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Inovio Stock Down on FDA Hold on VGX-3100 Phase III Study
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Inovio Pharmaceuticals, Inc’s (INO - Free Report) shares plunged 16.4% after the company announced that the FDA has placed a clinical hold on the proposed phase III program on its lead pipeline candidate, VGX-3100.
We note that a clinical hold is a notification issued by the FDA to a sponsor of the study informing a delay of the proposed study or suspension of an ongoing study. Also note that Inovio has neither initiated the phase III program on the candidate nor has it begun enrolling or dosing patients. The hold will, however not affect any other ongoing study that is being conducted by the company.
Inovio expects to receive a formal letter from the FDA with complete information within 30 days. In its initial communication, the regulatory agency had requested the company for additional data to support the shelf-life of the newly designed and manufactured disposable parts of the Cellectra 5PSP immunotherapy delivery device.
Inovio is currently working with the FDA to address the concerns. The company expects the requested data to be out by the end of 2016. It further anticipates the begining of the phase III program to be delayed to the first half of 2017, subject to the resolution of the issues raised by FDA.
We remind investors that following a successful end-of-phase-II meeting with both the FDA and the European Medicines Agency, the company was looking to begin a pivotal phase III study on VGX-3100 for the treatment of HPV-16/18-related in the fourth quarter of 2016.
With no approved product in its portfolio and VGX-3100 being the company’s lead pipeline candidate, the latest development is a setback for the company. Moreover, Inovio’s pipeline is mostly early-to-mid-stage in nature.
Inovio carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Infinity Pharmaceuticals, Inc. , BioMarin Pharmaceutical Inc. (BMRN - Free Report) and Exelixis, Inc. (EXEL - Free Report) . All the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Exelixis’ loss estimates narrowed from 71 cents to 63 cents for 2016 and from 19 cents to earnings of 3 cents for 2017 over the last 60 days. The company has posted a positive surprise twice in the four trailing quarters with an average beat of 9.1%. Its share price has skyrocketed over 100% year to date.
BioMarin’s loss estimates narrowed from 28 cents to 25 cents for 2016 and from $1.16 to $1.11 for 2017 over the last 60 days.
Infinity’s loss estimates narrowed from $3.84 to $3.79 for 2016 and remained stable for 2017 over the last 60 days. The company has posted a positive surprise in all the four trailing quarters with an average beat of 67.62%.
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Inovio Stock Down on FDA Hold on VGX-3100 Phase III Study
Inovio Pharmaceuticals, Inc’s (INO - Free Report) shares plunged 16.4% after the company announced that the FDA has placed a clinical hold on the proposed phase III program on its lead pipeline candidate, VGX-3100.
We note that a clinical hold is a notification issued by the FDA to a sponsor of the study informing a delay of the proposed study or suspension of an ongoing study. Also note that Inovio has neither initiated the phase III program on the candidate nor has it begun enrolling or dosing patients. The hold will, however not affect any other ongoing study that is being conducted by the company.
Inovio expects to receive a formal letter from the FDA with complete information within 30 days. In its initial communication, the regulatory agency had requested the company for additional data to support the shelf-life of the newly designed and manufactured disposable parts of the Cellectra 5PSP immunotherapy delivery device.
Inovio is currently working with the FDA to address the concerns. The company expects the requested data to be out by the end of 2016. It further anticipates the begining of the phase III program to be delayed to the first half of 2017, subject to the resolution of the issues raised by FDA.
We remind investors that following a successful end-of-phase-II meeting with both the FDA and the European Medicines Agency, the company was looking to begin a pivotal phase III study on VGX-3100 for the treatment of HPV-16/18-related in the fourth quarter of 2016.
With no approved product in its portfolio and VGX-3100 being the company’s lead pipeline candidate, the latest development is a setback for the company. Moreover, Inovio’s pipeline is mostly early-to-mid-stage in nature.
INOVIO PHARMAC Price
INOVIO PHARMAC Price | INOVIO PHARMAC Quote
Zacks Rank & Stocks to Consider
Inovio carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Infinity Pharmaceuticals, Inc. , BioMarin Pharmaceutical Inc. (BMRN - Free Report) and Exelixis, Inc. (EXEL - Free Report) . All the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Exelixis’ loss estimates narrowed from 71 cents to 63 cents for 2016 and from 19 cents to earnings of 3 cents for 2017 over the last 60 days. The company has posted a positive surprise twice in the four trailing quarters with an average beat of 9.1%. Its share price has skyrocketed over 100% year to date.
BioMarin’s loss estimates narrowed from 28 cents to 25 cents for 2016 and from $1.16 to $1.11 for 2017 over the last 60 days.
Infinity’s loss estimates narrowed from $3.84 to $3.79 for 2016 and remained stable for 2017 over the last 60 days. The company has posted a positive surprise in all the four trailing quarters with an average beat of 67.62%.
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>