Shares of Waltham, Mass.-based Dyne Therapeutics Inc. (NASDAQ:DYN) were trading at $34.40, up $6.72, or 24%, on word of positive data from two clinical efforts. Dyne offered findings 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. Both studies are ongoing. New data with regard to DM1 as well as DMD showed a “compelling” impact not only on key disease biomarkers but also improvement in multiple functional endpoints, plus favorable safety profiles.

Endeavor hits phase IIa goals in IPF and is ready for more

With positive phase IIa data for idiopathic pulmonary fibrosis (IPF) in hand, Endeavor Biomedicines Inc. said it’s ready to begin further phase II studies in the indication. The company’s lead candidate, ENV-101, a small-molecule inhibitor of the Hedgehog signaling pathway, produced a statistically significant improvement in lung function and a statistically significant increase in total lung capacity. Endeavor said next steps include a phase II in patients with IPF and a parallel cohort in those with progress pulmonary fibrosis. The complete phase IIa study data was presented to the American Thoracic Society 2024 International Conference in San Diego.

Erasca buys-in assets from two China biotechs, slashes workforce

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.

Dong-A ST invests 25B in Ildong subsidiary, inks cancer deal

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). “Partnering, [along with] large-scale investment, with a leading company like Dong-A ST highlights the value of Idience’s R&D capabilities and pipeline,” Idience CEO Won Sik Lee said. “We will work with Dong-A ST to successfully discover innovative cancer treatments and develop new drugs.”

Recent FDA activity hints at impending commercial speech enforcement

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. Kellie Combs, a partner at the law firm of Ropes & Gray LLP, told an audience during the annual meeting of the Food & Drug Law Institute that there are several indicators that the FDA intends to ramp up enforcement of commercial speech activities, indicators that include warning letters to life science companies from across the spectrum.

BioWorld Insider Podcast: Fibrobiologics walks the unconventional financing path

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.

Also in the news

Achieve, Adolore, Amgen, Amplexd, Astrazeneca, Azitra, Bayer, Briacell, Bristol Myers Squibb, Cervomed, Chroma Medicine, Coya, Drug Farm, Foghorn, Haemalogix, Hutchmed, Inhibikase, Inventiva, Marinus, Nurexone, Nuvalent, Polarityte, Rapport, Recce, T2, Virios