The Centers for Medicare & Medicaid Services announced on Nov. 25, 2025, what Medicare would pay for 15 drugs starting Jan. 1, 2027. Austedo, Teva Pharmaceuticals’ drug for tardive dyskinesia and Huntington’s chorea, was on the list. Its negotiated price is $4,093 for a 30-day supply, against a 2024 list price of $6,623, according to Manatt Health’s analysis of the CMS figures.
INGREZZA, the drug that supplies most of Neurocrine Biosciences’ revenue, competes with Austedo for the same patients. CMS did not include it in that round or in the January 2026 round that set up prices for 2028. Neurocrine’s chief executive, Kyle Gano, expects INGREZZA to come up next. Negotiations “will start next year,” he said on the company’s second-quarter earnings call, and Neurocrine will learn the price “that would be applied to INGREZZA in 2029.”
Neurocrine is spending INGREZZA’s income in the meantime, and one of the newest uses is a Phase 2 trial in Alzheimer’s cognition that the Food and Drug Administration cleared in August. Index funds and specialists hold the stock through that period. BlackRock reported 13,711,607 Neurocrine shares as of June 30, valued at $2.31 billion, according to InsiderSet’s compilation of 13F filings. RTW Investments held 1,267,925 shares, and Armistice Capital, the New York hedge fund, held 535,838 shares worth $90.3 million.
The Franchise in 2026
The FDA first approved INGREZZA in 2017 for tardive dyskinesia, the uncontrolled, repetitive movements some patients develop after years on antipsychotics, and later for chorea in people with Huntington’s disease. The drug’s second-quarter net sales were $716 million, 15% more than a year before, Neurocrine reported July 30. Both new patient starts and total prescriptions set records, and the company raised its 2026 INGREZZA forecast to a range of $2.825 billion to $2.875 billion from $2.7 billion to $2.8 billion. In the first quarter, INGREZZA had brought in $656.9 million, up 20%, out of total revenue of $814.5 million, and Neurocrine held about $2.65 billion in cash and investments at March 31.
Management said demand is still widening. “This market overall continues to grow double digit year to year,” Gano said on the call. Chief Commercial Officer Eric Benevich said, “INGREZZA outgrew the market.” Gano said the drug had “great access this year with about 70% of all Medicare lives covered,” and Chief Financial Officer Matt Abernethy said the company expects INGREZZA’s pricing “to remain relatively consistent year to year.”
Austedo is growing quickly too. Teva reported U.S. Austedo revenue of $676 million in the second quarter, up 33%, and raised its 2026 forecast for the drug to $2.45 billion to $2.6 billion, according to a Nasdaq summary of Teva’s earnings call. Total Austedo prescriptions rose 14% and milligrams dispensed rose 21%, and global Austedo revenue grew 40%. Austedo XR, the once-daily version, accounted for more than 60% of new Austedo patient starts.
Between them, the two drugs produced more than $1.3 billion in second-quarter sales. Starting in January, Medicare will pay a negotiated price for one and not the other.
What the Medicare Clock Means
The Inflation Reduction Act lets Medicare negotiate prices for drugs with high program spending that have been on the market for several years without generic competition. CMS has now picked drugs for three rounds. CMS chose the second-round drugs in January 2025. Prices from that round, which included Austedo, average a 62% discount to 2024 list prices, Manatt found. KFF reported that CMS put the savings at about $12 billion, or 44%, relative to 2024 net prices, and estimated that Medicare beneficiaries would save $685 million once the 2027 prices apply. Austedo’s price landed roughly 38% under its 2024 list price, a little above Manatt’s estimate of the ceiling CMS could have set.
For the third round, announced in January 2026 for prices starting in 2028, CMS chose Anoro Ellipta, Biktarvy, Botox, Cimzia, Cosentyx, Entyvio, Erleada, Kisqali, Lenvima, Orencia, Rexulti, Trulicity, Verzenio, Xeljanz and Xolair, and picked Tradjenta for renegotiation, according to a list published by the Academy of Managed Care Pharmacy. The group made up about $27 billion, or 6%, of Medicare Part B and Part D spending. INGREZZA was left off.
Gano’s timeline puts INGREZZA in the fourth round, with negotiations in 2027 and a price in effect in 2029. Abernethy told analysts that future “EPS variability is really going to be based upon, as you said, the impact of the IRA implementation in 2029.” Gano said, “there will be a place for MFP adjacent products for Medicare beneficiaries.”
From January 2027 until INGREZZA’s own price takes effect, the drug will compete against a rival with a negotiated Medicare price.
Spending the Cash
Neurocrine’s total second-quarter revenue reached $959 million, up 39%, and would have been $998 million on a pro forma basis with a full quarter of VYKAT XR. Two newer drugs sit beside INGREZZA. CRENESSITY, cleared by the FDA at the end of 2024, treats classic congenital adrenal hyperplasia, an inherited disorder of the adrenal glands; its sales were $184 million, up 247%. VYKAT XR, which treats hyperphagia in Prader-Willi syndrome, came with the purchase of Soleno Therapeutics and added $54 million after the deal closed May 18. Its pro forma sales for the full quarter were $94 million.
Neurocrine announced the Soleno purchase on April 6 at $53 a share in cash, a $2.9 billion equity value. A tender offer expired May 15, and the deal closed three days later, when Soleno’s stock stopped trading on Nasdaq. VYKAT XR had been on the market since its FDA approval on March 26, 2025; it is cleared for patients 4 and older with Prader-Willi, a rare genetic condition marked by constant hunger. Gano called the closing “an important advancement in Neurocrine’s mission to deliver life-changing treatments.” “We welcome our Soleno colleagues to Neurocrine and share their deep commitment to the Prader-Willi syndrome community,” he said.
The company paid with cash on hand. “We acquired [Soleno] for approximately $2.9 billion and financed the transaction with cash on hand,” Abernethy said. Cash, cash equivalents and marketable securities dropped to about $482 million at June 30 from $2.543 billion at the end of 2025, and Neurocrine had $1 billion available under a revolving credit facility. “We ended the second quarter with approximately $500 million in cash, and no debt,” Abernethy said.
Spending plans went up. Neurocrine lifted its 2026 guidance for GAAP research and development expense to $1.275 billion to $1.325 billion, from $1.2 billion to $1.25 billion, and for GAAP selling, general and administrative expense to $1.575 billion to $1.6 billion, from $1.375 billion to $1.4 billion. Second-quarter GAAP net income was $144 million, or $1.39 a diluted share, compared with $108 million, or $1.06, a year earlier. Non-GAAP net income was $297 million, or $2.85 a share, up from $166 million, or $1.65.
Abernethy said the company expects about $150 million in acquisition-related costs from the Soleno deal and that VYKAT XR “is immediately accretive to non GAAP earnings.” A potential launch of osavampator in depression “would require a step up in overall investment,” he said. Benevich said, “we have a substantial footprint today in psychiatry, as well as in long term care,” and added, “I do not anticipate any near term changes to our footprint.”
CRENESSITY has room to grow. “Approximately 15% of the estimated diagnosed patient population has now been prescribed CRENESSITY,” Abernethy said in his prepared remarks. Benevich said the number of prescribing doctors had “nearly tripled compared to 1 year ago,” though “Most of the physicians that have tried CRENESSITY have only treated 1 patient so far.” More than 90% of patients were “paying $10 or less per month” out of pocket, he said. Gano cited long-term data showing that “70 percent of patients, at the 2 year period were on a physiologic dose” of glucocorticoids, the steroids patients with the disorder have historically needed at high doses.
VYKAT XR lost patients after the acquisition. Abernethy said the company expected to be “through the bolus of the discontinuations here this quarter” and to “drive sequential quarterly growth exiting 2026.” Gano said he expected the discontinuation rate to settle “in the 25 to 30 percent range,” similar to other orphan drugs, and that the drug’s patent protection extends to “the mid-2040s.” Soleno had withdrawn its European filing for the drug during the closing process, Gano said. Benevich said VYKAT XR has “the potential to become the third blockbuster in our portfolio.”
“Our second quarter performance demonstrates the power of a strategy designed to compound over time,” Gano said in the earnings release.
Who Holds the Stock
BlackRock’s 13,711,607 shares were the largest position among the holders InsiderSet listed as of June 30. Three Vanguard entities followed: Vanguard Portfolio Management with 4,974,083 shares, Vanguard Capital Management with 4,545,339 and Vanguard Fiduciary Trust with 647,763, about 10.2 million combined. State Street held 4,385,598 shares, valued at $739.1 million.
RTW Investments reported 1,267,925 shares valued at $213.7 million at the end of June.
Armistice reported 535,838 shares valued at $90.3 million, about 1.1% of its reported portfolio, StockZoa data show. The fund held about 25% fewer shares than at the end of March. Neurocrine is one of several neuroscience companies in Armistice’s filing. The largest of those listed by StockZoa, Supernus Pharmaceuticals, was valued at $123 million after a 39% increase in shares during the quarter. Armistice also held Harmony Biosciences at $57 million and Alto Neuroscience at $23 million.
Armistice reported $8.17 billion across 333 holdings as of June 30, according to 13f.info. Its top five positions were put options on the SPDR S&P 500 ETF Trust and the iShares Russell 2000 ETF, Madrigal Pharmaceuticals, call options on Cytokinetics, and Supernus.
An Alzheimer’s Trial Clears the FDA
On Aug. 26, the FDA accepted Neurocrine’s investigational new drug application for a Phase 2 study of NBI-1117567 in Alzheimer’s cognition. The compound is an oral muscarinic agonist with a preference for the M1 receptor and activity at M4, according to Nxera Pharma, which discovered it with NxWave, its structure-based drug design platform. Nxera said M1 is a potential target for cognition and M4 for psychosis.
Nxera received a $10 million milestone payment for the acceptance and expects to book the full amount as revenue in its third fiscal quarter of 2026. The companies signed their collaboration in November 2021, covering M4, M1 and dual M1/M4 agonists for schizophrenia, dementia and other neuropsychiatric disorders. Nxera can earn up to $2.6 billion in research funding and milestones, plus royalties. Neurocrine funds global development, except for M1 agonists in Japan, where Nxera kept the rights and Neurocrine holds options to share development and profits.
“Alzheimer’s cognition remains an area of significant unmet medical need globally,” said Christopher Cargill, Nxera’s president and chief executive.
NBI-1117567 is the third compound from the partnership cleared for Phase 2. Direclidine, formerly NBI-1117568, was the first NxWave-designed molecule to reach Phase 3 and is in that stage for schizophrenia, and NBI-1117570 is in Phase 2. Neurocrine expects Phase 3 results for direclidine in schizophrenia and for osavampator in major depressive disorder in 2027, according to its second-quarter release.
Those readouts fall in the same year INGREZZA’s Medicare negotiations are scheduled to begin. The Alzheimer’s trial is at an earlier stage, and neither Nxera’s announcement nor Neurocrine’s second-quarter release gave a date for its results.
Where the Alzheimer’s Trial Fits
The Alzheimer’s Association’s 2026 review of drugs in development, led by Jeffrey L. Cummings, listed 158 agents across 192 trials. A year earlier, the count was 138 agents and 182 trials. Of this year’s trials, 89 were Phase 2 studies covering 84 drugs, more than either Phase 1 or Phase 3. The review expected eight Phase 3 trials to reach primary completion in 2026 and 29 Phase 2 trials to finish.
Treatments targeting the biology of the disease accounted for nearly three-quarters of the agents, at 73%. Drugs meant to improve cognition, the category NBI-1117567 would join, came to 18%, and drugs for neuropsychiatric symptoms 10%. More than a third of all agents, 56 of them, were drugs first approved for something else. Over 10 years, the review found, amyloid programs shrank from a third of the pipeline to about a fifth, and tau and inflammation programs each grew to about a fifth from 6%. At least one drug in current trials addresses each of 17 different aspects of the disease.
“Alzheimer’s is no longer an untreatable disease,” Cummings said. “Biomarkers are increasingly used for trial eligibility as well as being integrated as trial outcomes.” Maria C. Carrillo, the Alzheimer’s Association’s chief science officer, said “there is still a great unmet need for drug development to address the needs of the growing population.”
Bristol Myers Squibb is testing its own muscarinic drug in Alzheimer’s, aimed at psychosis rather than memory. Cobenfy, approved for schizophrenia, is in three ADEPT studies. Bristol Myers pushed the first data from those studies into early 2027, citing slower enrollment in two of them and slower accumulation of relapse events in the third, FiercePharma reported. In April, the company had still expected all three to report in 2026, and ADEPT-1 could have an interim analysis later this year. Cobenfy’s second-quarter sales were $63 million. “There has been no change, in any way, in our confidence in both the underlying science,” Chief Medical Officer Cristian Massacesi said on Bristol Myers’ earnings call.
A Change in the Medical Office
A month after the FDA acceptance, Neurocrine changed chief medical officers. The company said Sanjay Keswani would leave the role by mutual agreement and that Eiry W. Roberts would return to it, effective immediately, RTTNews reported Sept. 29.
Roberts held the job from 2018 to 2025 and had advised the company since. During her earlier tenure, she led the work to expand INGREZZA’s approved uses and oversaw the crinecerfont program that produced CRENESSITY. Before joining Neurocrine, she spent 26 years at Eli Lilly, including as a vice president of research and development.
Roberts returns as Neurocrine heads toward its two 2027 Phase 3 readouts and the start of the NBI-1117567 trial, and as the company prepares for INGREZZA’s Medicare negotiation.
Dates Ahead
Neurocrine reports third-quarter results on Monday, Nov. 2, after the U.S. market close, with a news release at 4 p.m. Eastern and a conference call at 4:30 p.m., according to BioPharmaWatch.
The rest of the timeline is set by regulators and trial schedules. Medicare’s negotiated price for Austedo takes effect Jan. 1, 2027. Neurocrine expects INGREZZA negotiations to begin in 2027, the same year direclidine and osavampator are due to report Phase 3 data and Bristol Myers expects its first ADEPT results for Cobenfy in Alzheimer’s psychosis. INGREZZA’s own negotiated price is expected to apply in 2029. Holdings as of Sept. 30 for BlackRock, Vanguard, State Street, RTW and Armistice will appear in 13F filings due by mid-November.
