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.
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.
Exactly. Happy talk from Helen is not going to cut it anymore. The more time that goes by without a deal, the more one suspects she is not capable of running this company and has been not telling the truth about HALO's future prospects. Time is running out, and quickly.
I still wonder if some RVNC insiders have an undisclosed position in Crown.
Barclays downgrades RVNC from overweight to equal weight and lowers PT from $10-$7. {What the what!?!}
Neither of these approvals is much of a surprise.
VKTX - MS reiterates overweight and $105 PT
Yes, sorry for the careless typo. It is JPM, not JMP.
VKTX - JMP initiates coverage with overweight rating and $80 PT
It was HTI to be exact. Yes, I'm one of them. Do you remember Rod? I often wonder what happened to him.
Roche subcu MAB approved but is not an Enhanz partner
-----------------------------------------------------------------------------------------------------------------------------------------
Roche’s PiaSky approved in the EU as the first monthly subcutaneous treatment for people with PNH
With the option to self-administer, PiaSky® (crovalimab) has the potential to reduce treatment burden for people with paroxysmal nocturnal haemoglobinuria (PNH) in Europe and their caregivers
Approval is based on COMMODORE 2, where subcutaneous (SC) PiaSky once a month was equivalent to intravenous eculizumab every two weeks1,2
PiaSky advances C5 inhibition through innovative recycling technology, which enables its monthly SC administration3
Basel, 27 August 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved PiaSky® (crovalimab), a novel recycling monoclonal antibody that inhibits the complement protein C5, for adults and adolescents (12 years of age or older with a weight of 40 kg and above) with paroxysmal nocturnal haemoglobinuria (PNH) who are either new to, or have been previously treated with C5 inhibitors. PNH is a rare and life-threatening blood condition where red blood cells are destroyed by the complement system – part of the innate immune system – causing symptoms such as anaemia, fatigue and blood clots, and potentially leading to kidney disease.4
“People with PNH are often burdened with life-long, frequent intravenous infusions with time-consuming clinic visits, meaning that their lives, as well as their caregivers’ and families’ lives, may revolve around the demands of their treatment,” said Prof. Alexander Röth, M.D., Head of Classical Haematology and Haemostasis at the West German Cancer Centre, University Hospital Essen, Germany. “More flexible treatment options such as PiaSky, which are just as effective but less frequent and can be given more quickly at home, are essential to give people with PNH greater control over their treatment and more independence.”
PiaSky is the first monthly subcutaneous (SC) treatment for PNH in the European Union, with the option to self-administer following adequate training. It provides an alternative option to current C5 inhibitors that require regular intravenous infusions, which could help to reduce treatment burden and disruption to the lives of people with PNH and their caregivers.3
“The PiaSky approval brings a new option to the PNH treatment landscape, combining the disease control achievable through C5 inhibition with a cutting-edge recycling technology that enables monthly subcutaneous administration,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are pleased to bring this new treatment to people with PNH in Europe with the hope it may lessen the treatment burden faced by many living with this condition.”
C5 inhibitors – treatments that block part of the complement system cascade – have been shown to be effective in treating PNH.5 PiaSky has been developed to address the needs of people living with PNH and some of the challenges that accompany these existing treatment options. It advances complement inhibition through its innovative recycling technology, which enables monthly SC administration by allowing the medicine to bind and inhibit the C5 protein multiple times and to act longer in the body with a small volume of medicine.1,3
This approval is based on the results from the Phase III COMMODORE 2 study in people with PNH who have not been previously treated with C5 inhibitors. The study demonstrated that PiaSky, administered as SC injections every four weeks, achieved disease control and was well-tolerated. PiaSky was non-inferior with comparable safety to eculizumab, an existing standard of care C5 inhibitor, given intravenously every two weeks. The rate of adverse events in people treated with PiaSky was similar to treatment with eculizumab.1,2 The application included supportive data from two additional Phase III studies, the COMMODORE 1 study, in people with PNH switching from currently approved C5 inhibitors, and the COMMODORE 3 study in people new to C5 inhibitor treatment in China.1,2,6-8
PiaSky is the first monthly SC treatment for PNH, approved in multiple territories around the world, including the US and Japan, based on results of the COMMODORE studies. It is being investigated in a broad clinical development programme, including five Phase III studies and three earlier phase studies in complement-mediated diseases, including PNH, atypical haemolytic uremic syndrome and sickle cell disease.2,6,8-13
About PiaSky® (crovalimab)
PiaSky® (crovalimab) is a novel recycling monoclonal antibody that inhibits the complement protein C5 and is designed to block the complement system – a vital part of the innate immune system that acts as the body’s first line of defence against infection. PiaSky has been engineered by Chugai Pharmaceutical Co., Ltd, to address the needs of people living with complement-mediated diseases. It provides patients with a potential for subcutaneous (SC) self-administration following adequate training, an initial intravenous infusion and weekly SC loading doses in the first month of treatment.1,3
PiaSky works by binding to C5, blocking the last step of the complement cascade and delivering rapid and sustained complement inhibition. It is also recycled within the bloodstream, enabling small volume SC administration every four weeks. In addition, PiaSky binds to a different C5 binding site from current treatments, which has the potential to provide a treatment option for people with specific C5 gene mutations who do not respond to current therapies.1,3
About the COMMODORE 2 study
The COMMODORE 2 study is a Phase III, randomised, open-label study evaluating the efficacy and safety of PiaSky® (crovalimab) versus eculizumab in people with paroxysmal nocturnal haemoglobinuria who have not been treated previously with C5 inhibitors. The study’s co-primary efficacy endpoints measure transfusion avoidance and control of haemolysis (the ongoing destruction of red blood cells measured by lactate dehydrogenase levels). The adults enrolled in the study were randomised in a 2:1 ratio to be treated with either subcutaneous (SC) PiaSky every four weeks or intravenous eculizumab every two weeks. The participants who were less than 18 years old were included in a non-randomised treatment arm and were treated with SC PiaSky every four weeks.1,2
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the fifteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
For more information, please visit www.roche.com.
Marketwatch on obesity contenders
https://www.marketwatch.com/story/obesity-drugs-next-wave-these-companies-could-snag-20-of-glp-1-market-analysts-say-ef88f377?mod=home-page
------------------------------------------------------------------------------------------------------------------------------------------------
Referenced Symbols
LLY
-0.23%
NVO
-1.22%
AMGN
-0.61%
VKTX
1.38%
GPCR
2.04%
SRRK
1.62%
ZLDPF
-2.47%
CRBP
-0.75%
While Eli Lilly & Co. and Novo Nordisk dominate the obesity-drug market, there’s a vast field of would-be competitors closing in behind them — and the most successful among those next-wave contenders stand to capture up to 20% of the lucrative market, Jefferies analysts said in a research note Monday.
With GLP-1 drugs set to generate north of $120 billion in annual sales globally by 2031, according to the analysts’ estimates, that 20% share could mean close to $25 billion in annual revenues.
The market’s power duo won’t fade away, in the analysts’ view: Lilly
LLY
-0.23%
will hold about 44% market share in the 2030s, the Jefferies analysts forecast, while Novo
NVO
-1.22%
is expected to hang on to about 36% share.
That leaves a healthy slice of the GLP-1 market up for grabs — and the growing competition could eventually help bring down weight-loss-drug prices for patients and payers, the analysts noted.
So which companies are currently best positioned to lead the next class of weight-loss drug developers?
Amgen Inc.
AMGN
-0.61%
is one of the best bets, the Jefferies analysts said, as investors await Phase 2 data on the company’s experimental diabetes and obesity drug MariTide. The analysts are looking for the drug to show an average weight loss of about 20% to 24% after one year of treatment, making it competitive with Eli Lilly’s weight-loss drug Zepbound. MariTide also stands apart from competitors with potential monthly or even less frequent dosing, a factor that could help control the unpleasant gastrointestinal side effects that often come with weight-loss drugs, analysts said.
Another leading experimental weight-loss drug belongs to Viking Therapeutics Inc.
VKTX
1.38%
, which is working on both oral and subcutaneous versions of VK2735. Like Lilly’s Zepbound, VK2735 acts on two different gut hormones, GLP-1 and GIP. The company said last month that it would advance the injectable version directly to Phase 3 trials, accelerating its development timeline. A Phase 2 study of the oral version will start in the fourth quarter, Viking said in late July.
Among the companies racing to develop oral weight-loss drugs, Structure Therapeutics Inc.
GPCR
2.04%
is another strong contender, in the analysts’ view. The company’s oral GLP-1 drug, GSBR-1290, is on track to enter a Phase 2b study in the fourth quarter of this year, the Jefferies analysts wrote, and could enter a Phase 3 trial in 2026. Structure said in June that patients taking the drug in a clinical trial lost, on average, 6.2% of their body weight after three months. Pill versions of GLP-1 drugs could help make the treatments cheaper and more broadly accessible and could also serve as maintenance medications once patients achieve their desired weight loss on injectable drugs, analysts have said.
With surging interest in obesity treatments, drugmakers and investors are also focused on drugs that can help preserve the lean muscle that is often lost during rapid weight loss. Scholar Rock Holding Corp.’s
SRRK
1.62%
experimental drugs apitegromab and SRK-439 stand out among a class of investigational treatments targeting myostatin, a protein that inhibits muscle growth, and could help maintain lean muscle mass in the potentially millions of patients who may use GLP-1 drugs for obesity, the Jefferies analysts wrote.
Zealand Pharma
ZLDPF
-2.47%
could add another novel twist to the weight-loss-drug market with its experimental drug petrelintide. Rather than a GLP-1 receptor agonist, petrelintide is an amylin analog — a type of drug that has been shown to increase feelings of fullness and may have fewer gastrointestinal side effects than GLP-1s. Full data from a Phase 1b trial of petrelintide are expected in November, the Jefferies analysts said.
Looking at earlier-stage experimental drugs, Corbus Pharmaceuticals Holdings Inc.’s
CRBP
-0.75%
CRB-913 stands out, the analysts noted. The drug, which is still in the pre-clinical stage, is a blocker of the CB1 receptor, which plays a role in appetite regulation and metabolism. Novo Nordisk has another CB1 receptor blocker in Phase 2 trials. An update is expected in the third quarter, and could have a significant impact on Corbus’s stock, the Jefferies analysts said.
That's a good summary, thanks. I've been thinking of dipping a toe in but I want to listen to the last call before I do and haven't yet had the time to devote to it.
And, don't worry about forgetting stuff; as long as you can still find your way home at the end of the day, you're ok! LOL!
Speaking of ABOS, what do you think of their chances for success in the Alzheimers space?
That is indeed interesting.
Chart would agree that a pause is nigh.
VKTX - Mufaso, I completely agree on the tolerability part of this epic competition. After all, this drug will be used mostly by willing customers who are voluntarily choosing it as a path to wellness, rather than a prescribed necessity for more acute diseases. Choice will come down to ease of use and that includes tolerability.
Vomiting and diarrhea are extremely effective weight loss MOAs.
What are your thoughts?
Holding until end of year. If no deals by then then I'll probably exit.
VKTX - Up over 17% on high volume, so yes, it caught my attention. Not your usual false alarm, IMHO.
That sums it up exactly. Failure to grasp this oncoming cliff is just whistling past the graveyard.
Enhanz is going to hit some competitive pressure one way or another. A company that's a one trick pony is always vulnerable to that.
One way to fend it off is to aggressively create new partnerships across a wide range of companies. Helen has failed in that mission, despite her endless delightedness. One thing I've learned through real life experience is never trust a CEO. They will lie to you right to your face. Words don't count. Only deals.
Hard to say what it means. They might have sold some covered calls as hedges and then had to give up some shares as a result, or they may have naturally lightened their number of shares when the dollar amount in their portfolio became a little overweighted in HALO as a result of the recent run up in the pps. Or, they know something we don't . LOL!
Howee, which service are you referring to? Thanks! -Fritz
ABOS - Any opinions on Accumen's sabirnetug prospects? TIA. -Fritz
If that turns out to be the case, the deal would potentially invalid. The BOD has a fiduciary duty to all shareholders and self-dealing might be frowned upon by the SEC and civil juries.
I'm wondering if management comes out of this with shares in the new enterprise in some kind of backdoor deal. That's the only way this would make sense to me.
My thoughts exactly. Deals implode all the time, so it's not out of the question. Nothing gained by just throwing away my hand now. I can afford to wait it out and see what comes next. Worst case scenario is already known, i.e. $6.66 per share.
Incomprehensible is the word that comes to mind.
Time will tell. I'm giving it a short leash at this point. I truly hope you win the debate! LOL!
Howee, don't give her all of that credit. Yes, she dumped PEGph20, but that was a forced move. And don't forget, she inherited some of the Enhanz deals and therefore she, as well as we, are profiting from that inheritance. The financing moves/buybacks are debatable; buybacks are a tool for mature companies. In a growth company like HALO they are a sign of a lack of imagination; and one has to wonder what better purpose they could have done with that ~$1.5 billion which was aimlessly spent on shares. She's got a beholden and compliant BOD, so not at risk for her job in any event. HALO makes money in spite of, not because of, the lackluster management IMHO.
My sentiments exactly. I really sensed that she was quite defensive when faced with multiple questions on this topic, and feeling pressured to say something positive, thus the "10 companies" comment.
Remember, she first stated unequivocally that there were going to be 3 deals 18 months ago; are we to assume that these are still "in talks"? I'm skeptical.
That's why I've got a timetable of 6 months to see if she starts delivering on her happy talk. That should be ample time to have at least one of them announced.
Not all analysts on the call upgraded their recommendations.
Benchmark analyst Rob Wasserman maintains BUY rating and reiterated $60 PT.
Mitch Kapoor from HC Wainwright maintains BUY rating and reiterated $65 PT.
So, it was a split decision.
You have a point, if one defines "deal" broadly enough, then she was accurate.
Yes, that's what she said but there has not been one deal per year; that is a gross exaggeration. Her statement about 10 companies in talks is not to be taken at face value either since there is no way to check its veracity. I will say that given recent positive developments in IP/patent legal protection and extension as well as the possibility of enhanced efficacy, there certainly should be a high degree of interest and deals should start coming in with regularity; but it's wait and see for me. Her words mean little, but the potential is there for a big run IMHO.
I thought there would be no upgrades because there was no news and the beat was due to some accelerated profits moved up from Q3 to Q2 so nothing new there either. Analysts can downgrade also if they realize they've been fed a load of BS, so I'd still be very cautious. New deals change everything, of course, as I've said many times.
Agree with 7 & 8.
Thanks, Howee, we are the old veterans on this board. (I often wonder whatever happed to Rod.) I value all input from all sides. That's why I'm here. Let's hope we get that old age drug working, or at least to phase III. LOL! Good luck to all.
1.) The upcoming PDUFA dates will have little impact because they are assumed to be successful. A rare failure will have an outsized impact in the other direction. (I don't expect this, just sayin,.)
2.) The earnings beat was due to some income accelerated from what was assumed to come from 3Q. Earnings predictions for the full year were not raised.
3.) Helen's talk about new deals will be under extreme scrutiny the longer we wait for them, but if they start rolling in, then, yes, this stock will have a significant move upwards.
4.) It's all about the new deals now, as was evident from the analysts questions yesterday. The longer we wait, the more the PPS will drift.