The Huntington's disease (HD) community was cheered this month by FDA approval of Austedo (deutetrabenazine), the deuterated tetrabenazine analogue from Teva Pharmaceutical Industries Ltd., to treat chorea, the involuntary, random and sudden, twisting and/or writhing movements associated with HD. (See BioWorld Today, April 5, 2017.)
Veliparib, Abbvie Inc.'s only shot at the oral poly-ADP ribose polymerase (PARP) market, failed two key phase III tests, missing the primary endpoints in studies evaluating the agent in combination with carboplatin and paclitaxel in patients with squamous non-small-cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC).
Rare disease player Ovid Therapeutics Inc. filed an S-1 with the SEC indicating its intention to raise up to $86.25 million in an IPO. Just three years old, the New York-based company previously raised $80 million in private capital – most of that in a $75 million series B – and snagged Jeremy Levin, former president and CEO of Teva Pharmaceutical Industries Ltd., to serve as its chairman. Levin, who helped to seed Ovid and holds 26.8 percent of its common stock, was named its CEO in 2015.
Shares of Neurocrine Biosciences Inc. (NASDAQ:NBIX) spiked more than 25 percent early Wednesday, coming within $2 of their 52-week high, after the FDA approved, on its PDUFA date, the selective vesicular monoamine transporter 2 (VMAT2) inhibitor, Ingrezza (valbenazine), to treat adults with tardive dyskinesia (TD).
Cirius Therapeutics Inc. (previously Octeta Therapeutics LLC) completed a series A financing of up to $40 million – drawing down $30 million in the initial tranche, according to an SEC filing – in a round that was co-led by Frazier Healthcare Partners and Novo A/S.
Biohaven Pharmaceutical Holding Co. Ltd., a clinical-stage biopharma registered in the British Virgin Islands, filed an S-1 with the SEC for an IPO of up to $100 million.
Following a string of big pharma deals dating back to 2010, Tokyo-based Peptidream Inc. inked a potential $1.15 billion multitarget discovery and optimization collaboration with Janssen Pharmaceuticals Inc. that could be its largest yet.
Jazz Pharmaceuticals plc ended a nearly seven-year spat over its blockbuster narcolepsy treatment, Xyrem (sodium oxybate), by granting Hikma Pharmaceuticals plc the right to sell an authorized generic version of the drug under its new drug application (NDA) in the U.S., beginning Jan. 1, 2023.
Privately held Zavante Therapeutics Inc. hopes to push the antibiotics envelope a bit further after its single agent, Zolyd (fosfomycin for injection, previously ZTI-01), met the primary endpoint of statistical noninferiority to piperacillin/tazobactam (Zosyn, Pfizer Inc.) at the highest approved dose in the pivotal phase II/III ZEUS trial in patients with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP).
Shares of Paratek Pharmaceuticals Inc. (NASDAQ:PRTK) spiked to a two-year high of $25 after the company reported that its lead candidate, omadacycline, met FDA primary and secondary endpoints and EMA co-primary endpoints in the phase III OPTIC (Omadacycline for Pneumonia Treatment in the Community) trial in patients with community-acquired bacterial pneumonia (CABP).
