Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
A detailed summary table for oral GLP-1s trials compiled by Goldman Sachs is listed at https://x.com/ohadhammer/status/1813573005873660330/photo/1
ARTV IPOs 16.0M* shares @$12.00:
https://finance.yahoo.com/news/artiva-biotherapeutics-announces-pricing-upsized-230800122.html
Pfizer’s blockbuster drug tafamidis for the treatment of the rare heart disease transthyretin amyloid cardiomyopathy (ATTR-CM) needs at least a 96% discount off its list price to be considered cost-effective under common benchmarks.
Specifically, the ICER report suggests that tafamidis—sold under the brands Vyndaqel and Vyndamax—should cost below or between $5,200 and $10,400 per year under two quality-adjusted life year (QALY) gained thresholds that are commonly used in cost-effectiveness reviews to help payers make decisions about drug coverage.
The range, even at its upper end, comes far below tafamidis’ current price, which is nearly $268,000 at the wholesale acquisition cost or around $194,000 after discounts. The tafamidis family has been a major growth driver for Pfizer, with sales up 36% last year to reach $3.3 billion.
https://www.fiercepharma.com/pharma/pfizers-attr-heart-disease-drug-needs-hefty-discount-says-icer-draft-report-what-about
AGEN -58% on FDA nixing of accelerated-approval pathway:
https://www.businesswire.com/news/home/20240718981038/en
FDA accepts Roche’s sBLA for Susvimo implant for DME/DR:
https://www.businesswire.com/news/home/20240718138245/en
Today, Roche also reported 2-year data from the two phase-3 trials whose 1-year data comprise the primary dataset supporting the sBLA.
Addendum—I would submit that ARDX’s lawsuit against Medicare is exactly the kind of case the US Supreme Court envisioned when reversing the longstanding “Chevron” doctrine of judicial deference to the interpretations of government agencies.
If ARDX were to allow CMS’s Part-D coverage decision to stand, they would probably go out of business in fairly short order.
It won't be long until private equity owns all of healthcare and that spells disaster.
Amarin announced today that Portugal health authorities have approved Vazkepa for reimbursement effective August 1, 2024. That reimbursement approval is the eighth such approval in Europe.
See post # 426,952 on AMRN IHub board for further details regarding Vascepa/Vazkepa use in treatment of patients to reduce patient risk of death, stroke, etc. from various aspects of cardiovascular disease, particularly patients that are afflicted with diabetes(like me, T1-D since 1957) and have one other risk factor(father and his 3 sisters each had deaths from heart disease as early as 1959 for my father, age 51, born in 1907). I was prescribed Vascepa in 2013, born in 1937 now age 87.
ARDX lawsuit vs CMS—>plainly motivated by SCOTUS “Chevron” decision:
https://www.globenewswire.com/news-release/2024/07/17/2914952/0/en/Ardelyx-AAKP-and-NMQF-File-Lawsuit-to-Protect-Dialysis-Patient-Choice-and-Timely-Access-to-Clinically-Meaningful-Medicines.html
Yes- many examples out there why obesity causes obstructive sleep apnea (OSA) and it has been known for years and years. And it's a reciprocal relationship because OSA caused sleep deprivation can make people gain even more weight. The title of the article that started this thread was "New Holy Grail for Weight-Loss Drugs: Sleep Apnea". Personally I don't think it's "New" or a "Holy Grail" for weight loss drugs. (The Holy Grail IMO is tolerability as I have stated many times before because tolerability is what is needed for everyone that needs these meds to be able to stay on them.).
The article itself is a good one as it comments on the fact that Lilly ran a trial so the FDA would have data that proves what everyone already knew about the link between obesity and OSA . Just maybe if someone with OSA lost weight they might get more sleep, not need a CPAP machine and not be so cranky during the day. The article might have been even better if they pointed out that it might payoff for insurers to cover weight loss drugs because of all the other comorbidities (CVD, joint , back problems etc.) unless everybody on them goes blind (NAION see #msg-174701898). Sorry if I'm a bit testy as I didn't get much sleep last night.
If anyone cares to no more about why being overweight causes OSA and vice versa, here is a link to an article and quote from a 2008 ADA publication:
Allogeneic CAR-T shows promise in autoimmune diseases:
https://www.fiercebiotech.com/biotech/allogeneic-car-t-cells-used-treat-autoimmune-disease-first-time
Caution: This is an n=3 dataset from a study conducted in China.
I am pretty confident these drugs will show a benefit for obese individuals with sleep apnea
there is a strong correlation between obesity and sleep apnea AFAIK
good to hear. As you know I have pointed out that drugs account for a small fraction of health care spending and the constant focus on drug pricing misses the larger picture of run away health care spending in this country (that is not to say there isn't room for some smart drug price reforms)
New Holy Grail for Weight-Loss Drugs: Sleep Apnea
https://www.msn.com/en-us/health/other/the-new-holy-grail-for-weight-loss-drugs-is-sleep-apnea/ar-BB1q0go4
Re: IRA drug-price “negotiations”
JNJ said on today’s 2Q24 CC that there were no unpleasant surprises on the IRA price negotiations for Stelara and Xarelto, two of the 10 drugs subject to 2026 price negotiation.
BMY, part-owner (with PFE) of Eliquis—the largest-selling drug subject to 2026 IRA price negotiation—is +5% today.
Fallout from Roche’s CT-996 data:
VKTX -13%
GPCR -12%
ZEAL.CO -8%
NVO -4%
LLY -3%
TERN -3%
Not affected: AMGN (flat).
The Zacks Analyst Blog Highlights Danaher, Morgan Stanley, Pfizer......
https://www.zacks.com/stock/news/2300964/the-zacks-analyst-blog-highlights-danaher-morgan-stanley-pfizer-elite-pharmaceuticals-and-oil-dri
Question: How do you avoid tolerability issues?
It slows your digestive system to a crawl, which has consequences.
Loss of muscle mass seems to be a continuing concern which won’t be ameliorated unless the doctor orders a gym membership or physical therapy to accompany weight loss. Perhaps losing weight by itself will lead to greater physical movement by the recipients of these medications, which will in turn help build back muscle and cardiovascular fitness.
Yes, weight loss in and of itself is a major bonus, as it would reduce the need for hip and knee surgery amongst highly obese people, as well as cardiovascular issues etc. The demand for weight loss drugs is projected to be $100 billion a year, so clearly people want it.
https://www.morganstanley.com/ideas/obesity-drugs-market-expanded-opportunity
Recent Biotech Bankruptcies/Liquidations/Dissolutions
[Added ASLN.]
*Emerged from bankruptcy as FCSC.
iHub
Company Date Reference
ACOR 4/24 #msg-174156166
ADLS 5/11 #msg-62813901
AFFY 6/14 #msg-103663749
AGIX 1/09 #msg-35019458
AKAO 4/19 #msg-148227772
ALNA 9/22 #msg-169875553
ALPIX.PA 11/23 #msg-173275218
ALTU 11/09 #msg-43509933
AMB.TO 8/09 #msg-40145970
AMPE 4/24 #msg-174111257
ANSV 1/10 #msg-45161615
ARAV 1/24 #msg-173646720
ARDM 2/19 #msg-146903332
ARLZ 8/18 #msg-142824112
ARNI 12/17 #msg-137120846
ARTE 12/08 #msg-33895436
ASLN 7/24 #msg-174767930
ASP.TO 1/23 #msg-171046860
ATHX 1/24 #msg-173589749
ATNX 5/23 #msg-171913749
AXLA 12/23 #msg-173374718
BAXS 11/14 #msg-108147336
BCART.BR 9/23 #msg-172903024
BIND 5/16 #msg-122328088
BIOA 5/18 #msg-140549553
Biolex 7/12 #msg-77324773
BPUR 7/09 #msg-39629524
BTTX 3/24 #msg-174037486
BVTI‡ 3/13 #msg-85440257
CALA 1/23 #msg-170898055
CBIO 6/22 #msg-169273606
CDAK 3/23 #msg-171544942
CJB.TO 7/10 #msg-52557510
CHKT 12/08 #msg-33949508
CLSC 8/09 #msg-40685152
CLVS 12/22 #msg-170599077
CRXT 9/22 #msg-170229149
CWBR 11/23 #msg-173138450
DCGN 11/09 #msg-43629379
DDXS 6/16 #msg-123229557
DMK 2/24 #msg-173773814
DMTK 6/24 #msg-174619409
DNDN 11/14 #msg-108004147
DXTR 12/17 #msg-136829445
Egenix 1/15 #msg-109921347
EIGR 4/24 #msg-174151841
ENDP 8/22 #msg-169707980
Epix† 7/09 #msg-39900524
EPRS 7/16 #msg-123687350
EYES 6/20 #msg-156388471
FRTX 9/23 #msg-172854853
GMDA 3/24 #msg-174125313
GNCA 5/22 #msg-168957883
GNTA 8/12 #msg-78123007
GTOP 9/08 #msg-32249160
HEMA 4/12 #msg-74167597
HGEN 7/23 #msg-172432338
HSTO 9/23 #msg-172847239
IGXT 5/24 #msg-174439828
ILIU 7/17 #msg-133264435
IMMG 8/17 #msg-134305213
IMNP 2/19 #msg-146936897
IMV 5/23 #msg-171814610
INFI 10/23 #msg-172941539
Inspiration 10/12 #msg-81024196
INSY 6/19 #msg-149302493
Introgen†† 12/08 #msg-33947783
Isolagen* 6/09 #msg-38746197
KBIO 12/15 #msg-119489701
KLDO 4/22 #msg-168491485
KV.A 8/12 #msg-78203130
LBPS 6/22 #msg-169255625
LHDX 2/22 #msg-171275021
LIAN 2/24 #msg-173835088
LMDX 12/23 #msg-173530663
MACK 2/24 #msg-173845049
MBRK 4/10 #msg-49658072
MBVX 3/19 #msg-151985211
MIIS 11/08 #msg-33720220
MIPI 12/10 #msg-57646943
MLNT 12/19 #msg-153074747
MNK 10/20 #msg-158843178
MRV.TO 3/23 PR link
NBSE 3/24 #msg-174119874
NEXI 11/23 #msg-173152495
NMTI 4/11 #msg-62251315
NMTR 7/23 SEC link
NOVN 7/23 #msg-172361873
NRGX 3/12 #msg-73415156
NRX 5/16 #msg-122331475
NSTG 2/24 #msg-173773766
NVDL 2/17 #msg-128923029
NVIV 2/24 #msg-173755991
NVLN 1/20 #msg-153111867
NVTA 2/24 #msg-173844970
OBSN.SW 2/24 #msg-173937364
ODT 3/21 #msg-162706983
ONCR 6/23 #msg-172037432
ONCS 6/23 #msg-172145325
OREX 3/18 #msg-139213097
ORPH 3/22 #msg-168169591
OSCI 7/09 #msg-39511719
OTIC 12/22 #msg-170737355
PEAR 4/23 #msg-171639648
PHAS 10/22 #msg-170272758
PLXP 4/23 #msg-171677346
PROMO.ST 10/23 #msg-173007859
PTX 2/19 #msg-146937356
PYMX 4/13 #msg-86313192
PZRX 12/17 #msg-136794351
QTNT 12/22 #msg-170676963
RCPI 8/16 #msg-127560117
REX 11/08 #msg-32189097
ROKA 8/17 #msg-133945967
ROSG 6/18 #msg-141797330
RUBY 2/22 #msg-171270235
RVALL 1/20 #msg-153358221
RVLP 10/23 #msg-173007859
RXPC 7/14 #msg-104103329
SGYP 12/18 #msg-145394802
SIEN 2/24 #msg-173834941
SIGA 9/14 #msg-106313111
SIOX 12/22 #msg-170699458
SNNA 9/19 #msg-151196707
SPHS 5/20 #msg-155712447
SRGA 6/23 #msg-172201878
SRNE 2/23 #msg-171193757
SVNT 10/13 #msg-92997648
TDLP 6/11 #msg-64744114
TLCV 12/09 #msg-44751578
TMBR 11/23 #msg-173254229
TOMDF 12/23 #msg-173490278
TPPH 2/08 #msg-26765260
VION 12/09 #msg-44654555
VLRX 2/20 #msg-153741993
VRA 10/07 #msg-18053275
VRAY 7/23 #msg-172361873
VVUS 7/20 #msg-156752080
ZSAN 6/22 #msg-169035970
ADVM—(-12%)—reports purportedly-positive interim phase-2 data_in wAMD:
https://www.globenewswire.com/news-release/2024/07/17/2914283/32452/en/Adverum-Biotechnologies-Presents-Positive-Ixo-vec-Clinical-Data-from-the-26-Week-Interim-Analysis-of-the-LUNA-Phase-2-Trial-at-the-2024-ASRS-Annual-Meeting.html
Note: The header of this post is almost identical to the header of the immediately preceding post, which is not a clerical error.
FDMT—(-34%)—reports purportedly-positive interim phase-2 data_in wAMD:
https://www.globenewswire.com/news-release/2024/07/17/2914359/0/en/4DMT-Announces-Positive-Phase-2-PRISM-Interim-Results-for-Intravitreal-4D-150-in-a-Broad-Wet-AMD-Population-Affirming-Favorable-Safety-Profile-and-Robust-Clinical-Activity.html
FDMT has risen either sharply or dropped sharply on each interim release from this trial.
It sure is crowded and is going to get even more crowded. There are a lot of undisclosed programs looking to advance.
I remain convinced that tolerability and safety will ultimately determine the degree of commercial success of any obesity/weight loss drug.
The Obesity field is getting crowded. I saw a mention regarding an oral route to maintain weight loss after stopping injections.
It'll be interesting.
Roche said it's oral qd obesity drug CT-996 demonstrated "clinically meaningful weight loss of -7.3% after four weeks of treatment" or -6.1% PBO adjusted.,(weight loss in placebo -1.2%; p < 0.001). They didn't release any tolerability data with the presser which is the norm for large pharma but they did say there were no discontinuations and said "The full study data will be presented at an upcoming medical meeting."
https://www.roche.com/media/releases/med-cor-2024-07-17
MNMD - MindMed - Patent July 19 - LYOPHILIZED ORALLY DISINTEGRATING TABLET FORMULATIONS OF d-LYSERGIC ACID DIETHYLAMIDE FOR THERAPEUTIC U.S. PATENT DOCUMENT
https://ppubs.uspto.gov/dirsearch-public/print/downloadPdf/12036220
XBI - pretty much sums it up (although the stocks I own should be up, lol)
https://x.com/RodriGo_ethe/status/1813290482652647555/photo/1
$PACB +67% #DDAmanda Video Analysis - #1 Stock Scanner/Screener
JNJ/BMY/AZN appeal lower-court dismissals_of IRA lawsuits:
https://www.fiercepharma.com/pharma/jj-bms-and-astrazeneca-strike-back-appeals-after-ira-litigation-loss-spring
It seems likely that at least one of these lawsuits will end of at the US Supreme Court.
VXRT .71 - continue to own a boatload...you just don't see under-a-buck biotechs receive such a huge commitment from the government? Looking forward to the first dosing...
Funds from the BARDA award will be used to conduct a 10,000-subject Phase 2b comparative study evaluating Vaxart’s oral pill COVID-19 vaccine candidate against a U.S. Food and Drug Administration (FDA)-approved mRNA vaccine comparator. With manufacturing preparations substantially complete and funding in place, Vaxart plans to initiate enrollment in this trial as early as summer 2024, pending regulatory alignment. An interim analysis for vaccine efficacy compared to an approved mRNA comparator may occur as early as the first quarter of 2025.
https://capedge.com/filing/72444/0001437749-24-020543/VXRT-8K/file/2
BCDA Phase 2 CellProthera and BioCardia Collaborate on Successful Phase II Trial of ProtheraCytes™ for the Treatment of Acute Myocardial Infarction
Pfe phase 2b data
https://pfizermedical.pfizerpro.com/api/vc/en/medical/assets/0f98ccb4-08bb-46d6-abfe-3a89b62dc8fc/Ibuzatrelvir%20Phase%202b%20Study%20results-updated%20poster%20%281%29.pdf
They had a placebo adjusted virologic response of .7-1.2
No data on clinical endpoints.
Their “modified full data set” only included patients with > 4 log baseline viral load. So median viral load was generally greater than 6 log. Enanta median was 5 at baseline.
PFE & etc
An heir to paxlovid
Covid is certainly killing and disabling a lot of people, but just because a disease kills and disables a lot of people doesn't mean that it's easy to prove that a drug reduces death or disability from that disease.
— Matthew Herper (@matthewherper) July 12, 2024
It really looked as if Shionogi's antiviral might be a better…
Malaria Shots From_Biggest Vaccine Maker Deployed in Africa
https://www.msn.com/en-us/health/other/first-malaria-shots-from-biggest-vaccine-maker-deployed-in-africa/ar-BB1q1g3H
More on the Roche CT-388 data (FierceBiotech):
https://www.fiercebiotech.com/biotech/roches-27b-carmot-bet-pays-phase-1-weight-loss-success
Roche reports 24w data_for CT-388 in obesity—(non-T2D)—cohort:
https://www.businesswire.com/news/home/20240515237076/en/Genentech-Reports-Positive-Phase-Ib-Results-for-Its-Dual-GLP-1GIP-Receptor-Agonist-CT-388-in-People-With-Obesity
I don't think the paper is flawed as long as the authors point out the biases that are inherent with this kind of a study. It's hypothesis generating at best, but for a rare condition that is hard to study prospectively is often a starting point. "Good" data will then always be needed to follow up on the *possible* association between drug and the AE.
The media attention is not helpful of course because it's not presented properly most of the time. It's a lot less sensational a headline when you point out the biases in such a study and there may not in fact be any link when studied more rigorously
MDWD $25M PIPE—>rumored SOLV deal is dead:
https://www.globenewswire.com/news-release/2024/07/15/2912942/30505/en/MediWound-Announces-25-Million-Strategic-Private-Placement-Financing.html
MDWD sold 1.45M shares @$17.20, a 19% discount to Friday’s closing price.
Likewise, my condolences.
Quality of life is important, especially if the prognosis is poor.
Having taken care of my wife for 3 years who passed from a glioblastoma at 33 I understand the question. It can be a challenge to not only get the diagnosis but also give up things that are part of your social enjoyment. I see the same
Issues with people struggling with many illnesses including weight loss.
I found this on the patient handout. I guess this answer the question. My friend likes a few drinks, not one drink, after another.
• The drinking of alcohol (in small amounts) does not appear to affect the safety or usefulness of lorlatinib.
"Just not sure they will follow thru with that suggestion [to check with their physician before drinking alcohol]"
Yeeeaah. That's probably just the changes in cognitive function that a significant number of pts can get) talking. If they do call, let us know what the response is - I've always wondered what the polite way of saying "You're f@king kidding me, right?" is.
Not at all, I suggested it also. Just not sure they will follow thru with that suggestion. I think they are trying to balance doing everything possible with keeping the fun quality of life activities in tact.
I was also thinking there may be some science involved that may make sense for tyrosine kinase inhibitors.
Thank you for your reply!
I'm hoping that suggesting they ask their oncologist (who has their full med history & can also confer with a pharmacist) isn't too obnoxious an answer.
OT. I have a friend with recurrent NSCLC. They are on lorlatinib 75mg. For quality of life they are wondering if they can consume alcohol moderately. Any science driven thoughts on how it may impact the effectiveness of this drug would be appreciated. Quality of life.
Thank you!
75 mg daily.
Followers
|
1525
|
Posters
|
|
Posts (Today)
|
0
|
Posts (Total)
|
252963
|
Created
|
11/14/02
|
Type
|
Free
|
Moderator DewDiligence | |||
Assistants Biowatch |
Biotech Values is a forum for discussing
all facets of biotech investing with an emphasis
on fundamental analysis and avoiding scams.
We generally do not discuss microcap stocks.
Compilations
Biotech Buyouts/Premiums
Oral Weight-Loss Drugs
Biotech-Newbie Misconceptions (see Reply chain)
Biotech Abbreviations and Acronyms
'Way Back' Archive (Greatest Hits 2003-2009)
Posts Today
|
0
|
Posts (Total)
|
252963
|
Posters
|
|
Moderator
|
|
Assistants
|
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |