This month's guidance from the FDA regarding gene therapy development put even more oomph behind PTC Therapeutics Inc.'s buyout of Agilis Biotherapeutics Inc., a move that brings aboard four programs, including one due for a BLA next year.
About one year after its sale to Bristol-Myers Squibb Co. (BMS), Boston-based IFM Therapeutics LLC is launching a subsidiary called IFM Tre with a $31 million series A round to support research into NLRP3 antagonists, "a very competitive space, both in the biotech and the pharma sector," Gary Glick, CEO and co-founder, told BioWorld. "NLRP3 is very large, and no one has been able to reproduce it recombinantly," he said. "The structure is not well-characterized. There are no natural ligands for it. [Researchers can't use] a lot of the tricks that folks would use and the tools that would be employed to find chemical matter early. It's very hard to work with."
In an SEC filing regarding its IPO, Rubius Therapeutics Inc. noted that the preclinical red cell therapeutics (RTC) work underway "will require substantial resources to demonstrate technical feasibility and establish clinical and regulatory validation," and those resources arrived as the company priced about 10 million shares at $23 each, for gross proceeds of $241.1 million.
Hotspot Therapeutics Inc.'s $45 million in series A money will last three years and "gives us the dry powder to bring the company to the point where we'll start clinical studies" with two lead candidates, co-founder and CEO Jonathan Montagu told BioWorld.
With the first biosimilar to Neulasta (pegfilgrastim) freshly approved and data due in the fourth quarter of this year from Beyondspring Inc.'s phase III Study 105 testing plinabulin against the Amgen Inc. blockbuster, Wall Street is busy handicapping the latter in chemotherapy-induced neutropenia (CIN).
As expected, the "radical cure" malaria drug tafenoquine from Glaxosmithkline plc (GSK) sailed through a meeting of the FDA's Antimicrobial Drugs Advisory Committee, with panelists voting 13-0 in favor of recommending its approval based on efficacy and 12-1 for marketing clearance based on safety.
The recent label expansions by the FDA and European regulators for UCB SA's pegylated anti-TNF therapy, Cimzia (certolizumab pegol), in moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy turned still more attention to the shifting market, where TNF blockers are still favored for new patients but where other mechanisms of action continue to gain ground.
With the detailing at a scientific conference by Spectrum Pharmaceuticals Inc. of phase III data with Rolontis (eflapegrastim), a long-acting granulocyte colony-stimulating factor (GCSF) for chemotherapy-induced neutropenia, attention turned to the prospects of such good news translating to the product's label.
Wall Street wasn't jumping up and down, but officials at Akebia Therapeutics Inc. and Keryx Biopharmaceuticals Inc. celebrated the synergy between the two firms in chronic kidney disease (CKD) as they agreed to an all-stock merger that would create a new entity under Akebia's name.
In May, when Aquinox Pharmaceuticals Inc. signed its potential $155 million deal with Astellas Pharma Inc. for once-daily, oral rosiptor (AQX-1125) for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS), hopes ran high for the first-in-class SHIP1 activator, which seemed on track to become the first such therapy to reach the market in 20 years.
