Last week, companies like Amgen AMGN and Regeneron REGN were present at the American College of Cardiology's (ACC) Annual Scientific Session with data on their PCSK9 inhibitors. Meanwhile, Nektar NKTR came out with some disappointing late-stage data on its experimental cancer treatment and ACADIA ACAD is facing yet another delay in the regulatory filing for its Parkinson's treatment.
Recap of the Week's Most Important Stories
1. Nektar came out with disappointing late-stage data on one of its most advanced pipeline candidates - NKTR-102. Top-line results from the phase III BEACON study in advanced breast cancer patients showed that NKTR-102 failed to achieve the primary endpoint of overall survival. Secondary endpoints like objective response rate (ORR) and progression-free survival (PFS) also did not achieve statistical significance in the study. Although Nektar did report improvements in certain patient subgroups, shares were down in pre-market trading .
2. Amgen presented promising long-term data on its PCSK9 inhibitor, evolocumab, at the recently held annual meeting of the ACC. Evolocumab consistently reduced LDL-C or "bad" cholesterol over a one-year period and lowered the rate of cardiovascular events when added to standard of care (Read more: Amgen Presents Encouraging PCSK9 Inhibitor Repatha Data ). Evolocumab is currently under regulatory review with the FDA expected to respond by Aug 27.
However, Regeneron and Sanofi are also looking to get their PCSK9 inhibitor, Praluent, approved and could get a head start over Amgen as the FDA action date for their candidate is Jul 24. Regeneron and Sanofi also came out with their own set of promising long-term data (18-month) on Praluent (Read more: Regeneron/Sanofi's PCSK9 Drug Praluent Data Published ).
3. There was some good news on the development front for Pharmacyclics PCYC with an Independent Data Monitoring Committee recommending that a late-stage study evaluating Imbruvica in chronic lymphocytic leukemia or small lymphocytic lymphoma patients should be unblinded. The recommendation was based on clinically meaningful and statistically significant treatment benefit observed in the Imbruvica arm (Read more: Pharmacyclics' Imbruvica Encourages in a Phase III Study ). This is good news for AbbVie ABBV as well - the company has signed an agreement to acquire Pharmacyclics for $21 billion. Imbruvica, currently approved for four indications, has multi-billion dollar potential. AbbVie is positioning Imbruvica as a "pipeline in a molecule" - the treatment is currently in more than 50 studies.
4. ACADIA saw its shares tumbling on news regarding yet another delay in the NDA filing for its experimental Parkinson's disease treatment, Nuplazid. The company also announced the exit of its CEO (Read more: ACADIA Down on Nuplazid NDA Delay and CEO Resignation ).
Over the last five trading days, Regeneron's shares were up the most (10.63%) among major biotechs. Vertex was the highest gainer (36.67%) over the last six months. Gilead GILD lost 3.27% during this period.
Overall, the NASDAQ Biotechnology Index gained 4.3% over the last five trading days (See the last biotech stock roundup here: AbbVie to Buy Pharmacyclics, FDA Approves First Biosimilar ).
Last 6 Months
What's Next in the Biotech World?
Companies like AbbVie and Amgen will be present at the annual meeting of the American Academy of Dermatology (AAD) with data on drugs like Humira and Enbrel and pipeline candidates like brodalumab.
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