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Spectrum price target lowered to $4 from $6 at H.C. Wainwright » 11:5811/2511/25/22
H.C. Wainwright analyst…
H.C. Wainwright analyst Edward White lowered the firm's price target on Spectrum Pharmaceuticals to $4 from $6 and keeps a Buy rating on the shares after the company received a complete response letter from the FDA regarding poziotinib for the treatment of patients with previously treated locally advanced or metastatic non-small cell lung cancer harboring HER2 exon 20 insertion mutations. The analyst is not surprised by the CRL following the negative recommendation from the FDA panel. He removed poziotinib from his valuation but believes there is a possibility for Spectrum to sell or partner poziotinib. This is a "potential opportunity as an upside call option," writes White.
Spectrum receives CRL from FDA regarding NDA for poziotinib » 06:0211/2511/25/22
Spectrum Pharmaceuticals announced that the company has received a Complete Response Letter from the U.S. FDA regarding Spectrum's New Drug Application for poziotinib for the treatment of patients with previously treated locally advanced or metastatic non-small cell lung cancer harboring HER2 exon 20 insertion mutations. The FDA issued a CRL indicating the poziotinib application cannot be approved in its present form. Based on the CRL, the Company would have to generate additional data including a randomized controlled study prior to approval. "While we are not surprised by the CRL given the ODAC recommendation in September, we are disappointed. After multiple interactions with the FDA since ODAC, and following careful consideration, we have made the strategic decision to immediately de-prioritize the poziotinib program," said Tom Riga, President and CEO of Spectrum Pharmaceuticals. "We continue to believe that poziotinib could present a meaningful treatment option for patients with this rare form of lung cancer, for whom other therapies have failed." The company will de-prioritize poziotinib program activities, effective immediately, and is in the process of reducing its R&D workforce by approximately 75%. Based on the anticipated cost savings from the restructuring, Spectrum believes it will be able to generate the working capital required to support its strategic refocusing through 2024.
|Over a week ago|
Spectrum downgraded to Neutral from Buy at B. Riley » 07:5411/1611/16/22
B. Riley analyst Mayank…
B. Riley analyst Mayank Mamtani downgraded Spectrum Pharmaceuticals to Neutral from Buy with a price target of $1, down from $1.50. The analyst sees "elevated uncertainty" on the prospects for poziotinib to receive an FDA approval at upcoming November 24 action date after an FDA panel voted 4-9 against the recommendation of granting accelerated approval. In addition, Spectrum has a challenging near-term pipeline catalyst profile given the low likelihood to continued poziotinib development in the ZENITH20 program and deprioritization of the early-stage pipeline announced in Q1 of 2021, says the analyst.
Spectrum reports Q3 EPS (12c), consensus (15c) » 16:1011/1011/10/22
Reports company had a…
Reports company had a total cash, cash equivalents, and marketable securities balance of approximately $100.3M at September 30. "The approval of ROLVEDON marks a significant accomplishment for Spectrum and our partner Hanmi Pharmaceutical. We are proud that the product became commercially available in October and are excited to be competing in an estimated $2 billion market opportunity. Importantly, we have been preparing for this milestone and have the financial runway to support ROLVEDON in the marketplace. While we are disappointed by the ODAC vote on poziotinib, we are awaiting the final response from the FDA and will continue to act in the best interest of the Company, our shareholders, and the patients who need our medicines," said Tom Riga, President and CEO of Spectrum Pharmaceuticals.
|Over a month ago|
Spectrum announces commercial availability of Rolvedon » 07:1210/2110/21/22
Spectrum announced the…
Spectrum announced the commercial availability of Rolvedon injection to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. Rolvedon received FDA approval in September.
Spectrum price target lowered to $6 from $9 at H.C. Wainwright » 11:0709/2309/23/22
H.C. Wainwright analyst…
H.C. Wainwright analyst Edward White lowered the firm's price target on Spectrum to $6 from $9 and keeps a Buy rating on the shares after lowering his view on the odds of of accelerated approval for poziotinib to 15% from 50% following a panel of FDA advisors having voted 9-4 that the current benefits of poziotinib did not outweigh its risks in patients with previously treated, locally advanced or metastatic non-small cell lung cancer harboring HER2 exon 20 insertion mutations. While noting that the FDA does not have to follow the recommendations of the ODAC, White believes the ODAC vote is negative for potential approval of poziotinib, adding that if accelerated approval is not achieved, then poziotinib could be ultimately approved with the confirmatory trial if Spectrum decides to proceed with it. His revised target is based on a sum-of-the-parts analysis based on probability-adjusted revenue forecasts for Rolvedon and poziotinib.
Spectrum price target lowered to $1.50 from $4 at B. Riley » 07:2909/2309/23/22
B. Riley analyst Mayank…
B. Riley analyst Mayank Mamtani lowered the firm's price target on Spectrum to $1.50 from $4 and keeps a Buy rating on the shares after an FDA panel voted 4-9 against the recommendation of granting accelerated approval to the company's lead program, poziotinib in previously treated, HER2 exon 20 insertion mutant non-small cell lung cancer patients. The vote is disappointing, but not unexpected, Mamtani tells investors in a research note. He sees an "uphill battle" ahead for poziotinib "with an NDA submission that may have been premature." Mamtani lowered his probability of technical and regulatory success from 50% to 20% and pushed out timelines for recognition of any meaningful poziotinib-related product sales.
Spectrum: FDA panel votes 9-4 that benefits of poziotinib did not outweigh risks » 15:3209/2209/22/22
Spectrum Pharmaceuticals announced that the U.S. FDA Oncologic Drugs Advisory Committee met to review poziotinib for the treatment of patients with previously treated locally advanced or metastatic non-small cell lung cancer harboring HER2 exon 20 insertion mutations. The committee voted 9-4 that the current benefits of poziotinib did not outweigh its risks. "We are disappointed by the outcome of the ODAC meeting, as patients with NSCLC HER2 exon 20 insertion mutations are in need of additional effective and safe therapies," stated Tom Riga, President and CEO of Spectrum Pharmaceuticals. "We plan to carefully evaluate our options for this program as we approach the November 24, 2022, PDUFA date. We would like to thank lung cancer patients and their families, as well as investigators and their staff, for their support."
FDA Oncologic Drugs Advisory Committee to hold a virtual meeting » 08:4509/2209/22/22
The Committee discusses…
The Committee discusses Spectrum Pharmaceuticals' New Drug Application (NDA) 215643 for Poziotinib tablets for the proposed indication for treatment of patients with previously treated, locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 exon 20 insertion mutations. The Committee will also hear an update on Oncopeptides A.B.'s New Drug Application (NDA) 214383 for PEPAXTO (melphalan flufenamide) for injection in the virtual meeting being held on September 22 at 9 am. Webcast Link