Bayer has teamed up with startup biotech NextRNA Therapeutics to develop small molecules targeting long non-coding RNAs (lncRNAs) in oncology. Under the terms of the deal, NextRNA can get up to $547m if all the milestones are reached, and the deal also included an undisclosed upfront payment. The companies will collaborate on two oncology programmes, the first involving a lncRNA-targeting small molecule in early preclinical development at NextRNA. For the second, NextRNA will pursue lncRNA targets identified by its platform, with Bayer having the option to choose one target for joint development. In 2022, Dana-Farber spinout NextRNA came out of stealth with $9.3m from a seed financing round and $46.8m from a Series A. This is the first high-profile pharma deal for the startup, which focuses on lncRNA-driven diseases. lncRNAs are RNA molecules over 200 nucleotides long that regulate gene expression without coding for proteins. They play key roles in ...
Bayer reported a Phase 3 test of Kerendia in heart failure led to statistically significant reductions in cardiovascular death and hospitalizations. Detailed results will be presented during the European Society of Cardiology annual meeting in September. By Frank Vinluan Bayer’s Kerendia, already FDA approved in one cardiometabolic indication, now has data from a pivotal test that support expanding the drug’s label to heart failure. In preliminary results reported Monday, Bayer said Kerendia reduced cardiovascular death and hospitalizations in heart failure patients, meeting the main goal of the Phase 3 clinical trial. The company did not release specific figures detailing the reductions, but said it will present the clinical data next month during the European Society of Cardiology Congress, which will be held in London. Bayer added that it plans to meet with the FDA to discuss a submission seeking regulatory approval for the drug in heart failure. Kerendia is a small ...
Bayer is set to pursue a label expansion for Nubeqa (darolutamide) in a distinct subgroup of prostate cancer patients—those with metastatic hormone-sensitive prostate cancer (mHSPC)—after announcing that a Phase III trial with the therapy met its primary endpoint. The company did not disclose detailed trial data, only stating that the combination of Nubeqa and androgen deprivation therapy (ADT) demonstrated “a statistically significant and clinically meaningful increase”, compared to the placebo and ADT combination, in the radiological progression-free survival (rPFS), the study’s primary endpoint. Bayer plans to share the detailed results from the trial at an upcoming scientific conference. Nubeqa has been approved by the US Food and Drug Administration (FDA) to treat patients with mHSPC, but only in combination with docetaxel chemotherapy. The company now plans to seek approval for the drug’s use mHSPC indication sans additional chemotherapy. To that end, Bayer plans to submit the Phase III ARANOTE trial ...
Amidst a successful conclusion to the 2024 JP Morgan Healthcare Conference, biotech and pharma layoff numbers are on a consistent rise with PMV Pharmaceuticals and Ikena Oncology being the latest to follow pharma giant Bayer’s recent restructuring plans. PMV Pharmaceuticals plans to fire 30% of its workforce in a bid to free capital that will go towards the development of its lead tumour agnostic therapy PC14586.As per the New Jersey-based company, the strategic restructuring will extend PMV’s cash runway until the end of 2026 and will allow the company to focus on discovery research efforts and prioritise initiation of a Phase II clinical study of p53 reactivator PC14586 that is slotted for commencement in Q1 2024. The precision oncology company’s latest restructuring follows a March 2023 pipeline optimisation effort, in which the company announced that its WIP-1 inhibitor and R273H mutation-targeting programs had been shelved to drive the development of ...
Bayer is launching a sweeping business overhaul as the German conglomerate sees “no viable alternative.” Bayer on Wednesday unveiled a restructuring of its organization that will “come at the expense of many managerial employees,” according to chairwoman of the executives committee on Bayer’s supervisory board, Barbara Gansewend. The job cuts will begin in the coming months and will end in 2025, the company said without providing a specific number for the jobs impacted. But the reductions will be “significant” at the group in Germany, the company said. Bayer declined to comment on the scale of the layoff or the functions involved. Reducing bureaucracy is the “central component” of the adjustments, a Bayer spokesperson told Fierce Pharma. The company’s new operating models are developed with customers at the center. “For this reason, there are no top-down targets and we will only gradually know what scale is really realistic here,” the spokesperson ...
CEO Bill Anderson said despite prior cost-cutting measures, Bayer still has too many layers of management and bureaucracy. A new restructuring will come with layoffs but the corporate shakeup plan does not yet include a separation of Bayer’s business units. By FRANK VINLUAN Bayer is implementing a corporate restructuring that will slash an unspecified number of jobs, particularly within management. But the strategy does not include a breakup of the conglomerate—at least not yet. In announcing its new strategy late Wednesday, Bayer said it aims to reduce hierarchies and eliminate bureaucracy in the company. The job cuts will happen over the coming months and will be completed by the end of next year at the latest, the company said. Bayer’s corporate shakeup is not entirely a surprise. CEO Bill Anderson, who joined Bayer last June after serving as the chief executive of Roche’s pharmaceuticals division, has been critical of bloat ...
Dec 23 (Reuters) – Bayer has won a trial in a lawsuit brought by a California man who said he developed cancer from exposure to its Roundup weedkiller, ending what had been a five-trial losing streak for the company in trials over similar claims. The verdict was handed down on Friday by a jury in San Benito County, California Superior Court, Bayer announced. The company said in a statement that the verdict was “consistent with the evidence in this case that Roundup does not cause cancer and is not responsible for the plaintiff’s illness.” Lawyers for plaintiff Bruce Jones did not immediately respond to requests for comment. Like most plaintiffs in Roundup lawsuits, Jones alleged that the product caused him to develop a form of cancer called non-Hodgkin lymphoma. Around 165,000 claims have been made against the company for personal injuries allegedly caused by Roundup, which Bayer acquired as part ...
Bayer’s stock price has plummeted to its lowest since 2005 after a clinical trial investigating the anti-coagulant drug asundexian was stopped early due to lack of efficacy. The Phase III OCEANIC-AF trial (NCT05643573) aimed to determine asundexian’s use as a treatment for people living with atrial fibrillation in a bid to prevent strokes or systemic embolisms. The Independent Data Monitoring Committee (IDMC) found that asundexian was inferior in terms of efficacy when compared to the control arm of the trial. The OCEAN-AF trial was a part of the overall OCEAN Phase III programme. However, the committee recommended continuing another Phase III OCEANIC-STROKE trial (NCT05686070) examining the use of the drug in stroke patients. Following the announcement on 19 November 2023, the German pharmaceutical firm’s stock value dropped from €41.45 ($45.38) per share down to €30.77 ($33.68), as of 28 November. It is the lowest price in 18 years. The last ...
After suffering setbacks in the clinic and in court over the last week, Bayer’s ability to overhaul its corporate structure is becoming more constricted, one group of analysts contends. Still, the German conglomerate is trying to keep its head up as it presses on with a strategic review under new CEO Bill Anderson. Bayer’s very bad week started with the failure of its potential blockbuster-in-waiting asundexian to top Bristol Myers Squibb and Pfizer’s Eliquis in a phase 3 trial. In light of the blood thinner’s inferior efficacy, Bayer elected to stop the study early while continuing to advance the asset in stroke. Bayer is counting on new drugs like asundexian to offset the upcoming loss of exclusivity on its Johnson & Johnson-partnered med Xarelto. Separately, a Missouri jury on Monday ordered Bayer to shell out $1.56 billion to four plaintiffs over claims the company’s Roundup weedkiller caused their cancer. Bayer ...
By Tristan Manalac Pictured: Bayer’s office in New Jersey Bayer on Sunday announced it was stopping the Phase III OCEANIC-AF study ahead of schedule due to the disappointing performance of its investigational factor XIa inhibitor asundexian. The decision to end OCEANIC-AF early is in line with the recommendation of an Independent Data Monitoring Committee, which during the ongoing surveillance of the study found that asundexian had “inferior efficacy” versus Bristol Myers Squibb’s and Pfizer’s Eliquis (apixaban). Bayer will take “appropriate measures” to close the study and will work with investigators to determine the next steps for patients. Bayer did not provide specific data from OCEANIC-AF in its news release, but said it will continue to analyze its results and publish the findings. Asundexian is an investigational inhibitor of the blood protein factor XIa, which is a key player in the coagulation cascade. The drug candidate is designed to be orally ...
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