Seattle Genetics, Inc. (NASDAQ:SGEN) has been slammed in recent action, with both sector weakness and Q3 data to blame. Investors will be looking for potential healing tomorrow as the stock continues to digest the company’s announcement on Monday that it has submitted a supplemental Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) based on data from the phase 3 ECHELON-2 trial evaluating ADCETRIS (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with CD30-expressing peripheral T-cell lymphoma (PTCL).
According to the release, “The positive topline results of the phase 3 ECHELON-2 clinical trial were announced in October 2018 and full data will be presented at the upcoming American Society of Hematology (ASH) Annual Meeting, December 1-4, 2018 in San Diego, Calif. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of several types of PTCL. ADCETRIS is currently not approved for the frontline treatment of PTCL.”
Seattle Genetics, Inc. (NASDAQ:SGEN) promulgates itself as a biotechnology company that focuses on the development and commercialization of targeted therapies for the treatment of cancer worldwide.
It markets ADCETRIS, an antibody-drug conjugate for the treatment of relapsed Hodgkin lymphoma and relapsed systemic anaplastic large cell lymphoma. The company also develops enfortumab vedotin, which is in Phase 1 clinical trial for Nectin-4-positive solid tumors, including bladder cancer; and tisotumab vedotin that is in Phase II clinical trial for patients with cervical cancer and solid tumors.
In addition, it conducts phase 3 clinical trials of ADCETRIS which includes ECHELON-1 for patients with newly diagnosed advanced stage classical Hodgkin lymphoma; ECHELON-2 for patients with newly diagnosed CD30-expressing MTCL; and the CHECKMATE 812 for patients with relapsed or refractory or transplant-ineligible, and advanced classical Hodgkin lymphoma.
Further, the company’s earlier stage clinical pipeline includes six other ADC programs consisting of ladiratuzumab vedotin, denintuzumab mafodotin, SGN-CD19B, SGN-CD123A, SGN-CD33A, and SGN-CD352A, as well as two immuno-oncology agents, including SEA-CD40 and SGN-2FF.
It has collaborations for its ADC technology with various biotechnology and pharmaceutical companies, including AbbVie Biotechnology Ltd.; Bayer Pharma AG; Celldex Therapeutics, Inc.; Genentech, Inc.; GlaxoSmithKline LLC; Pfizer, Inc., PSMA Development Company LLC; Takeda Pharmaceutical Company Limited, Unum Therapeutics, Inc., and Genmab A/S, as well as has co-development agreement with Agensys, Inc. Seattle Genetics, Inc. was founded in 1998 and is headquartered in Bothell, Washington.
In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($463.1M against $193.7M).
Searching for Support
We started off by noting that SGEN just hit the wires with the announcement that it has submitted a supplemental Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) based on data from the phase 3 ECHELON-2 trial evaluating ADCETRIS (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with CD30-expressing peripheral T-cell lymphoma (PTCL).
The stock is up on the news. Overall, shares of SGEN have rallied about 5% over the past week. That sets up an interesting context for the action tomorrow. Over the past month, as noted above, shares of the stock have suffered from clear selling pressure, dropping by roughly -26%.
“CD30 is expressed in several subtypes of peripheral T-cell lymphoma, an aggressive type of non-Hodgkin lymphoma, and the current standard of care for frontline treatment consisting of a multi-agent chemotherapy regimen called CHOP has not changed in several decades,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics.
“Results from the ECHELON-2 trial demonstrated a statistically significant and clinically meaningful improvement in progression-free survival and importantly, overall survival, in patients with previously untreated CD30-expressing PTCL who were treated with ADCETRIS in combination with CHP chemotherapy over standard of care CHOP chemotherapy. We believe these superior results over standard of care represent a significant advance for patients with CD30-expressing PTCL and for the medical community, and we look forward to working with the FDA during the review process of this application to bring this potential new treatment regimen to patients as quickly as possible.”
Seattle Genetics, Inc. (NASDAQ:SGEN) pulled in sales of $169.4M in its last reported quarterly financials, representing top line growth of 25.2%.