Pharmaceuticals

Novartis agreed to acquire full rights to Sironax's proprietary brain delivery platform for neurological disease treatments. The deal gives Novartis control of Sironax's technology designed to transport therapeutics across the blood brain barrier, expanding its toolkit for research into central nervous system disorders where treatment options remain limited. Novartis is a large pharmaceuticals group with a CHF218.8 billion market cap that researches, develops, manufactures, distributes, markets, and sells medicines globally, so gaining access to differentiated delivery technology directly links into its existing focus on complex neurological treatments. The Sironax platform speaks to the same advanced-therapy thesis that underpins Cosentyx's CHMP progress and remibrutinib's Phase 3 data, as Novartis seeks to own hard-to-reach biology where rivals like Roche and Biogen also compete for neurologists' attention. The flip side is that every new modality adds complexity, and recent trial setbacks such as pelacarsen and del-desiran keep development risk front and center, with analysts flagging that stacking capital-intensive projects on top of share buybacks could stretch the balance sheet of a business already carrying a high level of debt.

Bristol Myers Squibb announced positive two-year results from the late-stage POETYK PsA-2 study of Sotyktu, or deucravacitinib, including its open-label extension. Among patients entering the extension, clinical responses improved from week 16 through week 52 and were sustained through week 104, with robust results across ACR20/50/70 and Minimal Disease Activity in both continuous Sotyktu patients and those who switched from placebo at week 16. The safety profile remained consistent through week 104 with no new safety signals; adverse events occurred in 86.6% of 604 patients exposed to Sotyktu, while serious adverse events and discontinuations due to adverse events were reported in 12.6% and 7.6% of patients, respectively. Sotyktu, an oral selective tyrosine kinase 2 inhibitor approved in the United States and numerous other countries for moderate-to-severe plaque psoriasis and active psoriatic arthritis, generated $156 million in first-half 2026 revenues, up 24% year over year. Data from the POETYK SLE-1 and SLE-2 studies in systemic lupus erythematosus are expected later in 2026, while Amgen's Otezla and Takeda's investigational zasocitinib, whose new drug application the FDA recently accepted for plaque psoriasis, remain competitive threats.

Eli Lilly and Company announced that the U.S. Food and Drug Administration has granted full approval to Inluriyo, or imlunestrant, in combination with Verzenio, or abemaciclib, for adults with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy. The decision rests on the Phase 3 EMBER-3 trial, in which the combination doubled median progression-free survival versus Inluriyo alone, at 11.1 months versus 5.5 months, with a hazard ratio of 0.53 and a 95% confidence interval of 0.35 to 0.80, among the 159 patients with ESR1-mutated metastatic breast cancer. In that trial, 92 patients received Inluriyo alone and 67 received the combination after an aromatase inhibitor, with or without a CDK4/6 inhibitor, in either the adjuvant or metastatic setting. The approval marks the second FDA clearance for Inluriyo in less than a year, following its September 2025 monotherapy approval for the same ER-positive, HER2-negative, ESR1-mutated metastatic population. Inluriyo is also being studied in the Phase 3 EMBER-4 trial in the adjuvant setting for ER-positive, HER2-negative early-stage breast cancer, the largest adjuvant oral SERD trial with more than 8,000 patients enrolled across 650-plus sites in more than 30 countries, with initial results anticipated in 2027. The combination is now available in the United States.

AstraZeneca said the FDA accepted its regulatory filing for the investigational enzyme replacement therapy efzimfotase alfa in patients aged two years and older with hypophosphatasia, or HPP, and granted the application priority review, shortening the review period by four months, with a final decision expected during the first half of 2027. The filing is supported by data from three phase III studies: MULBERRY met its primary endpoint in treatment-naive children aged two to less than 12 years old, showing a significant improvement in bone health, and CHESTNUT showed that patients switching from Strensiq could maintain the benefits of treatment, while HICKORY did not meet its primary endpoint in treatment-naive individuals aged 12 years and older, though AstraZeneca reported a numerical improvement, particularly in patients with pediatric-onset disease. The company said efzimfotase alfa was generally well-tolerated with an acceptable safety profile across the three studies. The commercial angle rests on Strensiq, the established HPP treatment AstraZeneca gained through its 2021 acquisition of Alexion, which was approved by the FDA in 2015 as the first bone-targeted enzyme replacement therapy for HPP and generated $1.05 billion in sales in the first half of 2026, up 41% year over year. Efzimfotase alfa is designed to require lower injection volumes and substantially less frequent dosing, once every two weeks, compared with Strensiq's three- or six-times-weekly regimen. Elsewhere in the space, BioMarin Pharmaceutical entered HPP through its acquisition of Alesta Therapeutics, completed earlier this month, paying $275 million upfront with up to $215 million in additional milestone payments for ALE1, an oral small-molecule therapy in a phase I/IIa study, while Recursion Pharmaceuticals is developing the oral ENPP1 inhibitor REC-102, formerly REV102, which remains in IND-enabling studies with a data-driven decision on a phase I study expected before the end of this year.

Pfizer's decade-long streak of annual dividend increases has stalled, with its quarterly payout holding at $0.43 through the September 1, 2026 payment after the January 2026 ex-dividend date matched the prior four quarters instead of rising. The 6.20% yield remains covered by reaffirmed 2026 adjusted diluted EPS guidance of $2.80 to $3.00 against a run-rate $1.72 annual payout, and Q1 2026 adjusted EPS of $0.75 beat consensus for a fifth consecutive quarter above estimates. Cash outflow is real, with $2.4 billion in dividends paid in Q1 alone and $9.8 billion for full-year 2025, while Pfizer completed no buybacks in 2025 and anticipates none in 2026 despite $3.3 billion of unused authorization. On the August 4, 2026 call, incoming interim CFO Cecile Guegan said Pfizer would keep maintaining and over the long term growing the dividend, and Chairman and CEO Albert Bourla said the dividend will be maintained and eventually start growing again after the loss-of-exclusivity period. Peers have not frozen their payouts: Merck raised its quarterly from $0.81 to $0.85 starting with the December 2025 ex-date, and Bristol-Myers Squibb nudged its payout from $0.62 to $0.63 with the January 2026 ex-date. The pressure behind the pause is visible in the mix, with Comirnaty down 59% and Paxlovid down 62% in Q1 2026 and roughly $1.5 billion in additional generic and biosimilar headwind guided for the year, partly offset by launched and acquired products growing 22% operationally and Vyndamax exclusivity now running to June 2031.

Novartis announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending marketing authorization for Cosentyx, also known as secukinumab, in polymyalgia rheumatica. The opinion supports use in adults who have had an inadequate response to steroids or who relapse during steroid taper, and if approved, Cosentyx would be the first interleukin-17A inhibitor licensed in Europe for the disease. The recommendation rests on the pivotal REPLENISH Phase III trial, in which all primary and secondary endpoints were met across both the Cosentyx 300mg and 150mg arms, including complete sustained remission and time until patients needed additional treatment through week 52, with no new safety signals identified. Those data were published in the New England Journal of Medicine and presented at the 2026 European Alliance of Associations for Rheumatology Congress on June 3, 2026. The European Commission is expected to issue a final decision within approximately two months.

Supernus Pharmaceuticals reported second-quarter revenues of $211.3 million, up 27.7% year on year and exceeding analysts' expectations by 2.8%, as the broader group of 9 branded pharmaceuticals stocks tracked reported a strong quarter with revenues beating consensus estimates by 6.6% as a group. The company said full-year operating income guidance exceeded analysts' expectations and full-year revenue guidance slightly topped them, prompting President and CEO Jack Khattar to cite the continued strength and sustained momentum of its growth products and continued execution on its commercial strategy. Despite the beat, Supernus shares are down 5.9% since reporting and currently trade at $41.99. Among peers, Bristol-Myers Squibb reported revenues of $12.97 billion, up 5.7% year on year and 12.9% above expectations, while Corcept Therapeutics posted revenues of $256.1 million, up 31.7% and 21.6% above estimates, the biggest beat and highest full-year guidance raise of the group. Zoetis delivered the weakest performance, with revenues of $2.47 billion, flat year on year and 1.5% below expectations, alongside a significant miss of full-year EPS guidance estimates.

Merck announced that the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of KEYTRUDA, the company's anti-PD-1 therapy, in combination with Padcev as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment for adults with resectable muscle-invasive bladder cancer. The recommendation, which also includes KEYTRUDA SC, known as KEYTRUDA QLEX in the U.S., will now be reviewed by the European Commission for marketing authorization in the European Union, Iceland, Liechtenstein and Norway, with a final decision expected by the fourth quarter of 2026. The opinion is based on results from the Phase 3 KEYNOTE-B15 trial, also known as EV-304, conducted in collaboration with Pfizer and Astellas, in which the perioperative regimen reduced the risk of event-free survival events by 47% (HR=0.53) and the risk of death by 35% (HR=0.65) versus neoadjuvant chemotherapy and surgery in cisplatin-eligible patients, while pathologic complete response reached 55.8% versus 32.5%. If approved, KEYTRUDA plus Padcev would become the first and only PD-1 inhibitor plus antibody-drug conjugate regimen in the European Union for patients with MIBC regardless of cisplatin eligibility. In June 2026, the European Commission approved the combination for cisplatin-ineligible adults with resectable MIBC based on the Phase 3 KEYNOTE-905 trial, and in July 2026 the U.S. Food and Drug Administration approved it for adults with MIBC regardless of cisplatin eligibility based on KEYNOTE-B15.

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of Roche's Ocrevus, or ocrelizumab, intravenous infusion for patients aged 10 years and older with relapsing forms of multiple sclerosis, making it the first high-efficacy anti-CD20 treatment option for people with MS as young as 10 years old. The positive opinion rests on the Phase III OPERETTA 2 study, in which Ocrevus was non-inferior to fingolimod, the current standard treatment in paediatric MS, at controlling relapses and reduced the risk of relapses by 48% compared with fingolimod. In the same trial Ocrevus was superior at reducing brain inflammation, with significant reductions in new or enlarging T2 lesions of 48% and gadolinium-enhancing active T1 lesions of 87%, and its safety profile in children and teens was consistent with that seen in adults, with no patients stopping treatment due to side effects. The U.S. FDA approved Ocrevus for paediatric RMS patients in May 2026, and a final decision from the European Commission is expected in the near future. At least 40,000 children and adolescents are living with MS worldwide, with roughly one-third in Europe.

Eli Lilly has entered an exclusive research collaboration with QurCan Therapeutics to develop genetic medicines for nervous system diseases. The agreement centers on QurCan's polymer lipid nanoparticle delivery platform for central and peripheral nervous system targets, with Eli Lilly responsible for later development and commercialization. Lilly is also making a strategic investment in QurCan Therapeutics, tying capital directly to progress in genetic medicine delivery technology. The deal pushes Lilly further toward expansion in neurodegenerative and other specialty drugs alongside its well known GLP 1 portfolio, though pricing pressure and payer pushback still hang over Mounjaro, Zepbound and Foundayo. Investors will want to see a first concrete output such as a nominated development candidate or an announced IND timeline for at least one nervous system genetic therapy.

Bristol-Myers Squibb reported positive two-year Sotyktu results in psoriatic arthritis and affirmed a quarterly dividend of US$0.63 per share for November payment. The clinical and income news arrives as the company's share price has climbed 16.37% over the past 90 days and 17.55% year to date, with a 1-year total shareholder return of 44.42%. Bristol-Myers Squibb last closed at $62.84, while the most followed narrative pegs fair value at $66.21, a small valuation gap the market has not fully closed. The company's pipeline and life-cycle management for major brands, plus strategic partnerships with BioNTech, Philochem and Bain, are seen as offsetting upcoming patent expiries, though heavy dependence on drugs facing those expiries and increasing drug pricing pressure remain key risks.

AstraZeneca and Daiichi Sankyo reported DESTINY-Lung04 Phase III results showing ENHERTU delayed disease progression in HER2-mutant advanced NSCLC versus standard therapy, with 14.3 months median progression free survival and a 37% risk reduction versus pembrolizumab plus chemotherapy. Long-term follow-up data for TAGRISSO indicated eight-year survival benefits in early-stage EGFR-mutated lung cancer patients already on treatment protocols. Tozorakimab emerged as the first biologic to show efficacy in reducing exacerbations across a broad chronic obstructive pulmonary disease population in late-stage trials, with a 29% to 34% exacerbation reduction. Management has pointed to more than US$10b in potential peak risk adjusted revenue from new drugs, and investors will focus on US and EU COPD approval decisions ahead of the first quarter of 2027 Prescription Drug User Fee Act date. The article was produced by Simply Wall St.

Hengrui Medicine announced on the evening of September 17 its first buyback of A-shares, repurchasing 335,000 shares through centralized bidding that day, accounting for 0.005% of total share capital, with a total payment of 14.5036 million yuan. According to a previous announcement, the total repurchase funds this time are no less than 1 billion yuan and no more than 2 billion yuan, to be used for employee stock ownership plans or equity incentives, with an implementation period from August 19, 2026 to August 18, 2027. Since 2023, the company has issued four buyback plans, with cumulative repurchases reaching 2.855 billion yuan. According to statistics from Securities Times Data Treasure, as of September 17, 48 institutions have issued 1,990 buy-type ratings since September, covering 1,078 stocks, of which 64 stocks received ratings from five or more institutions. Sany Heavy Industry, Sailun Tire, and Anker Innovations each received ratings from 11 institutions, while BYD and Mindray Medical each received ratings from 10 institutions. Sany Heavy Industry's net profit attributable to the parent in the first half of the year was 5.69 billion yuan, up 9.13% year-on-year, and as of September 16, 2026, it had cumulatively repurchased 18.3685 million shares, paying 333 million yuan. Sailun Tire's net profit attributable to the parent in the first half was 2.16 billion yuan, up 17.97% year-on-year, with tire sales of 45.0135 million units in the first half, up 14.99% year-on-year. Among the 64 stocks, 28 received net margin buying since September, with Inspur Information, Inovance Technology, and China Yangtze Power ranking top in net buying amounts at 572 million yuan, 403 million yuan, and 280 million yuan respectively.

Onco360 has been selected by AstraZeneca as a national pharmacy partner for Etcamah, also known as camizestrant, the company announced. The therapy is indicated for adult patients with hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer upon detection of an ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test. Etcamah is an estrogen receptor antagonist that binds to the ligand-binding domain of ERα, antagonizing both wild-type and mutated ESR1 and inducing proteasome-dependent degradation of ERα without agonizing it. Its approval was based on the phase 3 SERENA-6 study, in which Etcamah plus a CDK4/6 inhibitor reduced the risk of disease progression or death by 56% versus an aromatase inhibitor plus a CDK4/6 inhibitor, with median PFS of 16 months versus 9.2 months and a hazard ratio of 0.44. The most common adverse reactions, occurring in at least 20% of patients, included decreased neutrophils, leukocytes, hemoglobin, lymphocytes and platelets, along with visual disturbances and fatigue.

Merck shares rose approximately 1.0% to $146.39 Thursday as the pharmaceutical and oncology heavyweight entered the next era of commercial space research, with its blockbuster cancer drug Keytruda already benefiting from work conducted in orbit. Research aboard the International Space Station helped scientists better understand protein crystallization, contributing to the development of a faster subcutaneous formulation of Keytruda, and NASA's research overview explains that microgravity can produce larger and more orderly protein crystals, potentially giving researchers clearer structural information. As the ISS approaches retirement, commercial stations could offer drugmakers dedicated equipment and more predictable research schedules, although regulators still lack a purpose-built approval framework for medicines manufactured in space. The commercial stakes are already enormous: Keytruda generated about $8.37 billion of Merck's latest $16.61 billion quarter, roughly half of total revenue, while the subcutaneous version contributed $463 million, or around 5.5% of Keytruda sales. At $146.39, Merck trades 21.85% above its GF Value estimate of $120.14, signaling that investors are already paying a meaningful premium to the model's estimate of fair value.

AstraZeneca secured a major access win for Enhertu in England after the NHS reversed an earlier cost-effectiveness rejection, Reuters reported Thursday. Roughly 1,000 women a year could now become eligible for Enhertu to treat HER2-low metastatic breast cancer. The drug carries a published British price of 1,455 per 100-milligram vial, but AstraZeneca, Daiichi Sankyo and NICE did not disclose the economics of the reimbursement agreement. Earlier clinical evidence showed the therapy extending survival by around six months for some patients, giving the NHS a meaningful clinical case to reconsider access. The decision could also help expand access in Wales and Northern Ireland, widening Enhertu's commercial reach across the U.K., though the confidential discount, treatment duration and patient persistence will ultimately determine how much of the expanded access flows through to AstraZeneca's bottom line.

Genentech, a member of the Roche Group, and Roche announced the grand opening of the Roche Genentech Innovation Center Boston, a 95,000 square foot facility at Harvard's Enterprise Research Campus in Allston under a 10-year lease with capacity for up to 500 people. The center focuses on cardiovascular, renal and metabolic diseases, bringing together scientists across discovery research, clinical development, artificial intelligence and data science in an end-to-end research environment spanning early-stage discovery through late-stage clinical development. The Innovation Center is part of Roche and Genentech's $50 billion investment in U.S. manufacturing and R&D, building on recent investments and manufacturing milestones in Holly Springs, North Carolina, and Hillsboro, Oregon. Roche and Genentech have approximately 25,000 employees in the United States, with 15 R&D centers and 13 manufacturing sites. Roche CEO Dr. Thomas Schinecker said the investment in Boston is an important part of the commitment to expand the U.S. manufacturing and R&D footprint, while Genentech CEO Ashley Magargee said the center places scientists at the heart of one of the world's most dynamic research communities.

Roche announced the grand opening of the Roche Genentech Innovation Center Boston, a new hub for Cardiovascular, Renal and Metabolism research located at Harvard's Enterprise Research Campus in Allston. The center will bring together scientists across discovery research, clinical development, artificial intelligence and data science, creating an end-to-end research environment spanning early-stage discovery through late-stage clinical development. Roche and Genentech have signed a 10-year lease for the 95,000 square metre center, which will have capacity for up to 500 people. The Innovation Center is part of Roche and Genentech's USD 50 billion investment in US manufacturing and R&D, building on recent investments and manufacturing milestones in Holly Springs, North Carolina, and Hillsboro, Oregon. Roche and Genentech have around 25,000 employees in the United States, with 15 R&D centers and 13 manufacturing sites across Pharma and Diagnostics.

Takeda Pharmaceutical Company Limited announced on September 14 that the FDA accepted its New Drug Application for zasocitinib under priority review for adults with moderate-to-severe plaque psoriasis, with a target action date in the first quarter of calendar 2027. The investigational once-daily oral treatment inhibits tyrosine kinase 2, or TYK2, which participates in inflammatory signaling. The application includes the pivotal Phase 3 LATITUDE PsO 3001 and 3002 studies, in which 71.4% and 69.2% of zasocitinib-treated patients achieved clear or almost clear skin on the static Physician Global Assessment at week 16, compared with 10.7% and 12.6% receiving placebo. Takeda also reported positive topline results in June from a head-to-head study against deucravacitinib, in which zasocitinib achieved statistical superiority at week 16 on complete skin clearance, or PASI 100. In the pivotal trials, treatment-emergent adverse events through week 16 occurred in 62.1% of patients receiving zasocitinib versus 46.9% receiving placebo, and the eventual label, coverage restrictions and net pricing will determine how much of the opportunity becomes revenue.

The FDA granted accelerated approval to AstraZeneca's camizestrant, sold as Etcamah, for a genetically driven form of metastatic breast cancer, Bloomberg reported on September 5, 2026, despite an FDA advisory panel voting in April that the drug lacked patient benefit. The approval covers use alongside a CDK4/6 inhibitor for patients with an ESR1 gene mutation, based on a Phase III trial showing the combination cut the risk of disease progression or death by 56% compared with standard treatment. Median progression-free survival reached 16 months versus 9.2 months with standard treatment. Etcamah is already approved in more than 30 countries and is projected to make over $5 billion in peak annual sales. The accelerated approval requires AstraZeneca to complete confirmatory studies, and the Oncologic Drugs Advisory Committee voted 6-3 against the drug's risk-benefit profile in April, with several members questioning the trial design and whether the treatment would provide long-term benefit.

Roche Holding reported that its Phase III CELESTIMO trial of Lunsumio plus lenalidomide met its primary endpoint in relapsed or refractory follicular lymphoma. The CELESTIMO data support regulatory submissions to expand Lunsumio's label to patients who have received at least one prior systemic therapy. Roche highlighted that the Lunsumio and lenalidomide combination is designed for outpatient administration, aiming to ease capacity pressure on hospitals. The key marker from here is the timing and outcome of health authority reviews of the CELESTIMO data, including whether the study converts Lunsumio's accelerated approval into full approval and secures a second line or later follicular lymphoma label. Roche Holding is a CHF289.6 billion pharmaceuticals and diagnostics group operating across Europe, the Americas, Asia, Africa and Oceania.

Roche announced that the phase III CELESTIMO study of Lunsumio, also known as mosunetuzumab, in combination with Revlimid, or lenalidomide, met its primary endpoint in people with relapsed or refractory follicular lymphoma who had received at least one prior line of treatment. The Lunsumio regimen produced a statistically significant and clinically meaningful improvement in progression-free survival versus MabThera/Rituxan, or rituximab, plus Revlimid, while overall survival data were immature at the interim analysis. The safety profile of Lunsumio plus Revlimid was consistent with the known profiles of the individual medicines, with no new safety signals reported. CELESTIMO is the confirmatory study required to convert Lunsumio monotherapy's accelerated approval and conditional marketing authorization for third-line or later follicular lymphoma into full approval, and it is also intended to support an indication in second-line or later disease. Roche plans to submit the data to health authorities and present it at an upcoming medical conference. Separately, Lunsumio is approved as a fixed-duration monotherapy for third-line or later relapsed or refractory follicular lymphoma in both intravenous and subcutaneous formulations, and in June 2026 the FDA accepted Roche's supplemental biologics license application for Lunsumio VELO in combination with Polivy for relapsed or refractory large B-cell lymphoma, with a decision expected on Feb. 9, 2027.

Bayer announced that the FDA has approved a label expansion for its kidney disease drug Kerendia, also known as finerenone, to treat adults with chronic kidney disease associated with type one diabetes. The drug, a selective non-steroidal mineralocorticoid receptor antagonist, was initially approved in the United States in 2021 for chronic kidney disease associated with type two diabetes, and its label was expanded in 2025 to include adults with symptomatic chronic heart failure with a left ventricular ejection fraction of at least 40 percent. This latest approval, the drug's third in the United States, follows a Priority Review designation and is supported by positive results from the pivotal phase three FINE-ONE study, in which Kerendia added to standard of care produced a statistically significant 25 percent reduction from baseline in the urine albumin-to-creatinine ratio over six months compared with placebo. The company said the expanded indication addresses an important unmet need, as approximately 30 percent of people with type one diabetes in the United States develop chronic kidney disease. Kerendia, marketed as Firialta in some countries, is approved for chronic kidney disease associated with type two diabetes in China, Europe and Japan, and finerenone is also approved for heart failure with a left ventricular ejection fraction of at least 40 percent in Europe, Japan, China and several other markets. Year to date, Bayer's shares have risen 29.8 percent compared with the industry's 10.9 percent growth, and sales of Kerendia skyrocketed 82.9 percent in the second quarter.

Bayer announced that the U.S. Food and Drug Administration approved KERENDIA, also known as finerenone, to reduce urinary albumin-to-creatinine ratio in adults with chronic kidney disease associated with type 1 diabetes, making it the first new treatment approved for this population in more than 30 years. The approval followed the agency's Priority Review of a supplemental New Drug Application and was supported by data from the Phase III FINE-ONE trial, which enrolled 242 adults and showed KERENDIA significantly reduced UACR versus placebo over six months, with reductions of 22% at Month 3 and 28% at Month 6. KERENDIA, a once-daily oral non-steroidal mineralocorticoid receptor antagonist, is the only MRA indicated for adults with chronic kidney disease associated with either type 2 or type 1 diabetes. Approximately 20-30% of people in the U.S. with type 1 diabetes also have chronic kidney disease. Detailed FINE-ONE results were presented at the American Society of Nephrology Kidney Week 2025 and published in the New England Journal of Medicine.

Roche announced that the phase III CELESTIMO study of Lunsumio, also known as mosunetuzumab, in combination with lenalidomide met its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival versus MabThera/Rituxan, or rituximab, plus lenalidomide in people with relapsed or refractory follicular lymphoma who have received at least one prior line of treatment. Overall survival data were immature at the time of interim analysis, and the safety profile of the Lunsumio and lenalidomide combination was consistent with the known profiles of the individual study medicines, with no new safety signals identified. CELESTIMO is a confirmatory study required to convert the accelerated approval and conditional marketing authorisation of Lunsumio monotherapy for third-line or later follicular lymphoma to full approval, as well as to secure an indication in second-line or later follicular lymphoma. Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development, said the results indicate that a two-drug outpatient Lunsumio regimen may offer these patients an effective new option earlier in their treatment journey. Lunsumio is already approved for people with third-line or later follicular lymphoma in 60 countries worldwide and has been used to treat over 3,800 patients, and the data from CELESTIMO will be submitted to health authorities and presented at an upcoming medical meeting.

AstraZeneca has pledged to invest $15bn in China, deepening Western pharmaceutical ties with a country that has become a bona fide drug superpower even as Washington moves to sever them. The company's chief executive, Sir Pascal Soriot, announced the investment during Sir Keir Starmer's Beijing visit, building on existing manufacturing and research sites in Beijing, Shanghai, Wuxi, Taizhou and Qingdao; China is now AstraZeneca's second-largest market, accounting for roughly 12pc of global turnover, with around 17,000 employees and four advanced manufacturing sites. GSK has struck a series of partnerships with Chinese labs, including a $1.3bn pact with Hutchmed for the bulk of licensing rights to what it called first-in-class cancer treatments, and an alliance with Hengrui Pharma worth up to $12bn. Industry-wide licensing deals totalled $138bn last year, a nearly tenfold jump since 2021, according to PharmCube. The US Biosecure Act, signed into law in December, bars companies reliant on federal contracts from working with Chinese biotech firms tied to the military, and the proposed Biotech Investment National Security Act would subject licensing deals involving Chinese companies to national security reviews. China had 1,255 drugs at the research stage by 2024, a nearly eight-fold jump in less than a decade, against 1,441 in America and 400 in Europe.

Swedish Orphan Biovitrum AB and Innate Pharma SA announced that their previously announced strategic partnership is now effective following the expiration of applicable antitrust waiting periods and completion of other conditions. The partnership, entered on the 10th of August 2026, enables initiation of the TELLOMAK-3 confirmatory Phase 3 study in cutaneous T cell lymphoma, a key step toward filing for accelerated approval of lacutamab in Sézary syndrome, with the first patient expected in Q1 2027. Under the agreement, Innate will conduct the TELLOMAK-3 Phase 3 confirmatory trial to support a planned accelerated approval filing for Sézary syndrome, and the study will also support applications for full approvals in key jurisdictions in Sézary syndrome and mycosis fungoides. Sobi will receive exclusive global rights to commercialise lacutamab upon potential accelerated approval and will be eligible to assume full global development rights following positive Phase 3 results. Sobi will pay Innate Pharma USD 75 million upon the partnership becoming effective, and Innate will be eligible to receive up to a further USD 40 million in near-term development milestones connected to Sézary syndrome, up to USD 465 million related to the option for Sobi to get full development rights and to future regulatory and commercial milestones, plus tiered double-digit royalties on net sales.

GSK agreed to acquire Chimagen's trispecific T cell-engager candidate for multiple myeloma, a drug asset the parties describe as a potential best in class trispecific T cell therapy. The deal expands GSK's blood cancer research portfolio and complements recent moves such as the Nuvalent acquisition that brought in Jideytro. Separately, GSK plans to close its German vaccine manufacturing site and consolidate production in Canada, with associated job reductions and supply chain changes. The key test will be whether GSK hits its stated timeline to move the trispecific T cell-engager into phase I trials in 2027, while advancing Jideytro's first line FDA submission planned for 2026. GSK is a £74.8b pharmaceuticals group that develops vaccines, specialty treatments and general medicines across major markets.

Weiguang Biological has received the third-stage acceptance report issued by the Belarusian state institution, the Republican Scientific and Practical Center for Transfusiology and Medical Biotechnologies, marking the successful completion and delivery of the Weiguang Biological–Belarus Blood Transfusion Center blood product cooperation project. The company has thus become the first Chinese enterprise to complete the export of blood product technology. The project officially began in December 2022 and was implemented in three major stages, with all tasks in each stage passing acceptance on the first attempt. In December 2023, Weiguang Biological completed the verification and delivery of technical documents. In October 2024, Belarusian technical personnel came to China for full-time training and all successfully completed the program. Afterward, Weiguang Biological traveled to the Gantsevichi base to conduct production condition inspections and on-site process guidance, successfully completing the trial production of human albumin and intravenous human immunoglobulin as stipulated in the contract. Through cross-testing by both parties, all indicators of the semi-finished and finished products met the standards of the Pharmacopoeia of the People's Republic of China and the relevant Belarusian quality standards. The Belarusian Blood Transfusion Center highly praised Weiguang Biological's professional technical capabilities.

Kanghui Co., Ltd. announced on the evening of September 16 that its wholly owned subsidiary Beijing Kanghui Zhichuang recently signed a Computing Power Service Contract with Company A. The total contract value is approximately 1.72 billion yuan including tax, with a contract term of five years. This amount is the total for the five-year period, and Beijing Kanghui Zhichuang will recognize revenue over five years. The contract stipulates that Beijing Kanghui Zhichuang is responsible for procuring high-performance computing servers, networking, storage, and other hardware infrastructure, and will provide Company A with computing resource services meeting agreed performance indicators as well as full-cycle operation and maintenance services. Company A will pay computing power service fees on a monthly basis. The announcement said that if the computing power services under the contract can be delivered on schedule, it is expected to add approximately 30 million yuan in revenue for the company in 2026, while the impact on net profit for 2026 cannot yet be determined. To ensure implementation of the contract, Beijing Kanghui Zhichuang signed a Purchase and Sale Contract for computing servers with Company G, with a total contract value of approximately 1.141 billion yuan including tax. The contract stipulates that full payment for each batch of computing servers must be made within 50 days after delivery. Company G is a controlling subsidiary of a company listed on both the A-share and H-share markets. The announcement also cautioned that the above 1.141 billion yuan in procurement funds will rely mainly on financing from financial institutions in addition to its own funds, and the company faces considerable financial cost pressure.

Johnson & Johnson reported new late-stage data showing that Caplyta improved sexual functioning among depression patients, adding a potentially important commercial argument for the drug. More than 80% of the study's 480 participants entered the trial reporting sexual dysfunction, and patients receiving 42 milligrams of Caplyta alongside their existing antidepressants recorded statistically significant improvements versus placebo across measures including desire, arousal, orgasm and pleasure. Caplyta already carries approvals for schizophrenia, bipolar depression and adjunctive treatment of major depressive disorder, so better tolerability could give J&J another lever to differentiate the drug in a crowded psychiatric market. J&J picked up Caplyta through its $14.6 billion acquisition of Intra-Cellular Therapies, a sizable bet equal to roughly 57.7% of the company's latest $25.3 billion in quarterly sales. J&J shares were roughly flat, slipping about 0.1% to $266.965, while the stock trades 38.04% above the $193.40 GF Value estimate.

Bayer received accelerated FDA approval for sevabertinib as a first-line therapy for certain HER2-mutant lung cancer patients, a decision that puts fresh attention on how the company's pharmaceutical pipeline could shape investor sentiment. The approval lands as Bayer shares have climbed strongly this year, with a 90 day share price return of 31.84%, a year to date share price return of 28.89%, and a 1 year total shareholder return of 79.40%. The most followed valuation storyline on the stock puts fair value at €56.83, roughly 14% above the recent €48.98 close, a gap that leans heavily on how future earnings and litigation play out. That bullish case rests on sustained advances in Bayer's pharmaceutical innovation pipeline, including robust uptake of recently launched drugs and late-stage assets such as asundexian and new indications for existing blockbusters, which are seen offsetting patent expirations and generic erosion. Still, the glyphosate and PCB lawsuits, along with pressure on key crop protection products, could quickly challenge the 14% undervalued narrative.