Alkermes plc’s placebo-controlled phase II study of alixorexton in treating narcolepsy type 2 (NT2) hit its dual primary endpoints, producing statistically significant and clinically meaningful improvement in wakefulness and excessive daytime sleepiness. Alkermes said alixorexton is the first oral orexin 2 receptor agonist that has showed efficacy in a large phase II clinical trial in those with NT2. The company’s stock (NASDAQ:ALKS) had dropped 7.5% at midday to $31.29 per share. Competitor Centessa Pharmaceuticals plc’s stock (NASDAQ:CNTA) on the other hand was up 13.5% at $25.60 each. Centessa also is developing an OX2R agonist for NT2.

Pazdur ‘optimal fit’ to lead FDA’s CDER

In reaching within to name 26-year FDA veteran Richard Pazdur as the next CDER director, FDA Commissioner Marty Makary likely chose the best possible person to helm the drug evaluation center at a time marked by uncertainty, morale issues and upheaval, according to several agency watchers. The Nov. 11 appointment came nine days after George Tidmarsh resigned from the post after being placed on administrative leave amid allegations of bribery and defamation. Noting that Pazdur is “highly respected, experienced, thoughtful and innovative” as the head of the FDA's oncology division, Brian Abrahams, head of global healthcare research at RBC Capital Markets LLC, said Pazdur is an “optimal fit” as CDER director and “arguably the most qualified candidate in the entire healthcare ecosystem.”

Could restricting diversity efforts stall women’s health research?

Recent progress in redressing the historical underfunding and neglect of women’s health is being undermined by the backlash against diversity, equity and inclusion (DEI) initiatives, according to executives participating in the FT Global Pharma and Biotech Summit 2025 in London Nov. 11-12. At one level, the withholding of information on sex, ethnicity and age of clinical trial participants makes it hard to carry out subgroup analyses. At another level, DEI edicts could create the impression that catering to the specific health needs of half the population is somehow “woke.” There is a risk that momentum that was building in terms of investment, innovation and involving more women in clinical trials is lost.

Lyell, ICT deal highlights CRC space; Cytomx, Alligator in play

In a back end-loaded deal, Lyell Immunopharma Inc. this week bought global rights to LYL-273, an autologous guanylyl cyclase-C-targeted CAR T-cell candidate for metastatic colorectal cancer (CRC) from Innovative Cellular Therapeutics Inc. for an up-front payment of $40 million and 1.9 million shares of Lyell common stock. The transaction pointed to a disease area where the efficacy bar remains low, yet success has proven elusive. Other prominent names in the CRC space include Cytomx Therapeutics Inc. and Alligator Biosciences AB.

Laekna hands China rights of AKT inhibitor to Qilu in ¥2B deal

Laekna Inc. outlicensed select rights to LAE-002 (afuresertib), an oral pan-AKT kinase inhibitor licensed from Novartis AG in 2018, to Qilu Pharmaceutical Co. Ltd. under a potential ¥2.045 billion (US$287.23 million) deal. Announced on the Hong Kong Stock Exchange Nov. 12, Shanghai-based Laekna granted Jinan, China-based Qilu exclusive rights to research, develop and commercialize LAE-002 in mainland China, Hong Kong, Macau and Taiwan. “This strategic partnership marks the beginning of our commercial journey,” Laekna Chairman and CEO Chris Lu said. “By leveraging the strong commercialization capabilities of Qilu Pharma, we are confident that LAE-002 (afuresertib) will achieve rapid and widespread adoption.”

The BioWorld Insider podcast: Esperion Therapeutics CEO Sheldon Koenig

The latest episode of the BioWorld Insider podcast features Sheldon Koenig, CEO of Esperion Therapeutics. The company developed and is commercializing two U.S. FDA approved oral, once-daily, non-statin medicines for patients who are at risk of heart attack or other heart procedures and are struggling with uncontrolled LDL-C.

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Abcellera, ACTG, Altimmune, Alzinova, Bayer, Belenos, Calliditas, Celecor, Eli Lilly, Engene, Esperion, Evox, Idorsia, Inovio, Insilico, Intellia, Kezar, LIB, Lytix, March, Medincell, Neuphoria, Neurocrine, Novo Nordisk, Odyssey, Oncotelic, Pharmaessentia, Precision, Prokarium, Prothena, Purdue, Salarius, Santa Ana, Sapu, Shilpa Medicare, Trimtech, Vividion, Vor