Oncology Therapeutics

Akeso has secured Phase I clinical trial clearance in China for AK158D1, a bispecific antibody drug conjugate targeting EGFR and TROP2 in advanced solid tumors. The clearance puts fresh attention on the company's pipeline as it pushes deeper into IO2.0 and ADC2.0. Akeso's shares recently traded at HK$90.5, up 3.37% over 90 days but down 20.12% year to date, against a consensus analyst price target of HK$158.28, with the most bullish target at HK$226.04 and the most bearish at HK$125.08. The company remains exposed to execution setbacks given its reliance on a handful of key drugs and a current net loss of CN¥967.2 million.

Merck received a positive opinion from the European Medicines Agency's CHMP for KEYTRUDA plus Padcev in muscle-invasive bladder cancer. The CHMP backed the combination as perioperative therapy for adults with resectable muscle-invasive bladder cancer in the European Union. If endorsed by the European Commission, the regimen would be the first PD-1 inhibitor plus antibody-drug conjugate option for this setting in Europe. The addressable group in Europe is relatively concentrated but clinically high need, with bladder cancer cases estimated at about 224,700 in 2022, roughly 25% of them classified as muscle invasive. The key near-term marker is the European Commission ruling expected by the fourth quarter of 2026, since the CHMP only issues recommendations.

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.

Johnson & Johnson has agreed to a $5.5 billion settlement covering nearly all of its remaining talc litigation, a deal that requires participation by plaintiff firms representing at least 95% of the remaining claims before it becomes effective, with a first payment of up to $3 billion expected in 2027 and additional payments beginning in 2028. The agreement addresses roughly 76,000 lawsuits alleging that the company's talc-based baby powders contained asbestos and caused ovarian cancer. The news comes as JNJ stock has risen 18.3% in the past three months and 30.6% this year, against a 10.9% gain for the industry, supported by a raised 2026 outlook and Innovative Medicine segment sales up 6.2% on an organic basis in the first half of 2026 despite the loss of exclusivity of Stelara. That segment has now posted five consecutive quarters of sales above $15 billion, while J&J's newer cancer drugs Carvykti, Tecvayli, Talvey and Rybrevant/Lazcluze combined for $2.6 billion in first-half sales. MedTech grew more slowly, with second-quarter sales up 4.5% year over year to $8.93 billion, or 3.6% operationally, as Abiomed sales fell 2% and cardiovascular operational growth reached just 3.1%. J&J still targets around $100 billion in 2026 revenues, with $49.4 billion already booked in the first half, and the Zacks Consensus Estimate for 2026 earnings per share has edged up from $11.59 to $11.61 over the past 30 days.

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.

On September 18, the Ministry of Industry and Information Technology, the National Development and Reform Commission, and eight other ministries jointly released the 15th Five-Year Plan for the Development of the Pharmaceutical Industry, proposing that by 2030, biopharmaceutical R&D and application will rank among the world's leaders, and the biopharmaceutical industry will accelerate its rise as a national emerging pillar industry. The plan sets 10 expected indicators covering industrial scale and efficiency, innovative development, enterprise cultivation, and cluster development, including operating revenue of pharmaceutical industrial enterprises above designated size exceeding 3.5 trillion yuan, an average annual growth rate of the innovative drug industry scale exceeding 20 percent, more than 5 products with global annual sales exceeding 1 billion US dollars, first-in-class innovative drugs accounting for more than 25 percent of the global total, more than 200 innovative medical devices launched, 50 pharmaceutical industrial enterprises with annual operating revenue exceeding 10 billion yuan, and 20 pharmaceutical industrial parks at the 100-billion-yuan level. Boosted by this news, the three major stock indices all rose more than 1 percent in early trading that day. Huatian Technology hit the daily limit up, with turnover of 6.065 billion yuan, nearly 1.47 million lots of sealed buy orders on the limit-up board, and nearly 3.3 billion yuan of main capital rushing in, ranking first in the A-share market. Zhou Sicong, fund manager of Ping An Pharmaceutical Select, believes innovative drugs are likely to become an important growth theme, and CITIC Securities said China's innovative drugs have entered a stage of global value realization. According to statistics from Securities Times Data Treasure, since September, Chengdu Leading Pharmaceutical, Asymchem Laboratories, Porton Pharma Solutions, and Hunan Warrant Pharmaceutical have led gains, all rising more than 10 percent, with Chengdu Leading Pharmaceutical up a cumulative 16.87 percent.

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.

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.

AbbVie announced that full results from the Phase 3 CERVINO study of its investigational drug etentamig will be featured in a plenary presentation at the 23rd International Myeloma Society Annual Meeting, held September 23-26, 2026, in Glasgow, Scotland. Topline results showed that etentamig, a second-generation BCMA x CD3 bispecific T-cell engager, met the study's dual primary endpoints of objective response rate and progression-free survival versus standard available therapies in adults with triple-class exposed relapsed/refractory multiple myeloma. Beyond CERVINO, AbbVie will present research spanning its myeloma pipeline, including ABBV-2001 (ISB 2001), a CD38 x BCMA x CD3 trispecific T-cell engager, and surzetoclax, a BCL-2 small-molecule inhibitor, alongside studies of etentamig across multiple treatment settings. Additional presentations will cover treatment sequencing, infection-related healthcare utilization and costs, and real-world outcomes. Etentamig, ABBV-2001 (ISB 2001) and surzetoclax are investigational medicines and are not approved by any health authorities worldwide.

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.

This year, the pace of Chinese innovative drugs going global has accelerated further, with total out-licensing deal value surpassing $120 billion, up 36% year-on-year. Upfront payments exceeded $10 billion. The market is also showing steady growth in average deal size, rising upfront payment amounts and their share of total deal value, and frequent large transactions. Guosen Securities noted that in the first half of 2026, the pharmaceutical industry's fundamentals continued to improve, with innovative drugs and CXO sectors performing particularly well. Revenue in the innovative drug sector grew 44.1% year-on-year, while CXO sector revenue and net profit rose 23.3% and 15.7% respectively. Growth accelerated further in the second quarter, with innovative drug revenue up 51.3% year-on-year. Domestic innovative drugs are entering a phase of volume expansion under medical insurance, while the second wave of innovative drug globalization is reaching a harvest period. Multiple products have met primary endpoints in global Phase III clinical trials and are about to enter global commercialization. As of 09:59 on September 17, 2026, the STAR Market Pharmaceutical ETF Penghua, tracking the SSE STAR Market Biomedical Index, rose 1.12%. Among constituents, Vazyme rose 5.60%, CanSino Biologics rose 4.38%, and HOB Biotech rose 3.61%, with Dizal Pharmaceutical and Hotgen Biotech also advancing.

BlossomHill Therapeutics closed up better than 18% on Wednesday, its strongest one-day performance since its August 7 IPO. The surge followed the company's Tuesday release of updated data from its ongoing Phase 1/2 SOLARA trial of lead program BH-30643 in EGFR-mutant non-small cell lung cancer. As of a May data cutoff, 16 of 40 patients with EGFR C797S-positive resistance to prior EGFR inhibitor treatment, with or without concurrent T790M, achieved a confirmed possible response and another two had an unconfirmed response, for an objective response rate of 45% and a disease control rate of 88%, with median follow-up of 6.9 months. BlossomHill said BH-30643 is designed to overcome the limitations of currently approved EGFR inhibitors for the treatment of EGFR-mutant NSCLC. One of the most prescribed therapies for NSCLC is AstraZeneca's Tagrisso, a third-generation EGFR inhibitor with a first-line indication that brought in $3.8B in the first half of 2026.

BioNTech reported detailed Phase 3 data showing its investigational lung cancer therapy gotistobart nearly doubled median overall survival compared with standard chemotherapy. The shares traded around US$96.69, with a 30 day share price return of 3.87% and a 90 day share price return of 4.85%, while the 1 year total shareholder return declined 2.59% and the 5 year total shareholder return fell 71.40%. BioNTech now trades at roughly a 22% discount to analyst targets, with the most followed fair value view at $120.62 against the last close of $96.69. The company's pipeline includes multiple late stage Phase II and III trials for BNT327 and mRNA cancer immunotherapies in lung and breast cancers, supported by the planned CureVac acquisition. Risks to the bullish case include late stage oncology trial failures and prolonged COVID-19 vaccine demand weakness and related litigation.

AstraZeneca shares rose 2.16% intraday after J.P. Morgan reiterated an Overweight rating, citing six Phase III readouts due in 2027 that together carry more than $10 billion in risk-adjusted peak sales and should improve confidence in the company's ability to keep growing beyond 2030. For laroprovstat, an oral PCSK9 inhibitor reading out in the first quarter of 2027, the bank models peak risk-adjusted sales of $3.2 billion against consensus of $2.4 billion, noting the drug showed a smaller LDL-C reduction than Merck's Lipfendra in earlier testing but carries no fasting requirement, which J.P. Morgan sees as the more important difference. On the bank's numbers, zibotentan with Farxiga in kidney disease gets an 80% probability of success on comparable earlier results, while balcinerenone with Farxiga in heart failure gets 50% because its partial mineralocorticoid receptor antagonism could dilute the benefit rivals have shown. In oncology, Datroway in triple-negative breast cancer and puxi-sam in endometrial cancer both carry 80%, and saruparib in prostate cancer is judged strong enough in the 30% of trial patients with HRR mutations to de-risk $3 billion of peak sales.

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.

Corcept Therapeutics raised its full-year 2026 revenue guidance to $1.10-$1.20 billion from an earlier expectation of $950 million to $1.05 billion, reflecting growing momentum in its lead marketed drug Korlym and other business activities. Korlym, approved for the treatment of Cushing's syndrome, recorded sales of $373.5 million in the first six months of 2026, up 6.2% year over year, and remains the majority driver of the company's top line. The company is working to diversify beyond Korlym, and in March 2026 the FDA approved Lifyorli, or relacorilant, in combination with nab-paclitaxel for adults with platinum-resistant ovarian cancer; Lifyorli generated $47.6 million in the second quarter of 2026, its first quarter of commercial availability. Corcept resubmitted its new drug application for relacorilant in hypercortisolism in June 2026, and the FDA accepted the application with a target action date of Dec. 17, 2026. The Zacks Consensus Estimate for 2026 earnings per share has risen from 58 cents to $2.02 over the past 60 days, while the 2027 estimate has increased from $2.27 to $3.44.

Parnassus Growth Equity Fund added Revolution Medicines, Inc. as a new holding during the second quarter of 2026, citing promising late-stage clinical results for its lead pancreatic cancer drug candidate, daraxonrasib. In its Q2 2026 investor letter, the fund said daraxonrasib has delivered strong late-stage clinical results in pancreatic cancer, with data suggesting it could become a new standard of care and support significant commercial potential, alongside additional opportunities in other cancers over time. Revolution Medicines is a clinical-stage precision oncology company developing novel targeted therapies for RAS-addicted cancers. The stock closed at $204.86 per share on September 15, 2026, down 6.53% over the past month but up 358.00% over the past 52 weeks, giving the company a market capitalization of $43.91 billion. The fund itself returned 17.49% net of fees for the quarter, outperforming the Russell 1000 Growth Index's 16.74%, and returned 6.17% year-to-date against the index's 5.33%.

Geron Corporation said it now expects 2026 RYTELO net revenue toward the midpoint to high end of its previously issued $220 million to $240 million guidance, or approximately $230 million to $240 million. Speaking at the H.C. Wainwright 28th Annual Global Investment Conference, Chief Executive Officer Harout Semerjian said the company reported record quarterly net revenue of $57.5 million, its highest since the July 2024 launch of RYTELO, also known as imetelstat, the first telomerase inhibitor approved for lower-risk myelodysplastic syndromes, with three consecutive quarters of growth. Geron is shifting commercial efforts toward community oncology practices, which account for about 80% of the lower-risk MDS market, and is adding 100 to 200 new RYTELO accounts per quarter, while 34% of its business, measured on a 12-month lookback, already comes from first- and second-line patients. Chief Medical Officer Joseph Eid said National Comprehensive Cancer Network guidelines have been updated twice since launch to position the therapy as a second-line option, and that luspatercept's move to first-line treatment has supported RYTELO uptake. Geron plans to outline its ex-U.S. strategy, particularly for Europe, before year-end without a traditional large-scale country-by-country buildout, and continues the 327-patient IMpactMF Phase 3 trial in relapsed or refractory myelofibrosis, which completed enrollment last September with overall survival as the primary endpoint. The company ended the period with more than $300 million in cash and reiterated 2026 operating-expense guidance of $230 million to $240 million.

Johnson & Johnson reported new clinical trial results for RYBREVANT-based regimens in EGFR-mutated NSCLC at a major oncology conference. The Phase 2b COPERNICUS study showed RYBREVANT plus LAZCLUZE for newly diagnosed patients with EGFR-mutated NSCLC had improved tolerability and fewer treatment-related adverse events. Final data from the Phase 3 PAPILLON trial found first-line RYBREVANT plus chemotherapy produced the longest reported median overall survival in EGFR exon 20 insertion NSCLC. Johnson & Johnson, a US-based pharmaceuticals heavyweight with a market cap of about $641.8b, holds RYBREVANT as a key lung cancer asset within its drug pipeline. The company's central bet is that a new cycle of oncology and immunology drugs offsets patent losses and legal overhangs, including STELARA's loss of exclusivity, keeping the pharmaceuticals arm a growth engine.

Business Alignment Public Company Limited, or BIZ, extended its congratulations on the occasion of Siriraj Hospital unveiling Asia's first Halcyon Version 5 radiotherapy machine. Chief Executive Officer Sompong Chuenkittiyanont and Assistant Chief Executive Officer for Finance and Human Resources Phuwit Silaphusit, together with a delegation of executives, attended the event. Professor Dr. Apichat Asavamongkolkul, Dean of the Faculty of Medicine Siriraj Hospital, Mahidol University, presided over the ceremony, and Professor Dr. Yongyut Sirivatanauksorn, Director of Siriraj Hospital, joined the press conference and the signing of a cooperation agreement between the Faculty of Medicine Siriraj Hospital and Siemens Healthineers. The Department of Radiology at the Faculty of Medicine Siriraj Hospital has adopted the Halcyon Version 5 radiotherapy machine to treat cancer and tumors with radiation therapy, making it the first in Asia. Its special features are revolutionary for the field of radiation therapy: faster speed, greater precision, and an improved patient experience. The event was held at the Roj Suwannasut Conference Room, Radiology Ratchanakharin Building, 2nd Floor, Siriraj Hospital.

Moderna and Merck reported positive results from the late-stage INTerpath-001 study of intismeran autogene (V940/mRNA-4157) in combination with Keytruda in patients with high-risk Stage IIB-IV melanoma whose tumors had been removed through surgery. The study met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival, with the companies stating the improvements were statistically significant and clinically meaningful, though no numerical data were disclosed. INTerpath-001 marks the first positive phase III readout for an individualized neoantigen therapy and an mRNA-based cancer therapy, and five-year follow-up from the phase IIb KEYNOTE-942 study showed the combination reduced the risk of recurrence or death by 49% and the risk of distant metastasis or death by 59% versus Keytruda alone. Moderna and Merck are evaluating intismeran across nine phase II and phase III studies spanning multiple tumor types, including non-small cell lung cancer, bladder cancer and renal cell carcinoma, while Moderna's broader pipeline includes separate mRNA-based cancer antigen therapies, a T-cell engager and a cell-therapy enhancer. Moderna shares have skyrocketed nearly 400% year to date, outperforming the industry's 7% growth, and the stock trades at 23.44 times forward 12-month sales versus the industry average of 1.90 times.

BioNTech SE reported that its investigational lung-cancer drug gotistobart produced a clinically meaningful overall-survival benefit in the Phase 3 PRESERVE-003 trial in patients with metastatic squamous non-small cell lung cancer whose disease had progressed after prior immunotherapy and chemotherapy. Reuters said gotistobart nearly doubled survival compared with standard-of-care chemotherapy, strengthening the case for the drug as a potential chemotherapy-free treatment in a population with significant unmet need. The result builds on earlier Stage 1 data, where gotistobart reduced the risk of death by 54% versus docetaxel, with a hazard ratio of 0.46; median overall survival was not yet reached for gotistobart versus 9.95 months for docetaxel, while the 12-month progression-free survival rate was 25.2% versus 0%. BioNTech is now awaiting the pivotal Stage 2 readout, which remains the critical test for registration and broader investor confidence, and the company says it has 14 ongoing pivotal trials and more than 10 novel combination programs, with its lung-cancer strategy spanning more than 16 ongoing clinical trials and five Phase 3 programs. BioNTech had €16.6 billion in cash, cash equivalents, and securities at June 30, 2026, despite spending €1.0 billion on adjusted R&D during the first half, while first-half 2026 revenue fell to €223.7 million from €443.6 million a year earlier and the company expects 2026 revenue of only €1.6 billion to €1.9 billion.