Aravive Biologics Inc. dispelled doubts that may have persisted after the disclosure of early data from the ongoing phase Ib portion of the phase Ib/II trial with AVB-500 in platinum-resistant ovarian cancer, and Wall Street rewarded the company’s shares (NASDAQ:ARAV) with an 48.1% hike, or $3.13, to close Wednesday at $9.64.
Cytomx Therapeutics Inc. CEO Sean McCarthy said earlier this month that the firm was “not ready to guide on specific response rates” that the company hopes for in the phase II study with anti-PD-L1 Probody CX-072 in combination with ipilimumab, or ipi (Yervoy, Bristol-Myers Squibb Co.) in patients with relapsed refractory melanoma.
Pairing the in-licensed muscarinic acetylcholine receptor agonist xanomeline with the well-known muscarinic antagonist trospium chloride in the single drug called Karxt gave Karuna Therapeutics Inc. the required phase II efficacy against acute psychosis in schizophrenia, while keeping a quite satisfactory safety and side-effect profile.
About two months ahead of the priority review action date, Novartis AG scored FDA clearance for Adakveo (crizanlizumab), previously known as SEG-101, to reduce the frequency of vaso-occlusive crises (VOCs), or pain crises, in adult and pediatric patients ages 16 and older with sickle cell disease (SCD).
Any worries by Promedior Inc. investors after Bristol-Myers Squibb Co. (BMS) backed away last year from its option to acquire the firm were resolved in a big way by last week's news that Roche Holding AG is taking over the company in a transaction valued as high as $1.39 billion. Privately held, Lexington, Mass.-based Promedior's lead asset is PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that won breakthrough designation from the FDA earlier this year for idiopathic pulmonary fibrosis (IPF).
CEO David Giljohann said the first indication in Exicure Inc.'s deal with Allergan plc is antigenic alopecia, but his firm doesn't "have anything else to disclose yet" about other hair loss diseases that the pact will include.
Avidity Biosciences Inc. CEO Sarah Boyce told BioWorld it's "a little too soon" to say when the company's lead program in myotonic dystrophy type I might reach the clinic, but the firm's $100 million series C financing will help with that effort and the portfolio in rare muscle diseases, as the antibody-oligonucleotide conjugate (AOC) platform undergoes further development.
Solid Biosciences Inc.'s chief technology officer, Joel Schneider, said the company is "not going to leave any stone unturned" as investigators begin to explore the severe adverse event (SAE) that led to the FDA's clinical hold on the phase I/II study with SGT-001 in Duchenne muscular dystrophy (DMD).
Within the first few minutes of a key opinion leader webinar on Alzheimer's disease sponsored by AC Immune SA, CEO Andrea Pfeifer brought up the decision by Biogen Inc. to file for regulatory approval of amyloid beta targeter aducanumab in early AD, based on results from a subset of patients in the phase III study called Engage.
Supernus Pharmaceuticals Inc. CEO Jack Khattar said the phase III failure in the study called P301 with SPN-810 (molindone hydrochloride) was "very puzzling" to the Rockville, Md.-based firm, which will be "digging very deep into the data" with hopes of figuring out what went wrong. Shares (NASDAQ:SUPN) closed Wednesday at $19.93, down $9.20, or 31.6%.
