Cerebral Therapeutics Inc. CEO Dan Abrams told BioWorld that his firm's closing of the $7.8 million extension to its series A financing by Granite Point Capital Management LP and Vivo Capital LLC should "allow us to do a substantial phase II trial" that will bring an epilepsy drug-device combo therapy to the next level.
As the Philippine Department of Justice (PDOJ) said it found probable cause to indict Sanofi SA and government officials over deaths caused by the Paris-based pharma giant's dengue vaccine, the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) reviewed the BLA for the product in an uneventful session.
Beam Therapeutics Inc. CEO John Evans told BioWorld that the company's $135 million series B influx – following sooner than some expected the $87 million series A raise last May – is meant to "make sure that resources aren't the limiting factor" in pushing along the company's next-generation CRISPR technologies, expanding the pipeline of base editing programs, and adding to the firm's scientific and technical leadership.
Verrica Pharmaceuticals Inc.'s positive phase III data from its pivotal Cantharidin Application in Molluscum Patients-1 (CAMP-1) and CAMP-2 trials with lead candidate VP-102 at the American Academy of Dermatology meeting in Washington, followed encouraging top-line results made known in early January and put the firm in position to submit an NDA in the second half of this year.
CEO Jan Møller Mikkelsen said Ascendis Pharma A/S is "still analyzing a lot of the data" from its phase III trial with its Transcon human growth hormone (hGH), a weekly therapy that beat daily growth hormone in the experiment called Height, but researchers are able to affirm that the better-than-expected outcome was "driven by the molecule itself, not by a difference in adherence between the two arms" of the study.
Last month, Hayward, Calif.-based Aradigm Corp. filed for protection under Chapter 11 of the U.S. Bankruptcy Code in the Alameda County Court District to sell its assets, and about a week later the company made known the bad news in notes from the type B meeting held with the FDA.
The dataset that emerged from Dublin-based Horizon Pharma plc's phase III trial with teprotumumab for active thyroid eye disease (TED) is "not just OK – it's amazing," said Raymond Douglas, co-principal investigator in the phase II and phase III programs with the compound.
Sarepta Therapeutics Inc. CEO Doug Ingram told Wall Street that the firm "has couple of things we've got to get done very soon and report back to you on," given early results in the first three-patient cohort of the MYO-101 study in patients with limb-girdle muscular dystrophy (LGMD) known as LGMD2E – strongly positive results that triggered an early exercise of the option to acquire Myonexus Therapeutics Inc. for $165 million.