Foresee Pharmaceuticals Co., Ltd.

TAIPEI, Jan. 13, 2025 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") announces that the U.S. Food and Drug Administration (FDA) issued a Day-74 letter. The Day-74 letter states that the PDUFA goal date for a decision on marketing approval for the 3-month version of CAMCEVI (leuprolide mesylate 21 mg, 3-month long-acting injectable (LAI) formulation) for the treatment of adult patients with advanced prostate cancer is August 29, 2025. "This marks another important regulatory milestone for the CAMCEVI franchise," said Dr. Ben Chien, Founder and Chairman of Foresee. "With the PDUFA goal date now set, we look forward to working with the FDA through the regulatory process to bring this treatment option closer to potential regulatory approval, followed by the successful commercial launch of CAMCEVI 21 mg in near future, providing patients and the medical community with a 3-month CAMCEVI LAI in addition to CAMCEVI 42 mg 6-month LAI, currently on the market. Foresee will have a complete, differentiated ready-to-use franchise." The NDA submission for the 3-month version of CAMCEVI is supported by a previously communicated successful Phase 3 clinical study with a total of 144 advanced prostate carcinoma patients enrolled, in which treatment with leuprolide mesylate injection every 3 months was demonstrated to be effective, safe and well tolerated, with 97.9% of the subjects achieving the primary efficacy endpoint. About Foresee Pharmaceuticals Co., Ltd. Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (TPEx: 6576). Foresee's R&D efforts are focused on two key areas, namely its unique Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) technology with derived drug products targeting specialty markets and secondly, its transformative preclinical and clinical first-in-class NCE programs targeting rare and severe disease areas with high unmet needs. Foresee's product portfolio includes late and early-stage programs. CAMCEVI 42 mg or the treatment of advanced prostate cancer, is now approved in the U.S., Canada, EU, Taiwan, Israel, and the UK and was launched in the U.S. in April 2022. Additionally, the U.S. NDA for the 3-month version of CAMCEVI has been submitted, while the EU regulatory submission for the 3-month version of CAMCEVI is still under preparation. For the second indication of CAMCEVI 6-month LAI formulation, central precocious puberty (CPP), the Casppian Phase 3 clinical study, is ongoing. CAMCEVI 6-month LAI formulation is also being developed in a Phase 3 clinical trial in premenopausal breast cancer in China in collaboration with its partner. Aderamastat (FP-025), a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, has been investigated in a Phase 2 proof-of-concept study in allergic asthmatic patients. The study had positive outcomes, with future development in rare immune-fibrotic diseases. Linvemastat (FP-020), a follow-on oral MMP-12 inhibitor, for which a Phase 1 study in healthy volunteers has been successfully completed, with development targeted in severe asthma, COPD and IBD. Mirivadelgat (FP-045) is a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which the FuschiA Phase 1b/2 Fanconi Anemia study is ongoing, and the Phase 2 WINDWARD study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients is in planning with targeted initiation in the first quarter of 2025. Building on the compelling biology of ALDH2, and translational data from several Foresee ALDH2 activators, a follow-on candidate from a new series of compounds is being selected for development in metabolic syndrome/healthy weight loss and the broader cardiovascular-renal-metabolic space. SOURCE Foresee Pharmaceuticals Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

TAIPEI, Dec. 4, 2024 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") announces that it has successfully completed an underwritten public offering of 18,000,000 shares of its common stock to the public at a price of NT$76 per share. The aggregate gross proceeds to Foresee from the offering were NT$1,368 million (or US$42.1 million at FX=32.5). The proceeds of the public offering will be used for general corporate purposes, including FP-014 (triptorelin), a ready-to-use long-acting injectable, administered either every three months or six months, in two Phase 3 clinical trials for advanced prostate cancer, respectively; FP-020 (linvemastat), an MMP-12 inhibitor, in two Phase 2 studies for both asthma and inflammatory bowel disease (IBD), and FP-045 (mirivadelgat), an ALDH2 activator, in a Phase 2 clinical trial for pulmonary hypertension associated with interstitial lung disease (PH-ILD). "We are pleased to announce the successful completion of the public offering. I would like to express my gratitude once again for shareholders' full support and trust in us." said Dr. Ben Chien, Founder and Chairman of Foresee. "This funding will enable us to accelerate our R&D progress and create more value for our shareholders." About Foresee Pharmaceuticals Co., Ltd. Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (TPEx: 6576). Foresee's R&D efforts are focused on two key areas, namely its unique Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) technology with derived drug products targeting specialty markets and secondly, its transformative preclinical and clinical first-in-class NCE programs targeting rare and severe disease areas with high unmet needs. Foresee's product portfolio includes late and early-stage programs. CAMCEVI® 42 mg or the treatment of advanced prostate cancer, is now approved in the U.S., Canada, EU, Taiwan, Israel, and the UK and was launched in the U.S. in April 2022. Additionally, the U.S. NDA for the 3-month version of CAMCEVI has been submitted, while the EU regulatory submission for the 3-month version of CAMCEVI is still under preparation. For the second indication of CAMCEVI 6-month LAI formulation, central precocious puberty (CPP), the Casppian Phase 3 clinical study, is ongoing. Another indication of CAMCEVI 6-month LAI formulation, premenopausal breast cancer, the Phase 3 clinical trial in China is ongoing as well. Aderamastat (FP-025), a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, has been investigated in a Phase 2 proof-of-concept study in allergic asthmatic patients. The study had positive outcomes, with future development in rare immune-fibrotic diseases. Linvemastat (FP-020), a follow-on oral MMP-12 inhibitor, for which a Phase 1 study in healthy volunteers has been successfully completed, with development targeted in severe asthma, COPD and IBD. Mirivadelgat (FP-045) is a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which the FuschiA Phase 1b/2 Fanconi Anemia study is ongoing, and the Phase 2 WINDWARD study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients is in planning with targeted initiation in the first quarter of 2025. Building on the compelling biology of ALDH2, and translational data from several Foresee ALDH2 activators, a follow-on candidate from a new series of compounds is being selected for development in metabolic syndrome/healthy weight loss and the broader cardiovascular-renal-metabolic space. SOURCE Foresee Pharmaceuticals Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Plus, news about Arrakis, Eli Lilly, Everest Medicines, Teva, Rondo Therapeutics, Trevi Therapeutics, Foresee Pharmaceuticals and Revolution Medicines: AstraZeneca taps new leader to run China business: The drugmaker named Iskra Reic as EVP of international, putting her in charge of its China business after Leon Wang was placed on leave while under investigation there. Wang was EVP of international and president of China. Reic, who launched the company’s vaccines and immune therapies unit, has been with AstraZeneca since 2001. — Jaimy Lee Janux’s $300M offering: The biotech is raising money after its stock soared on Tuesday thanks to early prostate cancer data . It’s been reported as a takeover target in the past. — Kyle LaHucik Arrakis shares first look at preclinical myotonic dystrophy type 1 data: Earlier this year, the RNA-targeted small molecule biotech helmed by industry veteran Michael Gilman shifted its focus from a lead cancer program to DM1, Endpoints News reported in March. “While there have been serendipitous discoveries of small molecule drugs that bind to RNA, we believe this is one of the clearest examples of a rationally designed small molecule that has been purpose-built to address an RNA disease target,” Gilman said in a Wednesday release. — Kyle LaHucik Lilly joins hot T cell engager space: The pharma giant, mostly in the news for its obesity medicines, has inked a cancer deal. It’s paying an undisclosed amount to California startup Rondo Therapeutics for a CD28-co-stimulatory bispecific antibody for an undisclosed cancer target. Multiple large pharmas have done T cell engager deals in recent months. — Kyle LaHucik Everest Medicines details early data for BTK inhibitor: In the ongoing Phase 1b/2a trial in China for patients with primary membranous nephropathy, 9 out of 11 (81.8%) patients taking the lowest dose achieved overall clinical remission after 36 weeks, and 10 out of 11 (91%) achieved immunological complete remission. In patients on the highest dose, 6 out of 7 (85.7%) patients achieved overall clinical remission. — Katherine Lewin Teva’s Ajovy bests placebo in pediatric migraine trial: Over 12 weeks, Ajovy “significantly” reduced monthly migraine days and monthly headache days compared to placebo in patients between six and 17 years old. The full data are set to be presented at the European Headache Congress in the Netherlands this week. — Katherine Lewin Trevi’s topline data for chronic cough drug: The human abuse potential study , which enrolled patients who are recreational drug users, showed a statistically significant lower “drug liking” for two doses of Trevi’s nalbuphine compared to butorphanol, a narcotic for pain with a high risk for addiction. But its stock $TRVI was down about 4% on Wednesday morning. — Katherine Lewin Foresee’s $42M raise: The Taipei and US biotech, which markets the prostate cancer drug Camcevi, secured the money by selling 18 million shares. — Kyle LaHucik Revolution Medicines upsized its public offering to $750 million, up from the $600 million it initially planned to raise . — Jaimy Lee