The shares of Spectrum Pharmaceuticals Inc. (SPPI) have dropped -30.77% to $2.25 in premarket trading. SPPI stock gained 3.83% to $3.25 in last trading session. SPPI stock traded 1.6 million shares, which is less than the 2.48 million shares traded daily on average during the last 50 days.
In the last five days, SPPI stock prices advanced 0.93%, but in the last one month, they lost -5.25%. The price of SPPI stock has increased 8.70% over the last three months and fallen -4.69 percent so far this year. The SPPI stock has lost ground ahead of today’s regular session because the U.S. Food and Drug Administration (FDA) has sent it a complete response letter (CRL).
The FDA has informed SPPI what?
Spectrum Pharmaceuticals, a biopharmaceutical company specializing in oncology therapies, acquires, develops, and commercializes novel treatments. SPPI possesses significant experience in managing complex biopharmaceutical business models. As part of its business model, SPPI acquires differentiated drugs, develops novel assets clinically, obtains regulatory approvals, and commercializes them in the healthcare sector. There are several novel assets in SPPI’s pipeline that address unmet needs. SPPI could be transformed by this pipeline in the near future.
Spectrum received a CRL from the FDA today regarding the company’s Biologics License Application (BLA) for ROLONTIS (eflapegrastim).
- SPPI is testing ROLONTIS for the treatment of neutropenia in cancer patients who receive myelosuppressive anticancer drugs.
- ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor (G-CSF).
- SPPI designed two identically constructed Phase 3 clinical trials for ROLONTIS, ADVANCE and RECOVER, which provided the basis for BLA.
- As part of both trials, SPPI evaluated ROLONTIS for the treatment of neutropenia associated with myelosuppressive chemotherapy in 643 patients with early-stage breast cancer.
- Manufacturing deficiencies were cited by the CRL and reinspection was recommended by FDA for SPPI’s BLA.
- SPPI said it will approach the FDA soon to gain further clarifications.
- SPPI’s disappointment over the CRL has prompted it to await a full understanding of the remediation timelines.
- SPPI, however, committed to remaining steadfast in their belief in ROLONTIS, and to completing the regulatory process diligently.
SPPI Stock to release quarterly results:
In a press release posted yesterday, Spectrum (SPPI) disclosed that it would hold a conference call to discuss its financial results for the second quarter of 2021 and to provide an update on its corporate activities on Thursday, August 12, 2021 at 4:30 pm Eastern Time. Also, a live webcast will be available from SPPI’s website at the Events and Presentations page, under Investor Relations. Following the event, SPPI will archive the presentation on its website.
