Several biotech companies came out with clinical data and regulatory updates this week. While Amgen (AMGN - Free Report) provided mixed updates, companies like Array (ARRY - Free Report) , Kite and GW Pharma (GWPH - Free Report) reported positive data on key pipeline candidates.
Recap of the Week’s Most Important Stories
Amgen’s Biosimilar Approved but Kyprolis Data Disappoints: Biotech giant, Amgen, has had quite an eventful few days with the company first getting encouraging news in the form of FDA approval for its biosimilar version of AbbVie’s multi-billion dollar drug, Humira (Read more: As Humira Alternative Gets FDA Approval, Is AbbVie in Trouble?). Amgen then announced that its regulatory application for its experimental osteoporosis treatment, romosozumab, which is being developed in collaboration with UCB, has been accepted for FDA review. A response from the regulatory agency is expected by Jul 19, 2017 (Read more: Amgen/UCB's BLA for Osteoporosis Drug Accepted in the U.S.).
However, Amgen suffered a setback in its plans for cancer drug Kyprolis in the first-line setting. The company announced disappointing top-line results from a phase III study in newly diagnosed multiple myeloma patients in which the Kyprolis regimen (Kyprolis, melphalan and prednisone) failed to show superiority to a Velcade regimen (Velcade, melphalan and prednisone) in the study. Amgen’s shares were down about 1%.
Array Shoots up on Cancer Data: Array’s shares shot up 81.1% on positive top-line data from the first part of a late-stage study on an experimental combination treatment - encorafenib (a BRAF inhibitor) plus binimetinib (a MEK inhibitor) - for a certain type of skin cancer. Array and partner Pierre Fabre said that median progression free survival (PFS) in BRAF-mutant melanoma patients was 14.9 months for their experimental combination treatment compared to 7.3 months for Zelboraf (vemurafenib, BRAF inhibitor).
Results from the second part of the phase III study (COLUMBUS) are expected in mid-17 with global regulatory submissions planned for 2017 (Read more: Array Hits 52-Week High on Positive Phase III Data). Meanwhile, Array is currently looking to raise approximately $115 million (gross proceeds) through the issuance of shares.
Kite Surges on CAR-T Data: Kite’s shares were up 9.2% on positive top-line data from an interim analysis of a pivotal study on its lead pipeline candidate, KTE-C19. KTE-C19 achieved an ORR of 76% including 47% complete remissions (CR) in patients with chemorefractory diffuse large B-cell lymphoma (DLBCL).
GW Pharma Gains on Third Set of Positive Data on Epidolex: GW Pharma’s shares jumped on positive data from a late-stage study evaluating Epidiolex for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy. The company, known for its efforts to develop treatments based on its proprietary cannabinoid product platform, had presented positive data from another phase III study for LGS in Jun 2016. GW Pharma had also reported positive data on Epidiolex for the treatment of seizures associated with Dravet syndrome this year. GW Pharma is set to seek FDA approval in the first half of 2017 (Read more: GW Pharma Attains 52-Week High on Positive Epidiolex Data). Epidiolex has orphan drug status in the U.S. for the treatment of LGS, Dravet syndrome, tuberous sclerosis complex and infantile spasms.
GW Pharma is a Zacks Rank #1 (Strong Buy) stock. You can see the complete list of today’s Zacks #1 Rank stocks here.
Priority Review for Regeneron Drug: Regeneron (REGN - Free Report) and partner Sanofi said that their blockbuster hopeful, dupilumab, has been accepted for priority review by the FDA. The agency will issue a response regarding the approval status of the experimental skin disease treatment by Mar 29, 2017 (Read more: Regeneron, Sanofi Skin Disease Drug Under Priority Review).
MEDICAL-BIOMED/GENETICS Industry Price Index
MEDICAL-BIOMED/GENETICS Industry Price Index
The NASDAQ Biotechnology Index was up slightly (0.7%) over the last five trading days. Among major biotech stocks, Regeneron was up 3.7% while Alexion (ALXN - Free Report) declined 4.4%. Over the last six months, Biogen was up 23.5% while Gilead (GILD - Free Report) lost 12.3% (See the last biotech stock roundup here: Tobira Soars on Acquisition Deal, FDA Says Yes to Sarepta DMD Drug).
What's Next in the Biotech World?
Watch out for the usual pipeline and regulatory updates from biotech companies.
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