This week, a few biotech companies came out with pipeline and regulatory updates. Horizon Therapeutics HZNP got a significant boost with the FDA approval of its thyroid eye disease (TED) drug. The FDA also accepted Clovis Oncology, Inc.’s CLVS application for Rubraca (rucaparib) as a monotherapy treatment of adult patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer.
Recap of the Week’s Most Important Stories:
FDA Approves Horizon’s Thyroid Eye Disease Drug: Horizon Therapeutics plc announced that the FDA approved Tepezza (teprotumumab-trbw) for the treatment of TED. Tepezza is a fully human monoclonal antibody (mAb) and a targeted inhibitor of the insulin-like growth factor-1 receptor (IGF-1R) that is administered to patients once every three weeks for a total of eight infusions. The FDA approval of the drug comes ahead of the Prescription Drug User Fee Act (PDUFA) goal date of Mar 8, 2020. The approval was based on statistically significant, positive results from the phase II study as well as the phase III confirmatory clinical study, OPTIC.
Clovis’ sNDA for Rubraca Gets Priority Review Status: Clovis Oncology, Inc. announced that the FDA accepted its supplemental New Drug Application (sNDA) for Rubraca (rucaparib). The agency granted Priority Review status to the application, with a PDUFA date of May 15, 2020. Clovis submitted the sNDA for Rubraca as a monotherapy treatment of adult patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer in November 2019.
A Priority Review designation is granted to proposed medicines that the FDA has found to have the potential to offer a significant improvement in the safety or effectiveness of the treatment, prevention or diagnosis of a serious condition. The designation shortens the review period from the standard 10 months to six months.
Clovis currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Kala Pharmaceuticals Completes Enrollment in Phase III: Kala Pharmaceuticals, Inc. KALA announced the completion of enrollment in its STRIDE 3 (Short Term Relief In Dry Eye) phase III study for KPI-121 0.25%, its product candidate for the short-term treatment of dry eye disease. Upon approval, the company plans to commercialize KPI-121 0.25% under the brand name Eysuvis. It also plans to report top-line results from the study during the first quarter of 2020. Additionally, the company targets to resubmit its New Drug Application (NDA) to the FDA in the first half of 2020.
BioNTech to Acquire Neon Therapeutics: BioNTech BNTX announced that it will acquire biotechnology company, Neon Therapeutics, Inc. , in an all-stock transaction, valued at approximately $67.0 million. Neon is developing novel neoantigen-based T cell therapies. Upon closing, it will operate as a subsidiary of BioNTech, a global clinical-stage biotechnology company focused on patient-specific immunotherapies for the treatment of cancer and other serious diseases. The transaction is expected to close in the second quarter of 2020 and will strengthen BioNTech’s immunotherapy pipeline.
The Nasdaq Biotechnology index lost 0.48% in the last four trading sessions. Among the biotech giants, Regeneron lost 6.17% in the period. Over the past six months, shares of Amgen have gained 36.95%. (See the last biotech stock roundup here: Biotech Stock Roundup: Updates From INCY & EXEL, APLS & LIFE Surge on Positive Data)
What's Next in Biotech?
Stay tuned for more pipeline updates.
Just Released: Zacks’ 7 Best Stocks for Today
Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.6% per year.
These 7 were selected because of their superior potential for immediate breakout.
See these time-sensitive tickers now >>