Shares of DBV Technologies SA (NASDAQ:DBVT) were trading at $22.99, up $5.01, or 27%, on positive top-line results from the pivotal phase III study with the Viaskin Peanut allergy patch for children, ages 4 to 7. DBV said the trial met its primary endpoint, with a statistically significant treatment effect (p-value of 0.001), as 46.6% of children in the Viaskin arm met the treatment responder criteria after 12 months compared to 14.8% of those in the placebo group. The difference in response rates was 31.8% (95% CI=24.5, 39%), exceeding the lower bound prespecified threshold of 15%. In the first half of next year, DBV will submit a BLA to the U.S. FDA.

Harbour Biomed closes busy year with $1B+ BMS deal

Harbour Biomed has added another collaboration to its end-of-year dealmaking, this time with Bristol Myers Squibb Co. to develop multispecific antibodies. Harbour is getting about $90 million up front, but milestones could top $1 billion. Harbour upped its AI antibody discovery game in November by launching the first fully human generative Heavy Chain-Only Antibody model, powered by its Hu-matrix AI platform built on its Harbour Mice platform. Other recent Harbour deals include two collaborations with Astrazeneca plc, one announced in March and then updated in November, an AI deal with Evinova AG also in November, and, in June, Harbour out-licensed its B-cell maturation antigen and CD3 bispecific T-cell engager HBM-7020 for autoimmune diseases to Otsuka Pharmaceutical Co. Ltd. in a deal worth up to $670 million.

Addition launches with an all-RNA, lipid nanoparticle-based gene therapy

Addition Therapeutics came out of stealth mode to highlight its Precise RNA-Mediated Insertion of Transgenes (PRINT) gene therapy platform. PRINT uses retrotransposase to insert genes into the genome using RNA that’s delivered to cells in a lipid nanoparticle. The company, which was spun out of the University of California, Berkeley in 2021, has raised about $100 million between its seed and series A rounds, including a recent extension of the latter.

FDA eyes less restrictive approach to RWE in regulatory decisions

The U.S. FDA announced Dec. 15 that it will take a more relaxed approach regarding the use of real-world evidence (RWE) in drug and device application reviews. Specifically, new guidance for device premarket applications will not require identifiable individual patient data collected from real-world data sources, and the agency indicated it intends to consider similarly updating guidance regarding submissions for drugs and biologics.

Alltrna advances tRNA-based strategy for stop codon diseases

Gene editing can repair mutations that prematurely halt protein synthesis, resulting in incomplete peptides that cause various diseases. However, other approaches achieve the same effect without altering the genome. Startup Alltrna Inc. has developed a strategy based on transfer RNA (tRNA) to bypass the premature stop codons that end early protein translation. The company already has a first clinical candidate that could treat metabolic diseases such as methylmalonemia or phenylketonuria.

The BioWorld Insider podcast: Finding a better, longer-lasting fix in opioid overdose

The opioid crisis may not be front and center anymore, but it’s raging still. A major problem is that overdose-reversal drugs don’t last long enough to help users who opt out of hospital treatment after they are revived. Elysium Therapeutics Inc. CEO Greg Sturmer talks with Randy Osborne about his firm’s candidate for a solution to the medical and societal problem. The NIH – which has been helpful to Elysium since the company’s founding – the FDA, and others are working to advance a longer-lasting reversal agent. Experiments already done with approved reversers, as well as computer modeling that’s been used by regulators previously, will help in the push, Sturmer said.

Also in the news

Abiogen, Adagene, Aeovian, Akari, Aldeyra, Allink, Ambros, Ankyra, Astrazeneca, Calluna, Chiesi, Daiichi, Generation, GSK, Imcheck, Invea, Ipsen, Maplight, Nuvalent, Organogenesis, Palvella, Polypid, Replicate, Royalty, Sandboxaq, Sprout, Tonix, Treefrog, Verastem, Xoma