Biotech Stock Roundup: Clinical Holds Hit Inovio & Aduro, Vertex Q3 Results Miss Estimates

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: Inovio Stock Down on FDA Hold on VGX-3100 Phase III Study).

Aduro Also Hit by Partial Clinical Hold: Inovio was the not the only company to receive a notice regarding a clinical hold from the FDA this week. Aduro, which has three distinct immunotherapy technologies, said that studies evaluating its LADD- (listeria-based immunotherapy construct) based agents have been placed on partial clinical hold with new patient enrollment being halted.

The hold was placed following the detection of a case of listeria in a metastatic pancreatic cancer patient. Aduro is working with the FDA to lift the partial hold so that new patient enrollment in the LADD studies can resume. The study protocols will be revised in accordance with the agency’s requirements (Read more: Aduro Stock Down on Partial Clinical Hold on LADD Studies).

Alkermes Soars on Depression Data: Alkermes’ (NASDAQ:ALKS) shares shot up on positive topline data from the FORWARD-5 pivotal study on experimental depression drug, ALKS 5461. ALKS 5461 is being evaluated for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressant therapies. With the study generating positive results, Alkermes intends to meet with the FDA’s Division of Psychiatric Products to determine the filing strategy for the treatment which has fast track status (Read more: Alkermes Depression Candidate Positive in Phase III Study).

We note that FORWARD-5 is the third phase III efficacy study to read out under the FORWARD program with results from the other two studies being announced earlier this year. Both studies failed to meet the primary endpoint.

Amgen Announces Xgeva Results: Amgen’s (NASDAQ:AMGN) Xgeva met the primary endpoint in a late-stage non inferiority study compared to Zometa (zoledronic acid) in delaying the time to first on-study skeletal-related event (SRE) in patients with multiple myeloma. Secondary endpoints of superiority in delaying time to first SRE and delaying time to first-and-subsequent SRE were not met. Amgen intends to submit these results to regulatory authorities (Read more: Amgen's Xgeva Meets Endpoint in Phase III Study). Amgen is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Performance

Medical - Biomedical and Genetics Industry Price Index

The NASDAQ Biotechnology Index declined 1.6% over the last five trading days. Among major biotech stocks, Vertex declined 5.1% while Gilead (NASDAQ:GILD) was up 1.4%. Over the last six months, Biogen (NASDAQ:BIIB) was up 0.4% while Gilead lost 27.3% (See the last biotech stock roundup here: 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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