An evolving COVID-19 treatment paradigm may have foiled Mesoblast Ltd.’s phase III with remestemcel-L in ventilator-dependent patients with moderate to severe acute respiratory distress syndrome (ARDS), CEO Silviu Itescu said, but hope remains in pediatric steroid-refractory acute graft-vs.-host disease (GVHD).
In the second half of November, Black Diamond Therapeutics Inc. gained attention from Wall Street by nominating BDTX-1535 as the firm’s development candidate for glioblastoma multiforme (GBM) and kicked off IND-enabling studies.
The licensing deal with Glaxosmithkline plc (GSK) gives Surface Oncology Inc. “enough cash to take us through the next three years” and plenty of flexibility to continue its internal work, CEO Jeff Goater told BioWorld. GSK, of London, is gaining exclusive worldwide development and commercial rights to Cambridge, Mass.-based Surface’s preclinical program with SRF-813.
Wall Street seemed to respond with thumbs down to positive data from the phase II study called Vadis with Sellas Life Sciences Group Inc.’s nelipepimut-S (NPS, or NeuVax) in breast ductal carcinoma in situ (DCIS), but the apparent reaction likely had little to do with the trial findings.
Gilead Sciences Inc.’s move to grab Myr GmbH for about €1.15 billion (US$1.39 billion) in cash up front, with €300 million if the latter’s Hepcludex (bulevirtide) wins FDA clearance, put chronic hepatitis delta virus (HDV) in the headlines and benefited the stock of another player in the space: Eiger Biopharmaceuticals Inc. (NASDAQ:EIGR), which closed at $10.27, up $1.51, or 17%.
Wall Street is liking the prospects of Neurocrine Biosciences Inc.’s NBI-827104, in the rare pediatric indication called epileptic encephalopathy with continuous spikes and waves during sleep. San Diego-based Neurocrine is moving the orally active, brain-penetrating T-type calcium channel blocker, licensed from Idorsia Ltd., of Allschwil, Switzerland, into phase II trials.
Questions of durability came up regarding Curis Inc.’s latest data with CA-4948, but that didn’t stop shares from soaring to $6.55 by day’s end, an increase of $5.11, or 355%. The ride came after Lexington, Mass.-based Curis rolled out positive preliminary data from the firm’s ongoing open-label, single-arm phase I dose-escalation study with the compound.
As expected, the FDA cleared Biocryst Pharmaceuticals Inc.’s oral, once-daily Orladeyo (berotralstat, formerly known as BCX-7353) for the prevention of hereditary angioedema (HAE) attacks. Last month, Biocryst, as part of its earnings report, said approvals of the compound, a kallikrein inhibitor evaluated by U.S. regulators without an advisory committee meeting, could come in Japan this month and in the EU by the first half of next year.
Frontier Medicines Corp. co-founder, chairman and CEO Chris Varma told BioWorld that his firm’s deal with Abbvie Inc. happened by way of a “highly competitive process, thankfully, with multiple parties at the table,” and the tie-up means money that could “well exceed” $1 billion.
The already intriguing IL-2 pathway as a therapeutic target gained still more traction after San Francisco-based Nektar Therapeutics Inc. unveiled melanoma data with bempegaldesleukin (bempeg), its CD122-preferential agent in the class.
