#Formycon

@newsen.bsky.social

3 months ago

Zydus and Formycon Collaborate for Biosimilar Keytruda in North America Zydus Lifesciences and Formycon have formed a strategic partnership to bring FYB206, a biosimilar of Keytruda, to the U.S. and Canada, enhancing patient access.

Zydus and Formycon Collaborate for Biosimilar Keytruda in North America #India #Ahmedabad #KEYTRUDA #Zydus_Lifesciences #Formycon

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Thiard News@F4F

@newsen.bsky.social

3 months ago

Formycon and MS Pharma Establish Key Partnership for Keytruda® Biosimilar in MENA Region Formycon AG and MS Pharma announce an exclusive licensing agreement for the Keytruda® biosimilar candidate. This partnership aims to enhance cancer treatment accessibility in the MENA region.

Formycon and MS Pharma Establish Key Partnership for Keytruda® Biosimilar in MENA Region #Germany #KEYTRUDA #MS_Pharma #Formycon #Planegg-Martinsried

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Profit Trading USA

@profittradingusa.bsky.social

7 months ago

Formycon reiterates 2025 guidance, expects stronger second half Investing.com -- Formycon AG (ETR:FYB) reported first-half revenue of €9.0 million and an EBITDA loss of €17.9 million on Wednesday, while maintaining its full-year 2025 guidance. The German biosimilar developer continues to expect annual revenues between €55-65 million and an EBITDA loss of €10-20 million. Current market consensus estimates for the year stand at €54 million in revenue and a €19 million EBITDA loss, according to Factset data. Formycon reiterated its timeline for reaching positive EBITDA, which it expects "as early as 2026, but no later than 2027." The company’s first-half performance included €1.7 million in revenue from its share in the commercialization of FYB202/Otulfi, its Stelara biosimilar, which has been on the market for approximately four months in both the US and Europe. Management anticipates significantly stronger performance in the second half of 2025, with results particularly weighted toward the fourth quarter. This expected improvement is driven by two key factors: building momentum in the FYB202 launch later in the year, and the anticipated signing of a partnership deal for FYB206, its Keytruda biosimilar, which would likely include an upfront payment. The company’s outlook aligns with commentary from Sandoz (SIX:SDZ) regarding its own Stelara biosimilar, Pyzchiva, which also expects stronger performance later in the year. This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

Click Subscribe #Formycon #Biosimilars #InvestmentNews #2025Guidance #HealthcareInvesting

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Profit Trading USA

@profittradingusa.bsky.social

8 months ago

Formycon rises on FYB206 trial progress, stays in lead on Keytruda biosimilar Investing.com -- Shares of Formycon AG (ETR:FYB) rose over 4% on Thursday after the company announced it had completed patient enrollment in the pivotal Dahlia pharmacokinetic (PK) study for FYB206, its biosimilar to Merck’s blockbuster cancer drug Keytruda. The PK trial, launched in June 2024 at selected Southeastern and Eastern European sites, enrolled 96 participants. It compares the pharmacokinetics, safety, and tolerability of FYB206 against Keytruda. Formycon said the first patients have completed all 17 treatment cycles, and results for the study’s primary endpoint are expected in the first quarter of 2026. The study is central to Formycon’s streamlined clinical development strategy for FYB206. In late 2024, the company submitted a modified clinical plan to the U.S. Food and Drug Administration (FDA), aiming to demonstrate therapeutic equivalence using analytical data and PK results alone. Following a favorable FDA response, Formycon halted recruitment for a previously launched Phase III trial in February 2025. Patients already enrolled in that trial continued treatment with the locally available Keytruda outside the study. This approach has allowed Formycon to significantly reduce development costs while accelerating its timeline, without compromising regulatory rigor. According to Dr. Andreas Seidl, Chief Scientific Officer at Formycon, the “last patient in” milestone reflects the company’s operational efficiency and strong recruitment performance across study centers. Keytruda posted global sales of US$29.5 billion in 2024, making it the world’s top-selling drug. Forecasts project sales could exceed US$50 billion by 2032, driven by its broad oncology indications. The International Agency for Research on Cancer estimates a 77% increase in global cancer diagnoses by 2050, highlighting the growing need for affordable immunotherapy options. However, competition looms. Merck (NSE:PROR) is expected to launch a subcutaneous (SC) formulation of Keytruda as early as this year, a move analysts suggest could complicate biosimilar substitution in the U.S. market. Formycon currently anticipates that FYB206 could enter the U.S. market after Keytruda’s exclusivity expires in 2029, and in the EU after 2030. RBC Capital Markets, which maintains an “Outperform” rating with a €51 price target, values FYB206 at €19 per share,over 37% of the firm’s valuation. While acknowledging Formycon’s leadership in the pembrolizumab biosimilar space, RBC maintains a “neutral” sentiment due to the speculative nature of biosimilar development, regulatory risks, and Merck’s lifecycle management strategies.

Click Subscribe #Formycon #FYB206 #biosimilars #Keytruda #clinicaltrials

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@4investors.de

8 months ago

Anleihe überzeichnet – Formycon fixiert Zins bei EURIBOR plus 7 Prozent Formycon hat ihre neue Unternehmensanleihe 2025/2029 mit einem Volumen von 70 Millionen Euro erfolgreich platziert. Ursprünglich hatte das Biotech-Unternehmen ein Zielvolumen von 50 Millionen Euro

#Anleihe überzeichnet – #Formycon fixiert Zins bei EURIBOR plus 7 Prozent: www.4investors.de/nachrichten/... #4investors

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@4investors.de

8 months ago

Formycon: Hohe Nachfrage nach der Anleihe Seit dem 18. Juni können Investoren die Premieren-Anleihe von Formycon zeichnen. Eigentlich sollte die Zeichnungsfrist am 30. Juni enden. Aufgrund der starken Nachfrage nach der Anleihe durch

Formycon: Hohe Nachfrage nach der Anleihe ... www.4investors.de/nachrichten/... #formycon #spillner #anleihe #ibo #biosimilar #4investors

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@4investors.de

8 months ago

Formycon: „Biosimilar-Markt wächst mit beeindruckender Dynamik“ Zum ersten Mal in der Unternehmenshistorie begibt Formycon eine Anleihe. Das Papier hat ein Volumen von bis zu 50 Millionen Euro und läuft bis 2029. Die genaue Verzinsung ist noch nicht klar. Die

Formycon: „Biosimilar-Markt wächst mit beeindruckender Dynamik“ ... www.4investors.de/nachrichten/... #formycon #aktien #anleihen #4investors

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Labdoo.org (Deutschland / Germany)

@labdoo-d.bsky.social

1 year ago

Im Büro der Firma Formycon AG stehen 2 Personen vor einer hellen Wand, darauf 3 große, hinterleuchtete Kreise in hell-, dunkelblau und gelb. Vom Betrachter aus rechts steht Patrick Stevens von Formycon, links Jaun vom Labdoo Hub München. Beide halten einen Laptops rechts und links fest und schauen in die Kamera. Auf einem Tisch zwischen beiden liegen gestapelte Laptops.

Vielen Dank #Formycon AG, Patrick Stevens und Team für eure großzügige IT-Spende über 105 Laptops.
Eure Laptops werden von den Labdoo-Helfern in München bearbeitet, um Bildungsprojekte zu unterstützen.
#labdoo #ITDonation #EducationForAll #martinsried #danke #thankyou #münchen #munich #Formycon

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Nebenwerte Magazin

@nebenwerte-magazin.bsky.social

1 year ago

Formycon Aktie, Wette auf Erfolg der Biosimilar's. Laufende Verfahren und Kasse lassen optimistisch werden. Gerade auf aktuellem Kursniveau! #smallcaps #nebenwerte #biotech #börse #investingtips #tradingtips #stockstowatch #DE000A1EWVY8 #Formycon
www.nebenwerte-magazin.com/?p=33701

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Michael Barck

@michaelbarck.bsky.social

2 years ago

EQS-News: Formycon und Fresenius Kabi geben die Annahme des Zulassungsantrags für FYB202, einen Bio... EQS-News: Formycon AG / Schlagwort(e): Zulassungsantrag Formycon und Fresenius Kabi geben die

Ich finde die Formulierung in der News von #Formycon potenziell missverständlich. Natürlich wurde #FYB202 durch die FDA noch nicht zugelassen, sondern der Antrag auf Zulassung zur Prüfung angenommen. Das kann man deutlicher formulieren, liebe Formycon-PR! www.4investors.de/nachrichten/...

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Posts tagged #Formycon