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Amicus Therapeutics Announces Approval of Pombiliti® (cipaglucosidase ...
Amicus Therapeutics Announces Approval of Pombiliti® (cipaglucosidase alfa) + Opfolda® (miglustat) in Japan Pombiliti® (cipaglucosidase alfa) + Opfolda® (miglustat) Now Approved in Japan for Adults with Late-onset Pompe Disease (LOPD) PRINCETON, N.J., and TOKYO, June 25, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: FOLD) today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Pombiliti (cipaglucosidase alfa) + Opfolda (miglustat) for the treatment of adult patients with late-onset Pompe disease (LOPD). "We are delighted that we will now be able to offer a compel...
Catalyst Pharmaceuticals Inc: 1 director
A director at Catalyst Pharmaceuticals Inc sold 200,000 shares at 26.087USD and the significance rating of the trade was 68/100. Is that information sufficient for you to make an investment decision? This report gives details of those trades and adds context and analysis to them such that you can judge whether these trading decisions are ones worth following. Included in the report is a detailed share price chart which plots discretionary trades by all the company's directors over the last two...
New Analysis of Pombiliti® (cipaglucosidase alfa-atga) + Opfolda® (mig...
New Analysis of Pombiliti® (cipaglucosidase alfa-atga) + Opfolda® (miglustat) Published in Muscle and Nerve PRINCETON, N.J., June 03, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: FOLD), today announced the publication of a post-hoc analysis of data from the ERT-experienced cohort of the PROPEL study of cipaglucosidase alfa-atga + miglustat (cipa+mig) in adults with late-onset Pompe disease (LOPD) in . In this new publication, based on a within group effect-size analysis, subjects who switched from alglucosidase alfa to cipa+mig achieved improvements or stability in most of the outcomes measured. ...
Catalyst Pharmaceuticals Announces Appointment of William T. Andrews, ...
Catalyst Pharmaceuticals Announces Appointment of William T. Andrews, MD, FACP as Chief Medical Officer Gary Ingenito, MD, PhD is retiring from Catalyst after a successful career CORAL GABLES, Fla., June 02, 2025 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (Nasdaq: CPRX) today announced the appointment of William (Will) T. Andrews, MD, FACP as Chief Medical Officer. Dr. Andrews will report directly to the Company’s President and Chief Executive Officer, Richard J. Daly, and will serve as a member of the Company’s executive leadership team. He succeeds Dr...
Amicus Therapeutics to Present at Upcoming Investor Conferences in Jun...
Amicus Therapeutics to Present at Upcoming Investor Conferences in June 2025 PRINCETON, N.J., May 30, 2025 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that management will participate in upcoming presentations at the following investor conferences in June. Jefferies Global Healthcare Conference 2025 in New York, NY, on Wednesday, June 4, 2025, at 11:40 a.m. ETGoldman Sachs 46th Annual Global Healthcare Conference 2025 in Miami, FL, on Tuesday, June 10, 2025, at 2:00 p.m. ET A live audio webcast of each presentation can also be accessed via the investors sectio...
Theriva™ Biologics Announces Presentation of Data from VCN-01 Retinobl...
Theriva™ Biologics Announces Presentation of Data from VCN-01 Retinoblastoma Phase 1 Clinical Trial at ASCO 2025 and Investigator Meeting to Review Topline Data from the VIRAGE Phase 2b Trial of VCN-01 in Metastatic Pancreatic Cancer - Safety and clinical outcomes of Phase 1 study of VCN-01 (zabilugene almadenorepvec) in refractory retinoblastoma patients to be presented in a poster session at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on Saturday, May 31st, 2025 – - Theriva senior management to attend the ASCO conference and participate in an off-site inves...
- Dave Nicoski
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Theriva™ Biologics Reports First Quarter 2025 Operational Highlights a...
Theriva™ Biologics Reports First Quarter 2025 Operational Highlights and Financial Results - VCN-01 Achieves Primary Efficacy and Safety Endpoints for Pancreatic Ductal Adenocarcinoma in VIRAGE Phase 2b Clinical Trial - - Closed a public offering on May 8, 2025, raising the Company’s cash balance and extending its cash runway into the first quarter of 2026 - ROCKVILLE, Md., May 14, 2025 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today...
Theriva Biologics Announces Closing of $7.5 Million Public Offering
Theriva Biologics Announces Closing of $7.5 Million Public Offering ROCKVILLE, Md., May 08, 2025 (GLOBE NEWSWIRE) -- Theriva Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced the closing of its previously announced “reasonable best efforts” public offering of 6,818,180 shares of common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to 6,818,180 shares of common stock at a combined offering price of ...
- Dominic Rose
- Naresh Chouhan
Merck KGaA - INITIATION - Springing to Life (BUY, TP EUR150, 54pgs)
We initiate with a BUY as we show why the SpringWorks deal transforms the outlook for Merck KGaA. We show it could be 17% accretive to group EPS by 2030, driven by our ~50% above consensus sales for Gomekli & Ogsiveo and we assume significant synergies. Moreover, we show that Healthcare sales now grow 5% CAGR to 2030 & EBITDA grows 8%. This is highly likely to drive a re-rating in the Merck KGaA shares in our view. There is upside potential from label expansions. Our view on the Life Science too...
Catalyst Pharmaceuticals Reports Record First Quarter 2025 Financial R...
Catalyst Pharmaceuticals Reports Record First Quarter 2025 Financial Results and Provides Business Update Catalyst Enters 2025 With Strong Momentum; Reiterates Confidence in Full-Year Outlook Delivers Record Q1 2025 Total Revenues of $141.4 Million, a 43.6% YoY Increase FIRDAPSE® and AGAMREE® Drive Sustained Organic Growth, Underscoring Execution Strength Reaffirms Full-Year 2025 Total Revenue Guidance Provided Earlier This Year of Between $545 Million and $565 MillionStrengthens Balance Sheet with Cash and Cash Equivalents of $580.7 Million and No Debt as of March 31, 2025 Confer...
Theriva Biologics Announces Pricing of $7.5 Million Public Offering
Theriva Biologics Announces Pricing of $7.5 Million Public Offering ROCKVILLE, Md., May 07, 2025 (GLOBE NEWSWIRE) -- Theriva Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced the pricing of its “reasonable best efforts” public offering for the purchase and sale of up to 6,818,180 shares of common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to 6,818,180 shares of common stock at a combined offerin...
Theriva™ Biologics Announces Primary Endpoints for Efficacy and Safety...
Theriva™ Biologics Announces Primary Endpoints for Efficacy and Safety Achieved in VIRAGE Phase 2b Clinical Trial of VCN-01 with Gemcitabine/nab-Paclitaxel in Newly-Diagnosed Metastatic Pancreatic Cancer Patients - Patients treated with VCN-01 (zabilugene almadenorepvec) plus gemcitabine/nab-paclitaxel standard-of-care (SoC) chemotherapy had increased overall survival, progression free survival, and duration of response compared to patients treated with gemcitabine/nab-paclitaxel SoC - - VCN-01 was well-tolerated, with transient and reversible adverse events (AEs), meeting primary safety e...
Amicus Therapeutics to Present at the Bank of America 2025 Health Care...
Amicus Therapeutics to Present at the Bank of America 2025 Health Care Conference PRINCETON, N.J., May 07, 2025 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that management will participate in a fireside chat at the Bank of America 2025 Health Care Conference in Las Vegas, NV on Wednesday, May 14, 2025, at 8:00 a.m. P.T. A live audio webcast of the presentation can also be accessed via the investors section of the Amicus Therapeutics corporate website at . About Amicus Therapeutics Amicus Therapeutics (Nasdaq: FOLD) is a global, patient-dedicated biotechnology ...
Amicus Therapeutics Announces First Quarter 2025 Financial Results and...
Amicus Therapeutics Announces First Quarter 2025 Financial Results and Corporate Updates 1Q 2025 Total Revenue of $125.2M, a 15% Increase Year-over-Year at CER Expanding Portfolio through In-Licensing of DMX-200 Phase 3 Program for Rare Kidney Disease with Significant Market Potential in the U.S. Maintaining 2025 Guidance for Galafold, Reflecting Strong Underlying Demand Updating 2025 Pombiliti + Opfolda Guidance with New Patient Starts Accelerating in 2H Adjusting 2025 Total Revenue Growth Guidance to 15-22% at CER Reiterating GAAP Profitability During H2 2025 Conference Call and We...
Dimerix and Amicus Therapeutics Announce Exclusive License Agreement f...
Dimerix and Amicus Therapeutics Announce Exclusive License Agreement for DMX-200 in the United States Amicus licenses exclusive U.S. rights to commercialize DMX-200 for the treatmentof Focal Segmental Glomerulosclerosis (FSGS) DMX-200 is in a pivotal Phase 3 trial for FSGS, a rare and fatal kidney disease with no FDA-approved therapies Dimerix successfully completed Type C meeting with the FDA in March 2025, aligning on proteinuria as the primary endpoint for approval Dimerix to receive US$30 million (~AU$48 million) upfront payment, up to US$560 million (~AU$892 million) for success-ba...
Catalyst Pharmaceuticals to Participate in the BofA Securities Health ...
Catalyst Pharmaceuticals to Participate in the BofA Securities Health Care Conference 2025 CORAL GABLES, Fla., April 30, 2025 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (“Catalyst” or “Company”) (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases, today announced that Richard J. Daly, President and CEO of Catalyst, along with other members of Catalyst's management team, will participate at the upcoming BofA Securities Health Care Conferenc...
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