Cytokinetics, Incorporated (CYTK) Investors Who Lost Money – Contact Law Offices of Howard G. Smith About Securities Fraud Investigation
BENSALEM, Pa.--(BUSINESS WIRE)--Law Offices of Howard G. Smith announces an investigation on behalf of Cytokinetics, Incorporated ('Cytokinetics' or the 'Company') (NASDAQ: CYTK) investors concerning the Company's possible violations of federal securities laws.
IF YOU ARE AN INVESTOR WHO SUFFERED A LOSS IN CYTOKINETICS, INCORPORATED (CYTK), CONTACT THE LAW OFFICES OF HOWARD G. SMITH ABOUT POTENTIALLY PURSUING CLAIMS TO RECOVER YOUR LOSS.
Contact the Law Offices of Howard G. Smith to discuss your legal rights by email at howardsmith@howardsmithlaw.com, by telephone at (215) 638-4847 or visit our website at www.howardsmithlaw.com.
What Happened?
On May 1, 2025, Cytokinetics disclosed that the FDA has extended the review period for its cardiac myosin inhibitor drug, aficamten, by three months, citing additional time required to review newly submitted Risk Evaluation and Mitigation Strategy (REMS). The Company further revealed that, 'following pre-NDA discussions with FDA in which safety and risk mitigation were discussed, Cytokinetics submitted the NDA for aficamten in oHCM without an accompanying REMS.'
On this news, Cytokinetics's stock price fell $5.57, or 12.9%, to close at $37.35 per share on May 2, 2025, thereby injuring investors.
Contact Us To Participate or Learn More:
If you purchased Cytokinetics securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact us:
Law Offices of Howard G. Smith,
3070 Bristol Pike, Suite 112,
Bensalem, Pennsylvania 19020,
Telephone: (215) 638-4847
Email: howardsmith@howardsmithlaw.com,
Visit our website at: www.howardsmithlaw.com.
This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Associated Press
7 minutes ago
- Associated Press
Arvinas Announces Submission of New Drug Application to U.S. FDA for Vepdegestrant for Patients with ESR1-Mutated ER+/HER2- Advanced or Metastatic Breast Cancer
– This submission is supported by the pivotal Phase 3 VERITAC-2 clinical trial, results of which were recently presented at the 2025 American Society for Clinical Oncology Annual Meeting and published in The New England Journal of Medicine – – VERITAC-2 data support vepdegestrant as a potential treatment option in patients with ESR1m ER+/HER2- advanced or metastatic breast cancer – NEW HAVEN, Conn., June 06, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) with its partner Pfizer Inc. (NYSE: PFE), for vepdegestrant for the treatment of patients with ER-positive (ER+)/human epidermal growth factor receptor 2 (HER2)-negative (ER+/HER2-) ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. This submission is based on results from VERITAC-2 (NCT05654623), a global, randomized Phase 3 trial evaluating vepdegestrant versus fulvestrant. 'This milestone comes after an exciting presentation at the American Society of Clinical Oncology's annual meeting,' said John Houston, Ph.D., Chairperson, Chief Executive Officer and President at Arvinas. 'We look forward to the NDA review and to the first ever FDA-approved PROTAC ER degrader potentially being available to patients who could benefit from a much needed, new treatment option.' Vepdegestrant is being jointly developed by Arvinas and Pfizer for the treatment of patients with advanced or metastatic ER+/HER2- breast cancer and was granted fast track designation as a monotherapy by the FDA. Results from the VERITAC-2 study were recently presented in a late-breaking oral presentation at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting and were selected for the ASCO press briefing and for Best of ASCO. Detailed results were also simultaneously published in the New England Journal of Medicine. About the VERITAC-2 Clinical Trial The Phase 3 VERITAC-2 clinical trial ( NCT05654623 ) is a global, randomized trial evaluating the efficacy and safety of vepdegestrant (ARV-471) as a monotherapy compared to fulvestrant in patients with ER+/HER2- advanced or metastatic breast cancer. The trial enrolled 624 patients at sites in 25 countries who had previously received treatment with a CDK4/6 inhibitor plus endocrine therapy. Patients were randomized 1:1 to receive either vepdegestrant once daily, orally on a 28-day continuous dosing schedule, or fulvestrant, administered intramuscularly on Days 1 and 15 of Cycle 1 and then on Day 1 of each 28-day cycle starting from Day 1 of Cycle 2. In the trial, 43% of patients (n=270) had ESR1 mutations detected. The primary endpoint was progression-free survival (PFS) in the ESR1-mutation and intent-to-treat populations as determined by blinded independent central review. Overall survival is the key secondary endpoint. About Vepdegestrant Vepdegestrant is an investigational, orally bioavailable PROTAC (PROteolysis TArgeting Chimera) protein degrader designed to specifically target and degrade the estrogen receptor (ER). Vepdegestrant is being developed as a potential monotherapy for ER+/HER2- advanced or metastatic breast cancer with estrogen receptor 1 (ESR1) mutations in the second line-plus setting. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will share worldwide development costs, commercialization expenses, and profits. The U.S. Food and Drug Administration (FDA) has granted vepdegestrant Fast Track designation as a monotherapy in the treatment of adults with ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy. About Arvinas Arvinas (Nasdaq: ARVN) is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. Through its PROTAC (PROteolysis TArgeting Chimera) protein degrader platform, the Company is pioneering the development of protein degradation therapies designed to harness the body's natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. Arvinas is currently progressing multiple investigational drugs through clinical development programs, including vepdegestrant, targeting the estrogen receptor for patients with locally advanced or metastatic ER+/HER2- breast cancer; ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma; and ARV-102, targeting LRRK2 for neurodegenerative disorders. Arvinas is headquartered in New Haven, Connecticut. For more information about Arvinas, visit and connect on LinkedIn and X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding: the NDA review and to the first ever FDA-approved PROTAC ER degrader potentially being available to patients who could benefit from a much needed, new treatment option; and vepdegestrant's development as a potential monotherapy for ER+/HER2- advanced or metastatic breast cancer with ESR1 mutations in the second line-plus setting. All statements, other than statements of historical fact, contained in this press release, including statements regarding Arvinas' strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words 'anticipate,' 'believe,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'target,' 'goal,' 'potential,' 'will,' 'would,' 'could,' 'should,' 'look forward,' 'continue,' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Arvinas may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on such forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements Arvinas makes as a result of various risks and uncertainties, including but not limited to: whether Arvinas and Pfizer will successfully perform their respective obligations under the collaboration between Arvinas and Pfizer; whether Arvinas and Pfizer will be able to successfully conduct and complete clinical development for vepdegestrant as a monotherapy; whether the VERITAC-2 clinical trial will meet the secondary endpoint for overall survival; risks related to our expectations regarding the potential clinical benefit of vepdegestrant to patients; uncertainties relating to regulatory applications and related filing and approval timelines, including the New Drug Application seeking FDA approval of vepdegestrant and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; whether FDA or other regulatory authorities will require additional information or further studies, or may fail or refuse to approve or may delay approval of vepdegestrant; whether Arvinas and Pfizer, as appropriate, will be able to obtain marketing approval for and commercialize vepdegestrant and other product candidates on current timelines or at all; Arvinas' ability to protect its intellectual property portfolio; Arvinas' reliance on third parties; whether Arvinas will be able to raise capital when needed; whether Arvinas' cash and cash equivalent resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; and other important factors discussed in the 'Risk Factors' section of Arvinas' Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent other reports on file with the U.S. Securities and Exchange Commission. The forward-looking statements contained in this press release reflect Arvinas' current views with respect to future events, and Arvinas assumes no obligation to update any forward-looking statements, except as required by applicable law. These forward-looking statements should not be relied upon as representing Arvinas' views as of any date subsequent to the date of this release. Contacts Investors: Jeff Boyle +1 (347) 247-5089 [email protected] Media: Kirsten Owens +1 (203) 584-0307 [email protected]
Yahoo
an hour ago
- Yahoo
Recreational salmon fishing resumes in California this weekend for limited time
After a two-year shutdown, fishing boats will fan out along the California coast angling for Chinook salmon this weekend as recreational fishing resumes under strict limits. Coastal salmon fishing was banned in 2023 and 2024 in an effort to help the population recover after years of declines. While commercial fishing remains canceled for a third consecutive year, fishery regulators recently decided to allow a limited season for recreational fishing on certain dates and with strict quotas. 'We're all very excited,' said William 'Captain Smitty' Smith, who was readying his charter fishing boat Riptide at Pillar Point Harbor in Half Moon Bay. 'There's a lot of buzz all around the harbor with everybody getting ready for it.' Smith and his two deckhands have been buying bait and preparing hooks, nets and other gear to take 18 passengers fishing Saturday and Sunday. He said within hours of the April announcement that limited fishing would be allowed, 'my regulars all called and basically filled the boat.' Smith is 71 and has been in the charter boat business for 50 years. The last time he was able to take passengers fishing for salmon was in 2022. As his business has struggled during the last two years, he has turned to other types of outings to make ends meet, including fishing for rockfish, leading whale-watching trips and holding burials at sea where mourners scatter the ashes of loved ones. He said anglers are 'chomping at the bit to go.' Each person will be allowed to catch up to two fish per day. Read more: U.S. panel calls for suspending commercial salmon fishing in California for third year The California Department of Fish and Wildlife is limiting ocean fishing under quotas in two windows in the summer and fall. The first is set to open Saturday-Sunday and allow for up to 7,000 salmon to be caught statewide. If that number of fish isn't reached during the opening weekend, salmon fishing will be allowed until the limit is reached in subsequent stretches, which may include July 5-6, July 31-Aug. 3, and Aug. 25-31. In addition to Half Moon Bay, fishing boats are expected to head out this weekend from other harbors in Central and Northern California such as Morro Bay, Santa Cruz, San Francisco, Bodega Bay and Fort Bragg. 'Given the 2-year ocean salmon fishery closure and the short duration of this fishing period, angler participation is expected to be high,' the department said in its announcement. 'Anglers should prepare for crowds and long wait times at public launch ramps and marinas and consider travel, parking, and launch ramp conditions when finalizing plans.' The agency said fishing will reopen in the fall in some regions — including from Point Reyes in Marin County south to near Half Moon Bay, and from there to Point Sur in Big Sur — under a separate harvest limit guideline of 7,500 Chinook salmon. The fishing industry depends on fall-run Chinook, which migrate upstream to spawn from July through December. For decades, government-run hatcheries in the Central Valley have reared and released millions of salmon each year to help boost their numbers. Read more: Salmon populations are struggling, bringing economic woes for California's fishing fleet Other salmon runs have suffered more severe declines. Spring-run Chinook are listed as threatened under the Endangered Species Act, and winter-run Chinook are endangered. Biologists say salmon populations have declined because of a combination of factors including dams, which have blocked off spawning areas, the loss of vital floodplain habitats, and global warming, which is intensifying droughts and causing warmer temperatures in rivers. During the severe 2020-22 drought, the water flowing from dams sometimes got so warm that it was lethal for salmon eggs. Although that drought was a major factor behind the declines in the salmon population, those who work in fishing also blame California's water managers and policies, saying too much water has been pumped to farms and cities, depriving rivers of sufficient cold water at the times salmon need it. Smith said he hopes to see 'responsible water management' where state officials prioritize river flows for fish, as well as efforts to restore floodplains and improve hatchery operations. Read more: 'A beautiful thing': Klamath River salmon are spotted far upstream in Oregon after dam removal Because salmon typically feed in the ocean for about three years and then return to their natal streams, the decline in the numbers of surviving juvenile fish during the drought left a reduced population of adult fish. Scientists expect the population should improve somewhat next year because of the boost they received during 2023's historic wet winter, though they also caution that the situation facing California's salmon remains dire. Smith said one change that has nurtured his hopes came last year, when the last of four dams were dismantled on the Klamath River in Northern California, enabling salmon to reach upstream spawning areas that had been sealed off for more than a century. 'I'm very hopeful for our future,' he said, adding that he is thinking about his 13-year-old grandson and the next generation. 'I want there to be a fishery for my grandson. I want him to be able to experience the thrill of catching a fish in the ocean.' This story originally appeared in Los Angeles Times.
Los Angeles Times
an hour ago
- Los Angeles Times
Recreational salmon fishing resumes in California this weekend for limited time
After a two-year shutdown, fishing boats will fan out along the California coast angling for Chinook salmon this weekend as recreational fishing resumes under strict limits. Coastal salmon fishing was banned in 2023 and 2024 in an effort to help the population recover after years of declines. While commercial fishing remains canceled for a third consecutive year, fishery regulators recently decided to allow a limited season for recreational fishing on certain dates and with strict quotas. 'We're all very excited,' said William 'Captain Smitty' Smith, who was readying his charter fishing boat Riptide at Pillar Point Harbor in Half Moon Bay. 'There's a lot of buzz all around the harbor with everybody getting ready for it.' Smith and his two deckhands have been buying bait and preparing hooks, nets and other gear to take 18 passengers fishing Saturday and Sunday. He said within hours of the April announcement that limited fishing would be allowed, 'my regulars all called and basically filled the boat.' Smith is 71 and has been in the charter boat business for 50 years. The last time he was able to take passengers fishing for salmon was in 2022. As his business has struggled during the last two years, he has turned to other types of outings to make ends meet, including fishing for rockfish, leading whale-watching trips and holding burials at sea where mourners scatter the ashes of loved ones. He said anglers are 'chomping at the bit to go.' Each person will be allowed to catch up to two fish per day. The California Department of Fish and Wildlife is limiting ocean fishing under quotas in two windows in the summer and fall. The first is set to open Saturday-Sunday and allow for up to 7,000 salmon to be caught statewide. If that number of fish isn't reached during the opening weekend, salmon fishing will be allowed until the limit is reached in subsequent stretches, which may include July 5-6, July 31-Aug. 3, and Aug. 25-31. In addition to Half Moon Bay, fishing boats are expected to head out this weekend from other harbors in Central and Northern California such as Morro Bay, Santa Cruz, San Francisco, Bodega Bay and Fort Bragg. 'Given the 2-year ocean salmon fishery closure and the short duration of this fishing period, angler participation is expected to be high,' the department said in its announcement. 'Anglers should prepare for crowds and long wait times at public launch ramps and marinas and consider travel, parking, and launch ramp conditions when finalizing plans.' The agency said fishing will reopen in the fall in some regions — including from Point Reyes in Marin County south to near Half Moon Bay, and from there to Point Sur in Big Sur — under a separate harvest limit guideline of 7,500 Chinook salmon. The fishing industry depends on fall-run Chinook, which migrate upstream to spawn from July through December. For decades, government-run hatcheries in the Central Valley have reared and released millions of salmon each year to help boost their numbers. Other salmon runs have suffered more severe declines. Spring-run Chinook are listed as threatened under the Endangered Species Act, and winter-run Chinook are endangered. Biologists say salmon populations have declined because of a combination of factors including dams, which have blocked off spawning areas, the loss of vital floodplain habitats, and global warming, which is intensifying droughts and causing warmer temperatures in rivers. During the severe 2020-22 drought, the water flowing from dams sometimes got so warm that it was lethal for salmon eggs. Although that drought was a major factor behind the declines in the salmon population, those who work in fishing also blame California's water managers and policies, saying too much water has been pumped to farms and cities, depriving rivers of sufficient cold water at the times salmon need it. Smith said he hopes to see 'responsible water management' where state officials prioritize river flows for fish, as well as efforts to restore floodplains and improve hatchery operations. Because salmon typically feed in the ocean for about three years and then return to their natal streams, the decline in the numbers of surviving juvenile fish during the drought left a reduced population of adult fish. Scientists expect the population should improve somewhat next year because of the boost they received during 2023's historic wet winter, though they also caution that the situation facing California's salmon remains dire. Smith said one change that has nurtured his hopes came last year, when the last of four dams were dismantled on the Klamath River in Northern California, enabling salmon to reach upstream spawning areas that had been sealed off for more than a century. 'I'm very hopeful for our future,' he said, adding that he is thinking about his 13-year-old grandson and the next generation. 'I want there to be a fishery for my grandson. I want him to be able to experience the thrill of catching a fish in the ocean.'
