News from Biogen Inc. and partner Eisai Co. Ltd. that U.S. regulators accepted the BLA related to aducanumab for Alzheimer’s disease (AD) – and assigned it priority review, no less – set Wall Street abuzz, especially as the companies noted in their press release that the FDA “if possible, plans to act early” on the anti-amyloid beta (a-beta) monoclonal antibody. Regulators’ decision came about 30 days after they took receipt of the submission; they could have waited 60.
A promising but side effect-ridden phase III study by Novartis AG with oral imatinib in pulmonary arterial hypertension (PAH) led Boston-based Aerovate Therapeutics Inc. to start exploring two years ago an aerosol form of the kinase inhibitor, and the project has won backing to the tune of $72.6 million in series A money.
About two weeks after European regulators gave their go-ahead for Blenrep (belantamab mafodotin-blmf), the B cell maturation antigen (BCMA)-targeting therapy from Glaxosmithkline plc (GSK) for relapsed/refractory multiple myeloma (MM), the FDA did likewise.
With strong results in hand from the phase I stage of its phase I/II study testing a would-be COVID-19 subunit vaccine, Novavax Inc.’s president of R&D, Gregory Glenn, said “it’s possible we could go down in the dose” as work proceeds and get similar efficacy.
With Glaxosmithkline plc (GSK) having sailed through an FDA advisory panel meeting July 14 centered on its belantamab mafodotin (belantamab), an antibody-drug conjugate (ADC) for multiple myeloma (MM), others in the B-cell maturation antigen (BCMA) space such as Legend Biotech Corp. are further piquing Wall Street’s interest.
Adopting a new strategy in food allergies and others, South San Francisco-based Iggenix Inc. launched with a $10 million series A round to fund work that CEO Bruce Hironaka told BioWorld puts the company “at the front of the wave.” Companies in the allergy space generally “have not taken full advantages of the developments that we’ve seen in the biotech industry over the last 20 or 30 years,” he said.
The matter of how adhesion of its Viaskin Peanut allergy patch relates to efficacy became a major problem for DBV Technologies SA, which drew a complete response letter (CRL) for the once-daily epicutaneous (EPIT) product. Shares of the Montrouge, France-based firm (NASDAQ:DBVT) closed Aug. 4 at $2.34, down $1.76, or 43%, in reaction to the CRL for the patch, designed to protect children ages 4 to 11. The FDA wants DBV to modify the patch, which means a new human-factor study; officials also are requiring clinical data for the modified patch.
Novartis AG didn’t say why the FDA has put off action until September – a delay of three months – on the sBLA for multiple sclerosis (MS) prospect Arzerra (ofatumumab, OMB-157), first cleared in October 2009 for chronic lymphocytic leukemia, but the holdup brought renewed attention to the bustling space, and Immunic Inc. – which held its R&D Day on May 27 – is coming on strong.
Unraveling the eagerly awaited data from Genocea Biosciences Inc.’s phase I/IIa study with neoantigen cancer vaccine GEN-009 turned out less than simple, and the rollout of results – characterized by the company as positive, albeit early – were followed by a haircut for shares (NASDAQ:GNCA), which closed at $3.45, down $1.52, or 31%.
