Entasis Therapeutics Holdings Inc. has initiated a phase III trial to evaluate ETX-2514 for treating patients in the U.S., Europe and Asia with pneumonia and bloodstream infections caused by carbapenem-resistant Acinetobacter baumannii.
Dyne Therapeutics Inc., founded and seeded last year by Atlas Venture, has completed a $50 million series A along with Forbion and MPM Capital. Cambridge, Mass.-based Dyne will target therapies for patients suffering from myotonic dystrophy type 1 (DM1), a rare and inherited disorder with life-limiting complications that affects about 40,000 people in the U.S. alone.
Evoke Pharma Inc. and Intelgenx Corp. each received FDA complete response letters (CRL) regarding NDAs for products in their pipelines. Evoke's CRL for Gimoti states that the FDA cannot approve the NDA in its present form and provided recommendations to address two remaining approvability issues for an NDA resubmission.
Stridebio Inc. landed a collaboration and license agreement with Takeda Pharmaceutical Co. Ltd. to develop in vivo adeno-associated virus- (AAV) based therapies for three targets, including Friedreich's ataxia (FA). Stridebio is eligible to receive about $680 million in future development and commercial milestones from Takeda, plus royalties on global net sales of commercial products the collaboration produces.
Springworks Therapeutics Inc. has closed a $125 million series B preferred stock financing, energizing its two late-stage rare disease oncology programs, nirogacestat (PF-03084014), a gamma-secretase inhibitor for treating desmoid tumors, and PD-0325901, an MEK inhibitor for the treatment of neurofibromatosis type 1-associated plexiform neurofibromas.
Gilead Sciences Inc. and Galapagos NV announced week 24 results for phase III studies Finch 1 and 3 of filgotinib in rheumatoid arthritis (RA), saying both studies reached their primary endpoints and that Finch 1 hit key secondary endpoints.
Stridebio Inc. landed a collaboration and license agreement with Takeda Pharmaceutical Co. Ltd. to develop in vivo adeno-associated virus- (AAV) based therapies for three targets, including Friedreich's ataxia (FA). Stridebio is eligible to receive about $680 million in future development and commercial milestones from Takeda, plus royalties on global net sales of commercial products the collaboration produces.
Eli Lilly and Co.'s new partnering deal with privately-held Immunext Inc. to research and globally license an antibody to treat certain autoimmune diseases is another sign that Lilly is deepening its commitment to the immunology space.
Sana Biotechnology Inc., which launched in January, has struck a license agreement with Harvard University's Office of Technology Development to produce hypoimmunogenic stem cells that can be transplanted into patients and not trigger immune rejection. Sana, a regenerative medicine company founded by former Juno Therapeutics Inc. execs Hans Bishop and Steve Harr, focuses on creating engineered cells as medicine for patients.
Spruce Biosciences' tildacerfont (SPR-001) for congenital adrenal hyperplasia (CAH), a rare endocrine disorder, passed muster in a phase II experiment. Proof-of-concept data were disclosed at the Endocrine Society's annual meeting in New Orleans, ENDO 2019, for the oral corticotrophin-releasing factor type 1 receptor agonist.
