Image Source: Zacks Investment Research <\/p>\n
EU Nod Based on AZN’s SERENA-6 Study <\/p>\n
The approval for the Etcamah combo in the EU was based on data from the phase III SERENA-6 study. <\/p>\n
Data from the same showed that treatment with Etcamah in combination with a CDK4\/6 inhibitor reduced the risk of disease progression or death by 56% in patients with an emergent ESR1 tumor mutation. <\/p>\n
The approval in the EU was expected, as in May 2026, the Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion recommending the EU approval of Etcamah in combination with a CDK4\/6 inhibitor for the first-line treatment of a certain type of breast cancer. <\/p>\n
Etcamah is the 11th new medicine out of the 20 that AstraZeneca expects to launch by 2030, with many of these new medicines already launched\/approved. <\/p>\n
AZN’s Recent Hurdle With Camizestrant in the United States <\/p>\n
In May 2026, AstraZeneca faced a setback when the FDA extended the PDUFA date for reviewing the new drug application (NDA) seeking approval of camizestrant in combination with a CDK4\/6 inhibitor (palbociclib, ribociclib or abemaciclib) for the first-line treatment of HR-positive, HER2-negative advanced breast cancer in patients whose tumors have an emergent ESR1 mutation. <\/p>\n
The extension follows the FDA’s request for additional data to support the application. This likely delayed the potential approval of the camizestrant combo in the United States. <\/p>\n
The extension of the review timeline for camizestrant came after the FDA’s Oncologic Drugs Advisory Committee voted 3-6 against recommending approval of the candidate in combination with CDK4\/6 inhibitors for the given breast cancer indication in April 2026. <\/p>\n
Last July, the FDA accepted the NDA for camizestrant in combination with a CDK4\/6 inhibitor, which was based on positive data from the pivotal phase III SERENA-6 study. <\/p>\n
AZN’s Zacks Rank & Stocks to Consider <\/p>\n
AstraZeneca currently carries a Zacks Rank #4 (Sell). <\/p>\n
Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY, Kiniksa Pharmaceuticals KNSA and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see\u00a0the complete list of today’s Zacks #1 Rank stocks here. <\/p>\n
Over the past 60 days, estimates for Harmony Biosciences’ 2026 earnings per share have risen from $3.20 to $3.30, while estimates for 2027 have increased from $3.64 to $3.87 during the same time. HRMY shares have lost 4.4% year to date. <\/p>\n
Harmony Biosciences’ earnings missed estimates in each of the trailing four quarters, with the average negative surprise being 25.16%. <\/p>\n
Over the past 60 days, estimates for Kiniksa Pharmaceuticals’ 2026 earnings per share have risen from $1.24 to $1.25, while estimates for 2027 have increased from $1.70 to $1.76 during the same time. KNSA shares have soared 52.8% year to date. <\/p>\n
Kiniksa Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 1.53%. <\/p>\n
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $2.97 to $3.02, while estimates for 2027 have increased from $4.81 to $4.92 during the same time. LQDA shares have surged 158.3% year to date. <\/p>\n
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%. <\/p>\n
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report<\/a> <\/p>\n AstraZeneca PLC (AZN) : Free Stock Analysis Report<\/a> <\/p>\n Liquidia Corporation (LQDA) : Free Stock Analysis Report<\/a> <\/p>\n Kiniksa Pharmaceuticals International, plc (KNSA) : Free Stock Analysis Report<\/a> <\/p>\n Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report<\/a> <\/p>\n This article originally published on Zacks Investment Research (zacks.com).<\/a> <\/p>\n