Camurus AB received a complete response letter (CRL) from the U.S. FDA for CAM-2029 (octreotide), its extended-release injection for acromegaly, due to “facility-related deficiencies” identified during a cGMP inspection of a third-party manufacturer. The Lund, Sweden-based company noted that the CRL did not indicate any concerns related to clinical efficacy or safety. Camurus will work with the FDA and the third-party manufacturer to address the concerns, said Fredrik Tiberg, president and CEO.
According to World Health Organization data, endometriosis affects about 10% of reproductive-age females globally. That already makes endometriosis a wildly underresearched and underfunded disease in relation to its prevalence. Plus, Rama Kommagani thinks even 10% is an underestimation. “Diagnosis is very underreported, particularly in low- and middle-income countries,” Kommagani, who is an associate professor of pathology at Baylor College of Medicine, told BioWorld.
Akeso Pharmaceuticals Inc. raised $250 million via a public offering that will allow the company to accelerate clinical development of its internally developed drugs in both China and international markets. The offering consists of 31.7 million shares priced at HKD$61.28 (US$7.88) per share and marks the second successful placement in 2024 for Guangdong, China-based Akeso. Following the offering, the company's cash on hand is expected to be $1.064 billion.
Gilead Sciences Inc. terminated a potential $785 million licensing deal with Yuhan Corp. inked in 2019 to develop metabolic dysfunction-associated steatohepatitis (MASH) therapies.
The U.S. FDA has issued yet another complete response letter (CRL) for dasiglucagon, a glucagon receptor agonist, being developed by Zealand Pharma A/S for treating congenital hyperinsulinism, an ultra-rare disease that is also being targeted by at least two other companies. This CRL is pegged to the timing of a third-party manufacturing facility reinspection that was done in August and September. The agency also wants some additional clinical analysis from the phase III study.
Judo Bio Inc. emerged from stealth mode and rolled out data showing the value of using megalin receptors for intracellular delivery of ligand-small interfering RNA (siRNA) therapeutics to the kidney as a way of reducing expression of the targeted genes.
Danish pharma giant Novo Nordisk A/S is set to launch its blockbuster glucagon-like peptide-1 therapy, Wegovy (semaglutide), in South Korea’s growing obesity therapeutics market next week, a company official confirmed to BioWorld.
Taiwan’s Caliway Biopharmaceuticals Co. Ltd. raised NT$6.4 billion (US$206 million) in its IPO on the Taipei Stock Exchange, making it the largest IPO in Taiwan’s biotech industry history and valuing the company at nearly $3 billion following the listing.
South San Francisco-based Septerna Inc. filed an S-1 with the U.S. SEC to conduct an IPO on Nasdaq about two years and eight months after launching operations with a $100 million series A led by Third Rock Ventures. The company is focused on G protein-coupled receptor oral small molecules derived from its Native Complex Platform, aimed at treating diseases within the endocrinology, immunology and inflammation, and metabolic diseases realms.
Neurobo Pharmaceuticals Inc., of Cambridge, Mass., reported top-line phase Ia study results of its obesity drug candidate, DA-1726, Sept. 30, causing the company’s shares to lose 11.7% of their value over two days.
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