It’s been a tough year for raising biotech money, according to the new U.K. Biotech Financing Report, but there are bright spots in an otherwise dark period. What happened last year in the U.K. basically mirrored what happened with global financings as IPOs are significantly down while venture capital rounds stood strong.
Coming off a tough year for raising money, Cadrenal Therapeutics Inc. is leading the charge into a new year by completing 2023’s first U.S. IPO. The company closed its IPO of 1.4 million shares at $5 each for $7 million. The stock (NASDAQ:CVKD) began trading Jan. 20 and closed 9.37% downward on Jan. 25 at $2.90 per share.
Axcella Therapeutics Inc. is working on its comeback to make something else go away. Just before Christmas, Axcella said it was repositioning itself to focus on long COVID-19 and was just granted regulatory guidance on a primary endpoint and study design from the U.K.’s MHRA to conduct a single registration trial of AXA-1125 for those with long COVID fatigue. Axcella will be meeting with the MHRA in the near term to discuss getting an innovative licensing and access pathway application, which is designed to accelerate the approval process. Axcella also has just submitted its IND to the U.S. FDA for a global phase IIb/III study for treating long COVID.
A lack of available options for treating idiopathic pulmonary fibrosis (IPF) is driving plenty of development into the indication. The latest data come from Pliant Therapeutics Inc., which posted positive 12-week interim data from 21 participants in the 320-mg dose group’s active arm and eight in the placebo arm in its phase IIa study of PLN-74809 (bexotegrast).
Next week, Cidara Therapeutics Inc. will make its case for rezafungin, an injectable treatment for candidemia and invasive candidiasis in adults, before the U.S. FDA’s Antimicrobial Drugs Advisory Committee. When it convenes Jan. 24, the adcom will vote either yes or no if it believes the overall benefit-risk assessment is favorable for the use of rezafungin for treating candidemia/invasive candidiasis in adults with limited or no alternative treatment options.
A year and a half gone, two HIV vaccine studies shut down. That’s the case with the Janssen Pharmaceutical Cos. of Johnson and Johnson as the phase III Mosaico study of its HIV vaccine regimen was not effective in preventing infection compared to placebo. Based on a data and safety monitoring board’s report saying the study was not expected to hit its primary endpoint, Janssen discontinued the clinical trial more than a year ahead of its estimated March 2024 completion date.
Now there are three. Moderna Inc. has posted strong phase III study data on its mRNA respiratory syncytial virus (RSV) vaccine, keeping pace with Pfizer Inc. and GSK plc’s candidates, which have May PDUFA dates. Moderna’s top-line results of the ConquerRSV pivotal efficacy study of mRNA-1345 show the vaccine hit its primary efficacy endpoints of 83.7% against RSV-associated lower respiratory tract disease in older adults.
Now in its 10th year, Clarivate’s newly released Drugs to Watch 2023 report primarily features treatments targeted to a particular biomarker, signaling the advance and increasing potential of personalized medicines. The 15 drugs on the list are anticipated to either register sales of more than $1 billion by 2027 or be clinical game changers. Nine are predicted to hit $1 billion annual sales each in China by 2030.
Two companies who needed partners have found each other, as privately held Elicio Therapeutics Inc. will merge with Angion Biomedica Corp. in an all-stock deal.
Oramed Pharmaceuticals Inc. has had a lot of success with testing its oral insulin, until now. The company will discontinue it oral insulin clinical work in treating type 2 diabetes after ORMD-0801 failed to hit its phase III study’s primary and secondary endpoints. The late-stage stumble clobbered the company stock (NASDAQ:ORMP), which lost 76% of its value on Dec. 12 to close at $2.54 each.
