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40 units of Jeuveau at $3.60/unit = best price: $144 COGS
40 units of Daxxify at $2.75/unit = best price: $110 COGS
Price them both the same and office makes $34 more profit with Daxxify.
I also feel strongly that 40U Daxxify will last longer than 40U Jeuveau.
Vin
After the fiasco with Revance I won't accept any beauty results from a clinical trial whereas the results are solely the decision of the patient. Revances #1 mistake was the promise of superiority.
If they promised little and delivered more they'd be king of the hill.
VNDA - the official version of the 'poison pill' has been posted...
https://capedge.com/filing/1347178/0001193125-24-099263/VNDA-8A12B
Is anyone able to make sense of this legalese mumbo jumbo? Ahhh, the promiscuity of the legal profession...
Evolus Announces Publication of Safety and Duration Data from Phase 2 Study for "Extra-Strength" 40U Formulation of Jeuveau®
Business Wire
Wed, Apr 17, 2024, 4:05 PM EDT9 min read
In This Article:
EOLS
-3.40%
The article published in Aesthetic Surgery Journal supports safety and duration of effect for temporary improvement in the appearance of moderate to severe glabellar lines presented at the 2023 ASDS Annual Meeting
Data showed duration effect of 26 weeks, or 6 months, based on a ≥ 1-point Glabellar Line Scale (GLS) improvement and return to baseline value using the Global Aesthetic Improvement Scale
NEWPORT BEACH, Calif., April 17, 2024--(BUSINESS WIRE)--Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a focus on building an aesthetic portfolio of consumer brands, today announced that the Aesthetic Surgery Journal has published the safety and duration of effect results from the Phase 2 study of 40U Jeuveau® (prabotulinumtoxinA-xvfs) for the treatment of moderate to severe glabellar lines in adult patients.
The "extra-strength" glabellar line study is a multicenter, double-blind, randomized, Phase 2 trial following 150 patients for up to 12 months or until the patient loses their correction. The study has three arms: Jeuveau® Extra-Strength 40U and two active controls, BOTOX® 20U and Jeuveau® 20U.
Efficacy results demonstrated 26 weeks, or 6 months duration across the multiple metrics presented, including the time it took for patients to return to their baseline GLS score after their treatment, the duration of effect for a patient with at least a one-point GLS improvement, and the time it took a patient to return to their baseline using the Global Aesthetic Improvement Scale. The safety profile was similar across all three arms and overall, 88.9% of adverse events were rated as mild and no serious adverse events were identified.
"This publication provides the details of the study design along with the efficacy and safety data from the Phase 2 Jeuveau extra-strength study and makes it accessible to all," said Dr. Rui Avelar, MD, Chief Medical Officer and Head of R&D of Evolus. "The study confirms the correlation between increasing dose and increasing duration, while maintaining a similar safety profile, with the majority of adverse events rated as mild."
Thanks, Doc (eom).
I believe its entirely or almost entirely due to the actual weight loss. The same phenomenon was seen in the bariatric surgery literature with similar results and seen across the board for different surgical techniques (slight exception with Lap Band showing less weight loss and less AHI reduction). Blinding is of course difficult with bariatric surgery and many of these are uncontrolled studies. Other weight loss drugs have also seen good OSA data. Though results were pretty much a foregone conclusion, the main positive for the GLP-1's is that this data will help to get insurance to cover patients who do not have DM/hyperglycemia
Here's a review
https://www.sciencedirect.com/science/article/pii/S217351151630046X?via%3Dihub
As you stated:
It's not a chicken-and-egg question, IMO. After we see the full dataset, we can form reasonable suppositions as to whether Zepbound has a direct effect on OCA, or merely an indirect one. For the direct effect to have credibility, there has to be a plausible MoA (i.e. something other than weight loss).
How_Much_Does Weight Loss_Help_with Sleep Apnea?
https://www.healthline.com/health/sleep-apnea/sleep-apnea-weight-loss
Weight loss tends to reduce problems with sleep apnea (and snoring,) so I’m not sure how you can disentangle the two questions.
I.e., which came first, the chicken or the egg? If weight loss reduces sleep apnea, and weight loss drugs reduce weight, are they specifically reducing sleep apnea or is that a beneficial side effect?
Net bad news for the stock need for a booster would have far outweighed any new barrier to competing vaccines that this creates
Good news/bad news for GSK’s Shingrix:
https://www.gsk.com/en-gb/media/press-releases/new-long-term-data-show-shingrix-continues-to-provide-high-protection-against-shingles-in-adults-aged-50-and-over-for-more-than-a-decade/#
Shingrix’s protection is longer lasting than most people expected. Corollary: It’s unlikely that patients will need booster shots (beyond the initial two-dose regimen).
I couldn't tell from the article whether OSA symptoms were reduced concomitant with weight loss -which would be expected - or were a direct result of the exposure to the drug?
LLY’s Zepbound—>statsig clinical benefit_in sleep-apnea phase-3 trials:
https://www.fiercepharma.com/pharma/eli-lillys-tirzepatide-scores-again-time-2-sleep-apnea-trials
GLP-1, Parkinson’s Disease, and Neuroprotection
Author: David G. Standaert, M.D., Ph.D. https://orcid.org/0000-0003-2921-8348Author Info & Affiliations
Published April 3, 2024
N Engl J Med 2024;390:1233-1234
DOI: 10.1056/NEJMe2401743
VOL. 390 NO. 13
https://www.nejm.org/doi/full/10.1056/NEJMe2401743
VNDA implements poison pill in response to unsolicited takeover proposal:
https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-adopts-limited-duration-stockholder-rights-plan-302119627.html
Bluebird management should read and learn this!! wtf !! K & Q’s too !! Delayed again!!
PACB—Slow payment by customers would boost the Accounts receivable line, but it wouldn’t reduce revenue (unless some of the payments were deemed unrecoverable). There must be another explanation for the revenue flatlining.
ABT 1Q24 results and guidance:
#msg-174255199 1Q24 results/2024 guidance
#msg-174255202 Sales/growth by business segment
The timing of this presentation should coincide with data from the Shionogi drug. They announced completion of enrollment in December but said the trial would be kept blinded for 3 months to get 12 week data on symptoms for a look on drug effect on long covid (they are planning to follow patients for 6 months total).
VNDA 5.00 (premarket) - Future Pak Confirms Proposal to Acquire Vanda Pharmaceuticals for $7.25 to $7.75 Per Share in Cash
https://finance.yahoo.com/news/future-pak-confirms-proposal-acquire-103000446.html
Enanta Pharmaceuticals Announces Data Presentation at ESCMID Global 2024
Apr 17, 2024
WATERTOWN, Mass.--(BUSINESS WIRE)--Apr. 17, 2024-- Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for indications in virology and immunology, today announced that data from the company’s SPRINT (SARS-Cov-2 PRotease INhibitor Treatment) study of EDP-235 has been accepted for a poster presentation at ESCMID Global 2024 (formerly ECCMID) being held April 27–30 in Barcelona, Spain.
The poster presentation includes primary and post-hoc analyses from the double-blind, placebo-controlled Phase 2 clinical trial of EDP-235, a 3CL protease inhibitor, in non-hospitalized, symptomatic adults with mild or moderate COVID-19 who were not at high risk for severe disease.
Poster Title: “Efficacy and Safety of EDP-235 in Non-Hospitalized Adults with Mild or Moderate COVID-19: Results from the Phase 2 SPRINT Study”
Abstract Number: 02980
Poster Number: PO423
Day: April 27, 2024
Time: 12:00 p.m. CEST / 6:00 a.m. ET
Session Location: Poster Area
Session Title: COVID-19 (incl virology, epidemiology, evolution, immune response, diagnosis, treatment, vaccination, prevention, response and societal impact)
Presenter: Scott T. Rottinghaus, M.D., Chief Medical Officer, Enanta Pharmaceuticals, Inc.
The scientific program for ESCMID Global 2024 can be found at https://www.eccmid.org/scientific-programme
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-announces-data-presentation-escmid-global
With interest rates through the roof, congress diddling with the accelerated depreciation deductions and the questions surrounding the economy I'm seeing many mid sized companies sitting on their hands recently.
The big boys are buying, they just don't like paying.
Mondelez just submitted a contract stating that their current terms are that they will pay on the 3rd Friday of the month which will be no sooner than 210 Days after the invoice is accepted.
PACB—(-44%)—pre-announces flat 1Q24 revenue:
https://www.prnewswire.com/news-releases/pacbio-announces-preliminary-first-quarter-2024-revenue-and-updates-2024-revenue-guidance-302117738.html
<<<< Hire a secretary or someone to track expenses…
Correct annual reporting is a must for any small business—and a legal requirement for all publicly traded companies. Learn more about how to create annual reports for your business…
If you've never created an annual report before, we strongly recommend meeting with a financial advisor (such as your CPA, business banker, or bookkeeper) to discuss how and why to draw up annual reports. Your financial professional can advise you on what reports to create, then help you interpret the results to make wise business decisions moving forward. >>>
What are you talking about???
EWTX. well here's the 24 mth open label data to hopefully derisk their program
https://ih.advfn.com/stock-market/NASDAQ/edgewise-therapeutics-EWTX/stock-news/93659509/edgewise-therapeutics-announces-positive-two-year
Kiwi
Hire a secretary or someone to track expenses…
appreciate the reply
thanks
ONVO—Other FXR agonists for NASH (most notably ICPT’s Ocaliva) have failed due to pruritis and/or liver toxicity, so ONCO’s FXR314’s low rate of pruritis at the tested doses is what stands out. The question is whether the drug has enough efficacy at these doses to do more than merely reduce liver fat.
I didnt see any ONVO posts on this board, so any opinions welcome on todays NEWS
Organovo Announces Positive Phase 2 Results for FXR314 in Metabolic Dysfunction-Associated Steatohepatitis (MASH) Showing Both Reduction in Liver Fat Content and Strong Safety and Tolerability Compared to Placebo $ONVO https://t.co/qqgRlzGZXz
— Health Stocks News (@health_stocks) April 15, 2024
RZLT. P2 DME trial ending approximately next week ...now data chk / cleaning etc ...results probably late next month .
Anyone else following this ?
https://ir.rezolutebio.com/news-events/press-releases/detail/322/rezolute-completes-enrollment-of-its-phase-2-study-in
Kiwi
CARM belatedly released their earnings on April 1ST. No accounting issues were at hand yet the company did announce a cost cutting restructuring (pipeline and workforce) along with the resignation or perhaps removal of a director. During the two year working relationship with Moderna the company seems to have come to the revelation that they are a Car-Monocyte platform company as opposed to a company focused on ex-vivo CAR-Macrophages in oncology. Their analogy is Car-Mono works like a pro-drug of Car-Macro, monocytes are being converted into macrophages within tissue, with a 5x higher dosing advantage and one day development time as oppose to five days for Car-Macro.
https://ir.carismatx.com/static-files/6fb480b2-625c-4101-9118-a0623cac87ef
There's a lot to discuss on slide 6 of the 04/24 investor presentation. The prudent cost cutting measure of halting development of CAR-Macro CT-0508 makes sense along with the continued clinical advancement of the ex-vivo oncology construct CT-0525+Pembro in HER2+ solid tumors. What doesn't make sense is labeling CT-1119 a "Next-Gen CAR (*using SIRP knockdown technology)", which targets mesothelin+ solid tumors, yet at the same time halting pre-clinical development of this program while advancing an unnamed CAR in liver fibrosis which is still in the discovery stage. For now CT-1119 only looks good as a CAR-Mono pipeline placeholder in a company trying to rebrand itself. How else can they make themselves look good? Would it be in CARM's best interest to make their sole development partner look bad?
Two years ago MRNA signed an exclusive, worldwide, in-vivo, CAR-Monocyte license for twelve co-developed constructs in oncology.
https://www.prnewswire.com/news-releases/moderna-and-carisma-establish-collaboration-to-develop-in-vivo-engineered-chimeric-antigen-receptor-monocytes-car-m-for-oncology-301456651.html
If you look at slide 6 you will see the two MRNA partnered constructs are listed as CAR-Macrophages in their pipeline. Carisma goes through great lengths to downplay their ex-vivo CAR-MACRO constructs and highlight their ex-vivo CAR-Mono constructs yet it appears there's a chance the partnered constructs may be mislabeled. If they are mislabeled is MRNA aware, perhaps condoning mislabeling for competitive purposes? Or is there a legal disagreement that may have led to the late 10-K filing in which CT-1119 is shelved and a director axed? You can read through the entire now released CARM 10-K and you will never see "Moderna" and "CAR-Monocyte" in the same sentence. Only the ambiguous, generic term CAR-M which is highly subjective.
BTW the company refuses to answer my questions on this topic.
US_district_court pauses MRNA’s patent-infringement suit vs PFE/BNTX pending USPTO input:
https://www.reuters.com/legal/litigation/pfizer-wins-pause-modernas-covid-19-patent-lawsuit-2024-04-12/
(EGRX)—For reasons that are unclear to me, more and more biotech companies are failing to file SEC reports on time; here’s the latest instance:
https://www.globenewswire.com/news-release/2024/04/12/2862382/0/en/Eagle-Pharmaceuticals-Announces-Receipt-of-Notification-of-Deficiency-from-Nasdaq-Regarding-Requirement-to-Timely-File-Annual-Report-on-Form-10-K.html
EGRX has not yet filed either the 2023 10-K or the 3Q23 10-Q!
Screaming into the void
I’m holding what I have but not buying. I’d like to think it can’t go much lower but it continues to surprise me.
If I sell here, I lock in my losses. If I hold here, I can’t lose much more than I would have if if if I’d sold at 36 when I had the chance.
BTW, saw the total eclipse of the sun on Monday. That was amazing.
ENLV—(-54%)—reports purportedly-positive phase-2 data in sepsis:
https://finance.yahoo.com/news/enlivex-announces-topline-results-phase-120500002.html
Judge dismisses LLY lawsuit against unauthorized Mounjaro compounding pharmacy:
https://www.law360.com/healthcare-authority/policy-compliance/articles/1823803/pharmacy-gets-eli-lilly-s-mounjaro-suit-tossed
The judge ruled that only the US government has standing to enforce FDA regulations on drug compounding.
The article is behind a paywall, but the full first sentence is: “A Florida federal judge tossed Lilly's lawsuit against a Miami compounding pharmacy on Wednesday, ruling that Lilly can't ‘use state law as a back door to privately enforce the Federal Food, Drug, and Cosmetic Act’.”
Market has no patience these days. RVNC was focused on fixing the damage caused by the initial launch
So we need a few quarters to see if the relaunch will bring success but market already written it off
It’s cheap but it seems bottomless.
I have been adding here and there, it’s plain ugly
alertmeipp
Rvnc has to close to a bottom at this point. I would like to buy but after the whipping it gave me last year I won't touch it.
Revance will never become the company that we all hoped for but it can play in this field. It needs a new vision.
Can you do one for RVNC? Lol.
It is trading like it is going out of business soon
ALPN - another company where someone posted on this board
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=99588181
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