Investors have known for some time that the GLP-1 receptor agonist class offers tremendous promise for treating the largely underserved obesity population worldwide, but news from Novo Nordisk A/S on cardiovascular outcomes data sent a shiver throughout the space on Aug. 8. Top-line results from the Select trial comparing subcutaneous once-weekly Wegovy (semaglutide) 2.4 mg with placebo showed the treatment reduced major adverse cardiovascular events by a statistically significant 20%. “This is going to change the whole field of reimbursement and also the ability of patients to access the drug,” said Chris Bardon, a co-managing partner at MPM Biocapital. Novo’s stock (NYSE:NVO) bounced 16.3% and was trading at $187.71 midday. Other companies with GLP-1 receptor agonists also climbed, with Zealand Pharma A/S up 8.5%, Viking Therapeutics Inc. rising 7%, and Eli Lilly and Co. enjoying a 14.3% surge.

Astex gets $35M up front in expanded Merck deal targeting p53

Astex Pharmaceuticals Inc. is getting $35 million up front and up to $500 million per program as it extends its drug discovery collaboration with Merck & Co. Inc. to include small-molecule activators of the p53 tumor suppressor protein. The number of programs was not disclosed, but they will target forms of p53 that have lost their function as a result of cancer-induced mutations in the TP53 gene. The aim will be to override the mutation and restore the ability of the wild-type protein to bind DNA and perform its functions as a transcription factor.

Chinese CAR T-maker Gracell raises $150M in private financing

Gracell Biotechnologies Inc. stands to gain up to $150 million from an assorted bouquet of private U.S. health care investors to lay a solid foundation for clinical trials of its leading dual-targeting CAR T-cell candidate, GC-012F, and provide a cash runway into the second half of 2026.

Biopharma raises an average of $5.46 billion per month in 2023

Biopharmas raised $5.87 billion through 96 financings transactions in July 2023. The total amount raised is similar to the first six months of 2023 average of $5.48 billion per month, ranging from $3.74 billion in February to $8.02 billion in March of this year.

Newco news: Connext to kick off phase I/II trial for Dupuytren’s contracture drug

South Korean biopharma Connext Co. Ltd. is set on outdoing standard-of-care therapies for Dupuytren’s contracture. The company recently secured U.S. FDA IND approval for a phase I/II trial on its recombinant collagenase clostridium histolyticum, called CNT-201, inching closer to its goal of providing an affordable but high-quality therapeutic option for patients with the rare, progressive connective tissue disorder.

UK MHRA facing clinical trial application backlog as agency transitions out of EMA

A logjam of clinical trial applications that has built up at the U.K. Medicines and Healthcare products Agency (MHRA) is deterring companies from conducting studies in the U.K., according to the Bioindustry Association (BIA).The delays and lack of predictability on clinical trial applications and amendments “has been a hot topic for members large and small,” said Steve Bates, CEO of the BIA. The latest performance data from MHRA, published in mid-July, show the time taken to assess applications to conduct a phase I volunteer trial had doubled from an average of 29.23 days in July 2022 to an average of 61.83 days in March 2023. It rose further to 83.33 days in May 2023 and fell back to 74 days in June 2023.

Also in the news

Amarin, Anixa, Apogee, Ascentage, Bavarian Nordic, Bayer, Biocity, Biogen, Cardiff, Dunad, Emergent, Fibrogen, Foghorn, Formycon, Fresenius Kabi, Halia, Harbour, Huidagene, Humanigen, Impact, Indaptus, Iveric, Jacobio, Kiora, Mapi, MBX, Medicenna, Mira, Nektar, Neopharm, NS, Oncolytics, Passage, Pfizer, Praxis, Processa, Rhythm, Sorrento, Sparian, Tonix, Viatris, Vigil, Vistagen