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Pancreatic cancer drug daraxonrasib from Revolution Medicines succeeds in trial

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Pancreatic cancer drug daraxonrasib from Revolution Medicines succeeds in trial

Pancreatic cancer, illustration

Nemes Laszl | Science Photo Library | Getty Images

Revolution Medicines‘ drug for pancreatic cancer succeeded in a highly anticipated Phase 3 trial, almost doubling the typical length of survival and slashing the risk of death by 60% versus chemotherapy, the company said Monday.

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RevMed said its daily pill, daraxonrasib, met all primary and secondary endpoints in a trial of people whose cancer had already progressed on another treatment. People who took daraxonrasib typically lived for 13.2 months versus 6.7 months for people who took chemotherapy, an increase of 6.5 months, RevMed said in a press release.

“These are dramatic, practice-changing outcomes, and our focus now is moving quickly to bring this potential new treatment option to patients who urgently need new treatment,” RevMed CEO Mark Goldsmith said in an interview.

Goldsmith called the results “unprecedented,” saying no drug has shown an overall survival benefit greater than one year in a Phase 3 trial for pancreatic cancer. The company plans to soon seek Food and Drug Administration approval using a Commissioner’s National Priority Voucher, which grants a review within a matter of months.

RevMed’s pill could bring a new option for people with pancreatic cancer, an aggressive disease that has the lowest five-year survival rate of any major cancer, at 13%. Daraxonrasib broadly targets RAS mutations, which drive tumor growth and are found in about 90% of pancreatic cancer cases.

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“These results usher in a new era of RAS-targeted medicines for pancreatic cancer, which has been exclusively treated with cytotoxic intravenous chemotherapy,” Goldsmith said.

The company’s shares jumped more than 30% following release of the results Monday.

RevMed said the drug showed a manageable safety profile and that no new concerns were observed. The drug can produce rash, a side effect highlighted last week by former Republican Sen. Ben Sasse, who shared his experience taking the drug in an interview with The New York Times. Goldsmith said the company can’t comment on any individual patient, but that a rash is a known side effect and one that’s generally manageable.

The company will seek approval for second-line treatment, or in patients whose cancer has already spread while taking another drug. It’s conducting a Phase 3 trial for newly diagnosed patients.

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Tyneside digital agency Podium looks to the future following successful MBO

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Ownership of the 14 year old agency has transferred to Sarah McKevitt, Lia Gordon and Katie Toman

The Podium team in Newcastle

The Podium team in Newcastle(Image: Podium)

A Tyneside digital marketing agency is looking to the future following a successful management buyout. The team at Gosforth based Podium has completed the MBO with ownership transferring to three long-standing members of its senior team.

Ownership of Podium, which specialises in SEO, PPC (Pay-Per-Click) and social media management, has transferred to Sarah McKevitt, Lia Gordon and Katie Toman. Founder and managing director Andy Thevarokiam, who set up the company in 2012, is stepping back from day-to-day leadership.

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Ms McKevitt, Ms Toman and Ms Gordon have held long-standing roles within the company and have been closely involved in its growth over a number of years. They will now jointly lead the next phase of the business, with a focus on continuity for clients and further development of the agency’s offering.

They said the deal ensures the company remains independent, and that they plan to boost their local client base by 20% over the next year.

Mr Thevarokiam will remain involved while handing over operational control to the new ownership team. He said: “This decision comes with a great deal of pride. It’s not goodbye, but the start of something new.

“Sarah, Lia and Katie have been central to the business for years and know it inside out. The service and results our clients expect will remain unchanged, with fresh energy driving the next phase. The business is in safe hands, and I’ll continue to support the team as they take it forward.”

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Ms McKevitt added: “The chance to lead a business I’ve helped shape since 2017 was an opportunity I couldn’t pass up.

“We are staying true to the values Andy instilled, exceptional results and a modern, flexible workplace, while pushing the boundaries of what we can achieve for our clients over the next 12 months.”

The agency will continue to operate under the Podium brand.

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Wendy Hopkins Family Law Practice marks 30 years as it continues to expand

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The Cardiff-based family law firm was established in 1996 with co-founder Mel Hamer with an appetite for sustained growth

Wendy Hopkins Family Law Practice directors Melanie Hamer, David James, Sarah Wyburn, Rebecca Knight, Sam John.

A leading family law firm is celebrating 30 years as it continues to expand. Cardiff-based Wendy Hopkins Family Law Practice was established as the first specialist family law firm in Wales, and one of the first in the UK, in May 1996.

It launched with just two partners, one paralegal and three secretaries – drawn from the family law team at the Cardiff office of Eversheds (now Eversheds Sutherland). The firm was then known as Wendy Hopkins & Co.

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Melanie Hamer, one of its original co-founders, along with the late Wendy Hopkins, is still with the firm today.

Director Ms Hamer said: “I was just 30 years old, newly married and was presented with this enormous opportunity by Eversheds. It was a risk, as with all new firms, but I felt at the time it was a manageable risk. I decided that I would give it three years and if it did not work, I could always get out and get a job. I had to borrow just £35,000 from the bank to co-finance the firm at the beginning.

Fast forward 30 years and the firm’s revenues have grown from £220,000 gross in its first year of trading to nearly £3m in its last financial year. The team has increased from six to 22.

READ MORE: The knowhow built up in Wales’ contact centre sector is an asset worth redirectingREAD MORE: Expansion for community-owned west Wales seaweed and shellfish farming venture

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Ms Hamer said: “We started on client number 100 because we did not want anybody to be client number 1 and for the outside world to think we didn’t have any clients. We are now on client number 13,365 meaning that over the last thirty years we have serviced 13,265 clients.

“I can’t quite believe my luck. I never set out with a big ambition or business plan to be one of the best family law firms in the UK. In the early days, I just hoped to make enough money to pay my mortgage.

“The success of the firm has exceeded all my wildest expectations, and I have great faith in my team that it will continue the great reputation of the firm for years to come, and we shall continue to punch above our weight, often attracting work from London as well as closer to Wales.”

The firm’s clients include high net worth individuals, celebrities, sports personalities and business owners. It recently acted on a case worth £77m.

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The firms’ ownership structure also evolved over the years. At launch the only option available was to be a partnership. As soon as it able to it became a limited liability partnership (LLP) and latterly a limited company. It has expanded from two partners to five directors and three shareholders. Originally operating out of rented office space at 26 Windsor Place, it now own occupies 10,000 sq ft of owned space at the 12 and 13 Windsor Place.

Melanie Hamer back in 1996.

On the success of the firm over the last 30 years, Ms Hamer said: “It is a combination of matters. We employ clever and conscientious people, and we make sure we look after them. From day one we have grown organically by taking lawyers on as paralegals and then in due course promoting them to trainee solicitor and then solicitor etc. Indeed, one of my shareholders and directors started as my trainee in the year 2000.

” Another director and shareholder started as a paralegal in 2011. The firm genuinely feels like a part of my extended family, and I care deeply about them all. I was also blessed with being in partnership until two years ago with one of my best friends, Thea Hughes, who retired in May 2024.

Ms Hamer, 60, says she no plans to retire. She added: “I still love my job, and I still feel that I do a good job, so as long as I continue to tick those boxes, then I see no reason to retire.”

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E15 debate gains traction as fuel costs rise

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E15 debate gains traction as fuel costs rise

Lawmakers weigh year-round sales as consumers face higher gasoline prices.

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Sigma Foods acquires smoked meats producer

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Sigma Foods acquires smoked meats producer

Roger Wood is the No. 1 smoked sausage company in the southeast United States, according to Sigma.  

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Scorpio Tankers faces earnings test as war drives record rates

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Scorpio Tankers faces earnings test as war drives record rates

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Earnings call transcript: FTI Consulting Q1 2026 misses EPS, revenue beats

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Earnings call transcript: FTI Consulting Q1 2026 misses EPS, revenue beats

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Form 144 ENSIGN GROUP For: 4 May

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Form 144 ENSIGN GROUP For: 4 May

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Celcuity Stock Soars 14% to $143 on Positive Phase 3 Breast Cancer Trial Data

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Celcuity Stock Soars 14% to $143 on Positive Phase 3

NEW YORK — Celcuity Inc. shares surged more than 13.8 percent to $143 in early trading Monday, May 4, 2026, after the clinical-stage oncology company announced that its Phase 3 VIKTORIA-1 trial met the primary endpoint with clinically meaningful improvement in progression-free survival for patients with PIK3CA-mutant advanced breast cancer. The positive topline results for gedatolisib sent the biotech stock to new highs and reignited investor enthusiasm for the company’s targeted therapy pipeline just weeks before a potential FDA submission.

Celcuity reported that both the gedatolisib triplet and doublet regimens demonstrated statistically significant and clinically meaningful improvement in progression-free survival compared to the control arm in the PIK3CA mutant cohort. The data, released late Friday, May 1, triggered a sharp after-hours rally that carried into Monday’s session. The company said the results support advancing toward a supplemental New Drug Application (sNDA) filing with the FDA, with a potential PDUFA target in July 2026.

The VIKTORIA-1 trial evaluated gedatolisib in combination with standard therapies for HR+/HER2- advanced breast cancer patients who had progressed after prior CDK4/6 inhibitor treatment. Gedatolisib, a first-in-class PI3K/mTOR inhibitor, targets a pathway frequently altered in breast cancer. Positive data in the PIK3CA mutant population — a subgroup with historically poorer outcomes — positions the drug as a potential new standard of care option in a market estimated to exceed $5 billion annually at peak.

Celcuity CEO Brian Sullivan called the results a “transformational milestone” for the company and patients. “These data demonstrate gedatolisib’s potential to meaningfully improve outcomes in a population with significant unmet need,” Sullivan said in the company’s release. The firm is now accelerating commercial launch preparations while advancing additional indications for the drug across multiple solid tumors.

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The stock reaction reflects high expectations. Celcuity has been on many biotech investors’ radars due to gedatolisib’s profile and its near-term regulatory timeline. Analysts have issued bullish price targets, with some projecting peak annual revenue exceeding $2.5 billion if the drug secures approval across multiple lines of therapy. Monday’s surge pushed the company’s market capitalization well above $6 billion.

The trial success comes at a pivotal time for Celcuity. The company has been advancing its precision medicine platform, which uses live tumor cell testing to identify patients most likely to benefit from targeted therapies. Gedatolisib represents the lead asset in this approach, and positive Phase 3 data significantly de-risks the program while strengthening its position ahead of potential partnership or commercialization discussions.

Broader market context amplified the move. Biotech stocks have shown renewed strength in 2026 amid improving regulatory sentiment and investor appetite for late-stage assets with clear paths to approval. Celcuity’s data stands out for its statistical robustness and clinical relevance in a competitive breast cancer landscape dominated by CDK4/6 inhibitors and antibody-drug conjugates.

Analysts reacted swiftly. Citizens initiated coverage with a Market Outperform rating and $150 price target earlier in the week, citing the drug’s potential. Other firms have highlighted the July 2026 PDUFA timeline as a key catalyst. While some caution remains around commercial execution and competition, the overall sentiment has turned increasingly bullish following the topline readout.

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For patients and physicians, the results offer hope for better options in later-line HR+/HER2- breast cancer. PIK3CA mutations occur in approximately 40 percent of cases, and effective targeted therapies have been limited. Gedatolisib’s mechanism and tolerability profile could fill an important gap if approved.

Celcuity has cash reserves to support operations through key milestones, including potential approval and launch. The company continues enrolling patients in additional trials exploring gedatolisib in other settings and tumor types, positioning it for potential label expansion in the years ahead.

As trading continued Monday morning, volume remained elevated and the stock held near session highs. The move underscores the biotech sector’s sensitivity to clinical data, where positive Phase 3 readouts can drive outsized gains even in a broader market environment focused on macro signals and Federal Reserve policy.

Looking forward, all eyes are on the full dataset presentation at an upcoming medical meeting and the company’s regulatory strategy. If the FDA accepts the filing with priority review, approval could come as early as late 2026, setting the stage for Celcuity’s transition from clinical developer to commercial-stage oncology company.

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The surge in Celcuity stock serves as a reminder of the high-reward potential in targeted oncology. For investors who backed the company through its development phase, Monday’s gains validate the long-term bet on gedatolisib. As the story unfolds, the biotech community will watch closely to see whether this positive momentum translates into sustained value creation in the competitive breast cancer market.

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Oatly concerned about ‘volatility’ of Middle East conflict on business

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Oatly concerned about ‘volatility’ of Middle East conflict on business

The company now has 30% retail share in US oat milk segment.

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US, EU Officials Hold Talks After Trump Raises Car Tariffs to 25%

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US, EU Officials Hold Talks After Trump Raises Car Tariffs to 25%

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