DUBLIN – Shares in Pharnext SA plunged by more than 40% Friday on news that the FDA requires the company to undertake a second phase III trial of its Charcot-Marie-Tooth disease type 1A (CMT1A) therapy PXT-3003.
DUBLIN – Immunicum AB found itself at odds with its shareholders on the interpretation of top-line data for its immunostimulatory allogeneic dendritic cell (DC) therapy ilixadencel, which has completed a phase II trial in 88 patients with metastatic renal cell carcinoma (RCC).
DUBLIN - It's not over until it's over. Celgene Corp.'s fabled business development engine is still cranking out deals, even though its acquisition by Bristol-Myers Squibb Co. now looks likely to close this year, following this week's $13.4 billion divestment of Otezla (apremilast) to Amgen Inc.
DUBLIN – Amgen Inc. is picking up Celgene Corp.'s oral phosphodiesterase 4 (PDE4) inhibitor Otezla (apremilast) for $13.4 billion, in a move that strengthens its hand in inflammatory disease, while paving the way for Bristol-Myers Squibb Co. to complete its $74 billion cash-and-shares acquisition of Summit, N.J.-based Celgene.
DUBLIN – Shares in both Sillajen Inc. and Transgene SA took a hit Friday on news that an independent data monitoring committee recommended that a phase III trial of the oncolytic virus pexastimogene devacirepvec (Pexa-Vec) in advanced liver cancer cease enrolling patients, following an interim futility analysis, which showed that the study was not going to meet its objectives.
DUBLIN – Alizé Pharma 3 SAS closed a €67 million (US$75.7 million) series A round to progress a pair of preclinical assets in development for rare endocrine and metabolic disorders.
DUBLIN – Every technology shift has its winners and losers. Ireland, long a key location for small-molecule and biologics manufacturing, is now gearing up to ensure it is on the right side of the divide as the rollout of cell and gene therapies (CAGT) gathers momentum. There are no guarantees that the same technological and economic factors that contributed to its success during earlier eras of pharmaceutical and biopharmaceutical manufacturing will apply to the coming era of regenerative medicine. But the country's inward investment agency, IDA Ireland, is betting that its long-established relationships with the top tier of biopharma companies and its longstanding expertise in meeting FDA manufacturing requirements will help in the battle to win new investment projects.
DUBLIN – Zambon SpA is acquiring Breath Therapeutics BV for €140 million (US$155.8 million) up front plus up to €360 million more in regulatory and commercial milestones linked to the progress of Breath's drug-device combo, which is currently in phase III development for bronchiolitis obliterans syndrome (BOS), a fatal form of airway inflammation that can arise in lung transplant recipients.
DUBLIN – To no one's great surprise, the underwriters of Genmab A/S's IPO on Nasdaq exercised their overallotment option, the company announced Friday, taking the total gross to $581.8 million. The Copenhagen-based antibody developer priced the offering of about 32.8 million American depositary shares at $17.75 Thursday. The stock (NASDAQ:GMAB) ended the week at $18.10.
