Shares of Structure Therapeutics Inc. (NASDAQ:GPCR) were trading midday at $30.19, down $28.97, or almost 49%, on an update of progress with GSBR-1290, an oral GLP-1 agonist. Structure offered top-line phase IIa data from the first study in type 2 diabetes that show significant reductions in hemoglobin A1c (HbA1c) and weight at 12 weeks. Interim findings from the phase IIa obesity cohort demonstrate significant reduction in weight at eight weeks, with full 12-week obesity data expected in the second quarter of 2024. Leerink analyst David Risinger said in a report that the diabetes results “appear to fall short” of Eli Lilly and Co.’s oral GLP-1 player, orforglipron, which has reached the phase III stage, but “looks closer” to the Lilly compound in nondiabetic obesity.
Invivyd stock spikes as MAb vaccine shows strength against COVID
Invivyd Inc.’s VYD-222 produced positive initial top-line results in the ongoing pivotal phase III Canopy study for preventing symptomatic COVID-19. The monoclonal antibody produced high serum virus neutralizing antibody titer levels in immunocompromised participants, roughly the same as it did in its phase I study of healthy volunteers. Invivyd also said it saw the potential early signal of strong clinical protection from symptomatic COVID. The company said it plans to take the data to the U.S. FDA so it could ask for emergency use authorization. Invivyd’s stock (NASDAQ:IVVD) greatly enthused investors at midday as shares were up 148% and selling for $4.04 each.
Neuren’s NNZ-2591 meets endpoints in phase II trial in Phelan-McDermid syndrome
Neuren Pharmaceuticals Ltd. plans to progress NNZ-2591 to phase III trials following positive top-line phase II results in children with Phelan-McDermid syndrome, a genetic neurodevelopmental disorder for which there are no approved treatments. “We had very high expectations for NNZ-2591, but this result has exceeded even those expectations and gives us very high confidence as we now move forward to try to get the first treatment approved for Phelan-McDermid syndrome,” Neuren CEO Jon Pilcher said during a Dec. 18 conference call with investors.
Caliway raises $100M for late-stage subcutaneous fat reducing drug
Taiwan’s Caliway Biopharmaceuticals Co. Ltd. said it secured more than $100 million in an oversubscribed capital raise to advance CBL-514, its lead asset for subcutaneous fat reduction nearing phase III studies. CBL-514 is a small-molecule lipolysis drug known to up-regulate the capsase-3 and ratio of Bax-to-Bcl2 expression, helping to trigger adipocyte apoptosis. Caliway is investigating the drug for multiple indications, including Dercum’s disease, cellulite and lipoma.
Top Trends of 2023: Pipeline dynamics drive biopharma restructurings in 2023
More than 17,000 jobs losses were announced by 206 biopharma companies in 2023, down about 7% from the more than 18,400 workforce reductions attributed to biopharma last year. All told, there were 17,169 workforce reductions in 2023, not including undisclosed numbers. The most significant occurred at Barcelona, Spain-based Grifols SA, where an 8% cut, approximately 2,000 positions, was implemented as part of operational improvement plan announced in February.
Top Trends of 2023: First CRISPR-based therapeutic is scientific, regulatory milestone
Both the U.K. MHRA and the U.S. FDA approved their first CRISPR-based gene therapy in 2023. Crispr Therapeutics AG and partner Vertex Pharmaceuticals Inc.’s Casgevy (exagamglogene autotemcel, exa-cel) was approved by the MHRA in November and the FDA on Dec. 8. The U.K. approval is for both severe sickle cell disease (SCD) and transfusion-dependent thalassemia (TDT). In the U.S., the approval is for severe SCD, with a PDUFA date for TDT coming up in spring 2024.
BioWorld Insider Podcast: Six biopharma executives consider a tough 2023 and are hopeful for a better 2024
One aspect of 2023 our group of executives completely agreed on: the past year was tough financially. And they all foresee a more vibrant year ahead for the market. Giving all of them hope were technological breakthroughs such as artificial intelligence, game changing weight loss drugs, the surging fascination with ADCs and hope for lower interest rates. But uncertainty looms about the upcoming general election in the U.S. and ground-shifting gene therapies. In a preview of the annual Biotech Showcase conference, an investor conference for private and micro- to mid-cap biotech companies Jan. 8-10 in San Francisco, BioWorld spoke with Dave Bearss, CEO of Halia Therapeutics Inc., Vimal Mehta, CEO of Bioxcel Therapeutics Inc., Paul Lammers, CEO at Triumvira Immunologics Inc., Chris Pirie, COO of HDT Bio Corp., Thijs Spoor, CEO of Perspective Therapeutics Inc., and Shelley Hartman, CEO of Aegle Therapeutics Corp. They offered insights brought about by years of hard-won experience.
Topic alerts now available for all BioWorld subscribers
Are you trying to stay on top of developments in CAR T therapies? Drug resistance? Emerging compounds? Updates from certain regulatory agencies? Want to be the first to learn about new biomarkers or business deals? You can still find these articles in the daily BioWorld e-newsletters or on the website, but if you’re laser-focused on a specific topic, we have a way to highlight the news you need as it happens, whether we’ve published a full-length feature story or a brief update. You asked and we listened. Now, in addition to the daily news lineup, you can create topic alerts to be delivered directly to your inbox or via an RSS reader. It’s easy to set up. Instructions can be found here: https://www.bioworld.com/featured-feeds.