Celgene Corporation (NASDAQ:CELG) and the Lymphoma Study Association (LYSA) gave investors reason to raise a red flag today, as shares start to slip almost 5% in after-hours trading. The Lymphoma Academic Research Organisation (LYSARC) unleashed Phase III RELEVANCE trial results from the drug maker’s randomized, open-label, international study evaluating Celgene’s Revlimid in combination with Rituximab (R²), designed to treat previously untreated patients suffering from follicular lymphoma.
Investor confidence got shaken considering the R2 treatment arm failed to realize superiority in the co-primary endpoints of complete response as well as unconfirmed complete response (CR/CRu) at 120 weeks as well as progression-free survival (PFS) throughout the pre-planned analysis (the final analysis of CR/CRu coupled with the interim analysis of PFS).
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REVLIMID plus rituximab (R2) followed by R2 maintenance failed to impress the Street when compared against the standard of care with rituximab plus chemotherapy (R-CHOP, R-bendamustine or R-CVP) followed by rituximab maintenance in patients with previously untreated follicular lymphoma. Neither arm was superior for either of the co-primary endpoints. The safety findings were consistent with the known profiles of the regimens investigated. Additional analyses are ongoing and planned.
“This is the first Phase III trial to evaluate a chemotherapy-free regimen to the established standard of care in patients with previously untreated follicular lymphoma and represents a landmark study in this disease setting,” said Prof. Gilles Salles, President of the Lymphoma Study Association (LYSA). “We look forward to further analyzing and presenting these important data at a future medical congress.”
“We thank the patients, their families, the Co-Primary Investigators, Franck Morchhauser MD1, PhD, and Nathan Fowler, MD2 and the investigators for participating in the RELEVANCE trial,” said Jay Backstrom, M.D., Chief Medical Officer and Head of Global Regulatory Affairs for Celgene. “We remain committed to advancing our broad pipeline of novel therapies to establish new standards of care for patients with lymphoma.”
CELG has a 1-year high of $147.17 and a 1-year low of $94.55. The stock’s 50-day moving average is $103.72 and its 200-day moving average is $125.42.
On the ratings front, Celgene has been the subject of a number of recent research reports. In a report issued on December 14, Oppenheimer analyst Leah R. Cann assigned a Buy rating on CELG, with a price target of $166, which represents a potential upside of 54% from where the stock is currently trading. Separately, on December 13, Leerink Swann’s Geoff Porges reiterated a Buy rating on the stock and has a price target of $120.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Leah R. Cann and Geoff Porges have a yearly average loss of -1.0% and a return of 7.2% respectively. Cann has a success rate of 41% and is ranked #3756 out of 4727 analysts, while Porges has a success rate of 46% and is ranked #1280.
Overall, one research analyst has rated the stock with a Sell rating, 9 research analysts have assigned a Hold rating and 13 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $127.26 which is 18.0% above where the stock opened today.
Celgene Corp. is an integrated global biopharmaceutical company, which engages in the discovery, development and commercialization of therapies for the treatment of cancer and inflammatory diseases. Its targeting areas include intracellular signaling pathways, protein homeostasis and epigenetics in cancer and immune cells, immunomodulation in cancer and autoimmune diseases and therapeutic application of cell therapies. The company’s products include Revlimid, Vidaza, Thalomid, Pomalyst/Imnovid, Abraxane, and Istodax.