An FDA advisory panel voted in favor of approving Regeneron (REGN – Analyst Report) and partner Sanofi’s PCSK9 inhibitor, Praluent. A few deals were also signed over the last few days by companies like Vertex (VRTX – Analyst Report), Celgene (CELG – Analyst Report) and Seattle Genetics (SGEN – Analyst Report).
Recap of the Week’s Most Important Stories
1. Regeneron and Sanofi are a step closer to gaining FDA approval for their PSCK9 inhibitor with an FDA advisory panel voting in favor (13:3) of approving Praluent. A final decision from the FDA should be out by Jul 24. Approval would make Praluent the first fully human monoclonal antibody targeting PCSK9 in the U.S. Praluent is also under review in the EU.
The cholesterol market represents huge commercial opportunities, and Praluent has blockbuster potential. Meanwhile, Amgen (AMGN – Analyst Report) is also looking to get its PCSK9 inhibitor, Repatha, approved. The FDA advisory panel will be meeting today to discuss Amgen’s application (Read more: Amgen’s Repatha Briefing Document Gives Mixed Review).
2. SAGE Therapeutics’ (SAGE – Snapshot Report) shares shot up 15.4% with the company announcing positive top-line data from an exploratory study on SAGE-547 in women with postpartum depression (PPD). The patients achieved a statistically significant improvement and SAGE-547 was found to be well-tolerated. Based on the encouraging data, the company intends to move the candidate from the initial open-label exploratory phase into a placebo-controlled study.
3. Vertex, which is focused on the development of cystic fibrosis (CF) treatments, is working on strengthening its pipeline and has signed up with Parion Sciences for the development of epithelial sodium channel (ENaC) inhibitors for the treatment of CF and other pulmonary diseases. Vertex made an upfront payment of $80 million and could end up paying up to $1.09 billion on the achievement of certain milestones plus tiered royalties. In return, Vertex acquires global development and commercial rights to Parion’s investigational ENaC inhibitors, including P-1037 and P-1055, for CF and other pulmonary diseases.
4. Celgene has signed up with Lycera for a deal focused on Lycera’s proprietary pipeline of cancer and immune-mediated diseases. Celgene has an exclusive option to license Lycera’s portfolio of ex vivo RORgamma agonist compounds. Lycera will get an upfront payment of $82.5 million and could get an additional $22.5 million related to the ex vivo licensing option rights. Celgene will also gain the exclusive right to acquire Lycera upon conclusion of the option period or on Lycera’s achievement of pre-specified clinical milestones.
5. Seattle Genetics is collaborating with Unum Therapeutics for the development and commercialization of novel antibody-coupled T-cell receptor (ACTR) therapies for cancer. Seattle Genetics will make an upfront payment of $25 million and will invest $5 million in Unum’s next round of private financing. Unum could end up receiving up to $615 million under the deal (Read more: Seattle Genetics-Unum Therapeutics Tie Up for Cancer Drugs).
Over the last five trading days, Regeneron recorded the highest gain (3.38%) among major biotechs. Alexion (ALXN – Analyst Report) saw its shares declining 2.97% during this period. Regeneron was the highest gainer (21.59%) over the last six months as well. Alexion lost 20.39% during this period.
The NASDAQ Biotechnology Index declined slightly (0.35%) over the last five trading days (See the last biotech stock roundup here: ImmunoGen Soars on ASCO Data, Amgen Collaborates with Roche).
Last 6 Months
What’s Next in the Biotech World?
Amgen’s Repatha will be coming up before the FDA’s endocrinologic and metabolic drugs advisory panel today.
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