Biotech Stock Roundup: Clinical Holds Hit Inovio & Aduro, Vertex Q3 Results Miss Estimates
Zacks Investment Research | Oct 25, 2016 09:43PM ET
Vertex (NASDAQ:VRTX) reported results earlier this week – though the company missed estimates, Vertex's pipeline update regarding its next generation correctors brought some relief. Meanwhile, a couple of companies – Inovio (NASDAQ:INO) and Aduro (NASDAQ:ADRO) - were hit by clinical holds placed by the FDA on their pipeline candidates.
Recap of the Week’s Most Important Stories
Vertex to Move Triple Combination Regimens into Phase II: Vertex, which holds a strong position in the cystic fibrosis (CF) market, reported third quarter results this week. While loss (including the impact of stock-based compensation expense) was wider-than-expected, revenues fell short. However, investor focus remained on the company’s pipeline update. Vertex said that it intends to move its next generation correctors VX-440 and VX-152 in triple combination regimens with tezacaftor (VX-661) and Kalydeco into phase II studies by year end. The company is also moving additional next-generation correctors into clinical development.
Inovio Shares Fall on FDA Clinical Hold: Inovio suffered a setback with the FDA placing a clinical hold on the company’s late-stage program for VGX-3100. The company was looking to move VGX-3100 into phase III development in the fourth quarter but with the clinical hold in place, the company is now expecting that the program will be delayed until the first half of 2017 pending resolution of the FDA’s requests.
On its second quarter earnings update, Inovio had said that it is looking to evaluate VGX-3100 for the treatment of HPV-16/18-related high grade cervical dysplasia. The FDA has asked the company to provide additional data supporting the shelf-life of the newly designed and manufactured disposable parts of the Cellectra 5PSP immunotherapy delivery device. The company expects that the requested data will be available by year end (Read more: the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here .
Performance
Medical - Biomedical and Genetics Industry Price Index
ARIAD Down on Drug Pricing Tweet, Regeneron Study on Clinical Hold ).
What's Next in the Biotech World?
Watch out for earnings reports from companies like Amgen, AbbVie, Celgene (NASDAQ:CELG), Alexion, and BioMarin in the coming days. Moreover, Regeneron has a regulatory event coming up with the FDA expected to decide on the approval status of sarilumab for the treatment of patients with active, moderate-to-severe rheumatoid arthritis (RA).
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