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IOVA just stated they have in excess of 100 patients enrolled for commercial treatment in 2nd line melanoma. They do not book revenue until the treatment in injected so that means their 1st quarter of sales (June 30th) will exceed $60 mil. Nice start.
Correction—RVNC’s 1Q24 non-GAAP operating expenses were $73.6M, consistent with the low end of the 2024 guidance range of $290-310M.
Note the Department of Justice, Antitrust Division, PR 24-591, announcement of the formation of a task force to investigate
HealthCare Monopolies and Collusion.
RVNC formally launches Daxxify for cervical dystonia:
https://investors.revance.com/investors/Press-Releases/news-details/2024/Revance-Expands-into-the-U.S.-Therapeutics-Market-with-the-Launch-of-DAXXIFY-for-the-Treatment-of-Cervical-Dystonia/default.aspx
Kind of down the middle. Step in the right direction.
RVNC reports 1Q24 results—reiterates 2024 guidance:
https://investors.revance.com/investors/Press-Releases/news-details/2024/Revance-Reports-First-Quarter-2024-Financial-Results-Provides-Corporate-Update/default.aspx
1Q24 financial highlights
• 1Q24 Daxxify sales were $22.1M, -8% QoQ — due to $2.0M of redeemed coupons and normal seasonality in the aesthetics business — and +44% YoY.
• 1Q24 Daxxify volume (units shipped) was +7% QoQ.
• 1Q24 dermal-filler sales were 29.6M, -14% QoQ and -2% YoY.
• Cash at 3/31/24 was $277.1M, a $23.2M increase relative to 12/30/23 due to $94.0M of net proceeds from the Mar 2024 public offering.
• 1Q24 non-GAAP operating expenses (excluding COGS) were $68.9M, slightly below the quarterly run rate for RVNC’s full-year 2024 guidance of $290-310M.
2024 guidance
• RVNC re-iterated 2024 guidance for product revenue (Daxxify + RHA) of >=$280M.
• RVNC re-iterated 2024 guidance for non-GAAP operating expenses of $290-310M.
My daughter also takes a compounded GLP-1. Cheaper injection. $400 for 2 months but she is only half max
Dosage. Helped her autistic behaviors more than her weight .
I was recently in Cancun and they were selling highest dose GLP-1 for $400.
Have you heard much about behavior changes? I m curious if the behaviors are improvements since my own daughters behaviors are better, and I have heard of
cases where depression and addiction have been helped
Compounded GLP1's - Glad your brother has found something that works for him especially given the diabetes. The majority (99%?) of these compounded GLP1's are legit but unfortunately you never know when you might get the something which is not the real thing or worse. IMO- one needs to be especially wary of Medspa's offering compounded weight loss drugs. Barron's had some comments on this some time ago and so did I. (See #msg-172259286)
Minor detail- The article you referenced says that NVO can't take action on their own and I don't know what the basis might be if they were suing those providing compounded semaglutide.
RAPT- Trading for a little more than cash on hand but hard to see much value in what's left.
My brother (who has a good job but lousy insurance) has been doing a compounded semaglutide for the past 6 months at about $125/month. It comes in vials instead of a pen so he has to draw up and inject. It is apparently bought in bulk by the compounding pharmacist (drug probably from Asia)and each batch is chemically verified and tested. He's lost 30 pounds and DM is well controlled. It looks like Novo is aware of the compounded pharmacies and has sued some. I have no idea how much this path cuts into profits as compounded pharmacies would not be reporting script data.
https://www.reuters.com/business/healthcare-pharmaceuticals/compounded-semaglutide-poses-serious-us-health-issue-novo-nordisk-ceo-says-2024-03-08/
Let me preface this post by offering full disclosure:
I own substantial position in Protara and I am NOT trying to pump( already posted the forgoing piece on another thread that ‘promotes’ posters ‘flavor of the day’)… I’m merely asking if anybody follows the Bladder cancer space and more specifically NMIBC??
This company -- ImmunityBio (IBRX) rose more than 75%(late April ) after the US Food and Drug Administration approved a combination of the company's Anktiva immunotherapy and the Bacillus Calmette-Guerin bacterium in patients with a form of non-muscle invasive bladder cancer that previously was unresponsive to BGC therapy….
Protara is in clinical- PH2’s)but an Oppenheimer analyst see’s potential with a 8 fold target price( currently trading below cash) and today Tipranks put out a piece that is propelling stock higher:
https://blog.tipranks.com/these-2-strong-buy-penny-stocks-could-surge-over-400-says-oppenheimer/
I know most talk about tickers that trade teens and higher, but curious if anyone has a position or at least follows space ?? Thanks in advance
( PS- large position in RVNC and look forward to todays Q1 and CC ..GLTA
RAPT—(-34%)—ends_clinical_programs_in atopic dermatitis and asthma:
https://finance.yahoo.com/news/rapt-therapeutics-reports-first-quarter-120000252.html
In Jan 2024, NVO restarted selling lower-dose strengths of Wegovy in the US, which had been curtailed in Jun 2023 due to supply constraints. The reintroduction of lower-dose strengths lowered the average selling price for Wegovy in 1Q24 relative to prior quarters.
NVO- this may be old news from last week but while the market for GLP1 based drugs for T2D/Obesity drugs continues to expand on a dollar basis, it is worth noting the price is declining slightly in the US for NVO’s drugs according to the CFO “as volumes and competition have increased...” In the US it is possible that LLY’s Trizepatide is starting to affect what NVO is doing with Ozempic/Wegovy. Or it could be that this could be because of political pressure or because supply issues are being taken care of and the drug is more available with NVO wanting to maximize share. Here is the link:
https://www.reuters.com/business/healthcare-pharmaceuticals/novo-nordisk-wegovy-ozempic-prices-us-fell-q1-2024-05-02/
FWIW- a similar article also appeared around British pricing which indicated that both Mounjaro (from LLY) and Wegovy (from NVO) prices were falling. They indicated the reason was competition between on-line pharmacies, not cuts by the manufacturer so a different reason than the US price decline for Wegovy. Note that Tirzepatide (aka – Mounjaro) has not yet been approved in Europe for Weight loss yet. Mounjaro is for T2D and Wegovy is for weight loss but the drugs are often conflated into being for the same things.). Also worth noting was the price for the starter dose of Mounjaro at 159 pounds ($198) has now gone to 149 pounds ($186) which is unsurprisingly considerably less than the US List price of approx. $1000! Here is the link for that story:
https://www.reuters.com/business/healthcare-pharmaceuticals/british-pharmacies-vie-weight-loss-patients-with-drug-price-cuts-2024-05-02/
Thank you https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174382614
$CTMX hilarious price action. From press release, it was obvious partial responses were seen in pancreatic cancer and not yet in other cancers. Those partial responses are ongoing. Yet after a waterfall plot is shown market is newly skittish ?
— avidresearch (@avidresearch) May 8, 2024
CTMX—(-37%/AH)—My reading of the PR is that they had only 2 partial responses among 51 enrolled patients in all cancer types. The PR obfuscates, but it didn’t fool investors, evidently.
https://finance.yahoo.com/news/cytomx-therapeutics-announces-positive-initial-201000477.html
$ctmx 4 to 9 then hellacious fall to 2 thoughts anyone?
basically went all the way back to its offering price almost a year ago
Private Placement 14,423,077 $2.08 11,538,462 $30,000,000 BVF 2023-6-30 8:00
https://dilutiontracker.com/app/search/CTMX
$CTMX +83% AH, EGFRxCD3 surprising findings:
— BayAreaBiotechI (@BayAreaBiotechI) May 8, 2024
1. It's a masked Probody but they are still step dosing and using tocilizumab prophylaxis
2. From a basket of EGFR+ cancers, the only PRs are in panc?? CRC, NSCLC, HNSCC, gastric, and esophageal all enrolled $JANX pic.twitter.com/NWjmqbZDV9
DeepMind’s AI can predict protein structure & interactions
DeepMind’s AI can ‘predict how all of life’s molecules interact with each other’
https://www.msn.com/en-us/health/other/deepmind-s-ai-can-predict-how-all-of-life-s-molecules-interact-with-each-other/ar-BB1m2sAE
Urine test identifies high-risk prostate cancers
https://www.nih.gov/news-events/nih-research-matters/urine-test-identifies-high-risk-prostate-cancers
MDGL- Recently I came across some old notes that I never posted on what Madrigal said at JPMorgan back in January but never posted them. I was going to post something when MDGL got approval for Rezdiffra but got busy and never did. I did listen to MDGL’s cc when they got approval and they said the same things they said at JPM except they got clarity on the label which was as good as could be expected in that no Biopsy would be required for diagnosis treatment.
In any event I thought it would be worthwhile to post what CEO Bill Siebold said back in January to what has transpired since. In many respects, everything he said has tracked with what happened and is happening now so he appear to have a really good handle on reality. (Bill Sibold was at Sanofi Genzyme and heavily involved with Dupixent and looks to have a pretty impressive track record.)
Here are my old notes from January:
- While there are 1,500,000 diagnosed with NASH, and 525,000 have significant fibrosis only 315000 are actually seeing specialists (F2/F3) - these 315,000 are the target patients MDGL is pursuing. (Source - Forian Claims Data)
- ICER (Institute for Clinical and Economic Review) cost effectiveness is $39,5600 to $50,100 (Mufaso update- MDGL list price for Rezdiffra set at 47k)
- Don’t think Label will support F4 use and won’t go after it. (Mufaso update- Label doesn’t support F4 usage)
- MDGL is conducting “Outcomes trial” (in well compensated Nash (f4) currently looking at this which will take 36 months) F0 and F1 managed other ways.
- Its progression of Fibrosis that leads to bad outcomes
- 1st program to hit on both NASH Resolution and >= 1 stage fibrosis improvement. Plus impressive LDL cholesterol data
- Depth of response is 90% when you have had either NASH Response or >=1 stage fibrosis improvement
- Note- Placebo effect where there was a liver fat reductions was only associated with NASH res and not Fibrosis improvement-very important point when comparing to GLP1’s (Mufaso update note- this was before the data on Tirzepatide in the SYNERGY-NASH trial became available which suggested Tirzepatide had a “clinically meaningful” effect on fibrosis improvement. See #msg-173784185)
- Safety- when patient pop is on other drugs- noted that discontinuations were higher in placebo at 52 weeks than resmetirom - also placebo and TEAEs were similar between placebo and treatment arms- also in 100mg group most AE discontinuations were GI related with incidence decreasing after first few weeks
- No drug induced Liver injury events (DILY)
- Ready to go with specialty launch on Mar 15th (hiring now) - not just hiring for launch but for 2-3 year period (CEO worked with Dupixent) Will stay focused where they studied (F2 and F3)
- Have patients that are waiting for this drug to be approved…
- Will biopsy be required? – Don’t think Biopsy will be part of label or indication. Not sure yet on label because first- even if label is broad – not changing who they go after and if its narrow (f2 f3- that’s fine- when they have data in F4 from outcomes trial and then it would be a target (Mufaso update- the label did not require biopsy for diagnosis so MDGL/Sibold was spot on back in January on this point)
- EPI numbers are larger that everyone has heard- who already had a coding for NASH (is 1.5 Million) see below for EPI definition (Mufaso note- I didn't know what "EPI" was so I looked it up- Epi Patient Based definition->Epidemiological or epi-based forecasting. This is a patient-based approach where the starting point is typically a country’s population or sub-population based on age or gender. Then a disease prevalence rate, a diagnosis rate and a treatment rate are applied. This defines a target population in terms of number of treated patients.)
- Still need to have conversations with payers.
- How will patients diagnosed? MDGL understanding that only 2-3% of patients have biopsy- one of the challenges is Biopsy takes a narrow piece and not definitive (not like basel cell carcinoma)- newer experts moving away from biopsy because there are other NIT techniques that allow diagnoses with certainty in these experts view-that is a - combination of blood tests and imaging- right now the standard is fib4 and Fibroscan – other like MRI and MRE and Blood work like Elf – right now no one paying attention cause what do you do- no drug available till now- think everyone will figure out how to sequence tests
- GLP1 perspective – one big diff – they have clinical data on reversal of fibrosis- pdff placebo helped validate this - does it translate to MOA- they think so…GLP1 can play in the area where you try and prevent. But for someone who has NASH F2/F3, you take time to do titration of dose and more- will you be willing to wait to see if weight loss has impact before fibrosis progresses?
Overall, the MDGL plan seems to be a realistic one and they will be on the market without competition for at least 3 years.
MDGL- Rezdiffra supposedly has coverage currently in place for 30% of the US according to the article you referenced:
Thanks. Very helpful. (EOM)
More on MDGL’s Rezdiffra launch:
https://www.fiercepharma.com/pharma/remarkable-interest-madrigal-touts-early-launch-progress-first-mash-drug-rezdiffra-despite
Tirzepatide(Mounjaro/Zepbound) and the drugs that are coming to treat obesity (and T2Diabetes) is the main reason the market is not interested in investing in MASH. Obesity is the main risk factor for having fat accumulate in the liver which in turn is the main cause of Fibrosis/Inflammation. Diabetics who are obese are especially at risk. These multi agonist GLP1's are showing promise in reducing liver fat for those that already have it and will theoretically reduce the number of people who develop MASH.
The treatment for MASH before MDGL's rezdiffra became available was weight loss with alcohol intake stopped or at least no more than 30grams a day (2 standard beers). While not especially effective, simple weight loss which is easier said than done, did work at times to stop progression and sometimes reverse the progression (the liver is the only solid organ in the human body that can regenerate itself after damage as it can regrow to its normal size even after up to 90% of it has been removed.)
The jury is out on whether the market sentiment is right here as there are many factors. There are a lot of people who have MASH F2-F4 now and it will be a while before the GLP1's can make a real impact due to supply constraints (5-10 years?) Once you find out you have MASH, do you want to try an "inferior" treatment to see if it works. Plus, genetics can play a role as skinny people can get NASH as well so obesity is not the only cause.
I'm not sure I understand the question
doctors south of the equator are going to have sick kids too and I don't think they are less apt to enroll on a per pt basis. The youngest cohort is the one in whom Beyfortus could lower incidence and severity of disease, so that could slow enrollment. There are also fewer sites in that part of the world. So the risk is that they have to go back to the northern hemisphere for peds too and enroll in sept-nov and data can get pushed to Q1 2025 I guess. The RSV season in places like south Africa are already peaking so I would hope that the second half 2024 guidance still holds.
Note that infants who get beyfortus are likley to get RSV the following season because it is only passive immunity so their immune system is still naive to the virus once it is out of the system in 6 months, so the commercial impact is less than most think - it shifts to older ages, where you are less susceptible to more severe disease which is good, but you also need more drug based on weight based dosing
In your estimation, what has caused the downturn in interest in MASH?
MDGL market cap is only $4.6B even with the $1.1B cash they have and they won't have competition in MASH for at least 3 yrs unless you count off label usage of Mounjaro/Tirzepatide.
Again, the market for MASH at this point for MASH specific compounds is not turning out to what many thought it would be. (I personally think the market has been overly bearish on MASH.)
Makes one wonder how they (and others) were able to raise so much cash recently.
Sagiment (SGMT) went from $5-6 a share to $18 a share back in Jan on good 52 week phase 2b MASH data. They raised cash at $12.50 immediately after the release and since then have steadily declined to $4.34 today.
Just further evidence that the MASH market is out of favor with investors.
MDGL—(-8%)—reports 1Q24 results:
https://finance.yahoo.com/news/madrigal-pharmaceuticals-reports-first-quarter-110000708.html
No revenue was booked in 1Q24 because the Rezdiffra launch occurred in April.
MDGL had $1.1B of cash at 3/31/24 thanks to the public offering immediately following FDA approval of Rezdiffra (#msg-174068028).
VKTX-VK2809 should readout the phase 2B Voyage 52-week data from liver Biopsy in near term for MASH. The main bar Viking's VK2809 will look to surpass will be vs MDGL’s resmetirom/(rezdiffra) since that is the only approved drug on the market for MASH for stages f2 and f3. The key data will be on Fibrosis improvement.
Previously resmetirom showed a MASH resolution of 30% absolute and 20% PBO adjusted and a greater than one stage improvement in Fibrosis with no worsening of MASH of 26% which turned out to be 8% PBO adjusted. (For reference, please see #msg-173733016 for a detailed discussion of VKTX, MDGL and SGMT drugs at 52 weeks.)
At 12 weeks, in this same Voyage phase 2B study, Raymond James commented on VK2809 vs Madrigal resmetirom saying:
The obesity market is something that has driven massive market cap gains in LLY and NVO over the last several years. Every large pharma wants a piece.
Lately, large pharma companies have released very limited info on NME’s for obesity (NVO with Amycretin and now Amgen with Maritide. They have generally only focused on top line weight loss figures or generating “Hope”. I learned a long time ago that hope is not a strategy.
I believe that press releases/management comments have been misleading on new MOA’s for obesity drugs when safety/tolerability data is not released. I’m not buying the idea that companies are not being more forthcoming for competitive reasons if they release info that is only good. (if safety/tolerability data was good, you can bet that info would be released).
Why would these companies be doing this? Only thing I can think of is that share price declines would hurt management bonuses and that kicking the can down the road is better than releasing real less than ideal data on safety/tolerability. Caveat emptor especially on companies who are not transparent on tolerability if you are expecting their new compounds in obesity to drive much value.
I saw that they are filling in the rest of the young in the "Southern Hemisphere". You would think that the Northern Doctors should have some experience here with the trial, It could be you just have to follow the disease into the Southern winter,
Any concern?
The news was slightly negative in one quarter delay enrollment (with potential to slip further I guess) and 1 quarter less cash
To me this doesn’t move the needle at all but the stock is so volatile every little bit of news seems to get magnified.
I’m holding steady I still thikk the RSV program is likely to be positive and whether that’s in q3,4, or early 2025 I don’t care
I recently heard of BioGPT. Haven’t tried it.
BioGPT: Generative Pre-trained Transformer for Biomedical Text Generation and Mining
https://www.microsoft.com/en-us/research/publication/biogpt-generative-pre-trained-transformer-for-biomedical-text-generation-and-mining/
Looks like the biggest piece of news is update on the RSV peds study which has more granularity they have enrolled >70 of the 90 total, and they hope to wrap up enrollment in time to report by end of year now (vs Q3 originally)
The other is cash runway which is 1 quarter less, which is about 3 years of cash. Seems like the burn is going to have to drop for this to happen, but not unrealistic once they wrap up the RSV studies in the next few quarters, but I have to think this does not factor in any phase 3 development for RSV or significant phase 2s for immunology (not sure if this was asked on the call)
otherwise fairly ho hum ? I didn't catch the call but nothing doing after hours right now
(EXAS)—FDA approves colorectal-cancer diagnostic from private company, Geneoscopy:
https://www.businesswire.com/news/home/20240506185019/en
Geneoscopy is commercializing the test in a collaboration with Labcorp.
ENTA reports FY2Q24* results—raises FY2024 expense guidance:
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-reports-financial-results-its-fiscal-39
• 3/31/24 cash = $300.3M, a decrease of $37M relative to 12/31/23.
• FY2Q24 royalty revenue was $17.1M, -10% QoQ and -4% YoY. 54.5% of ENTA’s Mavyret royalties are payable to OMERS (Canada’s largest pension fund), and this amount is treated for accounting purposes as an amortization of debt (see discussion in #msg-172603887).
• FY2Q24 R&D expenses were $35.6M, consistent with ENTA’s updated fiscal-year guidance of $125-145M (raised from the $100-120M guidance given in Nov 2023).
• FY1Q24 SG&A expenses were $14.2M, consistent with ENTA’s updated guidance of $50-60M (raised from the $45-50M guidance given in Nov 2023). Legal expenses for the Paxlovid lawsuit against PFE were a material portion of the SG&A expenses for the quarter.
• ENTA says its cash and expected royalty revenue are sufficient to fund operations through the end of FY3Q27, which is one quarter earlier than the prior guidance of end of FY2027.
*ENTA’s fiscal year ends on September 30.
I have not used Perplexity or any other AI chatbot on a regular basis.
Addendum—PFE can boost its liquidity at any time by paring its HLN stake of 2.1B ordinary shares, worth ~$9B at the current market price:
https://www.sec.gov/Archives/edgar/data/1900304/000007800324000082/hln13d-a7.htm
Note: 1 HLN ADS = 2 ordinary shares.
Thx Dew. Do U use Perplexity at all ?
A quick search on the difference between Eyepoint and Ocular
EYPT—(-38%)—misses phase-2 primary_endpoint_in DR:
https://www.globenewswire.com/news-release/2024/05/06/2875682/0/en/EyePoint-Pharmaceuticals-Announces-Topline-Data-from-the-Phase-2-PAVIA-Trial-of-DURAVYU-in-Non-Proliferative-Diabetic-Retinopathy.html
PFE hiring suggests more M&A coming—Citi biotech_analyst_ to_head_business_development:
https://www.businesswire.com/news/home/20240506861564/en
Andrew Baum’s title will be EVP, Chief Strategy and Innovation Officer. He will report directly to PFE’s CEO.
GLYC—(-79%)—misses phase-3 primary endpoint_in AML:
https://finance.yahoo.com/news/glycomimetics-announces-results-pivotal-phase-100000750.html
See #msg-171216181 for related info.
Doc328
Boehringer and Walgreens partner to enhance clinical trial accessibility
May 3, 2024
The deal will aid in using select Walgreens pharmacies as clinical trial sites for individuals with obesity, overweight, and type 2 diabetes. Credit:
Boehringer Ingelheim and US-based pharmacy store chain Walgreens have entered into a strategic partnership to optimize clinical trial recruitment and improve accessibility, inclusivity and equity.
This deal expects to use select Walgreens pharmacies as clinical trial sites for individuals with obesity, overweight, and type 2 diabetes, focusing on Phase III clinical research.
The initiative targets the dismantling of barriers to clinical trial participation, aiming to achieve equitable health representation, particularly among Black and Hispanic communities in the US.
These groups are claimed to have historically been facing underrepresentation in clinical trials and are more likely to be affected by obesity.
https://www.clinicaltrialsarena.com/news/boehringer-walgreens-trial-accessibility/
Mystik Dan by a nose:
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