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Monday, June 30, 2025

High Turnover in Small Pool of Bond Traders Hits Canadian Banks

 


Banks are luring former bond traders out of retirement in Canada, as a high level of staff turnover shakes up the government finance sector at a busy time in the market.

Brad Pederson joined Royal Bank of Canada last month as a senior government bond trader, a spokesperson said. Pederson had retired after bowing out from running Canadian rates trading and government finance at Toronto-Dominion Bank.

At TD, Steve Fraser returned from a hiatus in April to become director of government spread product trading, a spokesperson said. Jamie Williams, who previously led Canadian government trading at HSBC and Canadian Imperial Bank of Commerce, joined ATB Capital Markets earlier this year, according to people familiar with the matter.


Banks are also poaching from one another. TD hired Dan Wilson away from RBC after it lost Sameer Rehman and David Gourlay to rival firms earlier this year. The chain reaction of replacement hires rippled through the sector.

“There are elevated levels of movement on the street across Canadian fixed income,” said Dan Ram, RBC’s global head of rates and foreign-exchange forwards. 

The churn on trading desks is happening at a time when Canada’s public-sector debt market is adapting to higher volumes of new bonds, as economic uncertainty and the trade war do damage to government finances. 

Canadian provinces are just beginning to face the repercussions of slowing demand and new US tariffs, Laura Gu, senior economist with Desjardins Group, wrote in a June 3 report. Provincial governments are increasing capital spending to boost growth: combined provincial budget deficits are expected to widen to C$45 billion (RM138.98 billion) in the current fiscal year from around C$20.1 billion, Gu wrote at the time. 

Federally, Prime Minister Mark Carney has yet to release a budget, but his plans to shore up the Canadian economy and military suggest higher deficits to come. 

All of that points to more public-sector bonds to underwrite and trade for Canadian banks. 

“Heightened volatility and robust public-sector issuance will continue,” RBC’s Ram said. “We’re preparing for this environment by investing in talent and experience.”

The bank created a leadership position — head of Canadian bond trading — for Gourlay. Pederson, fresh out of retirement, will also train juniors on the team in addition to trading, Ram said. 

The recruitment pool is limited for government finance positions in banking because the roles require specialised expertise and deep relationships built over decades, said Bill Vlaad, who runs Toronto-based recruitment firm Vlaad & Co. People in these jobs tend to stay at the same banks, he added, and the high turnover probably won’t continue.

https://www.bloomberg.com/news/articles/2025-06-30/high-turnover-in-small-pool-of-bond-traders-hits-canadian-banks

US Supreme Court to Decide on Controlling-Investor Challenges

 


The US Supreme Court will consider whether activist investors can use an 85-year-old law to challenge corporate moves bolstering controlling shareholders, in a case being closely watched by some of Wall Street’s biggest investment funds.

In a setback to hedge fund manager Boaz Weinstein, the court agreed to review a decision allowing a lawsuit against closed-end fund provider FS Credit Opportunities Corp. and others, including BlackRock Inc., the world’s largest asset manager.

https://www.bloomberg.com/news/articles/2025-06-30/us-supreme-court-to-decide-on-controlling-investor-challenges

Klotho Neurosciences Moves Forward with Manufacturing Gene Therapy for the Treatment of ALS



Klotho Neurosciences (NASDAQ: KLTO) announced advancement in manufacturing and process development for KLTO-202, its investigational gene therapy treatment for amyotrophic lateral sclerosis (ALS). The company has licensed a unique RNA splice variant of the human alpha-Klotho gene from the Autonomous University of Barcelona for developing advanced gene therapies.

The company's research has demonstrated that overexpression of secreted alpha-Klotho (s-KL) using gene therapy has shown positive therapeutic outcomes in multiple animal studies, including mouse and non-human primate models. The timeline for development indicates approximately 8 months for manufacturing and 4-6 months for regulatory processes, with Phase I/II clinical trials expected to begin by Q3 2026.

KLTO plans to collaborate with contract research organizations (CROs) to manage manufacturing and clinical trials, maintaining operational efficiency without significant staff expansion. The company aims to use an AAV vector to deliver the s-KL gene directly to motor neurons affected by ALS, a disease that typically leads to paralysis and death within 2-3 years of diagnosis.

Unicycive Gets CRL in Chronic Kidney Disease Trial



Unicycive Therapeutics (Nasdaq: UNCY) announced receiving a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC), intended to treat hyperphosphatemia in chronic kidney disease patients on dialysis.

The CRL cited deficiencies at a third-party manufacturing vendor unrelated to OLC itself. The FDA did not raise concerns about pre-clinical, clinical, or safety data. The company has identified a second manufacturing vendor that has already produced OLC drug product and could help resolve the Clinical Manufacturing and Controls (CMC) issues.

Unicycive plans to request a Type A meeting with the FDA to discuss next steps. The company reports an unaudited cash balance of approximately $20.7 million, with runway expected into the second half of 2026.

Amgen's FGFR2b-targeting cancer candidate boosts overall survival in phase 3

 Amgen’s investigational monoclonal antibody paired with chemotherapy significantly improved overall survival for patients in a phase 3 stomach cancer trial compared to chemotherapy alone, according to the pharma.

Based on the interim results, Zai Lab—a biotech that holds co-development and commercialization rights for bemarituzumab in greater China—will prepare a regulatory submission for the cancer candidate in the country, according to a June 30 release

The late-stage study, called Fortitude-101, enrolled 547 patients across 37 countries. All participants had unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer, were non-HER2 positive and had an overexpression of fibroblast growth factor receptor 2b (FGFR2b).

At the center of the trial was bemarituzumab, a first-line candidate designed to target tumors overexpressing FGFR2b, which occurs in about 38% of patients with advanced G/GEJ cancer.

The study met its sole primary endpoint, with bemarituzumab and chemotherapy tied to a significant improvement in overall survival compared to chemotherapy by itself, according to the release. However, Amgen and Zai didn’t release any efficacy data behind the win, with more detailed findings slated for presentation at a future medical meeting. 

Previously, in a phase 2 FGFR2b-overexpressing group of patients, bemarituzumab plus chemotherapy were linked to a median overall survival of 24.7 months versus 11.1 months with just chemotherapy.

As for safety in the phase 3 trial, the most common treatment-emergent adverse events for patients receiving the investigational combo were reduced visual acuity, corneal inflammation, anemia, neutropenia, nausea, corneal epithelial defect and dry eye.

Amgen said the ocular events were observed in both arms and consistent with phase 2 findings but that the events occurred with greater frequency and severity in the late-stage investigational arm. The companies didn’t share any other safety information at this time.

Analysts with William Blair said the ocular adverse event rates and discontinuation rates will be “important data points to evaluate the potential market opportunity,” in a June 30 note.

“Most patients with gastric cancer are diagnosed at an advanced stage, with poor prognosis, low survival rates and limited therapeutic options,” Amgen’s R&D head Jay Bradner, M.D., said in a release from the pharma. “These first positive top-line results of an FGFR2b targeted monoclonal antibody from our phase 3 FORTITUDE-101 study mark a meaningful advance in the development of effective targeted therapy for gastric cancer.”

A few years back, the FDA granted bemarituzumab breakthrough therapy status for gastric cancer patients with at least 10% of tumor cells overexpressing FGFR2b.

Back in 2021, Amgen picked up the phase 3-ready candidate in a $1.9 billion acquisition of Five Prime Therapeutics. The biotech had granted Zai Lab an exclusive license for bemarituzumab in mainland China, Hong Kong, Macau and Taiwan, rights the biotech still retains.

Now, the companies are also running another phase 3 trial of the investigational combo plus nivolumab—marketed as Opdivo—in first-line gastric cancer, with a readout expected in the second half of this year. 

https://www.fiercebiotech.com/biotech/amgens-fgfr2b-targeting-cancer-candidate-boosts-overall-survival-phase-3

Biogen Phase 3 Trial Targets 36,000 Patients With Rare Kidney Disease, No Approved Treatments



Biogen (Nasdaq: BIIB) has initiated PROMINENT, a Phase 3 clinical study of felzartamab for treating primary membranous nephropathy (PMN). The study will evaluate the drug's efficacy and safety compared to tacrolimus in approximately 180 adults with PMN, with results expected in 2029.

PMN is a rare kidney disease affecting an estimated 36,000 patients in the U.S., with no currently approved treatments. Felzartamab, an investigational anti-CD38 monoclonal antibody, targets CD38+ cells, including plasma cells that produce harmful autoantibodies. Notably, up to 80% of PMN patients have autoantibodies against PLA2R generated by these cells.

The 104-week PROMINENT trial (NCT06962800) will measure complete remission rates of proteinuria at week 104 as its primary endpoint. Previous Phase 2 studies (M-PLACE and NewPLACE) showed promising results, with most patients experiencing reduced aPLA2R titers and improved proteinuria levels. This marks Biogen's third Phase 3 trial of felzartamab launched this year, alongside TRANSCEND for kidney transplant rejection and PREVAIL for IgA nephropathy.

Hikma to splash $1B on US production and R&D

 Drugmakers have continued to make U.S. manufacturing pledges throughout the year. Now, India’s Hikma Pharmaceuticals is joining the queue with a major investment plan that challenges the notion that Trump’s trade duties might be too much to bear for the lower-margin generic medicine industry.

Hikma plans to throw down $1 billion by 2030 to expand its manufacturing and R&D firepower in the U.S., where the company has been in operation since 1991. The new outlay builds on more than $4 billion in U.S. investments over the past 15 years, Hikma said in a June 28 press release. The company’s U.S. workforce stands at around 2,300, according to a statement from Hikma Rx President Hafrun Fridriksdottir, Ph.D.

The investment plays into the Trump administration’s touted aim to increase the production of drugs for U.S. patients on U.S. soil, with Hikma branding the initiative “America Leans on Hikma: Quality Medicines Manufactured in the USA.”

Hikma will use the investment to beef up sites in Columbus and Cleveland in Ohio as well as Cherry Hill and Dayton in New Jersey.

Hikma announced the domestic cash infusion in tandem with a groundbreaking ceremony at an upcoming research and production facility in Columbus, which was attended by U.S. Representatives Mike Carey and Buddy Carter. Carter is a licensed pharmacist and chairman of the American-Made Medicines Caucus.

Hikma produces a broad range of lower-cost generic medicines for the U.S. market. In the last 15 years, Hikma has asserted itself as one of the U.S.’ top three sterile injectable suppliers by volume, Bill Larkins, Ph.D., president of Hikma Injectables, said in a statement. Hikma’s sterile injectable manufacturing in particular is set to benefit from the $1 billion cash infusion, Larkins noted.

“It's important that we onshore the production of these critical drugs,” Rep. Carter said in a statement on the investment. “I will continue working with Hikma to strengthen our national security and public health by making life-saving generic medications here, in America.”

Restoring the U.S.’ manufacturing base has been a major goal of the second Trump administration’s trade policy. Even though pharmaceutical import tariffs have yet to materialize, the threat alone has spurred an outpouring of investment announcements from pharma companies in recent months.

Still, Hikma’s investment is unique given the company’s role as a producer of generic medicines. To date, the vast majority of production pledges made this year have come from branded drugmakers.

Unlike branded drugmakers, generics companies operate on much thinner margins and have “little resilience” to weather a pharmaceutical trade war, Ronald Piervincenzi, Ph.D., CEO of the United States Pharmacopeia (USP), warned in an interview earlier this year.

Any disruption to the industry could trigger manufacturing discontinuations, shortages and myriad other issues for off-brand drugmakers and the many U.S. patients who rely on their products, he said.

Piervincenzi’s remarks came shortly after USP published a report concluding that the U.S. produces just 12% of the active pharmaceutical ingredients (API) used in domestic medicines. Roughly 90% of the U.S.’ total prescription volume consists of generics, with around 35% of those copycat drugs made from APIs manufactured in India, the report asserted.

The USP chief is hardly alone in his views, with Sandoz CEO Richard Saynor telling Reuters in late April that if tariffs are imposed on pharmaceuticals, his company might have to withdraw some of its products from the U.S. market. The threat of generics makers pulling lower-margin products from the U.S. over tariff pressures was one echoed by USP’s Piervincenzi.

Pharmaceuticals were exempted from Trump’s much-anticipated Liberation Day tariff reveal in early April, though the administration has repeatedly indicated that drug duties are still on the table. To that end, the administration launched a Section 232 investigation earlier this year, which gives the President the power to impose tariffs and other restrictions if the probe uncovers national security threats within the U.S.’ pharmaceutical trade network.

Such investigations have been used to justify tariffs on other goods like steel, aluminum and automotive imports.

Trump most recently told reporters in mid-June that pharma tariffs are expected “very soon,” and that the move is “going to bring all the companies back into America.” Still, as with previous pharmaceutical tariff announcements, details were slim, and a firm timeline was not provided.

https://www.fiercepharma.com/manufacturing/hikma-splash-out-1b-us-production-rd-joining-branded-drugmakers-tariff-spurred