It’s not often that disclosure of a complete response letter (CRL) causes a company’s share price to rise, but that was case for Aquestive Therapeutics Inc., which saw its stock (NASDAQ:AQST) rising 41% in midday trading on news the U.S. FDA declined to approve the NDA for Anaphylm (dibutepinephrine), delaying the commercial entry of what could be the first oral alternative to Epipen. Granted, the CRL had been largely expected. A month earlier, the company acknowledged receipt of an FDA letter identifying deficiencies in the NDA, precluding discussion of labeling and postmarketing commitments, an update that knocked shares down nearly 40% and left investors awaiting further detail and revised timelines. With the CRL in hand, Aquestive executives provided an update on both, signaling a clear path forward and potential resubmission in the third quarter of this year.

AI-based tool for breast cancer cuts rate of interval cancers

An AI-based software developed by Screenpoint Medical BV could help detect breast cancers earlier and reduce the number of cancers that appear between routine screenings. In a trial of over 100,000 women, the use of the company’s Transpara Detection system resulted in a 12% reduction in the rate of interval cancers, compared to standard mammography screening. The results from the Mammography Screening with Artificial Intelligence study was published in The Lancet.

Sanofi’s venglustat wins in Gaucher, falters in Fabry

Paris-based Sanofi SA disclosed mixed phase III data with its oral glucosylceramide synthase inhibitor venglustat. The Leap2mono study in type 3 Gaucher disease met the primary and three out of four key secondary endpoints. In Fabry disease, the Peridot experiment did not show superiority on the patient-reported primary endpoint. The phase III Carat study in the same indication is ongoing.

China NMPA approves Sciwind’s GLP-1 injection for diabetes

Sciwind Biosciences Co. Ltd. said Jan. 30 it won Chinese approval for self-developed glucagon-like peptide-1 (GLP-1) receptor agonist, ecnoglutide (Xianyida), to treat adults with type 2 diabetes. "As the world's first approved cAMP-biased GLP-1 receptor agonist, ecnoglutide's successful approval marks a major milestone for Sciwind," founder and CEO Hai Pan said. The firm has focused on developing novel drugs for weight management using its Sciwindcore platform, including ecnoglutide, since its founding in 2017.

Research links 22 genes to chronic diseases caused by Epstein-Barr

An Anglo-American team of researchers has devised a new computational method for quantifying Epstein-Barr virus directly from human genome sequences and used this to identify 22 genes that link higher levels of the virus to a range of chronic diseases. The new method sets the scene for further exploration of biobank DNA sequence data to gain greater understanding of the nature and the role of the human virome, the 10(13) – largely unstudied – viral particles that coexist in humans.

Amgen quits Kyowa Kirin deal, returning rocatinlimab

Amgen Inc. quit a development deal with Kyowa Kirin Co. Ltd., returning global rights for rocatinlimab, Kyowa Kirin’s T-cell rebalancing therapy being investigated for moderate to severe atopic dermatitis. Tokyo-based Kyowa Kirin is planning to submit marketing authorization applications in the first half of 2026, filing with the U.S. FDA first, followed by Japan, before expanding to other markets. Rocatinlimab’s novel approach as a T-cell rebalancing therapy directly targeting the OX40 receptor expressed on pathogenic T cells shows potential to deliver long-term disease control. Kyowa Kirin said Amgen exited the deal following a strategic portfolio review.

Inventiva, others crowd MASH space

As the march toward a new therapy continues in metabolic dysfunction-associated steatohepatitis (MASH), new approaches are drawing Wall Street’s attention. Among them is Inventiva SA’s pan-PPAR approach. It makes scientific sense, and the company has offered positive phase IIb data from the Native trial in noncirrhotic MASH, which turned up competitive improvements in liver fibrosis and MASH resolution at six months. Previously known as NASH, or nonalcoholic steatohepatitis, MASH was already hot as an indication and the commercial success of Madrigal Pharmaceuticals Inc.’s thyroid hormone receptor-beta agonist Rezdiffra (resmetirom) fueled enthusiasm further.

In vivo CAR T cells reduce liver fibrosis

Liver fibrosis in the course of metabolic dysfunction-associated steatohepatitis (MASH) could be significantly reduced using CAR T-cells generated in vivo. Scientists at the Icahn School of Medicine at Mount Sinai have developed an experimental cell therapy that eliminates only one type of liver cell, the stellate cells that express fibroblast activation protein alpha. This strategy not only reduced fibrosis but also reversed liver damage. While not a cure for MASH, the results demonstrate the wide range of applications for CAR T cells beyond cancer and how this technology is evolving toward in-body production.

Phase III wins propel Capricor, Belite and DBV higher in December

BioWorld tracked 215 clinical trial readouts spanning phases I through III in December 2025, including 11 phase III trials with positive outcomes. Shares of San Diego-based Capricor Therapeutics Inc. (NASDAQ:CAPR) closed Dec. 3 at $29.96, up $23.60, or 371%, after the company reported positive top-line results from the pivotal phase III Hope-3 trial of deramiocel in Duchenne muscular dystrophy.

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Also in the news

Agomab, Alps, Altimmune, ALX, Amgen, Bayer, Biomarin, Chiesi, Coya, Eli Lilly, Immunocore, IO, Johnson & Johnson, Jyong, Kyowa, Lexicon, Merz, Moderna, Pharmnovo, Poxel, Promis, Protalix, Quince, Recordati, Regeneron, Samsung Bioepsis, Sanofi, Spyglass, Tonix, Ultragenyx, Unicycive, Vaxcyte