"We got it wrong," mourned Maxim analyst Jason McCarthy after Waltham, Mass.-based Proteon Therapeutics Inc. disclosed results from the phase III trial called Patency-2, a 603-patient experiment with vonapanitase, made up of recombinant human elastase, in patients with chronic kidney disease (CKD) undergoing creation of radiocephalic (wrist) fistulas for vascular access in hemodialysis. Read More
Stridebio Inc. landed a collaboration and license agreement with Takeda Pharmaceutical Co. Ltd. to develop in vivo adeno-associated virus- (AAV) based therapies for three targets, including Friedreich's ataxia (FA). Stridebio is eligible to receive about $680 million in future development and commercial milestones from Takeda, plus royalties on global net sales of commercial products the collaboration produces. Read More
Less than a year after completing its $256 million IPO, South San Francisco-based Tricida Inc. presented robust phase III extension data for its chronic kidney disease (CKD) and metabolic acidosis candidate, TRC-101 (veverimer), paving the way for a new drug application filing through an accelerated pathway in the second half of this year. Read More
DUBLIN – Investor interest in Polyneuron Pharmaceuticals AG's Antibody-Catch technology for selectively removing pathological auto-antibodies from the circulation was "very astonishing," CEO and co-founder Ruben Herrendorff told BioWorld. The result was a solid CHF22.5 million (US$22.6 million) series A round led by Sofinnova Partners and co-led by New Enterprise Associates (NEA), which will enable it to complete phase I development of its lead drug candidate, to prepare for a phase II trial and to progress several other earlier stage indications. Read More
VIENNA – In addition to the internet and the graphical user interface, a cure for the common cold could soon feature among the many technological achievements supported by the Defense Advanced Research Projects Agency (DARPA). Early last year, London-based startup Virion Biotherapeutics Ltd. received £3 million (US$4 million) in funding from the U.S. Department of Defense's research funding arm to develop a broad-spectrum antiviral technology, based on defective interfering viruses, which it calls Therapeutic Infectious Particles (TIPs). The company has maintained a relatively low profile since its inception in 2017, but it has recently completed a reboot, with a new name and a new leadership team in place, and it set out plans to move to the clinic in the next couple of years during the BIO Europe meeting. Read More
Scott Gottlieb may be stepping down as FDA commissioner next week, but he's still shaping new policy that could have national impact long after he's gone. Read More
The U.K.'s National Institute for Health and Care Excellence (NICE) recommended that Astrazeneca plc's Imfinzi (durvalumab) be available through the Cancer Drugs Fund for people with locally advanced unresectable non-small-cell lung cancer who have already had platinum-based chemoradiation. Read More
Precision Biosciences, of Durham, N.C., priced its IPO of 7,900,000 shares of common stock at a public offering price of $16 per share, for total gross proceeds of $126.4 million, before deducting underwriting discounts and commissions and expenses payable by Precision. Read More
