The FDA has placed a clinical hold on a LogicBio Therapeutics application to begin human testing of its experimental gene-editing therapy for a rare, inherited liver disorder. LogicBio (NASDAQ: LOGC) disclosed the clinical hold for its gene-editing therapy, LB-001, after Monday’s market close. The Cambridge, MA-based biotech said that the hold concerns “certain clinical and […]

Pharvaris has appointed Peng Lu to serve in the newly created position of chief medical officer. Lu joins the Leiden, Netherlands-based drug developer from Takeda Pharmaceutical (NYSE: TAK), where she was vice president and global program lead for rare diseases. Lu will be based in Pharvaris’s Boston office. The company’s lead drug candidate, PHA121, is […]

Longtime Myriad Genetics (NASDAQ: MYGN) president and CEO Mark Capone has resigned. The Salt Lake City-based molecular diagnostic company said Myriad and Capone—who has been with the company for 17 years—mutually agreed it was the right time for a leadership transition. Bryan Riggsbee, Myriad’s chief financial officer, was appointed interim president and CEO. He will […]

Gene editing biotech Beam Therapeutics raised $180 million in its initial public offering Wednesday after offering 48 percent more shares than it initially anticipated. Beam, which was slated to begin trading Thursday on the Nasdaq exchange under the stock symbol “BEAM,” sold 9.25 million shares, up from the 6.25 million it said it planned to […]

Titan Medical didn’t meet its goal of submitting its robotic surgical system for FDA clearance by the end of 2019. Now the company says it needs another $85 million to get its medical device to the finish line or it might have to put itself up for sale. The robotic systems developer spelled out the […]

A year ago Passage Bio launched with $115.5 million and plans to advance a handful of gene therapies discovered at the University of Pennsylvania. Now the Philadelphia-based biotech is preparing to join the public markets and raise millions more to move its three lead programs into the clinic. Passage, which has three preclinical programs and […]

An Aimmune Therapeutics drug developed to treat peanut allergy won FDA approval late Friday—the first time the agency has approved an oral immunotherapy for a food allergy. The Aimmune (NASDAQ: AIMT) drug, Palforzia, was developed to desensitize patients to peanuts. The FDA decision covers patients between the ages of 4 and 17 who have a […]

Moderna (NASDAQ: RNA) named Melanie Ivarsson as its chief development officer. Ivarsson was most recently vice president, head of clinical operations at Takeda Pharmaceuticals (NYSE: TAK). Her previous experience includes serving as senior director, head of clinical strategy and operations at Pfizer (NYSE: PFE), and in roles within the early clinical development group at Eli Lilly […]

A Philadelphia-area biotech is developing therapies for neurodegenerative diseases it says have the potential to perform better than others by targeting multiple proteins involved in the brain’s breakdown. Now the company, Berwyn, PA-based Annovis Bio, has raised $12 million in an initial public offering to advance clinical development of its lead therapy in patients with […]

Two privately held biotechs on Tuesday announced plans for reverse mergers, transactions that provide a faster route to go public than a conventional IPO and also give struggling public companies a chance to recoup some value for their shareholders. San Diego regenerative medicine company Histogen announced an agreement to gain a Nasdaq listing through a […]

About 7 million couples in the US have difficulty getting or staying pregnant. A new biotech is using insights into the biology of male reproductive cells—the sperm that must meet its female equivalent, an egg cell, for fertilization to occur—to develop products meant to make assisted reproductive technologies such as in vitro fertilization (IVF) more […]

Beam Therapeutics has promoted Chief Scientific Officer Giuseppe “Pino” Ciaramella to president. He will continue to serve as the Cambridge, MA, biotech’s CSO, a role he has held for nearly two years. Before joining Beam, Ciaramella was the CSO of Moderna (NASDAQ: MRNA). His experience also includes positions at AstraZeneca (NYSE: AZN) and Boehringer Ingelheim. […]