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TPE:6446

8 stories mentioning TPE:6446Updated just now

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Asia

PharmaEssentia Gets Experts Board's Recommendation to Continue Phase 3 Myelofibrosis Drug Trial

PharmaEssentia (TPE:6446) said an independent Data and Safety Monitoring Board recommended continuing its Phase III trial of its drug for pre-fibrotic/early or overt primary myelofibrosis.The drug, dubbed ropeginterferon alfa-2b (P1101), is being studied in adults under the multinational, multicenter HOPE-PMF trial, according to a Friday filing with the Taiwan bourse.The company said the study will continue according to its protocol, with the core study expected to be completed in 2027.

TPE:6446
Asia

PharmaEssentia Corp Submits Post-approval Applications to Taiwan Regulator to Expand Besremi Use

PharmaEssentia Corp (TPE:6446) has submitted post-approval applications to Taiwan's Food and Drug Administration to expand the use of Besremi (ropeginterferon alfa-2b) and modify its dosing regimen for polycythemia vera (PV), according to a Friday filing to the Taiwan stock exchange.The company has sought approval to use Besremi in all adult patients with essential thrombocythemia (ET), regardless of treatment line, broadening its current indication for patients resistant or intolerant to hydroxyurea.It has proposed to change the PV dosing regimen from the current regimen of a starting dose of 100 mcg followed by 50 mcg increases every two weeks, to a higher initial dose and accelerated titration (HIDAT) regimen consisting of a starting dose of 250 mcg, increased to 350 mcg after two weeks, and further increased to the target dose of 500 mcg after another two weeks.Besremi was approved in Taiwan in 2020 for adults with PV without symptomatic splenomegaly.

TPE:6446
Asia

PharmaEssentia Clarifies Report Projecting 2026 Revenue

PharmaEssentia (TPE:6446) clarified a Taiwan's Economic Daily News projecting the company's full-year profit would exceed twice its paid-in capital was media speculation and was not based on any financial or business forecast provided by the company.The report also said Japan's health ministry expert panel had endorsed expanding BESREMi (Ropeginterferon alfa-2b) to all essential thrombocythemia patients and that approval could come as early as mid-August.PharmaEssentia said the actual review timeline, approved indication and regulatory outcome in Japan remain subject to an official decision by the country's Ministry of Health, Labour and Welfare.The company asked investors to only rely on its disclosures on Taiwan's MOPS for official updates.

TPE:6446
Asia

PharmaEssentia, Subsidiary Hit By Cyberattack; Shares Rise 6%

PharmaEssentia (TPE:6446) said certain information systems at the company and its unit, Panco Healthcare, were affected by a cyberattack, according to a Monday Taiwan Exchange filing.Shares gained 6% in Tuesday's afternoon trade.The biotechnology company said its preliminary assessment showed the incident has no significant impact on its operations.PharmaEssentia said it has activated its cybersecurity defense mechanisms, engaged external cybersecurity experts to support the response and reported the incident to the relevant authorities.The company added it is continuing to investigate the incident and will strengthen the security management of its network and information infrastructure.

TPE:6446
Asia

PharmaEssentia's Besremi Wins Macau Import Approval; Shares Surge 9%

PharmaEssentia's (TPE:6446) said the Institute of Pharmaceutical Supervision and Administration of Macau approved adding a new indication to the prior authorization for the import of medicines for Besremi, according to a Sunday filing with the Taiwan Exchange.The medication is used to treat adult patients with essential thrombocythemia.Following the approval, the drug can now be exported to and marketed and sold in Macau for the newly approved indication.Shares of the biopharmaceutical company surged over 9% in Monday trading.

TPE:6446
Asia

PharmaEssentia Swings to Profit in May as Revenue Balloons 108%

PharmaEssentia (TPE:6446) reported May net profit attributable to shareholders of NT$993 million, compared with a loss a year earlier, according to a Wednesday Taiwan Exchange filing.Revenue for the month ballooned 108% year-on-year to NT$2.46 billion, while earnings were NT$2.66 per share.For the first quarter, audited net profit attributable to shareholders increased 70% from a year earlier to NT$2.15 billion. Meanwhile, revenue soared 57% annually to NT$5.12 billion.

TPE:6446
Asia

PharmaEssentia Rebuffs Media Report Speculating Profit, Revenue for 2026

PharmaEssentia (TPE:6446) refuted a Commercial Times report claiming that the company's full-year 2026 revenue could exceed NT$20 billion, and profits may surpass two times paid-in capital, potentially making it the most profitable biotech firm in the sector.The biotech company described the figures as speculative, stating that it did not provide any financial or business forecasts, according to a Thursday Taiwan Exchange filing.It added that investors should rely solely on official disclosures via the Market Observation Post System, according to its filing.

TPE:6446
Asia

PharmaEssentia Completes Enrollment for Phase III Primary Myelofibrosis Drug Study

PharmaEssentia (TPE:6446) completed the enrollment of 160 patients in a Phase III clinical trial testing its drug ropeginterferon alfa-2b (P1101) for early and low-risk primary myelofibrosis.The global study, called HOPE-PMF, is expected to be completed in 2027, according to a Wednesday Taiwan Exchange filing.The company said the drug is already approved for other blood disorders in several countries, but this new indication is still under development.

TPE:6446

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