Shares of Dyne Therapeutics Inc. (NASDAQ:DYN) closed May 20 at $35.38, up $7.70, or 28%, on word of positive data from the phase I/II Achieve trial of DYNE-101 in myotonic dystrophy type 1 (DM1) and the phase I/II Deliver effort with DYNE-251 in Duchenne muscular dystrophy (DMD) who are amenable to exon 51 skipping. CEO John Cox, who joined Waltham, Mass.-based Dyne eight weeks ago, said he “couldn’t be more proud to be part of this team.” Studies are ongoing, but new data with regard to DM1 as well as DMD showed a “compelling” impact, Dyne said, plus satisfying safety profiles. Read More
With positive phase IIa data for ENV-101 in idiopathic pulmonary fibrosis (IPF) in hand, showing some lung damage was reversed, Endeavor Biomedicines Inc. said it’s ready to begin further phase II studies in the indication. Read More
Shaking up corporate and pipeline structure, San Diego-based cancer developer Erasca Inc. in-licensed two assets from China-based biopharmas in all-cash deals, while laying off 18% of its workforce, primarily in drug discovery. The flurry of announcements made on May 16, which included $160 million raised in private placement, showed that Erasca would scrap three existing pipeline assets – ERAS-007, ERAS-801 and ERAS-4 – and reshape development to a RAS-targeting franchise. Read More
To strengthen its cancer pipeline, South Korea’s Dong-A ST Co. Ltd. made a strategic investment of ₩25 billion (US$18.45 million) in Seocho-gu, Seoul-based Idience Co. Ltd., a cancer-focused subsidiary of Ildong Pharmaceutical Co. Ltd. on May 20. The equity buyout makes Dongdaemun-gu, Seoul-based Dong-A ST the second largest shareholder of Idience, following Ildong Pharmaceutical. The two companies also shook on a co-development deal for Idience’s lead cancer asset, venadaparib (IDX-1197). Read More
The U.S. FDA has several methods for signaling its enforcement intentions regarding medical devices and drugs, but there are times when warning letters are the vectors for communicating the agency’s current thinking. Read More
Biopharmas raising money in public or private financings, including: Amplexd, Briacell, Coya, Foghorn, Inhibikase, Polarityte, Rapport, Virios. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Achieve, Astrazeneca, Bayer, BMS, Hutchmed, Inventiva, Marinus, Recce. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Drug Farm, Nuvalent. Read More
A non-traditional route for financing has been the path to success for Fibrobiologics Inc. In the newest BioWorld Insider podcast, CEO Pete O’Heeron offers insight into the company’s unusual path to a Nasdaq listing in January. SPACs, reverse mergers and traditional IPOs weren’t attractive enough for Fibrobiologics’ management or board, so they decided to go public through a direct listing with no banks as underwriters. It took about seven months to get the company ready for its listing, an around-the-clock effort that O’Heeron said was worth the effort. “We couldn’t be more happy with the outcome,” he said. Read More
