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Listen to the article 5 min This audio is auto-generated. Please let us know if you have feedback. Today, a brief rundown of news involving Crinetics and the Food and Drug Administration, as well as updates from Eli Lilly, Biogen and Gossamer Bio that you may have missed.Crinetics on Thursday won clearance from U.S. regulators to begin selling a new drug for the rare hormonal disorder acromegaly. Called Palsonify and, previously paltusotine, the drug is the first once-daily oral therapy for the condition and cleared for adults who aren't eligible for corrective surgery or haven't adequately responded to it. Palsonify is “poised to challenge the Goliaths of pharma,“ among them Novartis and Pfizer, with a “broad label and an attractive [annual] $290,000 list price,“ wrote Leerink Partners' Joseph Schwartz, who is predicting $375 million in peak yearly sales in the U.S. and Europe. Ben FidlerThe federal government this week announced multiple new initiatives designed to foster gene therapy research. The Food and Drug Administration on Wednesday published draft guidance outlining accelerated approval pathways, post-approval requirements and new clinical trial designs. And on Thursday, the Advanced Research Projects Agency debuted two programs aiming to speed development and assist with manufacturing, so the complex medicines are less costly to produce. Ben FidlerBristol Myers Squibb will begin selling its psoriasis drug Sotyktu online at a discounted price, the company said Thursday. Starting in January, Bristol Myers will offer Sotyktu at a cost more than 80% lower than its current list price for people who are uninsured, underinsured or pay for the medicine out of pocket. The initiative is part of a growing trend among pharmaceutical companies to provide products directly to consumers while bypassing traditional drug distribution channels. Bristol Myers started offering its heart drug Eliquis online at a reduced price this month. Ben FidlerEli Lilly announced the location of the second of the four new U.S. manufacturing plants it intends to build, a factory in Houston that will make the active ingredients for several small molecule drugs, including its experimental obesity medicine orforglipron. Lilly will pour $6.5 billion into the factory, which it says will employ 4,000 peopleduring constructionand 615 at the plant once it is operational in five years. Earlier this month, the company said it will locate another plant near Richmond, Virginia,as part of a promise to spend $50 billion on domestic manufacturing. Details regarding the two other factories will be announced this year. Jonathan GardnerThe FDA rejected a high-dose version of Biogens spinal muscular atrophy drug Spinraza. Study results last year showed that the newer form of Biogens drug appeared to slow neurodegeneration faster than the marketed treatment and, according to Biogen, the agency didnt cite any deficiencies with its clinical data. Instead, the FDA requested an update to certain technical information in the portion of its application dealing with manufacturing. Biogen intends to respond and update its application promptly, but its unclear whether the resubmission will be a Class 1 or Class 2 filing, each of which have different review timelines, wrote William Blair analyst Myles Minter. Ben FidlerGossamer Bio secured an option to acquire privately held pulmonary arterial hypertension drug developer Respira Therapeutics, the companies said Thursday. The deal provides Respira with funding to develop its lead candidate, an inhaled drug called RT234, for up to two years as the companies advance development. Respira completed a Phase 2b studyearlier this year.Gossamer issued 2.5 million shares of common stock upon signing the deal, and would add another 1.5 million if it exercises the acquisition option. Last year, Gossamer sold rights to its own PAH drug, seralutinib,to Italy-based Chiesi Farmaceutici. Gwendolyn WuAn experimental drug Harmony Bioscienceshas been developing for Fragile X syndrome failed a late-stage trial. In a Wednesday announcement, the company said its drug, ZYN002, failed to meet its main goal of improving social avoidance because of a higher than expected placebo response rate. Harmony acquired ZYN002, a topical, synthetic cannabidiol, in a 2023 buyout of Zynerba Pharmaceuticals. The compound previously failed studies in epilepsy and osteoarthritis-related knee pain. Gwendolyn Wu '

The White House is considering a significant event as soon as next week to tout its efforts to reduce US drug prices, roping in several different initiatives, according to several sources familiar with the planning. That could include a multi-pronged announcement about President Donald Trump’s “most favored nation” program to bring US drug prices level with those of other countries. The White House would also likely provide an update on Medicare price negotiations that are part of the Inflation Reduction Act signed under former President Joe Biden, according to the sources, who described the planning on condition of anonymity. The White House is also expected to unveil three new pricing demonstration programs under the Centers for Medicare and Medicaid Innovation (CMMI), including a voluntary Medicaid pricing pilot program, a mandatory Medicare Part B program, and a third program involving Medicare Part D. There were hints of those plans in a yet-to-be published policy , referred to in a federal database as the “Global Benchmark for Efficient Drug Pricing (GLOBE) Model.” Demonstration programs through CMMI are usually narrow in nature and apply to specific regions or health systems. It wasn’t immediately clear who would participate in them or what drugs would be included. The plans for the rollout underscore Trump’s effort to bring drugmakers to heel. The most favored nation initiative, first outlined in a May executive order, has been a frequent refrain for Trump, who has demanded that the US pay the same for drugs as other countries. But the expected announcements would also fall far short of the goals Trump set forth in his May order and in a series of letters to the world’s biggest drugmakers in July, demanding that companies guarantee most favored nation pricing for all new drugs, offer steep discounts in Medicaid, repatriate profits made abroad, and set up widespread direct-to-consumer purchase programs. Trump gave 60 days to respond to that demand — a period that ends on Sept. 29. The expected announcement follows weeks of meetings between the administration and companies, according to multiple people familiar with the negotiations, as the government has tried to figure out how to move ahead with Trump’s goals. People familiar with those sessions described the government as still working to get its arms around highly complex, and often confidential, global drug pricing dynamics. It’s possible the plans for the event could change, and several companies that had been in talks with the administration said they hadn’t yet received any invitation to appear at the White House. It’s also possible the administration could announce a series of one-off agreements with companies. “The White House is committed to delivering on President Trump’s push to end global freeriding and lower drug prices for everyday Americans to MFN rates. Unless officially announced by the White House, however, any reporting about specific policy actions should be treated as speculative,” White House spokesperson Kush Desai said in a statement to Endpoints News . The pressure from the White House has given companies cover to raise their drug prices abroad. Those efforts have been particularly sharp in the UK, where drugmakers have repeatedly criticized the government there over its policies, and in some cases pulled back on investments in the country. Eli Lilly announced last month that it would raise the price of diabetes drug Mounjaro. This week, Bristol Myers Squibb said it would make the list price of its schizophrenia drug Cobenfy the same in the UK as it is in the US. Trump’s most favored nation effort has included a focus on how the government might enable the sale of drugs directly to consumers at lower prices. Some companies have recently taken steps to do that for a small handful of their drugs, in an effort to respond to the administration’s asks. And at least two companies have new direct-to-consumer sales plans in the works that would offer a discount on list prices of several brand-name products, according to people familiar with those programs. On Thursday, Bristol Myers said it would start selling its psoriasis drug Sotyktu at an 80% discount to its list price beginning in January 2026. The DTC platform will “allow for the addition of other BMS medicines that are appropriate for this model in the future.” Pfizer and BMS previously announced that their jointly-marketed blood thinner Eliquis would be sold directly to patients at a 40% discount from the list price. Novo Nordisk and Lilly have been selling their weight loss drugs directly to patients as well. Pfizer CEO Albert Bourla, who chairs the major pharmaceutical trade organization PhRMA, told investors on a company earnings call last month that the member companies were supportive of the White House’s push for direct-to-consumer sales. “They are all ready to roll up their sleeves and execute something like that,” he said of his fellow CEOs at the time. The future announcement may provide a slight reprieve for companies that have been trying to tactfully navigate a barrage of proposals from the administration that they feel threaten their industry. The drug pricing proposals were at the top of those concerns, but industry-wide tariffs and limits on pharmaceutical ads have also been sources of consternation.