Biotech stocks have been in the news recently with expectations remaining high that steps taken by the Trump administration to drive down drug prices will not be as draconian as previously expected. Meanwhile, companies like Portola (PTLA - Free Report) and Regeneron (REGN - Free Report) provided regulatory updates.  

Recap of the Week’s Most Important Stories

Portola Soars on FDA Approval: Portola’s shares shot up 46.6% with the FDA granting approval to the company’s anticoagulant Bevyxxa (betrixaban). FDA approval makes Bevyxxa the first and only anticoagulant for hospital and extended duration prophylaxis (35 to 42 days) of venous thromboembolism (VTE) in acutely ill medical patients. Portola expects to launch the product between August and November this year.

EU Approval for Regeneron/Sanofi’s RA Drug: Regeneron and partner Sanofi gained EU approval for their rheumatoid arthritis (RA) drug Kevzara. Kevzara has been approved for use in combination with methotrexate (MTX) for the treatment of moderately to severely active RA in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs), such as MTX.

Kevzara, an IL-6R antibody, was approved in the U.S. in May this year. While Kevzara has blockbuster potential, the RA market is highly crowded given the presence of treatments like Humira and Xeljanz among others. However, the patient population is huge with many patients spending years on different treatments without achieving their treatment goals. With RA affecting about 1.3 million Americans and 2.9 million people in Europe, Kevzara represents a new treatment option for patients.

Regeneron is a Zacks Rank #1 (Strong Buy) stock. The company has outperformed the Zacks-categorized Medical-Biomedical/Genetics industry year-to-date with the company gaining 39.8% while the industry is up 8.9%. 

AVEO Kidney Cancer Drug a Step Closer to EU Nod: AVEO Oncology (AVEO - Free Report) is a step closer to gaining EU approval for its kidney cancer treatment, Fotivda (tivozanib), with the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), recommending its approval for the treatment for patients with advanced renal cell carcinoma (RCC). The European Commission (EC), which usually follows the CHMP’s recommendation, will make a final decision in about 67 days.

AVEO has had its share of setbacks where Fotivda is concerned. The company had received a complete response letter for the drug in the U.S. in Jun 2013 and was asked to conduct an additional study. Then in 2014, Astellas returned rights to tivozanib. AVEO subsequently entered into a licensing agreement with EUSA. Meanwhile, results from a pivotal study in the U.S. for third-line RCC are expected in the first quarter of 2018.

CHMP Positive on Gilead and AbbVie HCV Drugs: Gilead (GILD - Free Report) also got a positive opinion from the CHMP for Vosevi, an investigational, once-daily, single tablet regimen (sofosbuvir/velpatasvir/voxilaprevir - SOF/VEL/VOX) for the treatment of chronic hepatitis C virus (HCV)-infected patients. The regimen is under review in the U.S. as well where a response from the FDA is expected by Aug 8, 2017. Gilead’s HCV franchise, which was a major contributor to sales, is under considerable strain due to new competition and pricing pressure.

AbbVie (ABBV - Free Report) too got a positive CHMP opinion for Maviret (glecaprevir/pibrentasvir), an investigational, pan-genotypic treatment for HCV. Approval would provide patients with a ribavirin-free, shorter 8-week pan-genotypic once-daily option. A final response regarding approval should be out in the third quarter.

Xenon/Teva Drug Fails in Mid-Stage Study: Xenon and partner Teva suffered a pipeline setback with their experimental post-herpetic neuralgia (PHN) treatment, topical TV-45070, failing in a mid-stage proof-of-concept study. The study failed to meet the primary as well as secondary endpoints. The data will be analyzed further to determine the path forward. We note that TV-45070 had previously failed in a mid-stage study in pain due to osteoarthritis of the knee.

Alnylam’s Givosiran to Move into Phase III Later this Year: Alnylam (ALNY - Free Report) had some good news with the company reporting new positive interim results on givosiran, an investigational RNAi therapeutic targeting ALAS1 for the treatment of acute hepatic porphyrias.

Results showed that givosiran has the potential to prevent porphyria attacks in patients with acute intermittent porphyria (AIP) suffering with recurrent attacks. The company intends to move the candidate into late-stage development later this year. If developed successfully and approved, givosiran would provide patients with a potentially transformative treatment option that could prevent porphyria attacks and be administered once monthly.

Biogen’s Humira Biosimilar Gets CHMP Backing: Another company that got a positive CHMP opinion is Biogen (BIIB - Free Report) -- the company’s biosimilar version of AbbVie’s top-selling blockbuster drug, Humira, got a positive opinion. If approved, Imraldi (or SB5) would be used for a whole range of indications including rheumatoid arthritis, axial spondyloarthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis, polyarticular juvenile idiopathic arthritis, active enthesitis-related arthritis, hidradenitis suppurativa and non-infectious uveitis.

Biogen has a joint venture with Samsung BioLogics for biosimilars and Imraldi is the third anti-TNF candidate to be submitted in the EU under the joint venture. We note that earlier this year, Amgen gained EU approval for Amgevita, its biosimilar version of Humira.

Performance

Medical - Biomedical and Genetics Industry 5YR % Return

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Medical - Biomedical and Genetics Industry 5YR % Return

The Nasdaq Biotechnology Index gained 0.4% over the last five trading sessions. Among major biotech stocks, Gilead gained 6.6% while Vertex lost 2.8%. Over the last six months, Vertex was up 75.8% while Biogen was down 5.1%.