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Biotech Stock Roundup: Ophthotech Slumps on Fovista Results, Achaogen Skyrockets on Data

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This week, several companies presented data on pipeline candidates as well as approved products. While companies like Achaogen soared on positive data, others like Horizon and Ophthotech were hit by study results. Meanwhile, Alexion’s shares were impacted by the sudden departure of top executives.

Recap of the Week’s Most Important Stories

Achaogen Soars on Positive Data on Lead Compound: Achaogen’s shares shot up 148.2% on positive late-stage data on lead pipeline candidate, plazomicin. The candidate achieved the primary endpoint of non-inferiority (for the FDA) and superiority (for the European Medicines Agency - EMA) compared to meropenem in patients with complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). Results from another phase III study showed a lower rate of mortality or serious disease-related complications for plazomicin compared with colistin therapy in patients with serious infections due to carbapenem-resistant Enterobacteriaceae (CRE).

Achaogen intends to seek FDA approval for the treatment in the second half of 2017 and EMA approval in 2018.

Horizon Hit by Actimmune Study Failure: Horizon’s efforts to expand the label of Actimmune met a roadblock with the company saying that the product failed to meet the primary as well as secondary endpoints in a late-stage study in patients with Friedreich's ataxia. Based on these results, Horizon has decided to drop the development program for Friedreich's ataxia, a debilitating, life-shortening and degenerative neuro-muscular disorder that affects about 4,000 to 6,000 people in the U.S. Horizon’s shares were down 22.5% on the study results (Read more: Horizon Stock Sinks, Friedreich's Ataxia Study Fails).

Year-to-date (YTD), Horizon has lagged the Zacks categorized Medical- Biomedical/Genetics industry with the company declining 32.9% compared to the industry decline of 26.3%.

Alexion Down on Abrupt Exit of Two Top Executives: Alexion’s shares were down on the departure of two top executives in the midst of an ongoing probe into improper sales practices. The company said that the Board has named David Brennan as Interim Chief Executive Officer (CEO), who will be succeeding David Hallal who resigned for personal reasons, effective immediately. Meanwhile, David J. Anderson has joined the company as Chief Financial Officer (CFO) succeeding Vikas Sinha, who left Alexion to pursue other opportunities. Meanwhile, the company said that the ongoing Audit and Finance Committee investigation is almost complete with the company expecting to file the Form 10Q for the September quarter in Jan 2017 or earlier (Read more: Alexion Slips to 52-Week Low as CEO, CFO Quit amid Probe).

Ophthotech Plunges on Fovista Data, Regeneron Gains: Ophthotech’s shares got punished for disappointing late-stage data on the company’s anti-PDGF therapy, Fovista. Results showed that adding Fovista to a monthly Lucentis regimen did not lead to a benefit compared to Lucentis alone in patients with wet age-related macular degeneration (wet AMD). While Ophthotech’s shares plunged 86.4% on the results, Regeneron’s (REGN - Free Report) shares gained 3.8% reflecting an improvement in the competitive scenario for Regeneron’s eye drug, Eylea (Read more: Ophthotech Hits 52-Week Low on Unfavorable Fovista Data).

Regeneron is a Zacks Rank #2 (Buy) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Actelion-J&J Talks End, Discussions Ongoing with Other Party: Healthcare giant, Johnson & Johnson, is no longer in talks with Actelion regarding a possible strategic deal. Actelion, however, said that it is engaged in discussions with another party. Even though Actelion did not name the interested suitor, the market buzz is that French pharma giant, Sanofi, is most likely the other party.    

We note that Actelion has often been considered an attractive takeover target mainly due to its rare disease portfolio. In addition to holding a strong position in the pulmonary arterial hypertension (PAH) market, Actelion’s portfolio also has treatments approved in certain countries for specialist diseases like type I Gaucher disease, Niemann-Pick type C disease, digital ulcers in patients suffering from systemic sclerosis, and mycosis fungoides type cutaneous T-cell lymphoma.

Gilead Seeks FDA Nod for SOF/VEL/VOX Regimen: Gilead (GILD - Free Report) continues to work on expanding its hepatitis C virus (HCV) franchise – the company has filed for FDA approval of its investigational, once-daily single tablet regimen containing sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of direct-acting antiviral (DAA)-experienced chronic HCV patients. Approval would make this the first once-daily single tablet regimen to be indicated as a salvage treatment for HCV patients with genotype 1-6 who have failed prior treatment with DAA regimens including NS5A inhibitors.

Performance

Medical - Biomedical and Genetics Industry Price Index

The NASDAQ Biotechnology Index declined almost 2% over the last five trading days. Among major biotech stocks, Regeneron gained 3.5% with the stock reacting favorably to negative data on a potential competitor for Eylea. Alexion shares were down 11.4% reflecting concerns regarding the ongoing probe and the change in management. Alexion has been underperforming the Zacks categorized Medical-Biomedical/Genetics industry YTD with the stock declining 39.7%. Over the last six months, Biogen (BIIB - Free Report) was up 13.9% while Alexion lost 17.5% (See the last biotech stock roundup here: Actelion Remains in M&A Spotlight, ASH Data in Focus).

What's Next in the Biotech World?

Watch out for the usual pipeline and regulatory updates from biotech companies.

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