Pharma Stock Roundup: Pipeline/Regulatory Updates From GSK, PFE & Others

This week, the FDA granted approval to Glaxo’s (NYSE:GSK) asthma drug, Nucala for pediatric use. Meanwhile, Pfizer (NYSE:PFE) , Allergan (NYSE:AGN) and Roche (OTC:RHHBY) provided regular pipeline/regulatory updates J&J (NYSE:JNJ) , AstraZeneca (NYSE:AZN) and Eli Lilly (NYSE:LLY) presented data from studies at medical conferences held this week.

Recap of the Week’s Most Important Stories

FDA Nod to Glaxo’s Asthma Drug for Children: The FDA granted approval to Glaxo’s severe eosinophilic asthma drug Nucala for use in pediatric patients (aged six to 11 years) in the United States. The drug is already marketed in the United States and EU for severe eosinophilic asthma patients aged 12 years or older. In the EU, it received approval for pediatric use (from aged six-17 years) in August last year.

Lilly’s RET Inhibitor Shrinks Tumors in NSCLC Study: At the World Conference on Lung Cancer (WCLC) 2019 held in Spain, Lilly presented data from a phase I/II registrational study on its oral RET inhibitor, ponesimod versus Sanofi’s Aubagio in adults with relapsing multiple sclerosis at ECTRIMS. The data demonstrated superior efficacy of ponesimod versus Aubagio on the primary endpoint and most secondary endpoints. In July, the company had announced that the OPTIMUM study met its primary and most secondary endpoints. Along with the latest release, the company said that treatment with ponesimod led to a statistically significant reduction of annualized relapse rate (ARR), which was the study’s primary endpoint, compared to Aubagio.

J&J’s two phase III studies evaluating its newly approved anti-depressant, Spravato (esketamine) nasal spray in severely ill patient population, met their respective primary efficacy endpoint. The primary endpoint of the studies was a reduction in depressive symptoms at 24 hours after the first dose, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS). Data showed that treatment with Spravato plus comprehensive standard of care (SOC) treatment led to rapid reduction of depressive symptoms in adult patients with major depressive disorder who have active suicidal ideation with intent. The data was presented at the European College of Neuropsychopharmacology (ECNP) meeting held in Copenhagen, Denmark.

Detailed Data from AstraZeneca’s CASPIAN Study: At the WCLC, AstraZeneca presented detailed data from the phase III CASPIAN study on Imfinzi in first-line extensive-stage small cell lung cancer — the most aggressive type of lung cancer. Interim data from the study was presented in June when the company said that that treatment with Imfinzi plus platinum-based chemotherapy led to a statistically-significant and clinically-meaningful improvement in OS versus chemotherapy alone. Along with the latest release, AstraZeneca said that the median OS was 13.0 months in the Imfinzi plus chemotherapy arm versus 10.3 months for standard of care medicines. The PFS rate at 12 months was higher at 17.5% in the Imfinzi plus chemotherapy arm versus 4.7% in the SOC arm. The confirmed ORR was 67.9% in the Imfinzi plus chemotherapy arm versus 57.6% in the SOC arm.

The NYSE ARCA Pharmaceutical Index declined 0.3% in the last five trading sessions.

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Written By: Zacks Investment Research