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Geron Stock Rallies More Than 60% in a Year: Here's Why
GERNGeron(GERN) ZACKS·2025-01-08 16:40

Core Viewpoint - Geron Corporation experienced a transformational year in 2024 with the FDA approval and commercial launch of Rytelo (imetelstat) for treating low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia, leading to a significant increase in its stock price [1][3]. Company Performance - Geron's shares increased by 61.1% over the past year, contrasting with a 15.6% decline in the industry [1]. - Rytelo generated sales of 28.2millioninitsfirstfullquarterpost−launch,surpassingcompanyexpectationsduetohighunmetneedsinlower−riskMDS[3].−LossestimatesforGeronimprovedfrom26centspershareto25centsfor2024,andfrom10centsto6centsfor2025overthepast60days[8].RegulatoryDevelopments−TheEuropeanMedicinesAgency′sCommitteeforMedicinalProductsforHumanUse(CHMP)recommendedRytelo′sapprovalintheEU,withadecisionfromtheEuropeanCommissionexpectedinthefirsthalfof2025[4].ResearchandDevelopment−GeronisconductingaphaseIIIIMpactMFstudyforRyteloinpatientswithrelapsed/refractorymyelofibrosis(MF),withearlyfindingsfromtheIMproveMFstudyindicatingpotentialtolerabilityofimetelstatandruxolitinibasacombinationtherapyforMF[5].FinancialPosition−Geronsecured28.2 million in its first full quarter post-launch, surpassing company expectations due to high unmet needs in lower-risk MDS [3]. - Loss estimates for Geron improved from 26 cents per share to 25 cents for 2024, and from 10 cents to 6 cents for 2025 over the past 60 days [8]. Regulatory Developments - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended Rytelo's approval in the EU, with a decision from the European Commission expected in the first half of 2025 [4]. Research and Development - Geron is conducting a phase III IMpactMF study for Rytelo in patients with relapsed/refractory myelofibrosis (MF), with early findings from the IMproveMF study indicating potential tolerability of imetelstat and ruxolitinib as a combination therapy for MF [5]. Financial Position - Geron secured 375 million in funding through synthetic royalty and debt financing, enhancing its cash position to support the commercial launch of Rytelo in the U.S. and potential EU launch, as well as ongoing studies in MF [6].