Castle Creek Biosciences Inc. CEO John Maslowski told BioWorld the firm’s $75 million financing will propel phase III research with FCX-007 in recessive dystrophic epidermolysis bullosa (RDEB), with top-line data due in the first quarter of 2021 – “a big inflection point” for the Exton, Pa.-based company, which plans a BLA filing for that year as well.
Cytomx Therapeutics Inc. CEO Sean McCarthy told BioWorld that the longish hiatus between deals broken by the tie-up with Astellas Pharma Inc. was “very deliberate. Over that period of time, we were generating our first clinical data to get experience with how the technology works in cancer patients with our first two lead programs,” both of which have reached the phase II stage. A year ago in January, he said, the South San Francisco-based firm brought aboard Chief Business Officer Nick Galli to “hit the gas pedal a bit more in business development,” which led to the signing with Astellas, of Tokyo. Shares of Cytomx (NASDAQ:CTMX) closed March 24 at $6.53, up $1.60, or 32%.
Cytomx Therapeutics Inc. CEO Sean McCarthy told BioWorld that the longish hiatus between deals broken by the tie-up with Astellas Pharma Inc. was “very deliberate. Over that period of time, we were generating our first clinical data to get experience with how the technology works in cancer patients with our first two lead programs,” both of which have reached the phase II stage.
Stoke Therapeutics Inc. is marching ahead in the second half of this year with its phase I/IIa study with STK-001 in Dravet syndrome (DS), one of the more abysmal forms of epilepsy, although the FDA has temporarily hobbled part B of the test, pending preclinical data that will more fully characterize the safety profile of the antisense oligonucleotide (ASO).
Princeton, N.J.-based Soligenix Inc.’s quick response testing SGX-301 (synthetic hypericin) – with results shown after just six weeks of treatment – puts the company in strong position against cutaneous T-cell lymphoma (CTCL) as it readies for a “robust” discussion with the FDA.
Geneva-based Obseva SA’s phase III Primrose 2 trial with gonadotropin-releasing hormone (GnRH) antagonist linzagolix in heavy menstrual bleeding (HMB) due to uterine fibroids (UFs) hit the primary endpoint in 94% of patients, and the company in the second quarter of 2020 will report six-month data from the Primrose 1 study, which is also a phase III experiment, in the same indication.
DBV Technologies SA officials took pains to reassure investors that data wanted by the FDA with regard to the BLA for Viaskin Peanut allergy therapy are already in hand and need only be turned over to the agency, but that didn’t stop shares (NASDAQ:DBVT) from sliding 55.7%, or $2.93, to close March 17 at $2.33.
Anti-drug antibodies noted in the phase Ib portion of the PREVAIL study in lupus drew queries for Oldwick, N.J.-based Provention Bio Inc. during a conference call related to earnings, but analysts seemed more interested in the company’s later-stage push in type 1 diabetes (T1D).
With a phase IIb readout coming in the third quarter of 2020, Cambridge, Mass.-based Fulcrum Therapeutics Inc. might be set up for a win in facioscapulohumeral muscular dystrophy (FSHD), a genetic muscle disorder for which there’s no treatment.
