IntellaTurn, LLC

• Last week, the FDA said it refused to file Moderna’s application over regulatory issues.

• The company maintained that the refusal had nothing to do with the safety and efficacy of its vaccine candidate.

• On February 18, Moderna broke the news in a press release that the FDA had accepted its application for review following a high-priority, Type A meeting with the agency.

From Moderna: “To advance the review, Moderna proposed a regulatory pathway based on age, seeking full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older, along with a post-marketing requirement to conduct an additional study in older adults,” said the company.

From the government: The Health and Human Services (HHS) spokesperson Andrew Nixon said “the company refused to follow very clear FDA guidance from 2024 to test its product in a clinical trial against a CDC recommended flu vaccine to compare safety and efficacy.”

• Nixon claimed Moderna exposed older trial participants to “substandard” care during the trial, though the company said the regulators had reviewed and cleared the design of the trial more than a year ago.

• FDA authorized a once-monthly SC schedule for amivantamab/hyaluronidase plus lazertinib, offering an earlier switch to monthly maintenance (from ~week 5) in frontline EGFR-mutant advanced NSCLC.

• Paloma-2 supported non-inferior clinical performance versus q2-week SC dosing, with objective response rate as the primary endpoint in previously untreated advanced/metastatic EGFR-mutated disease.

• Commercially, monthly dosing strengthens differentiation by simplifying logistics while maintaining EGFR/MET bispecific pathway targeting, potentially improving treatment persistence and clinic capacity utilization. (PharmExec)

• Ocular reported a phase 3 win that it believes can validate its attempts to challenge Regeneron’s entrenched position in wet age-related macular degeneration (AMD) with investigational Axpaxli, a hydrogel version of Pfizer’s now off-patent kidney cancer med Inlyta (axtinib).

• The company compared Axpaxli, an intravitreal injection, to Regeneron’s leading Eylea (aflibercept) in its phase 3 SOL-1 study, finding that the drug met its primary endpoint of superiority at week 36 with “high statistical significance,” according to a press release.

• But the results didn’t appear to deliver what investors had expected. By midday Feb. 17, the company’s shares were down some 25%. (Fierce Pharma)

• Cyrano Therapeutics is savoring a phase 2 victory. With the Flavor study hitting its primary endpoint, the biotech is preparing to take its treatment for persistent smell loss into phase 3 in the second half of the year.

• The midphase trial randomized 151 patients with persistent post-viral loss of smell to receive CYR-064 or placebo.

• CYR-064 is an intranasal formulation of the phosphodiesterase inhibitor theophylline. Scientists have explored the potential for theophylline to fix smell loss in patients with hyposmia for decades—one clinical trial began in 2000—and the effect of COVID-19 infection on smell fueled renewed interest in the idea. (Fierce Biotech)

• The stock prices of at least four companies were up by mid-single digits to low-double digits at certain points throughout the day.

  • GH Research and Helus Pharma, two small biotechs respectively based in Ireland and Canada, saw the biggest gains of nearly 12%.

  • Shares of AtaiBeckley and Definium Therapeutics, which rebranded from MindMed last month, increased between 5% and 8% at their peak.

• Initial data from the first of those trials, which pitted one dose of the compound against a placebo in treatment-resistant depression, came last summer.

• Compass unveiled more results on Feb. 17, including that a second dose of its therapy, codenamed COMP360, helped a significant portion of one subset of patients go into remission.

• As large corporations pursue greater efficiency and bottom-line growth, AI is replacing human workers at an astonishing clip. Amazon announced 16,000 layoffs last month after it already axed 14,000 jobs earlier in the year.

“I wouldn’t say that AI is necessarily replacing jobs one-for-one,” said Jae Yoo, executive director of EPM Scientific, a recruitment firm specializing in pharma, biotech and R&D hiring. “It’s rehousing and reshaping the types of jobs that are now coming in.”

• A recent poll of industry executives echoed that sentiment, with pharma’s C-suite leaders reporting that they don’t think AI will lead to major job losses.

• In fact, AI has added jobs at some Big Pharma companies. Eli Lilly announced it’s working with NVIDIA to build an “AI factory for drug discovery” that will create thousands of manufacturing and construction jobs, as well as jobs for engineers, scientists, operations personnel and lab technicians, NVIDIA said.

• AI hiring is also top of mind for the life sciences industry, with more than half of surveyed biotech execs saying that AI experts are among the top three roles they need to fill in the coming years. The search for AI talent is especially critical as life sciences companies invest in and build more in-house AI teams.

• Pharma job titles are also being reshaped by AI, creating hybrid roles that merge several functions and capabilities, such as commercial analytics and market access.

• Commercial analytics roles are also in high demand, with a need for workers who can analyze commercial data and real-world evidence.