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.

https://www.stocktitan.net/news/BIIB/biogen-initiates-phase-3-study-of-felzartamab-for-the-treatment-of-k4b21sw9hd1g.html

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

First China Weight Loss Drug Rival to Novo, Lilly Emerges

 

Novo Nordisk A/S and Eli Lilly & Co, the pharmaceutical giants dominating the global obesity drug market, now face their first serious rival in China.

Suzhou-based Innovent Biologics Inc. secured approval last week for its treatment mazdutide, a turning point in China’s efforts to combat rising obesity and diabetes rates with local innovation. With over 600 million Chinese adults projected to be overweight by 2050, the emergence of a viable local alternative to Novo and Lilly’s blockbuster GLP-1 treatments could make weight loss drugs more accessible in the world’s second-largest economy.

https://www.bloomberg.com/news/articles/2025-06-30/first-china-weight-loss-drug-rival-to-novo-lilly-emerges

Vor Biopharma stock rating upgraded to Buy by H.C. Wainwright on telitacicept deal

 H.C. Wainwright upgraded Vor Biopharma , Inc. (NASDAQ:VOR) from Neutral to Buy with a price target of $3.00 following the company’s exclusive licensing agreement with RemeGen Co., Ltd. The upgrade comes as Vor’s stock has surged over 265% in the past week, with the company currently valued at $132.46 million.

Vor announced on June 25 that it entered into an exclusive license agreement with RemeGen to develop and commercialize telitacicept, a recombinant fusion protein targeting BlyS and APRIL, in territories outside Greater China. Under the agreement, RemeGen will receive an upfront payment of $125 million, consisting of $45 million in cash and $80 million in warrants. 

The deal could potentially yield over $4 billion in regulatory and commercial milestone payments to RemeGen, along with tiered royalties upon successful commercialization. Telitacicept has already received marketing approvals in China for systemic lupus nephritis in November 2023, rheumatoid arthritis in July 2024, and generalized myasthenia gravis in May 2025.

RemeGen has initiated a randomized, double-blinded, placebo-controlled Phase 3 study with telitacicept for generalized myasthenia gravis in the U.S., EU, and South America, with initial data expected in the first half of 2027. If successful, Vor could potentially begin commercialization in the U.S. by mid-2028.

H.C. Wainwright cited the "quick resurrection of the company" and the acquisition of a "de-risked asset" as key factors in its upgrade decision, noting that the transaction strengthens Vor’s asset portfolio, finances, and management. 

https://www.investing.com/news/analyst-ratings/vor-biopharma-stock-rating-upgraded-to-buy-by-hc-wainwright-on-telitacicept-deal-93CH-4116771

Artelo Biosciences Positive First-in-Human Data for Novel Non-Opioid Treatment

Artelo Biosciences (Nasdaq: ARTL) has announced positive results from its first-in-human Phase 1 Single Ascending Dose (SAD) study of ART26.12, a novel non-opioid pain treatment candidate. The study, involving 49 subjects, demonstrated favorable safety and pharmacokinetic profiles for the first orally active Fatty Acid Binding Protein 5 (FABP5) inhibitor tested in humans.

Key findings from the study include excellent safety results with only mild, transient, and self-resolving adverse events, predictable pharmacokinetics with dose-dependent linear absorption, and a wide safety margin between therapeutic plasma concentrations and highest exposure levels. The drug represents a first-in-class approach targeting the multibillion-dollar pain management market.

The chronic pain therapeutics market exceeded $97 billion globally in 2023 and is projected to surpass $159 billion by 2030. A Multiple Ascending Dose study is planned to commence in Q4 2025 to further evaluate ART26.12's safety, tolerability, and pharmacokinetics with repeated dosing.

https://www.stocktitan.net/news/ARTL/artelo-biosciences-announces-positive-first-in-human-data-for-art26-txkdgnt4jgy6.html

Eyenovia expands HYPE token holdings by over 265,000

 Eyenovia, Inc. (NASDAQ:EYEN), a $65 million market cap company currently trading near $12.74, has acquired an additional 265,872 HYPE tokens, bringing its total holdings to 1,306,452 tokens purchased at an average price of $34.83 per token, the company announced Monday. According to InvestingPro data, the company faces challenges with cash burn and liquidity, with short-term obligations exceeding liquid assets.

The ophthalmic technologies firm, which describes itself as the first publicly-listed U.S. company to build a strategic treasury of HYPE tokens, plans to use the expanded holdings to support ecosystem growth initiatives, including its validator operations and upcoming yield generation opportunities at the protocol level. While analysts project 65.92% revenue growth for fiscal year 2025, InvestingPro analysis indicates the company is not expected to achieve profitability this year.

"We continue to see strong signals from the market and prospective partners affirming the importance of HYPE’s role in next-generation financial infrastructure," said Hyunsu Jung, Chief Investment Officer of Eyenovia, in a press release statement.

HYPE is the native token of Hyperliquid, a layer one blockchain optimized for high-frequency trading that features onchain perpetual futures and spot order books. According to the company, the token has become the 12th-largest cryptocurrency by market capitalization as of June 2025.

Eyenovia maintains a dual focus on developing its proprietary Optejet User Filled Device (UFD) for topical eye treatments while building its HYPE token treasury. The company states this strategy aims to provide shareholders with exposure to the Hyperliquid ecosystem.

https://www.investing.com/news/company-news/eyenovia-expands-hype-token-holdings-by-over-265000-93CH-4116856