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Home » Newsletters » BioWorld

BioWorld

May 20, 2024

View Archived Issues
Person sitting in wheelchair

Dyne in: Wall Street sits down as phase I/II DM1, DMD table set

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

Hitting reverse: Endeavor meets phase IIa goals in IPF

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
Concept of business partnership

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. Read More

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). Read More
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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. Read More

ICYMI: Week in review, May 13-17, 2024

A quick look back at top stories. Read More

Biggest gainers and losers for May 13-17, 2024

The top 10 biopharma stock gainers and losers for the week. Read More

Appointments and advancements for May 20, 2024

New hires and promotions in the biopharma industry, including: Cervomed, Chroma Medicine, Haemalogix, Nurexone. Read More

Financings for May 20, 2024

Biopharmas raising money in public or private financings, including: Amplexd, Briacell, Coya, Foghorn, Inhibikase, Polarityte, Rapport, Virios. Read More

In the clinic for May 20, 2024

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Achieve, Astrazeneca, Bayer, BMS, Hutchmed, Inventiva, Marinus, Recce. Read More

Regulatory actions for May 20, 2024

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Drug Farm, Nuvalent. Read More

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. Read More

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