Nutrition Disorders

Sionna Therapeutics and Odyssey Therapeutics have joined Metsera and Maze in an attempt to go public via the still rocky IPO route. The biotechs, focused on cystic fibrosis and immunology respectively, filed for their initial public offerings on Friday evening. Sionna and Odyssey departed last week’s annual JP Morgan Healthcare Conference with plans for public life as $SION and $ODTX . They join the Nasdaq queue alongside obesity drug developer Metsera and kidney disease startup Maze , which has spun out other companies and formed joint ventures over the years. None of the IPO hopefuls have yet outlined the size of their planned debuts. If all four biotechs follow through with their plans, they’d create a buzzy start to 2025 compared to the relatively dry IPO market of the past few years. The new entrants Sionna and Odyssey are both well-funded, clinical-stage biotechs with experienced management teams, ticking most of the boxes that public market investors seek for drug development startups in the current IPO environment. Last year, Boston-based Sionna in-licensed three cystic fibrosis drug candidates from AbbVie, just months after disclosing a $182 million Series C that would take it through 2026, CEO Mike Cloonan told Endpoints News last July. Cloonan was a long-time Biogen executive and Sage Therapeutics operating chief before joining Sionna in spring 2021. New details on the AbbVie deal were revealed in Sionna’s S-1 paperwork, which was filed on 17 January. AbbVie got $5 million upfront and $8.6 million worth of common stock. The pharma giant could also get up to $360 million in development and commercial biobucks, plus up to $130 million in commercial and sales-based milestones, according to the S-1 filing . Sionna had $180 million in cash, equivalents and marketable securities at the end of September, according to the filing. The mid-stage biotech spent about $43 million on R&D in the first nine months of 2024, a $12 million jump over the same period the prior year, per the S-1. Sionna has raised about $330 million since its 2019 founding. RA Capital owns the largest chunk of the biotech at 29.2%. TPG Growth holds 17.4%, Atlas Venture owns 11.4% and OrbiMed maintains a 9.9% stake. OrbiMed is also one of the largest stakeholders in Odyssey. SR One is the biggest shareholder at 16.2% followed by OrbiMed (14.3%), Fidelity (6.7%) and Foresite Capital (6%), according to Odyssey’s S-1 filing . Odyssey is developing small molecule therapies for ulcerative colitis, Crohn’s disease, atopic dermatitis, systemic sclerosis and other indications. It’s also creating protein therapeutics for vitiligo, type 1 diabetes, systemic lupus erythematosus and asthma. The preclinical asthma program is part of the burgeoning TSLP arena. Gary Glick, a chemistry professor-turned-serial entrepreneur, leads Odyssey. The biotech startup formed in 2021 and quickly disclosed three successive megaround financings, most recently a $101 million Series C in December 2023. Glick is also a co-founder of Scorpion Therapeutics. During last week’s JPM, Eli Lilly said it would buy Scorpion for up to $2.5 billion . Odyssey spent $81 million on R&D in the first nine months of 2024, a $5 million decrease compared with the same period of 2023. The company had about $155 million in cash, equivalents and marketable securities at the end of September.

The China-to-US experimental medicine pipeline is ballooning: yet another US-based biotech formed around a candidate from China’s Keymed Biosciences on Monday. Life sciences investment firm RTW has set up a company called Prolium to take forward a CD20×CD3 bispecific known as CM355 outside Asia, the companies said in a press release and Hong Kong Stock Exchange filing . Prolium will get rights to develop the antibody in both oncology and non-oncology indications in exchange for $17.5 million upfront and up to $502.5 million in biobucks. Keymed will split its earnings with partner Beijing InnoCare. The companies will also get a minority equity stake in the new company, according to the HKEX filing. China-derived drug candidates have featured prominently in the pipelines of recently launched biotechs: four of the 10 megarounds so far this year have gone to biotechs developing such assets. Chengdu-based Keymed is one of the many biopharmas driving the trend, having out-licensed candidates to two new companies earlier this month. Timberlyne Therapeutics emerged with $180 million and Ouro Medicines debuted with $120 million. And last year, Belenos Biosciences broke cover with two Keymed assets and a former Biohaven executive at the helm. RTW, meanwhile, has recently taken part in similar newco formations. It helped form Kailera Therapeutics , which launched last year with $400 million and a Phase 3-ready obesity drug candidate from China-headquartered Hengrui.

The U.S. Department of Health and Human Services unveiled 15 additional drugs chosen for the Medicare Drug Price Negotiation Program on Friday. Many healthcare leaders are applauding the list of selected drugs, while drug manufacturers are coming out against it. Under the program, which was created through the Inflation Reduction Act, the federal government is able to negotiate the price of selected drugs with participating drug companies. The first 10 drugs were announced in August 2023 and the negotiated prices will go into effect in 2026. Negotiations for the next 15 drugs will take place this year and the negotiated prices will go into effect in 2027. The additional drugs selected for the program are: Healthcare Using Data to Help Healthcare Practices Succeed A new report from Relatient, A Data-Driven Guide to Patient Access Succes, highlights how focusing on data accuracy and relevance can enhance the performance of healthcare practices. By Relatient Ozempic; Rybelsus; Wegovy Trelegy Ellipta Xtandi Pomalyst Ibrance Ofev Linzess Calquence Austedo; Austedo XR Breo Ellipta Tradjenta Xifaxan Vraylar Janumet; Janumet XR Otezla These drugs accounted for about $41 billion in total gross covered prescription drug costs under Medicare Part D between November 2023 and October 2024, according to HHS. In addition, during the same time period, about 5.3 million people with Medicare Part D coverage used these drugs for conditions like cancer, type 2 diabetes and asthma. While HHS is touting the program and additional list of drugs as a way to reduce drug prices, some of the drug manufacturers selected for the program say the program is causing more harm than good. For example, Pfizer, the manufacturer of Ibrance, argued in a statement that the Inflation Reduction Act “establishes a dangerous price-setting system that allows the government to dictate the value and price of certain medicines, discouraging continued development.” Novo Nordisk — the manufacturer of Wegovy, Ozempic and Rybelsus — also came out against the list of additional drugs for the program. Sponsored Post The Funding Model for Cancer Innovation is Broken — We Can Fix It Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches. By Eve McDavid - CEO of Mission-Driven Tech “Novo Nordisk remains opposed to government price setting through the IRA and has significant concerns about how the law is being implemented by this administration, including aggregating multiple products that individually would not meet the requirements of the statute,” a spokesperson said in an email. It’s worth noting that multiple drug companies (including Novo Nordisk) have filed lawsuits against the drug price negotiation program. Teva Pharmaceuticals is the latest to do so. While manufacturers oppose HHS’ announcement, AARP, a nonprofit for Americans aged 50 and older, applauded the list of additional drugs chosen for the negotiation program. “For too long, big drug companies have padded their profits by setting outrageous prices at the expense of American lives, forcing seniors to skip prescriptions they can’t afford. … With Medicare negotiating to lower prices on more drugs and the new out-of-pocket cap, seniors are finally starting to see relief from high drug prices,” said Nancy LeaMond, AARP executive vice president and chief advocacy and engagement officer, in a statement. Patients for Affordable Drugs, a patient advocacy organization, also celebrated the announcement, stating that it will lower costs for millions of patients. However, more work is needed to protect the negotiation program, according to Merith Basey, executive director of Patients for Affordable Drugs. “Let’s be clear: we must keep pushing to expand the wildly popular Medicare negotiation program,” Basey said in a statement. “Patients fought extremely hard for the passage of these reforms and they continue to vigorously defend them against pharma’s attacks – because nobody should have to choose between life-saving drugs and their basic needs.” One healthcare executive — Brooke Boyarsky Pratt, founder and CEO of knownwell — is particularly excited about the selection of Ozempic and Wegovy for the negotiation program. The company offers metabolic health services, primary care, nutrition counseling and health coaching. “Price negotiations for Ozempic and Wegovy have the potential to completely change patient access to comprehensive obesity care,” Boyarsky Pratt told MedCity News. “As has been discussed at length, the question about GLP-1s is about their affordability, not their efficacy. HHS has the opportunity to make these medications affordable for those living with obesity across America and pave the way for commercial plans to cover these medicines at scale.”