contentSlug

type

ContentSlug_ContentQuery

slug

ContentPageContentQuery

content

trendingContent

query ContentSlug_ContentQuery(
  $contentSlug: String!
  $type: [ContentType!]
) {
  ...ContentPageContentQuery_13QmVO
}

fragment CompanyDetails_Content on Content {
  __isContent: __typename
  companies {
    name
    description
    pageUrl
    id
  }
}

fragment ContentBasicInfo on Content {
  __isContent: __typename
  id
  type
  title
  lang
  companies {
    viewerIsFollowing
    id
    name
    pageUrl
  }
  tags {
    viewerIsFollowing
    id
    name
    pageUrl
  }
  ...PublishingDetails
  ...Reactions
}

fragment ContentMetadata on Content {
  __isContent: __typename
  type
  title
  lang
  pageUrl
  alternatePageUrls: translations {
    __typename
    pageUrl
    lang
  }
  imgUrl
  description
  ... on Video {
    liveTime
    videoUrl
  }
  ... on Webcast {
    liveTime
    videoUrl
  }
}

fragment ContentPageContentQuery_13QmVO on Query {
  content(slug: $contentSlug, type: $type) {
    __typename
    id
    type
    title
    isPremium
    lang
    htmlBody
    summary
    companies {
      forum {
        latestPosts {
          ...ForumPosts
        }
      }
      name
      id
      viewerIsFollowing
      pageUrl
      defaultInstrument {
        isin
        id
        marketOpen
        marketClose
        marketplace {
          region
        }
        returns {
          total
        }
      }
    }
    tags {
      viewerIsFollowing
      id
      name
      pageUrl
    }
    createdAt
    ... on Video {
      liveTime
    }
    ... on Webcast {
      liveTime
    }
    slug
    ... on CompanyReport {
      reportUrl
    }
    ... on ThirdPartyCompanyReport {
      reportUrl
    }
    ... on StockExchangeRelease {
      reportUrl
    }
    ...ContentBasicInfo
    ...ContentMetadata
    ...PriceAndRecommendation_Content
    ...CompanyDetails_Content
    ...ReportLink_Content
    ...KeyFigures_Content
  }
  ...TrendingContent_1jQ2Cn
}

fragment ForumPosts on ForumPost {
  text
  likesCount
  url
  author
  postedAt
  authorImgUrl
}

fragment KeyFigures_Content on Content {
  __isContent: __typename
  companies {
    defaultInstrument {
      estimateData {
        modelType
        reportingCurrency
      }
      snapshot {
        transaction {
          date
          actualized {
            year
            quarter
            revenue
            revenueGrowth
            ebitAdjusted
            ebitReported
            ebitda
            enterpriseValue
            epsAdjusted
            dividend
            dividendYield
            sharePrice
            nav
            navPerShare
            opexOfNav
            quarterlySharePrice
          }
          estimates {
            year
            quarter
            revenue
            revenueGrowth
            ebitAdjusted
            ebitReported
            ebitda
            enterpriseValue
            epsAdjusted
            dividend
            dividendYield
            sharePrice
            nav
            navPerShare
            opexOfNav
            quarterlySharePrice
          }
        }
      }
      id
    }
    id
  }
}

fragment PriceAndRecommendation_Content on Content {
  __isContent: __typename
  createdAt
  companies {
    name
    pageUrl
    defaultInstrument {
      priceData {
        tradeCurrency
      }
      snapshot {
        priceData {
          date
          lastPrice
          tradeCurrency
        }
        transaction {
          date
          recommendation
          targetPrice
        }
        prevTransaction {
          recommendation
        }
      }
      id
    }
    id
  }
}

fragment PublishingDetails on Content {
  __isContent: __typename
  createdAt
  publishers {
    name
    imgUrl
  }
  authors {
    __typename
    id
    name
    slug
    imgUrl
    jobTitle
  }
  ... on Video {
    liveTime
  }
  ... on Webcast {
    liveTime
  }
}

fragment Reactions on Content {
  __isContent: __typename
  id
  reactionGroups {
    reactionType
    reactionsCount
    viewerReacted
  }
}

fragment ReportLink_Content on Content {
  __isContent: __typename
  type
  isPremium
  ... on CompanyReport {
    reportUrl
  }
  ... on ThirdPartyCompanyReport {
    reportUrl
  }
  ... on StockExchangeRelease {
    reportUrl
  }
}

fragment TrendingContent_1jQ2Cn on Query {
  trendingContent(type: ARTICLE) {
    __typename
    id
    title
    lang
    pageUrl
    createdAt
    type
    imgUrl
    companies {
      squareLogoUrl
      name
      id
    }
    authors {
      __typename
      imgUrl
      id
    }
    publishers {
      imgUrl
    }
  }
}


__typename

title

isPremium

lang

htmlBody

summary

companies

createdAt

publishers

authors

reactionGroups

pageUrl

translations

imgUrl

description

Analyst

Antti Siltanen

Faron is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company's lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments.

That new policy stating that two pivotal trials (usually meaning randomized phase 3) might not be necessary if the signal is clear might not change anything for us, i.e., in oncology: ”In practice, many recent drug approvals have already relied on a single pivotal trial—especially in oncology and rare diseases, where clinical conditions or small patient populations make multiple large trials difficult or infeasible. A recent analysis found that approximately two-thirds of novel drugs approved in 2024 were based on just one pivotal study. The FDA emphasized that a one-trial default does not eliminate robust scientific scrutiny. Sponsors will be expected to provide supplementary confirmatory evidence alongside the pivotal trial. This could include mechanistic data, results from related indications, animal studies, or real-world evidence that supports the biological rationale behind the product. The agency also retains the discretion to require multiple trials in cases where a single study does not provide sufficient clarity.” More interesting, however, is what the new FDA guidance in MDS means for Faron. Juho webcast: ”Confidence in CR as an approval endpoint: FDA guidance and meeting minutes support this. Precedents in solid tumors (PFS/CR with duration). • Accelerated approval: First-line is moving towards full approval with CR. In r/r, potential approval after Phase 2 if Bex’s benefit is clear.” ”We’ll sit down with the FDA and then come to an agreement. What we would like is for OS, i.e., overall survival, to be changed to CR, i.e., complete remission rate. That would then be the final endpoint. The FDA has discussed this with us and has already written in its guidance to the industry that it can be used. In itself, it should be quite okay. This is how we can make the Phase 3 part shorter and more efficient.” We haven’t seen the meeting minutes from the summer EOP2 meeting; we’ve seen the FDA’s stances as Faron’s press releases, and they were quite strict regarding final approval (both CR+CReq and OS required), although the patient number was flexible and AA was based on responses alone, so the partner might have relied on those until the post-ASH plans changed. A voluntary binding Special Protocol Assessment (SPA) might not have been sought; the regulator’s stance was already known, and if the involved partner had wanted it for confirmation, it would have been sought. However, there’s no information on whether it was or not. And it no longer matters whether it was. Now, reference is being made to the new guidance https://www.fda.gov/media/187373/download suggesting that OS might not necessarily be mandatory anymore. If such a new, more lenient practice is pursued as a goal, the partner will likely demand a binding SPA decision from the FDA instead of it being voluntary. And in addition to the new endpoints: From Juho’s Scrip interview in the thread: ”About half of the studies utilize RWD and biomarkers to support decision-making and regulatory review. This shift is estimated to shorten development timelines by 10–20 percent and improve late-stage success chances by up to approximately 10 percentage points” What is this based on? For example, this?: https://www.fda.gov/science-research/real-world-evidence/fda-use-real-world-evidence-regulatory-decision-making Or this, January 2026: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence ”Advances in the availability and analysis of RWD have increased the potential for generating robust RWE to support FDA regulatory decisions.” Listed are drugs where this real-world evidence—meaning data from everyday life rather than clinical trials—has been utilized in final market approval. Whether these points are relevant for Bex’s potential approval would require clarification from Faron or KOLs, and preferably ultimately from the FDA. An expensive bridge is being built, and now people want to know what’s waiting at the other end. A cheaper pontoon bridge is under construction at City of Hope for the r/r market, though it has now been communicated that its marketing authorization would also be conditional on the phase 2b first-line responses. More communication is needed regarding the new plan and all the new regulatory stances it is based on.

It definitely eases and levels the playing field for these small pharmas’ negotiating positions relative to BP. Right now, many are in a tight spot specifically when it comes to securing funding. At the same time, it creates pressure on the big players to make an offer or partnership earlier and with better terms. Definitely good news.

That was already the intention earlier for the diseases supported through investigator-initiated research, but blinded tests are required. Good question: if all the criteria are relaxed, is 90 people enough or should it be expanded back to 120? Especially if this enables full marketing authorization more reliably under the new upcoming criteria, which Faron surely has had an inkling of.

Is it too much wishful thinking to hope that the 40m offering Faron is dreaming of would take them straight to the goal and that dealings with Big Pharma would move to a completely new level?

In the article referred to here (New England Journal of Medicine, requires registration), FDA Chief Makary talks about a new policy that will accelerate drug development.  It seems that Faron was already aware of this (from Juho’s latest presentation): the upper chart is the FDA’s “old guidance” and the lower chart describes a new, proposed “De-risked, staged approach,” where survival (OS) would no longer be a hurdle to obtaining marketing authorization.  In other words, surrogate endpoints (for example, improvement in blood values, etc.) are also recognized as proving the drug’s efficacy.  The FDA says that the new guidance will be published later this spring. We’ll see if Faron’s plans will have to be redone once again. Would this be good news for Faron(?); at least it requires a lot of familiarization again.

Or does it mean that Phase 2 companies no longer exist? You have to be able to very carefully plan the Phase 3 study along with its financing right away. So, a bit like Faron also tried to transition seamlessly to Phase 3. It occurs to me that this could be difficult for a small firm in terms of financing, if the funding also needs to be planned with some level of precision at the start of the (registration) study.

As a layman, I understand the FDA’s new stance to mean that if, FOR EXAMPLE, Bexmab2 is a complete success, we’ll be straight at the finish line.  In practice, things may prove to be more complicated. The “medics” will probably clarify this.

Faron Pharmaceuticals

Faron Pharmaceuticals is a clinical stage biopharmaceutical company whose three drug candidates relate to the modulation of immune system or inflammatory response. Faron is a very high-risk ...

<p>Faron Pharmaceuticals is a clinical stage biopharmaceutical company whose three drug candidates relate to the modulation of immune system or inflammatory response. Faron is a very high-risk investment as drug development requires frontloaded investments in research, while the success of commercialization is very uncertain. If the drug candidates enter the market, the invested capital can be multiplied. However, failure of drug development is frequent and, in that case, the invested capital may be partially or totally lost. We believe the share provides sufficient expected return to counterbalance the high risk. The share is suitable for a long-term investor that tolerates high risk as part of a well-diversified portfolio. A person investing in Faron must also be prepared for share issues.</p> 

	2021	22e	23e
Revenue	0.0	0.0	0.0
growth-%
EBIT (adj.)	-21.1	-22.0	-0.8
EBIT-% (adj.)	-527,700.0 %	-550,000.0 %	-19,500.0 %
EPS (adj.)	-0.40	-0.40	-0.02
Dividend	0.00	0.00	0.00
Dividend %
P/E (adj.)	neg.	neg.	neg.
EV/EBITDA	neg.	neg.	neg.

Risky investment with huge potential

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Key Estimate Figures08.08.2022

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