conference Call
8/11/2022, 4:00:00 PM CDT
https://register.vevent.com/register/BIf7194e08023144519bdc1637b8691927