Irlab Therapeutics AB’s phase IIb exploration of the dopamine D3-receptor with the Ipsen SA-partnered oral antagonist mesdopetam in Parkinson’s disease (PD) levodopa-induced dyskinesia (LID) fell short in terms of the primary endpoint, but the company is holding out hope. Mesdopetam missed the primary endpoint of change in daily hours of “on” time – periods of adequate PD control – without troublesome dyskinesia as shown in patient diaries, the company said.
An already-intrigued Wall Street appreciated Relay Therapeutics Inc.’s Jan. 10 update during the J.P. Morgan Healthcare Conference (JPM), where the company detailed progress across its development efforts, including those with RLY-4008, an oral small-molecule inhibitor of fibroblast growth factor receptor 2 (FGFR2), in the works for patients with FGFR2-altered cholangiocarcinoma (CCA) and other cancers. Shares of the Cambridge, Mass.-based firm (NASDAQ:RLAY) ran up by about 38%, or $6, in the five days ahead of Jan. 13. The stock closed Jan. 17 at $20.45, down 32 cents.
The accelerated approval by the U.S. FDA of Immunogen Inc.’s landmark antibody-drug conjugate Elahere (mirvetuximab soravtansine-gynx) injected further oomph into the NaPi2b space, where a handful of developers are due to yield important data shortly. In play are such names as Mersana Therapeutics Inc. and Zymeworks Inc., encouraged by historical – if not entirely successful – efforts by giant Roche Holding AG.
Although strides have been made in the space, biopharma’s hunt for a wider net to cast in vaccines for pneumococcal disease has recruited the likes of Vaxcyte Inc., GSK plc and Merck & Co. Inc., each racing for a candidate with improved valence.
Alpine Immune Science Inc.’s update in its earnings report Nov. 14 on its ALPN-303 program added more intrigue to the notion of targeting B cell cytokines B cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL) together in lupus, as other players are trying the dual approach as well, including China’s Remegen Co. Ltd. and Vera Therapeutics Inc.<
Since the advent of COVID-19 mRNA vaccines, the space has steadily grown hotter, a situation on which Anima Biotech Inc. has capitalized by way of a potential $580 million-plus deal with Abbvie Inc. to deploy mRNA biology modulators for three targets across oncology and Immunology.
As expected, the U.S. FDA gave its go-ahead to lecanemab, an amyloid-beta binder for mild cognitive impairment caused by Alzheimer’s disease (AD) and mild AD from Biogen Inc. and Eisai Co. Ltd, which have assigned to the compound the brand name Leqembi.
Parties to Astrazeneca plc’s potential $1.8 billion takeover of Cincor Pharma Inc. are keeping mum about contingent value rights included in the deal for baxdrostat, the phase III-bound aldosterone synthase targeter in the works to treat hypertension and chronic kidney disease. Another acquisition that captured headlines as the J.P. Morgan Healthcare Conference launched in San Francisco: the $1.4 billion-plus agreement whereby Chiesi Farmaceutici S.p.A. will take ownership of Amryt Pharma plc. And there was more, as Ipsen SA pledged $952 million to make Albireo Pharma Inc. its own.
As expected, the U.S. FDA gave its go-ahead to lecanemab, an amyloid-beta binder for mild cognitive impairment caused by Alzheimer’s disease (AD) and mild AD – together known as early AD – from Biogen Inc. and Eisai Co. Ltd, which have assigned to the compound the brand name Leqembi.
The serious adverse event in the first phase I/II patient dosed with nulabeglogene autogedtemcel (nula-cel) – a gene editing, autologous hematopoietic stem cell therapy for sickle cell disease (SCD) – may have involved the quality of the stem cells and not the conditioning regimen or characteristics of the patient at baseline. But researchers won’t know until more work is done.
