Trigr Therapeutics Inc., a private Irvine, Calif.-based cancer drug developer founded by industry veteran George Uy, is licensing global commercial rights to five early stage antibodies from South Korea's ABL Bio Corp. for $4.3 million up front and up to $500 million in milestones, plus potential royalties. Together, the companies expect to advance development of the immunomodulatory bispecific antibodies to investigational new drug filings in the U.S. beginning next year.
Shares of Adamis Pharmaceuticals Corp. (NASDAQ:ADMP) climbed 50 percent to $4.80 on Monday as – more than a year after FDA approval of Symjepi (epinephrine), its competitor for Mylan NV’s Epipen and other emergency epinephrine products – it secured a U.S. distributor and commercial partner for the product. Under terms of the 10-year deal, Adamis and Novartis Group’s generics arm, Sandoz Inc., will equally split net profits from sales of the single-dose pre-filled syringe of epinephrine.
A phase III study evaluating the ability of the red blood cell maturation agent luspatercept to help people with anemia caused by low- to intermediate-risk myelodysplastic syndromes — a type of blood cancer — minimize the need for blood transfusions met its primary endpoint, catapulting shares of drug originator Acceleron Pharma Inc. (NASDAQ:XLRN) 42.8 percent higher to $48.52 by Monday's market close. Global regulatory filings are now planned for the first half of 2019, the companies said.
One new IPO filing, three newly priced upsized IPOs and the revival of a once-postponed offering added fuel to an explosion of June fundraising, bringing the total number of IPOs on U.S. markets this month to 14, so far. Specialty pharma Aquestive Therapeutics Inc. is the latest to arrive, filing to raise up to $69 million. Meanwhile, immuno-oncology specialist Forty Seven Inc., kidney disease-focused Tricida Inc., and messenger RNA drug developer Translate Bio Inc. all increased their fundraising targets. Not to miss the moment, oral formulations expert Entera Bio Ltd. took its offering, earlier postponed, off ice.
South San Francisco-based Global Blood Therapeutics Inc. (GBT) is discussing pursuit of an FDA accelerated approval for its experimental sickle cell therapy, voxelotor, after meeting the primary endpoint in the first part of its pivotal phase III study, called HOPE. GBT reported statistically significant increases in hemoglobin vs. baseline using two different doses of the drug, a sickle hemoglobin shape modulator.
Despite winning FDA approval on Monday to market the antibiotic Zemdri (plazomicin) to treat adults with complicated urinary tract infections (cUTI) or pyelonephritis, Achaogen Inc. saw shares (NASDAQ:AKAO) sink 20.2 percent to $9.59 on Tuesday as the agency rebuffed its effort to secure approval to use the treatment of bloodstream infections (BSIs) with a complete response letter (CRL).
A man with prostate cancer has died after receiving a second dose of Sophiris Bio Inc.'s topsalysin during a trial testing the inactivated pore-forming protein therapy. Investigators are now holding off on administering second doses to two additional patients as they seek further details of the death. Meanwhile, company shares (NASDAQ:SPHS) fell 40.3 percent to $2.24 on Monday, amid initial uncertainty about how soon the cause of the death would become clear.
Ironwood Pharmaceuticals Inc. is kicking off twin phase III trials of a specially formulated bile acid sequestrant developed to help people with uncontrolled gastroesophageal reflux disease (GERD) minimize symptoms of the ailment, such as heartburn. The trials will test IW-3718, the lead non-guanylate cyclase-C candidate. If successful, they would provide the evidence needed to seek approval for the medicine, which would be marketed as an adjunct therapy to standard-of-care proton pump inhibitors (PPIs).
