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Algernon Pharmaceuticals Inc Class A (AGN)

CSE
Currency in CAD
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0.120
+0.010(+9.09%)
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AGN Comments

Significant progress has been made in their drug development while they've also secured additional funding. Recent news of Notice of Allowance from USPTO and successful rights offering only further validate their business model of repurposing drugs and protecting IP.
Recent news that AGN's received notice of allowance for NP-251 (Repirinast) as a promising candidate treating CKD and fatty liver disease is pretty interesting, adding another strong candidate in treating chronic diseases with unmet needs. Furthermore, preclinical studies are showing its a strong candidate for treatment.
Latest results from the phase 1 study of DMT for stroke patients is making solid progress with results from their 2nd cohort successfully dosed without any issues - 3rd cohort is receiving higher doses with the purpose of determining if hitting "Sigma 1" receptor with DMT can create enough brain derived neurotrophic factor to aid in healing process for stroke patients.
Good to hear that they've dosed the 2nd round of patients in the DMT Phase 1 trial. With nearly 800,000 people each year experiencing a stroke in the US alone, this provides a huge market opportunity and can be a life-changing form of treatment for many. So definitely keep tabs on development as research continues on the treatment.
DMT for stoke has been found safe to proceed to the next phase, now they're focusing on identifying the correct dosage amount for the best recovery effect. DMT could be a revolutionary drug in the space and could further legitimize psychedelics in healthcare as a whole.
Algernon announces they’ve dosed the first subject in the Phase 1 DMT clinical stroke study. This study is being conducted at the Centre for Human Drug Research in Leiden, Netherlands. The first part of this study will use a single-escalating dose design aimed at identifying a safe and tolerable dose that will not produce psychedelic effects. AGN’s DMT trial also positions them as one of the cheapest psychedelic stocks on the market
The DMT study makes AGN the first company to begin investigating its effects on stroke! Will be interesting to see the results as they continue with phase 1 and move into phase 2 later on.
The appointment of Dr. Peter Dicpinigaitis MD as a medical consultant to Algernon Pharmaceuticals' chronic cough research program is pretty significant. Dr. Dicpinigaitis is the founder and director of the Montefiore Cough Center, one of the few specialty centers in the world exclusively committed to the evaluation and management of patients with chronic cough. He’s authored many peer-reviewed journal articles and book chapters on cough and is considered an authority on the performance of cough challenge studies in clinical research. He also serves as the Editor-in-Chief of the journal LUNG. His expertise will be valuable to the company as they advance towards their upcoming Phase 2b chronic cough study of NP-120 (Ifenprodil).
Is Ifenprodil the next billion dollar cough drug? Algernon Pharmaceuticals recently received FDA Orphan Drug Designation for Ifenprodil in IPF treatment & CEO Christopher Moreau shares an update for a new Phase 2B study slated to commence in July 2023 which will determine if its superior to current cough treatments.
Catalyst alert with Algernon’s recent news that they’ve been granted orphan drug designation by the FDA for its use of Ifenprodil as a treatment for IPF. FDA orphan drug designation is massive due to the potential 7-year exclusivity following approval. Prices have climbed ~22%+ on the day of this news, more to come as they progress through the next steps of their clinical program.
Algernon Pharmaceuticals announces that they’ve initiated their DMT clinical stroke research program with their Phase 1 study in the Netherlands. The release today indicates the progress of this clinical trial with the screening of its first subjects for the phase 1 DMT human stroke study. As multiple DMT phase 1 studies have already been conducted, the company expects no serious adverse events or safety issues which will lead to an effective transition into phase 2 acute stroke and rehab studies.
Algernon reaches another milestone with the approval to commence phase 1 clinical trials in its investigation of DMT in treating ischemic stroke. This treatment will tap into a market worth $15B+ which only amplifies the urgent demand and need for new treatments. The phase 1 trials are on-track and expected to commence before the end of the year.
The phase 2 study with Yale will provide the company with joint ownership IP around the clinical use of DMT arising from the study developed jointly by the two parties and the option to negotiate licenses to both IP developed jointly and IP developed solely by Yale. I'm looking forward to seeing how the trials progress considering that Yale is one of the top universities in the world.
If approved, the orphan designation for Ifenprodil will provide 25% tax credits for qualified clinical trial expenses, exemption from user fees, ability to qualify to compete for research grants from the Office of Orphan Products Development, and potentially seven years of market exclusivity after approval which will greatly help drug development.
With DMT recently being approved for the phase 1 human study, there's a lot of previous work showing the potential of DMT here. Research shows DMT has neuroplastic and neurogenesis effects in cortical neuron assay (increased the growth of cortical neurons by up to 40% compared to control), it was previously effective in an animal stroke study, and DMT has already been through extensive research over long period of time with numerous studies conducted so there shouldn't be any safety challenges faced in the trials. Looking forward to seeing the trial results, especially when over 795,000 people in the US alone suffer from strokes.
IPF affects around 100,000 in the US alone, and with current treatments including pirfenidone and nintedanib (which only slow IPF’s progression), having a cost of $100,000 per year is something that is opening a significant market for AGN’s drug candidate. If they get approved for the orphan designation, there will be a good future ahead for Ifenprodil's use on IPF.
While Algernon eyes one of the most significant catalysts possible for any biotech stock with its orphan designation with the FDA pending for its use of Ifenprodil, they are also advancing their other formulation with approval to conduct their DMT study in the Netherlands with a treatment aimed at helping those that have suffered neurologically from strokes.
Solid developments recently with the $425k cash from Australia combined with the orphan drug application with the FDA. We should hear back from the orphan designation within the next 90 days, and will provide a great base to push Ifenprodil into phase 3 and onto the market.
Imagine if Algernon receives the orphan designation for Ifenprodil. Orphan designation is literally one of the strongest possible catalysts for any biotech stock due to its potential 7-year exclusivity after approval among other benefits, but many other biotech stocks have increased by at least 50-100% in the single day following news of FDA Orphan drug designation…
Excited to see the development here, especially with the recently announced DMT study. Considering the past results from preclinical studies and it already being a relatively safe drug, we'll have a lot of promising IP to work off of after the trial in Q4. Definitely keep a close eye out here as they continue to develop their DMT, Ifenprodil, and Reprinast treatments.
ICYMI - Algernon Pharmaceuticals recently reported positive results from their complete data set of its phase 2a study of Ifenprodil for treating idiopathic pulmonary fibrosis (IPF) and chronic cough with all data showing positive results including statistically significant improvement in measures of cough. AGN CEO, Christopher Moreau discusses this update in a new video on the Marketherald.
For reasons including Algernon’s unique position having a mere 2.4M shares OS, 3 main drug candidates all of which likely to be in Phase 2 trials in ‘23, and the positive results from the full data set of its Phase 2a study of Ifenprodil, Streetwise Reports issues an immediate buy rating from a new piece
AGN reports positive results from the full set of their Phase 2a trials evaluating Ifenprodil to treat IPF and chronic cough including statistically significant improvements in measures of cough. This full set follows up the previously announced positive results from top line data reported in mid July. As a result of the final results, AGN will present the data to the U.S FDA, including applying for orphan designation, the filing of a pre-IND application for a Phase 2b IPF with cough trial, and an application for Breakthrough Therapy designation.
AGN has one of the tightest floats of any drug or pharma stock on the market with only 2.3M OS. Major multi-bag potential with significant catalysts in the pipeline including the trials with DMT treating brain stroke. This piece provides a solid analysis on AGN’s winning drug repurposing strategy in the context of Merck’s failure in this (IPF treatment) space being AGN’s opportunity
Definitely noteworthy when Canada’s #1 most successful hedge fund company, AlphaNorth Asset Management, nearly doubled its ownership position in AGN to 13%, believing recent weakness in share price provides a great opportunity with strong belief in its management and drug pipeline moving forward in planned phase 1 studies of DMT for stroke.
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