It has been a pretty uneventful week for the biotech sector with updates from a few companies. While Incyte INCY got Priority Review for the cholangiocarcinoma drug, Biogen BIIB came out with positive results on the lupus drug. Meanwhile, Seattle Genetics SGEN collaborated with Merck MRK for a combination study.
Recap of the Week’s Most Important Stories:
Incyte's Pemigatinib Gets Priority Review: Incyte announced that the FDA has accepted the new drug application (NDA) for its investigational FGFR inhibitor, pemigatinib, as a second-line treatment for locally advanced or metastatic cholangiocarcinoma, also known as bile-duct cancer. With the FDA granting Priority Review to the NDA, a decision from the regulatory body is expected on May 30, 2020. The Priority Review designation will reduce the review time to eight months from the standard duration of 12 months. The NDA was based on data from the phase II FIGHT-202 study, which evaluated the safety and efficacy of the drug in the given patient population. Data from the study showed that treatment with pemigatinib monotherapy led to an overall response rate of 36% (primary endpoint) and a median duration of response of 7.5 months (secondary endpoint) with a median follow-up of 15 months.
Incyte currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Biogen Announces Positive Lupus Drug Data: Biogen Inc. (BIIB) announced positive top-line results from the phase II LILAC study, which evaluated the efficacy and safety of pipeline candidate BIIB059 in lupus patients. BIIB059 is a fully-humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2), currently being investigated for the treatment of active cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE). The study met its primary endpoints, demonstrating a statistically significant reduction of disease activity in patients with CLE and SLE, who received BIIB059 compared to placebo.
Seattle Genetics & Astellas Join Merck for Cancer Study: Seattle Genetics along with Japanese partner Astellas Pharma, Inc inked a collaboration agreement with pharma giant Merck. Per the deal, the companies will begin a registrational phase III study for evaluating the combination of Seattle Genetics and Astellas’ antibody-drug conjugate enfortumab vedotin and Merck’s PD-1/L1 inhibitor Keytruda (pembrolizumab) to address patients with previously untreated metastatic urothelial cancer. The study, which will be led by Seattle Genetics, is expected to being in the first half of 2020. It is likely to support global registrations of enfortumab vedotin.
Cara Down on Study Results: Shares of Cara Therapeutics, Inc. CARA declined after the company announced top-line results from its phase II dose-ranging study of oral Korsuva (CR845/difelikefalin) for the treatment of pruritus in patients with stage III-V (moderate-to-severe) chronic kidney disease (CKD). The study met its primary endpoint with a statistically significant reduction in mean worst itching intensity NRS scores with 1 mg tablet strength versus placebo after a 12-week treatment period. However, the study did not meet the secondary endpoints as the proportion of patients on 1 mg tablet strength achieving a 3-point or greater improvement from baseline in the weekly mean of the daily WI-NRS score at week 12 was 72% versus 58% for placebo but did not achieve statistical significance.
Axsome Gains on Positive Phase II Results: Shares of clinical-stage biopharmaceutical company, Axsome Therapeutics AXSM, gained after it announced positive results from a mid-stage study on pipeline candidate, AXS-12 (reboxetine). The candidate met the prespecified primary endpoint and significantly reduced the number of cataplexy attacks as compared to placebo in patients with narcolepsy in the CONCERT phase II study. AXS-12 also significantly reduced excessive daytime sleepiness (EDS), and improved cognitive function, sleep quality and sleep-related symptoms. AXS-12 has been granted Orphan Drug designation in the United States.
Performance
Medical – Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology index inched up 0.71% in the last four trading sessions. Among the biotech giants, Regeneron gained 6.15% in the period. Over the past six months, shares of Amgen have gained 38.91%. (See the last biotech stock roundup here (See the last biotech stock roundup here: Biotech Stock Roundup: CBAY Falls, CCXI Gains, Amgen Acquires Otezla & More)
What's Next in Biotech?
Stay tuned for more pipeline updates.
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