The U.S. FDA cleared an IND for Neurobo Pharmaceuticals Inc.’s weight loss drug, prompting the company to say a phase I study in obesity will begin sometime during the first half of this year. The stock catapulted upward on the news.
Halia Therapeutics Inc. has, its CEO confidently asserts, taken an atypical road to building its infrastructure and financing. The Lehi, Utah-based company just completed a $30 million series C financing to further develop its lead asset, a selective and orally bioavailable first-in-class NLRP3/NEK7 inflammasome inhibitor.
Despite Vertex Pharmaceuticals Inc.’s mostly positive phase III study results of a non-opioid for treating moderate to severe acute pain, the data for a key secondary endpoint show VX-548 is not as effective as Vicodin (hydrocodone, Abbvie Inc.).
Hookipa Pharma Inc.’s nearly $1 billion collaboration with Roche Holding AG dissolved along with 30% of the company’s staff. The New York-based company said Roche ended the October 2022 deal involving the HB-700 program in treating KRAS mutated cancers but did not say why the agreement fell apart. Leerink Partners analyst Andrew Berens wrote Jan. 29 that the firm spoke to management, which indicated the program was progressing according to plan and that Roche's decision was based more on its own internal pipeline strategy, lessening its focus on oncology after high profile failures vs. the program having issues in development.
The first IPO of 2024 is a greatly upsized one from CG Oncology Inc., which is selling 20 million shares (NASDAQ:CGON) of its common stock at $19 each. Shares closed Jan. 25 95.6% higher at $37.17 each. The company initially had looked to raise about $200.6 million by selling its shares somewhere from $16 to $18 each but adjusted its thinking before the Jan. 25 debut, now anticipating gross proceeds of $389 million.
The hearing has returned for the first person who has received gene therapy for treating genetic hearing loss in the U.S. Initial results from Akouos Inc.’s phase I/II study showed that within 30 days of receiving AK-OTOF-101, pharmacologic hearing was restored to an 11-year-old who had profound hearing loss from birth.
Getting revolutionary genetic medicines to the right place is the reason Genedit Inc. was created, and CEO Kunwoo Lee pared down the mission in one word. “Delivery, delivery, delivery,” Lee told BioWorld in describing the goal of Genedit’s Nanogalaxy platform that is focused on delivering genetic medicines into select tissue. Privately held Genedit will work with Genentech to find and develop hydrophilic nanoparticles for creating nucleic acid-based drugs to treat autoimmune diseases. Genedit is getting $15 million up front in a new deal that could bring in up to $629 million in near-term, preclinical and clinical development, commercial and net sales milestones.
Sagimet Biosciences Inc. stock (NASDAQ:SGMT) more than doubled Jan. 22 as shares closed 170% higher at $18.42 each as a phase IIb study of lead candidate denifanstat performed well against nonalcoholic steatohepatitis (NASH) compared to placebo. Top-line data from the 52-week, randomized, double-blind Fascinate-2 trial showed the oral fatty acid synthase inhibitor resulted in statistically significant improvements in biopsy-confirmed NASH patients with stage 2 or stage 3 fibrosis, which is moderate to severe disease, at week 52.
Edgewise Therapeutics Inc. priced an underwritten offering of 21.8 million shares at $11 each as it looks for about $240 million in gross proceeds to develop its Duchenne and Becker muscular dystrophies treatment. The offering propelled the company’s stock (NASDAQ:EWTX) Jan. 19 to close 34.5% higher at $13.04 each, their highest valuation in the past 12 months.
Acurx Pharmaceuticals Inc. continues to post positive data for its lead candidate ibezapolstat but that didn’t stop the stock from tumbling. The antibiotic outperformed vancomycin in a phase IIb study treating Clostridioides difficile infection (CDI). Vancomycin is a standard of care in the indication. Ibezapolstat eradicated fecal CDI at day 3 in 15 of 16 patients compared to vancomycin, which eradicated fecal CDI in 10 of 14 patients.
