San Diego-based Travere Therapeutics Inc. gained U.S. FDA accelerated approval for its dual endothelin angiotensin receptor antagonist, Filspari (sparsentan), to reduce proteinuria in adults with primary IgA nephropathy, or Berger’s disease.
The Biotechnology Innovation Organization (BIO) found in a new study that 77% of clinical programs focused on pain therapeutics five years ago are no longer active and that financings of companies working in the space are lackluster at best. Meanwhile, oncology companies, targeting an overall smaller market, have raised huge sums of venture capital money, $9.7 billion in 2021 vs. pain and addiction companies’ $228 million.
With the passage of the Inflation Reduction Act in the U.S. in August 2022, biopharma company leaders have re-evaluated pipelines, sought legal advice, and discussed ways to mitigate the potential impacts the legislation will have on pricing therapies and extending their reach to new indications.
The market downturn has left many biopharma companies searching for new ways to raise funds, with some eyeing the strong venture capital market as a potential resource. But having a disruptive technology and solid data may be the best way to stand out in a sea of companies, say financial executives that participated Feb. 6 in a panel discussion during the first full day of the BIO CEO 2023 conference in New York.
Starting out the year slow, biopharma financings are about 22% below where they were at the end of January last year, and they are well behind the first month of the previous two years as well, suggesting company executives may need to continue to prioritize costly programs as resources are depleted – at least for the near future.
Low enrollment in a phase III trial and a missed primary endpoint sent Aridis Pharmaceuticals Inc.’s shares tumbling by 35% on Jan. 26, although the company’s AR-301 (tosatoxumab) showed superior efficacy over the control group in Staphylococcus aureus ventilator-associated pneumonia (VAP) patients.
The volume of med-tech deals and M&As dropped in the fourth quarter of 2022, although it was a solid year for both types of transactions due to a growing interest in the digital health space.
Microbiome company Finch Therapeutics Group Inc. has suffered one blow after another in the past year with dwindling cash, delayed programs, a terminated deal and three workforce reductions. The latest reduction will bring the once healthy 189-person company down to a handful of employees, and it places the lead program – the oral microbiota product, CP-101, for Clostridiumdifficile infection – on the sidelines.
The U.S. FDA granted accelerated approval to Seagen Inc. on Jan. 19 for Tukysa (tucatinib), extending the therapy’s reach beyond HER2-positive metastatic breast cancer, and clearing its way for RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer.
While the fourth quarter (Q4) of 2022 raised the most money of any quarter this year, the overall amount collected through med-tech financings – $38.3 billion – is still 22.3% less than 2021’s $49.3 billion raised.
