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.
Getting hit AH
Thanks. EOM
Not questioning the thesis, but he actually does say that repeatedly. And why not? It's a part of their business model. Do you think an acqusition (by anybody) is imminent now that the smoke has cleared to a large degree? (Imminent defined as next Q or 2).
Yes, but he literally says that every time he's asked. LOL!
I really don't have a feel for all of the various dynamics at play, including time frame.
Dew, in your estimation, what are the odds of RVNC being bought out vs. charting a solo path?
TIA, and Happy New Year!
All the best,
-Fritz
Everybody knows that there are dozens, if not hundreds, of IV drugs that could be co-formulated with enhanze, yet the pace of these deals is perplexingly glacial. Any ideas why?
Agree about the useless computer generated stuff put out by that "research" site. Disagree about a significant bounce, at least for now.
My feeling is that we get back to the $40s and see a period of consolidation maybe in the low $50s. Another run is not imminent unless triggered by a news event.
As I mentined about a month ago, my opinion is that HALO is fullly valued at the mid $50s and I thought that the run to near $60 was overblown. I said a pullback to $55 was a near certainty and here we are. I did have my trading shares called away and I've elected to put those profits into another more promising investment. I continue to hold my core HALO shares and will constantly reassess that position as the year moves along. A market downdraft and a long stagnant period with no percieved progress could result in this stock reaching the 200 day which today is about $46. On the other hand, a good stretch of new deal announcements and we could be on our way to the next level. Time will tell.
Happy and healthy New Year to all who post and lurk here. My best to you and your loved ones.
-Fritz
It doesn't take much to feed their insanity.
Wondering what concrete things your theory is based on?
Thanks, -Fritz
Thanks for sharing that.
Just saw that. Would love to read these notes to get their take. I guess we can put aside the worry about downgrades fo now. LOL!
Fascinatng look into the industry. Thanks for sharing.
-Fritz
The operative word was "guessing". LOL
Interesting, I wonder what new scam they are cooking up this time.
Friday is expiry day so I'm guessing it's just partially rolling out to future dates and partially just ordinary hedging of new positions by the pros.
I appreciate your final point about the limitations Horizon may have had in terms of resources, and how Amgen might be able to fund the necessary trials. That may prove to be the key, but, as you say, only time will tell.
The Tepezza deal with Horizon goes back two years ago to December 2020 and according to Halozyme's web site it has not gotten past phase 1.
What is not clear to me is how Amgen's acquisition will change the dynamic. Unless I'm mistaken, Amgen has not entered into any deal with Halozyme, so I wonder what their commitment is to Enhanze subcu formulation. Horizon has not been in a particular hurry and Amgen has shown no interest, so I'm skeptical that Amgen/Horizon is a meaningful transaction for Halozyme.
https://www.fiercepharma.com/drug-delivery/horizon-pays-halozyme-190m-to-develop-subq-thyroid-eye-disease-med
https://halozyme.com/enhanze/#pipeline_group_1
How is that relevant here?
Right, looks like he sold about a quarter of his holdings. That's a little surprising.
Do you know when and how this litigation was brought to light?
The patent rolloff for enhanze is not far off but there is a potential lengthening of patent protection both in the US as well as Europe due to the argument that the co-formulation represents a new drug and therefore a new patent, or at least an extension, should be granted. This is being challenged in the courts and, if HALO loses, their income estimate might well be adversely affected. This topic has been a major source of confusion for a long time.
That is a major uncertainty.
This was a surprising week (for me at least) and it ended on a high note Friday with some decent volume, which had been missing, and end of day trades were at the highs. It might have a little more to run. Absent news I'm also expecting a retracement which could, in time, dip to about $47 or so, but that is assuming another long period of inactivity on the new deals front and the addition of other market downdrafts, both of which are probable. A near term retrace back to the mid $50s is almost inevitable, but I've no idea as to the exact timing there.
Things are moving along and your summary is perfectly on target; the one thing I'm not certain of is the pricing model used to get to that $69. How would you formulate that? How do you see the current pps given the earnings reported?
Looking at the chart, I think there is a good chance you'll have your order filled.
Yes, that was going to be my answer. They must feel pretty sure they'll get it approved for all indications based largely on your analysis of the nature of the trial.
They are stranglely vague about with which "authorities" they have filed. Europe? FDA? Both? The Bahamas?
Roche files for subcu Tecentriq
--------------------------------------------------------------------------------------------------------------------------------------------------------
Phase III results show Roche's subcutaneous formulation of Tecentriq is comparable to intravenous Tecentriq and delivered in minutes
Administered under the skin, the subcutaneous formulation reduces time spent receiving treatment to approx. seven minutes, compared with 30-60 minutes for IV infusion1
Roche has submitted data from the IMscin001 study to health authorities, seeking approval for the subcutaneous option across all approved indications of IV Tecentriq
If approved, Tecentriq would be Roche’s fourth subcutaneous cancer therapy,2-4 helping to improve the treatment experience for patients. In addition, it could save resources for healthcare systems5-10
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Basel, 1 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new pivotal data from the Phase III IMscin001 study, evaluating the investigational subcutaneous formulation of Tecentriq® (atezolizumab), a cancer immunotherapy approved for various tumour types.1 Data showed comparable exposure (levels of the molecule in the blood) and similar safety and efficacy for Tecentriq, when administered subcutaneously (injected under the skin), compared to standard IV infusion, in people with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC).
The data will be presented in a mini-oral abstract session at 09:55 CET on Thursday 8 December, at the ESMO Immuno-Oncology Congress 2022 (Abstract #61MO).11
If approved by health authorities, Roche aims to bring this innovation to patients who may benefit from treatment with Tecentriq across multiple tumour types. Data from IMscin001 have been submitted to health authorities globally.
“Checkpoint inhibitors have been transformational for people with cancer, but IV administration can be long and arduous for patients and increase strain on infusion centres,” said Dr. Mauricio Burotto, Medical Director, Bradford Hill Investigación Clínica. “Subcutaneous administration could allow patients to be treated much more quickly and easily compared to IV, improving their overall treatment experience, and reducing waiting lists and treatment delays.”
“These data show that the subcutaneous formulation of Tecentriq can deliver similar benefits to IV administration, without compromising on safety, while offering a faster and more flexible treatment option,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We're excited about the potential of this new formulation to improve both the treatment experience for patients and save resources for healthcare systems.”
Multiple oncology studies suggest that the majority of cancer patients generally prefer to receive treatment subcutaneously due to reduced discomfort, ease of administration and shorter duration of treatment, compared to IV infusion.5-9
While the IMscin001 trial was conducted within the hospital setting, the subcutaneous formulation may be appropriate for out of hospital administration by a healthcare professional.
About the IMscin001 study and data
IMscin001 is a Phase IB/III, global, multicentre, randomised study evaluating the pharmacokinetics, safety and efficacy of the subcutaneous formulation of Tecentriq, compared with IV Tecentriq, in patients with previously treated locally advanced or metastatic NSCLC for whom prior platinum therapy has failed. The study enrolled 371 patients.
In August, part 2 of the study met its primary endpoints, demonstrating comparable levels of Tecentriq in the blood during a given dosing interval on the basis of established pharmacokinetic measurements.11 The geometric mean ratios were 1.05 for observed serum Ctrough (the concentration of drug in the blood immediately before the next dose is administered; 90% CI: 0.88-1.24) and 0.87 for model-predicted area under the curve (a measure of overall exposure to the drug; AUC; 90% CI: 0.83-0.92).11
Efficacy, as measured by the overall response rate and progression-free survival, was similar between the subcutaneous and IV treatment arms and consistent with the known profile of IV Tecentriq.11 The safety profile of the subcutaneous formulation was also consistent with that of IV Tecentriq.11
About the subcutaneous formulation of Tecentriq
The investigational subcutaneous formulation combines Tecentriq with Halozyme Therapeutics’ Enhanze® drug delivery technology.
Tecentriq is a monoclonal antibody designed to bind with a protein called programmed death ligand-1 (PD-L1), which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.
The Enhanze drug delivery technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that locally and temporarily degrades hyaluronan – a glycosaminoglycan or chain of natural sugars in the body – in the subcutaneous space. This increases the permeability of the tissue under the skin, allowing space for Tecentriq to enter, and enables the subcutaneous formulation to be rapidly dispersed and absorbed into the bloodstream.
IV Tecentriq is approved for some of the most aggressive and difficult-to-treat forms of cancer. IV Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage NSCLC, small cell lung cancer (SCLC) and hepatocellular carcinoma (HCC). IV Tecentriq is also approved in countries around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer, PD-L1-positive metastatic triple-negative breast cancer and BRAF V600 mutation-positive advanced melanoma.
About Roche in cancer immunotherapy
To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link: https://www.roche.com/solutions/focus-areas/oncology/cancer-immunotherapy
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 thirteenth 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.
All trademarks used or mentioned in this release are protected by law.
References
[1] Tecentriq: highlights of prescribing information, US FDA 2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s028lbl.pdf. Accessed November 2022.
[2] MabThera SC / Rituxan Hycela: highlights of prescribing information, US FDA 2017. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761064s000lbl.pdf. Accessed November 2022.
[3] Herceptin SC / Herceptin Hylecta: highlights of prescribing information, US FDA 2019. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761106s000lbl.pdf . Accessed November 2022.
[4] Phesgo: highlights of prescribing information, US FDA 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf. Accessed November 2022.
[5] De Cock E, et al. A time and motion study of subcutaneous versus intravenous trastuzumab in patients with HER2-positive early breast cancer. Cancer Med. 2016;5(3):389-97.
[6] O’Shaugnessy, J. Patient (pt) preference for the pertuzumab-trastuzumab fixed-dose combination for subcutaneous use (PH FDC SC) in HER2-positive early breast cancer (EBC): Primary analysis of the open-label, randomised crossover PHranceSCa study. Presented at ESMO; 19-21 Sept 2020. Abstract #165MO.
[7] Pivot X, et al. Efficacy and safety of subcutaneous trastuzumab and intravenous trastuzumab as part of adjuvant therapy for HER2-positive early breast cancer: final analysis of the randomised, two-cohort PrefHer study. Eur J Cancer. 2017;86:82-90.
[8] Rummel M, et al. Preference for subcutaneous or intravenous administration of rituximab among patients with untreated CD20+ diffuse large B-cell lymphoma or follicular lymphoma: results from a prospective, randomized, open-label, crossover study (PrefMab). Ann Oncol. 2017;28(4):836-842.
[9] Denys H, et al. Safety and tolerability of subcutaneous trastuzumab at home administration, results of the phase IIIb open-label BELIS study in HER2-positive early breast cancer. Breast Cancer Res Treat. 2020;181(1):97-105.
[10] Anderson, K C, et al. Humanistic and economic impact of subcutaneous versus intravenous administration of oncology biologics. Future Oncol. 2019;15(28):3267-3281
[11] Burotto M, et al. IMscin001 (Part 2: Randomized Phase III): Pharmacokinetics (PK), efficacy and safety of
atezolizumab subcutaneous (SC) vs intravenous (IV) in previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC). Presented at ESMO IO; 7-9 Dec 2022. Abstract #61MO.
Roche Investor Relations
Dr. Bruno Eschli
Phone: +41 61 68-75284
e-mail: bruno.eschli@roche.com
Dr. Sabine Borngräber
Phone: +41 61 68-88027
e-mail: sabine.borngraeber@roche.com
Dr. Birgit Masjost
Phone: +41 61 68-84814
e-mail: birgit.masjost@roche.com
Dr. Gerard Tobin
Phone: +41 61 68-72942
e-mail: gerard.tobin@roche.com
Investor Relations North America
Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com
Intereting question about the convertibles. What are their functions in the original deal? What is the consequence to the financing arrangement if they choose to convert?
Currently HALO is fully valued, IMHO, so there is the risk of a downgrade. Efgartigimod is most likely not going to start showing up in the bottom line until 2nd half 2023 at the earliest.
Thanks. HALO PR department has some updating to do on their parter pipeline chart, both for
Nivolumab + Relatlimab (phase 1 to phase 3) and for Efgartigimod (now filed)
https://halozyme.com/enhanze/#pipeline_group_1
argenx Announces U.S. FDA Acceptance of Biologics License Application for Subcutaneous Efgartigimod in Generalized Myasthenia Gravis with Priority Review
November 22 2022 - 01:00AM
GlobeNewswire Inc.
- Prescription Drug User Fee Act (PDUFA) target action date is March 20, 2023
- Submission based on positive results from the Phase 3 bridging study demonstrating noninferior total IgG reduction at day 29 with subcutaneously (SC) administered efgartigimod compared to intravenous (IV) administration
November 22, 2022
Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a Biologics License Application (BLA) for SC efgartigimod (1000mg efgartigimod-PH20) for the treatment of adult patients with generalized myasthenia gravis (gMG).
The application has been granted a Prescription Drug User Fee Act (PDUFA) target action date of March 20, 2023.
SC efgartigimod is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology. ENHANZE facilitates the SC injection delivery of biologics that are typically administered via IV infusion.
“The FDA’s acceptance of our BLA is an exciting step toward fulfilling our vision of delivering the broadest gMG treatment offering that reflects the unique disease experience for each patient as they navigate life with this debilitating disease. We’re excited about the potential of SC efgartigimod to offer patients multiple ways to receive treatment through various administrations and an individualized dosing schedule,” said Keith Woods, Chief Operating Officer of argenx. “With an established PDUFA date, we are preparing for our second commercial product launch and look forward to potentially bringing forth another first-in-class option for gMG patients.”
The BLA submission is supported by data from the Phase 3 ADAPT-SC study evaluating the noninferiority of the pharmacodynamic (PD) effect of SC efgartigimod as compared with IV administered VYVGART in adult patients with gMG. The majority of enrolled patients were positive for acetylcholine receptor (AChR) antibodies, but the trial also included patients where AChR antibodies were not detected.
ADAPT-SC met its primary endpoint (p< 0.0001) of total IgG reduction from baseline at day 29 demonstrating noninferiority of SC efgartigimod to VYVGART. Patients treated with SC efgartigimod achieved mean total IgG reduction of 66.4% from baseline at day 29, compared to 62.2% reduction with VYVGART. Results were consistent across the overall population, including those with AChR antibodies and patients where AChR antibodies were not detected. Further, 69.1% of patients treated with SC efgartigimod were responders on the Myasthenia Gravis Activities of Daily Living (MG-ADL) score. Responders are defined as having at least a two-point improvement on the MG-ADL score for at least four consecutive weeks. 65.5% of patients treated with SC efgartigimod were responders on the Quantitative Myasthenia Gravis (QMG) score. Responders are defined as having at least a three-point improvement on the QMG score for at least four consecutive weeks. Minimal symptom expression (MSE), a measure of symptom-free status, was achieved in 37% of SC efgartigimod-treated patients after one treatment cycle. Onset of effect was also consistent with the Phase 3 ADAPT study.
The safety profile for SC efgartigimod was consistent with the ADAPT study. It was generally well-tolerated; the most frequent adverse event being injection site reactions (ISRs), commonly observed with biologics administered subcutaneously. All ISRs were mild to moderate and resolved over time. After completing ADAPT-SC, 95% of participants entered ADAPT-SC+, a three-year open-label extension study evaluating the long-term safety and tolerability of SC efgartigimod.
Phase 3 ADAPT-SC Trial Design
The Phase 3 ADAPT-SC trial was a multicenter, randomized, open-label, parallel-group study evaluating the noninferiority of the pharmacodynamic (PD) effect of SC efgartigimod (1000mg efgartigimod-PH20) as compared with VYVGART (10mg/kg) in patients with gMG. The pharmacodynamic effect as measured by percent change from baseline in total IgG levels at day 29, one week after the last dose of IV or SC efgartigimod, served as the primary endpoint in the ADAPT-SC trial. The correlation between total IgG reduction and clinical benefit in gMG was demonstrated in a Phase 2 trial and the Phase 3 ADAPT trial, which served as the basis for approval of VYVGART in the U.S., Japan and Europe. Safety, clinical efficacy, immunogenicity and pharmacokinetics (PK) were also assessed.
A total of 110 adult patients with gMG in North America, Europe and Japan enrolled in the ADAPT-SC trial and were treated. Inclusion criteria of the trial were the same as the Phase 3 ADAPT trial of VYVGART; enrolled patients had a confirmed gMG diagnosis and an MG-ADL total score of at least 5 with greater than 50% of the total score attributed to non-ocular symptoms, at screening and baseline. Patients were on a stable dose of at least one gMG treatment prior to randomization, including acetylcholinesterase inhibitors, corticosteroids or nonsteroidal immunosuppressive drugs, and were required to remain on that stable dose throughout the primary trial. Patients were eligible to enroll in ADAPT-SC regardless of antibody status, including patients with AChR antibodies (AChR-Ab+) and patients where AChR antibodies were not detected.
Patients were randomized in a 1:1 ratio to receive SC efgartigimod or IV efgartigimod for one treatment cycle consisting of four doses at weekly intervals. The total study duration was approximately 12 weeks, including seven weeks of follow-up after the treatment cycle.
See the full Prescribing Information for VYVGART in the U.S., which includes the below Important Safety Information. For more information related to VYVGART in Japan, visit argenx.jp.
IMPORTANT SAFETY INFORMATION FOR VYVGART® (efgartigimod alfa-fcab) intravenous (IV) formulation (U.S. PRESCRIBING INFORMATION)
What is VYVGART® (efgartigimod alfa-fcab)?
VYVGART is a prescription medicine used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive).
What is the most important information I should know about VYVGART?
VYVGART may cause serious side effects, including:
Infection. VYVGART may increase the risk of infection. In a clinical study, the most common infections were urinary tract and respiratory tract infections. More patients on VYVGART vs placebo had below normal levels for white blood cell counts, lymphocyte counts, and neutrophil counts. The majority of infections and blood side effects were mild to moderate in severity. Your health care provider should check you for infections before starting treatment, during treatment, and after treatment with VYVGART. Tell your health care provider if you have any history of infections. Tell your health care provider right away if you have signs or symptoms of an infection during treatment with VYVGART such as fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain.
Undesirable immune reactions (hypersensitivity reactions). VYVGART can cause the immune system to have undesirable reactions such as rashes, swelling under the skin, and shortness of breath. In clinical studies, the reactions were mild or moderate and occurred within 1 hour to 3 weeks of administration, and the reactions did not lead to VYVGART discontinuation. Your health care provider should monitor you during and after treatment and discontinue VYVGART if needed. Tell your health care provider immediately about any undesirable reactions.
Before taking VYVGART, tell your healthcare provider about all of your medical conditions, including if you:
Have a history of infection or you think you have an infection.
Have received or are scheduled to receive a vaccine (immunization). Discuss with your health care provider whether you need to receive age-appropriate immunizations before initiation of a new treatment cycle with VYVGART. The use of vaccines during VYVGART treatment has not been studied, and the safety with live or live-attenuated vaccines is unknown. Administration of live or live-attenuated vaccines is not recommended during treatment with VYVGART.
Are pregnant or plan to become pregnant and are breastfeeding or plan to breastfeed.
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the common side effects of VYVGART?
The most common side effects of VYVGART are respiratory tract infection, headache, and urinary tract infection.
These are not all the possible side effects of VYVGART. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088.
Please see the full Prescribing Information for VYVGART and talk to your doctor.
About Efgartigimod
Efgartigimod is an antibody fragment designed to reduce pathogenic immunoglobulin G (IgG) antibodies by binding to the neonatal Fc receptor and blocking the IgG recycling process. Efgartigimod is being investigated in several autoimmune diseases known to be mediated by disease-causing IgG antibodies, including neuromuscular disorders, blood disorders, and skin blistering diseases, in both an intravenous and subcutaneous (SC) formulation. SC efgartigimod is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.
About VYVGART
VYVGART® (efgartigimod alfa-fcab) is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating immunoglobulin G (IgG) autoantibodies. It is the first and only approved FcRn blocker. VYVGART is approved in the United States and Europe for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive, and in Japan for the treatment of adults with gMG who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs).
About Generalized Myasthenia Gravis
Generalized myasthenia gravis (gMG) is a rare and chronic autoimmune disease where IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness. Approximately 85% of people with MG progress to gMG within 24 months1, where muscles throughout the body may be affected. Patients with confirmed AChR antibodies account for approximately 85% of the total gMG population.
About argenx
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first-and-only approved neonatal Fc receptor (FcRn) blocker in the U.S., Japan and the EU. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, Twitter, and Instagram.
For further information, please contact:
Media:
Kelsey Kirk
kkirk@argenx.com
Another thing I don't understand: how an analyst can call for a move from $53 to $54 in 12 months and then list their buying recommendation as "overweight". That must look really odd to their customers.
Yes, thanks for the reminder on the PDUFA date. I'm not going to be selling calls as that approaches. LOL!
Interesting, thanks. He didn't mention the topic of patent extensions which remain a mystery to me.
Right, so it was out there, but may have been under the radar. The other thing, in terms of me pushing back against this big move, or the logic of it anyways, is that Helen confirmed, but did not raise, guidance for the year. That situation does not often accompany and support large upside moves. I expect a pretty large pullback after the exuberance of the macro environment dissipates. Chart is way overheated, IMHO.
Still, not complaining. It was a pretty good, if head scratching week.
I agree about the macro picture and biotech in general being risk on. A 20% HALO move in a week or so is still a little heady here IMHO. Was the Amivantamab news really that surprising? Normally a move into Phase 3 is not going to get everyone that amped up. Was this an undisclosed indication up until now?
Not familiar with this guy. Is he speaking strictly from a technical perspective? The strong upside moves he predicts would be welcome, of course, but they have to be based on fundamentals; and as you've noted, there are not any visible catalysts to support that at this time.