Lipella Pharmaceuticals, Inc.

Orlynvah’s path to approval was rocky, with the FDA concerned by the potential for “inappropriate use” of the drug to promote antibiotic resistance. Irish antibiotic specialist Iterum Therapeutics has started winding down its operations, citing limited cash amid the expensive commercialization of its only approved product, Orlynvah.Iterum filed a petition to dissolve the company with Ireland’s High Court on March 27, the company said, which is set to be heard on April 13.In addition to dwindling cash supplies, Iterum said the decision was based on its inability to regain its Nasdaq listing and on trouble finding a buyer for Orlynvah, which is approved for urinary tract infections caused by certain bacteria but has had “modest sales.”The company’s shares will stop trading effective April 1, according to a March 31 filing with the Securities and Exchange Commission.The failure to offload Orlynvah wasn’t for lack of trying—Iterum engaged with two potential suitors, according to the release, but a deal ultimately couldn’t be finalized.“The company has determined that there are no further reasonable avenues available at this time for an alternative strategic transaction outside the context of a liquidation,” Iterum said in the release.Orlynvah’s path to approval was rocky, with the FDA concerned by the potential for “inappropriate use” of the drug to promote antibiotic resistance. The medicine was the first approved oral version of a class of antibiotics called penems.Iterum took its time launching Orlynvah, debuting the drug in August 2025, almost a full year after securing approval. That quarter, Iterum pulled in $400,000 in sales of the antibiotic while incurring $6.5 million in expenses, which the company largely attributed to Orlynvah’s launch. The company had $11 million in cash at the end of September, and in a November release, CEO Corey Fishman outlined expectations for Orlynvah to bring in between $5 million and $15 million in 2026.By deciding to wind down, Iterum joins f5 Therapeutics, Lipella Pharmaceuticals and IO Biotech, which have all also announced plans to close up shop this month.

IO’s troubles began in earnest last September, after the FDA advised the company not to submit its cancer vaccine Cylembio for approval.\n Half a year after being spurned by the FDA and following deep layoffs, IO Biotech has decided to close its doors for good. The Danish biotech has ceased operations and said goodbye to its employees, C-suite and board of directors after filing for bankruptcy, according to a March 31 filing with the Securities and Exchange Commission.A trustee appointed by the Delaware bankruptcy court will take control of the company and liquidate its assets.IO’s troubles began in earnest last September, after the FDA advised the company not to submit its cancer vaccine Cylembio for approval. The agency’s decision was sparked by a phase 3 fail where Cylembio failed to top Merck & Co.’s Keytruda at improving progression-free survival in unresectable or metastatic melanoma.Because Cylembio’s survival mark just barely missed statistical significance over Keytruda, IO at the time was not deterred from pursuing approval. But subsequent interactions between IO and the FDA proved unfruitful, with the company not disclosing the outcome of a meeting scheduled for December. Once the door to approval seemingly closed on Cylembio, IO responded by halving its workforce and plotting a new trial of the therapeutic vaccine to meet the regulator’s requirements. Those layoffs were followed by consideration of even further cuts in January, around the same time the oncology outfit hired a financial advisor to help explore strategic alternatives.At the end of September 2025, IO had about $31 million in the bank. Before any layoffs, that cash was expected to last only until the first quarter of 2026.IO\'s shuttering comes the same day that Lipella Pharmaceuticals announced it had filed for bankruptcy. The Pittsburgh-based biotech was developing an anti-inflammatory mouthwash to treat symptomatic oral lichen planus, an autoimmune condition affecting mucus membranes in the mouth.Molecular glue biotech f5 Therapeutics also shut down earlier this month, with the company’s CEO citing how “brutal” the past few years have been for early-stage biotechs. The first company to be buried in the biotech graveyard this year was Nido Biosciences, which decided to wind down after its small molecule for a rare neurological disease disappointed in a phase 2 trial.

Nasdaq rescinded the company’s listing in June 2025 over certain private placement transactions that the stock market claimed had violated its listing rules.\n Lipella Pharmaceuticals’ ambition to develop the first treatment for an inflammatory mouth condition has reached the end of the road, with the biotech filing for bankruptcy.The Pittsburgh-based company had been working on a liposomal oral rinse of the immunosuppressant tacrolimus to treat symptomatic oral lichen planus (OLP), a chronic inflammatory condition affecting the oral mucosa.Back in September 2025, Lipella said its candidate, dubbed LP-10, had hit the key safety endpoint in a phase 2a study of 27 patients with OLP.  The biotech reported at the time that pain and sensitivity “improved significantly, with patients reporting meaningful reductions on numerical rating scales.”Based on the data, Lipella’s plan was to advance LP-10 into a phase 2b study, with the ultimate goal of scoring the first FDA approval in OLP.But that dream died yesterday, when the company announced it had filed a voluntary petition for relief under Chapter 11 of the U.S. Bankruptcy Code in the Bankruptcy Court for the Western District of Pennsylvania.The biotech plans to undergo an asset sale process to  “maximize value for creditors,” according to a post-market March 30 release. Further, it expects to seek customary “first-day” relief that would allow the business to continue day-to-day operations in the near term. The writing had been on the wall for Lipella for a while, with Nasdaq rescinding the company’s listing in June 2025 over certain private placement transactions that the stock market claimed had violated its listing rules.At the time, CEO Jonathan Kaufman, Ph.D., attempted to reassure investors that Lipella’s “underlying business remains strong.” “We are advancing meaningful therapies through the clinical program previously outlined, maintaining full SEC compliance, and actively pursuing relisting,” Kaufman wrote in a June 2025 letter. “Our mission, leadership team, and long-term strategy remain unchanged.”By September, Lipella’s cash reserves had dwindled to $1.8 million and the company was warning that bankruptcy loomed if the biotech couldn’t secure fresh funds.