Herantis Pharma - Halting Neurodegenerative Diseases

Market Potential Exists for Both

There is a real need for the main drug candidates of both companies. For example, there is currently no equivalent drug to the one developed by Herantis. Medicines developed for Parkinson’s disease have focused on treating the symptoms of the disease, rather than influencing its progression.

There are other companies that are trying to develop a disease-modifying drug, but Herantis does not have a direct competitor.

Herantis itself estimated in its annual report that the addressable market for Parkinson’s disease in the United States and the EU could reach 10 billion dollars by 2030. This estimate includes the assumption that disease-modifying drugs like HER-096 will become available on the market. Herantis anticipates, as a “conservative estimate,” that two billion dollars of this sum could accrue to Herantis’s annual revenue.

Last year, the market value of Parkinson’s disease treatment was just under seven billion dollars. Estimates vary slightly depending on the source.

There is also a great need for the cancer drugs developed by Faron, as cancers are constantly becoming more common. Faron’s drug candidate aims to help patients with intermediate and high-risk myelodysplastic syndrome (MDS).

According to Faron, the size of the MDS treatment market was approximately 1.4 billion dollars in 2023 and is projected to grow to 4.5 billion dollars by 2028, of which Faron, according to its own words, has a good chance of gaining a large share. This estimate also includes the entry of new drugs into the market.

Currently, Herantis’s market potential is thus greater than Faron’s. On the other hand, both companies are also seeking to expand their applications beyond their current main drug candidates.

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Financing as a Stumbling Block

The biggest problem for both companies at the moment is how to secure financing to carry the research to the next phase.

Faron’s funding is estimated to last until the first quarter of 2026, and Herantis’s until the second quarter of 2026. According to Siltanen’s estimate, Faron would need approximately 40 million euros to complete the third phase. Herantis has communicated externally that it needs about 15–20 million euros.

For both, the best option would be a partnership agreement with a larger pharmaceutical company that would finance the research and help commercialize the drug. Both companies have stated that discussions about agreements have taken place.

According to Siltanen, Faron possibly has slightly better prerequisites for securing an agreement faster, as more evidence and data are available from its studies.

Other options include, for example, various partnerships, share issues, and loan financing. For instance, Faron organized a share issue in spring 2025, raising gross proceeds of 12 million euros. Herantis has received funding from sources such as the European Innovation Council.

It is difficult to give a direct answer as to which company to invest in. Faron is scientifically further along, and the commercialization of its drug is closer, which also increases the probabilities of success.

“On the other hand, Faron then has a bigger price tag, and Herantis, as an earlier-stage company, is valued lower,” Siltanen summarizes.

Faron currently has more plans for different types of indications, and there is a need for several drugs in cancer treatments. Herantis is fully focused on Parkinson’s disease and bringing a new kind of solution to the market.

It is difficult to say which will ultimately prove to be the winning strategy. It is, of course, possible that both succeed, or neither.

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Caution with those upside percentages…

Faron Receives Buy Recommendation from Analysts

Herantis Pharma and Faron Recommendations and Target Prices.

Table with 7 columns and 2 rows. (column headers with buttons are sortable)
Company Market Cap, mil. Euros Share Price 29.10. Target Price, euros. Upside, %. Recommendation Analysts
Herantis Pharma 53,3 2,21 2,50 1,5% Reduce 1
Faron Pharmaceuticals 271,5 2,30 5,40 4,4% Buy 4
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Where are the upside percentages in that chart calculated from, when the stock price vs. target price in that chart gives completely different percentages (HP: 13% | Faron: 134%)

Edit: Inderes seems to have the same target price of 2.50 for both, but Faron gets an ‘add’ recommendation while Herantis Pharma has a ‘reduce’ recommendation

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It just speaks volumes about the quality of journalism at this rag/Arvopaperi. The journalist doesn’t even grasp basic economic matters when such a blunder gets through…

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It is now probably a good time for Herantis Pharma to find a suitable partner with the necessary resources and a track record of success in drug development.

The WSJ article provides an overview of the situation in that industry.

https://www.wsj.com/finance/investing/abivax-hedge-fund-investments-5e9bf955?st=MMFQ9g&reflink=article_copyURL_share

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In this video, the partnership agreement is set for spring 2026

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Anavex’s blarcamesine for Alzheimer’s treatment has now stalled in EMA’s review. https://www.anavex.com/post/anavex-life-sciences-provides-regulatory-update-on-blarcamesine-for-early-alzheimer-s-disease

"The Company was informed by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) of a negative trend vote on the Marketing Authorisation Application (MAA) for blarcamesine following its CHMP oral explanation. The CHMP is expected to adopt a formal opinion on the MAA at its December meeting. The Company intends to request a re-examination of the CHMP opinion upon its formal adoption, including providing relevant biomarker data, based on feedback and continued guidance from the CHMP, EMA and the Alzheimer’s disease community. The EMA procedures adopted by the CHMP allow an applicant to request re-examination of its decision, which would be undertaken by a different set of reviewers that conduct a new examination, independent from the first opinion."

So, the biomarker data, the analysis of which is still awaited from the HER-096 Phase 1b, appears to be a very important part of that assessment.

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Even though Vase three has already been completed?

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Completed, yes, but not passed with this data. It remains to be seen if Anavex’s additional data will be sufficient to convince EMA’s decision-makers. At least based on that announcement, Anavex’s biomarker data to date does not seem to have been sufficient, if they are indeed looking to submit more of it to the EMA.

edit: And so, effective anti-amyloid antibodies have recently been approved for the treatment of Alzheimer’s disease, so they also form a benchmark for these competing compounds.

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Key Takeaways from Anavex’s Update

• The CHMP issued a “negative trend vote” on blarcamesine’s MAA after Anavex’s oral explanation, with a formal opinion expected in December 2025.  This isn’t a final rejection yet—Anavex plans to request a re-examination, which involves a fresh review by a different CHMP panel, and intends to bolster its submission with additional biomarker data based on CHMP feedback. 

• Despite completing a Phase 2b/3 trial (ANAVEX®2-73-AD-003) showing statistically significant cognitive and functional benefits (e.g., 38.5% slowdown in progression at 50 mg dose vs. placebo), the EMA appears unconvinced by the current dataset, particularly on biomarkers supporting disease modification. 

Prior critiques have flagged issues like inconsistent reporting, reliance on post-hoc analyses (e.g., tipping point methods), and insufficient separation from placebo on key endpoints.  

• Broader context: EMA has recently approved anti-amyloid antibodies (e.g., lecanemab, donanemab) for AD, setting a high bar for efficacy signals, safety, and mechanistic evidence like amyloid/tau reduction or neuroprotection via biomarkers. Blarcamesine’s sigma-1 receptor mechanism (aiming for cellular homeostasis) may not yet align strongly enough without more robust supportive data.
This highlights EMA’s growing stringency for neurodegenerative approvals: Clinical outcomes alone (even from large Phase 3 trials) aren’t enough; integrated biomarker evidence (e.g., CSF/plasma markers of neurodegeneration, imaging, or pharmacodynamic changes) is increasingly pivotal to demonstrate disease-modifying potential and address unmet needs.

  1. HER-096 Program Overview and Current Status

• HER-096 is Herantis’s lead asset, a subcutaneously administered CDNF (cerebral dopamine neurotrophic factor) mimetic designed to protect and restore degenerating neurons in PD, potentially slowing disease progression without the dopaminergic side effects of current symptomatic treatments.
• The Phase 1b trial (completed dosing in August 2025) enrolled PD patients for repeated twice-weekly doses (200 mg and 300 mg) over four weeks, plus follow-up.  Topline results (announced October 7, 2025) were positive:
• Safety/Tolerability: Generally well-tolerated; mild, transient injection-site reactions were the main adverse events. No serious drug-related issues in active arms (one placebo-related SAE). 
• Pharmacokinetics (PK): Confirmed strong blood-brain barrier penetration and sufficient CSF exposure, consistent with healthy volunteer data—key for a CNS-targeted therapy. 
• Preliminary Efficacy: Motor symptoms (via MDS-UPDRS) remained stable in both active and placebo groups, but the trial wasn’t powered for this (short duration, small n=~30).
• Critically, full exploratory biomarker analysis (targeted/untargeted, e.g., neuroinflammation, dopamine neuron health markers) is still pending and expected by end-2025.   Herantis plans to advance to a Phase 2 efficacy trial in early-stage PD patients in 2026, with 300 mg twice-weekly dosing as the go-forward regimen. 
4. Direct Implications for HER-096
• Heightened Emphasis on Biomarkers: Anavex’s pivot to submit more biomarker data in re-examination mirrors the exact gap Herantis is addressing right now. EMA (and regulators like FDA) increasingly demand biomarker-backed evidence for disease modification in PD/AD—e.g., alpha-synuclein reduction, dopaminergic neuron preservation, or neuroprotection signals via PET/MRI/CSF assays.

  • If Herantis’s end-2025 biomarkers show clear pharmacodynamic effects (e.g., reduced neuroinflammation or stabilized dopamine markers), it could de-risk Phase 2 design and future MAA filings, positioning HER-096 as a differentiated option in a field with few disease-modifiers (current PD drugs like levodopa are symptomatic only)

. Weak or inconclusive data, however, could echo Anavex’s hurdles, forcing iterative submissions or trial redesigns later.
• Regulatory Caution for Early-Stage Programs: Anavex reached MAA filing post-Phase 3 but still hit a wall, underscoring that EMA doesn’t grant leniency even for advanced assets without ironclad integrated evidence. For Herantis (pre-Phase 2), this reinforces the need for early EMA engagement (e.g., scientific advice meetings) to align on endpoints. PD’s regulatory path is evolving too—FDA/EMA have accelerated approvals based on biomarkers (e.g., for spinal muscular atrophy analogs), but recent AD precedents show they’re quick to reject if data feels “shaky.” 

Herantis’s orphan drug potential (PD isn’t formally orphan but could qualify subsets) might offer some flexibility, but not immunity.
• No Direct Competition, But Shared Market Dynamics: Blarcamesine (oral, sigma-1 targeted) and HER-096 (subcutaneous, neurotrophic factor) aren’t head-to-head, but both vie for investor/regulator attention in the ~$50B+ neurodegenerative space. Anavex’s ~30% stock drop post-update (worst in 2 years) reflects market sensitivity to EMA signals.  For Herantis (microcap, Helsinki-listed), positive biomarkers could attract partnerships/funding amid this scrutiny, especially with Phase 2 looming. Conversely, any perceived “Anavex effect” might temper enthusiasm for CNS biotechs until Herantis delivers.
• Timeline Risks and Opportunities: With biomarkers due by December 2025 (aligning with Anavex’s re-exam window)

  • Herantis has a narrow but pivotal moment. Success here could enable smooth Phase 2 start in H1 2026; delays or underwhelming results might push timelines, mirroring Anavex’s extended path (they’re now eyeing FDA meetings too).  On the upside, Anavex’s dialogue (e.g., with patient communities) shows EMA values stakeholder input—Herantis could leverage PD advocacy groups similarly.
    In summary, Anavex’s stall doesn’t doom HER-096 but spotlights biomarkers as the “make-or-break” for EMA success in this space. Herantis’s topline momentum is encouraging, but the full dataset readout will be make-or-break for momentum into Phase 2. If you’re holding or tracking HTI (Herantis ticker), watch the Q4 2025 update closely—it could catalyze upside if biomarkers shine, especially against a backdrop of regulatory realism from cases like this.
  • For deeper dives, Herantis’s half-year report notes ongoing grant funding for Phase 2 prep. 
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For real-time updates, monitor Herantis’s investor releases or ClinicalTrials.gov.

  • If biomarkers confirm preclinical hits, HER-096 could differentiate as a “hit-and-run” modifier vs. symptomatic therapies.

HER-096 as a disease-modifying therapy for Parkinson’s disease

Kulesskaya, Natalia; Holmström, Kira M.; Huttunen, Henri J.*

https://pdfs.journals.lww.com/nrronline/2025/04000/brain_penetrating_neurotrophic_factor_mimetics_.23.pdf?token=method|ExpireAbsolute;source|Journals;ttl|1763282755190;payload|mY8D3u1TCCsNvP5E421JYK6N6XICDamxByyYpaNzk7FKjTaa1Yz22MivkHZqjGP4kdS2v0J76WGAnHACH69s21Csk0OpQi3YbjEMdSoz2UhVybFqQxA7lKwSUlA502zQZr96TQRwhVlocEp/sJ586aVbcBFlltKNKo+tbuMfL73hiPqJliudqs17cHeLcLbV/CqjlP3IO0jGHlHQtJWcICDdAyGJMnpi6RlbEJaRheGeh5z5uvqz3FLHgPKVXJzdZzClNyD/fKg9/eCkIUy6Hfbnzn0I6QpdS2qPtcoLIt4=;hash

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Recommendation update from Antti. Herantis: Share pricing attractive again - Inderes

Exceptionally without news, has the practice changed?

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In my understanding, it’s quite normal activity when the share price has fallen almost 50 percent from its peaks and nothing has changed since the previous information, and there’s 25% upside potential to the target price.

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Stock Exchange Announcement:

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Video 24.11.25 Herantis Pharma, latest info | EDISON

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This notification just arrived:

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Can’t you read “between the lines” from that, that the biomarker results were good?

It had surprisingly little effect on the stock price, as after the morning jump, we have already slid back to the starting position.

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Approximately 30-60 days were supposed to be spent on marker counting. October 25th was likely the day the phase ended. Perhaps they will hold onto the marker data a bit longer, and then something will happen in JP.

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