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Pharmaceuticals, Biotechnology & Life Sciences▲
Novartis Acquires Full Rights to Sironax Brain Delivery Platform
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.
AbbVie Unveils New VRAYLAR Real-World and Pediatric Safety Data at Psych Congress 2026
AbbVie shared new real-world and pediatric safety data for VRAYLAR in major depressive disorder and bipolar I at Psych Congress 2026. The findings covered routine clinical practice settings, including patients with complex comorbidities and underserved groups, while the pediatric data added information on safety and use in younger patients with mood disorders. AbbVie, a research-focused biopharmaceutical group with a US$466.6b market cap, positions VRAYLAR within a broad portfolio targeting chronic conditions including complex psychiatric disorders. The company said the next concrete checkpoint will be how these data feed into prescribing and label use over the next year, particularly uptake of newly approved low dose VRAYLAR in pediatric and adjunctive MDD settings, trackable in reported prescription trends and segment sales through 2027.
Amgen Fair Value Target Rises to US$388.03 as Analysts Split on Pipeline Risks
Amgen's updated analyst model lifted its fair value price target to US$388.03 from a prior US$371.93, with the revenue growth assumption rising to 3.50% from 2.93%, the net profit margin assumption moving to 25.15% from 24.84%, the future P/E multiple changing to 25.1x from 24.6x, and the discount rate shifting to 7.96% from 7.70%. The revision reflects a split analyst view, with UBS, Argus, TD Cowen, Scotiabank and Oppenheimer raising their Amgen price targets into a US$420 to US$460 range on the strength of a strong product portfolio, Q2 beats and higher guidance. Wells Fargo and Piper Sandler lifted their targets to US$435, citing external survey work and prescription data they believe support higher long term sales potential for cholesterol and cardiovascular products such as Repatha and Lipfendra. On the bearish side, HSBC downgraded Amgen to Hold and cut its target to US$425 from US$445, saying the stock price now more closely matches its assessment of fair value with limited near term upside, while BMO Capital shifted to a neutral Market Perform stance even with a higher US$450 target, citing ongoing loss of exclusivity headwinds and a need for more clarity on the competitive profile and sales potential of MariTide.
Akeso Wins China Phase I Clearance for AK158D1 Bispecific ADC
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.
ChemoMetec Posts Record DKK511 Million Revenue, Guides FY26/27 to DKK545-575 Million
ChemoMetec reported record revenue of DKK511 million for its Q4 2026 fiscal year, up 3% year over year and 7% at constant exchange rates, with EBITDA rising 9% to DKK281 million and the EBITDA margin expanding to 55% from 52.1%. Instrument revenue grew 13% on the strength of XM products including NC-203, whose revenue jumped to DKK68.1 million from DKK27.7 million a year earlier, while the life science business, representing 95% of group revenue, grew 6% to approximately DKK485 million. Consumables revenue fell 4% on the US federal government shutdown in fall 2025, US and Canada revenue slipped 6% in reported terms, and the animal semen, beer and milk business dropped 32% amid a continued market exit. The company repurchased 105,000 shares at year-end for about DKK39 million and roughly 206,600 shares, or 1.2% of share capital, as of the call date, and ended with a cash position of approximately DKK290 million and equity of approximately DKK725 million. For FY2026/27, ChemoMetec guided revenue to DKK545 million to DKK575 million, implying roughly 7% to 13% growth, EBITDA to DKK300 million to DKK330 million, and CapEx to approximately DKK120 million, with CEO Martin Behrens saying the outlook excludes any contribution from the Roche, Tecan and Hamilton collaborations and from delayed XM orders.
Adma Biologics Rises 2.01% as Earnings Beat Expected
Adma Biologics shares closed up 2.01% at $9.13, outpacing the S&P 500's 0.17% gain for the session. The infectious disease drug developer is expected to report quarterly EPS of $0.19, up 18.75% from the prior-year quarter, on revenue of $139.8 million, up 4.16% year over year. For the full year, the Zacks Consensus Estimates project earnings of $0.78 per share and revenue of $536.82 million, representing changes of +30% and +5.22%, respectively, from the prior year. The stock holds a Zacks Rank of #3 (Hold) and trades at a Forward P/E ratio of 11.52, a discount to its industry's average Forward P/E of 23.81.
Bristol Myers Sotyktu Shows Two-Year PsA Efficacy in POETYK Study
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.
FDA Grants Full Approval to Lilly's Inluriyo Plus Verzenio for ESR1-Mutated Breast Cancer
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.
BioMarin Targets $200 Million Amicus Synergies as VOXZOGO Nears $1 Billion
BioMarin Pharmaceutical said it is progressing with the integration of Amicus Therapeutics and expects $200 million in annual non-GAAP cost savings, with most synergies realized in 2027 and full realization in 2028. Speaking at Morgan Stanley's Global Healthcare Conference, President and CEO Alexander Hardy said Amicus had about 505 employees and BioMarin expects to retain approximately 192 over the long term, with about 70% of the savings coming from general and administrative expenses and the remainder from duplicated research and development functions. Chief Financial Officer Brian Mueller said the deal should be accretive in its first year, with substantial accretion beginning next year, and that leverage is now expected to fall below 2.5 times by the middle of 2027, nearly a year earlier than the initial target. Hardy said VOXZOGO delivered 20% quarterly patient growth despite U.S. competition and is expected to reach $1 billion in revenue this year, which would make it BioMarin's first blockbuster product, while a potential FDA approval in hypochondroplasia is not incorporated into its 2026 outlook. BioMarin projects peak sales of approximately $1.4 billion for GALAFOLD and $1.2 billion for POMBILITI + OPFOLDA by the mid-2030s, and said PALYNZIQ grew 27% to $135 million while VIMIZIM has the potential to exceed $1 billion in revenue.
FDA Grants Priority Review to AstraZeneca's Efzimfotase Alfa Filing for Rare Bone Disease HPP
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.
Novo Nordisk CEO Mike Doustdar Resets Obesity Strategy With "Novo Way"
Novo Nordisk CEO Mike Doustdar is resetting the drugmaker's culture and competitive focus under a new "Novo Way" emphasizing customer focus, competitiveness, clarity and care, as the company rebrands to the day-to-day name "Novo" after losing ground to Eli Lilly in obesity drugs. Novo pioneered the modern obesity-drug market with Wegovy in the U.S. in 2021, but Eli Lilly has since gained ground with Zepbound and more aggressive consumer-focused commercialization. Novo has moved into oral obesity treatment with its Wegovy pill, and expects oral drugs to account for more than one-third of GLP-1 obesity-treatment use by 2030; analysts expect the U.S. obesity-treatment market to exceed $100 billion annually by 2030. Novo's Wegovy pill had captured roughly 90% of the U.S. oral-obesity market as of August, although Lilly subsequently said its Foundayo treatment had already captured more than 30% of new U.S. oral-treatment patients. Doustdar's message is that Novo must operate differently to defend and expand its position, and the company's September 21 capital-markets day should show investors how the "Novo Way" will translate into stronger competitive performance.
AbbVie Inc. has declared another quarterly dividend of $1.73 per share, payable November 16, 2026, to shareholders of record as of October 15, holding the payout steady throughout 2026 after raising it from $1.64 earlier in the year. The $1.73 quarterly payment works out to $6.92 per share annually and a yield of roughly 2.7%, a moderate level that AbbVie has not raised again this year. The company's dividend growth record is the larger story: the quarterly payout has climbed from $1.41 in 2022 to $1.48 in 2023, $1.55 in 2024, $1.64 in 2025 and $1.73 in 2026, a roughly 23% increase over that span, and AbbVie has raised its quarterly dividend by more than 330% since it was established in 2013, with the latest increase at 5.5%. In its latest SEC filing, AbbVie reported $7.27 billion in operating cash flow for the first six months of 2026, up from $6.79 billion a year earlier, while paying $6.2 billion in cash dividends during the same period, and it spent about $1.1 billion on acquisitions and investments and another $1.1 billion on share repurchases in that half. AbbVie said future dividends remain subject to board approval and cited its financial condition, capital requirements and debt obligations as factors.
Pfizer's Dividend Streak Stalls at $0.43 as Peers Keep Raising
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 wins positive CHMP opinion for Cosentyx in polymyalgia rheumatica
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.
Avantor Expands RIM Single-Use Bioprocessing Portfolio Across APAC
Avantor has expanded the availability of its RIM single-use bioprocessing portfolio across the Asia Pacific region, strengthening its presence in a key biopharma manufacturing market. The portfolio includes single-use consumables such as bioprocessing bags, assemblies, tubing and components, plus mixing and storage hardware, and is manufactured at Avantor's Changzhou, China facility, the company's first single-use production site in APAC. That 2,600-square-meter plant operates under ISO 9001:2015 certification and Good Manufacturing Practice standards, and RIM products are available exclusively to APAC customers. The move aligns with management's broader Revival strategy, and in the second quarter of 2026 the Bioscience & Medtech Products segment posted double-digit order growth and a book-to-bill ratio of 1.1x, with management expecting the segment to return to organic growth in the second half of 2026. Avantor currently has a market capitalization of $10.56 billion, and its shares have gained 38.4% year to date versus 3.4% growth for the industry and a 10.1% rise in the S&P 500.
Arcturus Therapeutics to Present ARCT-810 Phase 2 OTC Deficiency Data on September 23
Arcturus Therapeutics Holdings Inc. announced it will host a virtual presentation on Wednesday, September 23, 2026, at 4:30 p.m. ET covering the ARCT-810 Phase 2 clinical program for Ornithine transcarbamylase deficiency and the company's mRNA liver therapeutics platform. The company will issue a press release summarizing the presentation prior to the call. Marshall Summar, M.D., a founding member and Executive Committee member of the NIH UCD Consortium and a recognized expert in rare diseases and OTC deficiency, will participate in the presentation. ARCT-810 is an intravenously administered investigational mRNA therapeutic designed to express normal functional OTC enzyme in the liver of individuals with OTC deficiency, and it holds Orphan Medicinal Product Designation and an approved pediatric investigation plan from the European Medicines Agency, plus Orphan Drug Designation, Fast Track Designation and Rare Pediatric Disease Designation from the U.S. Food and Drug Administration. In Europe and the U.S., approximately 10,000 people have OTC deficiency.
AbbVie Presents Real-World VRAYLAR Data at Psych Congress 2026
AbbVie presented new real-world data at Psych Congress 2026 in New Orleans supporting the effectiveness of VRAYLAR (cariprazine) in major depressive disorder and bipolar I depression. In the prospective observational CReW BP-I study of 118 adults with bipolar I depression, mean Montgomery-Åsberg Depression Rating Scale scores fell from a baseline of 32.2 to 19.9 at week 12, a change of -12.92 with p<0.0001, while Functional Assessment Short Test scores dropped from 43.4 to 30.7, a change of -13.11 with p<0.0001; nausea and dizziness were the most common treatment-emergent adverse events at 5.1% each. In an interim analysis of 76 participants in the ongoing ProACt study of adjunctive VRAYLAR in MDD, mean PHQ-9 scores decreased from 15.7 at baseline to 7.1 at week 6, a model-estimated change of -9.29 with a 95% CI of -11.13 to -7.45 and p<0.001, and 76.3% of patients reached minimal or mild depression severity by week 6. AbbVie also presented an anchored matching-adjusted indirect comparison of cariprazine and lumateperone in MDD, final long-term pediatric safety data, and patient preference research on treatment after inadequate antidepressant response. VRAYLAR, developed jointly by AbbVie and Gedeon Richter Plc, has been used by more than 150,000 clinicians to treat more than 1.9 million patients since its 2015 approval.
Xenon plunges 24% on trial pause; Netflix downgraded by Wells Fargo
Xenon Pharmaceuticals plunged 24% in premarket trading after submitting a New Drug Application to the U.S. Food and Drug Administration for azetukalner as a treatment for focal seizures in epilepsy while voluntarily pausing new patient enrollment in ongoing Phase 3 trials for major depressive disorder and bipolar depression. Netflix slipped 2.1% after Wells Fargo downgraded the streaming giant to Underweight from Equal Weight and cut its price target to $57 from $80, citing weakening engagement trends. Array Technologies fell 3.1% to $4.11 after UBS downgraded the solar tracking company to Neutral from Buy and cut its price target to $5 from $10, pointing to a shift from payment-in-kind to cash payments on preferred dividend obligations that UBS estimates will total roughly $162 million in cumulative cash payments through 2030. Steel Dynamics dropped 3.4% after guiding third-quarter 2026 earnings to $5.34 to $5.38 per diluted share, below the analyst consensus of $5.60. Frontline fell 6% as the tanker company went ex-dividend for a combined payout of $3.41 per share, made up of a regular second-quarter dividend of $2.61 and a special dividend of $0.80 funded by the sale of two very large crude carriers.
Andelyn Begins Commercial Manufacturing of Ultragenyx's FDA-Approved FAYUVI Gene Therapy
Andelyn Biosciences announced it is now manufacturing FAYUVI, Ultragenyx Pharmaceutical Inc.'s FDA-approved gene therapy for Sanfilippo syndrome type A, also known as mucopolysaccharidosis type IIIA, for commercial supply at its Columbus, Ohio facility. The move follows the U.S. Food and Drug Administration's approval of FAYUVI, making it the first FDA-approved gene therapy manufactured using the Andelyn AAV Curator Platform process. Sanfilippo syndrome type A is a rare, fatal lysosomal storage disease that primarily affects the central nervous system and is marked by rapid neurodegeneration beginning in early childhood; it is estimated to affect 3,000 to 5,000 patients worldwide, with a median life expectancy of 15 years. Andelyn Chief Executive Officer Wade Macedone said the company is proud to manufacture an FDA-approved gene therapy for commercial use using an AAV Curator Platform process, calling the milestone a reflection of the purpose behind Andelyn's founding. Andelyn, a full-service FDA-inspected cell and gene therapy commercial CDMO with more than 20 years of experience, has produced clinical and commercial material for more than 500 cGMP batches and 85 global clinical trials.
FDA Fully Approves Ultragenyx's Fayuvi for Sanfilippo Syndrome Type A
The FDA has granted full approval to Ultragenyx's Fayuvi, also known as UX111, for treating the neurologic manifestations of mucopolysaccharidosis type IIIA, or Sanfilippo syndrome Type A, in pediatric patients with preserved neurodevelopmental function. The approval makes Fayuvi the first FDA-approved treatment for this rare and fatal neurodegenerative disorder and marks Ultragenyx's second gene therapy approval and sixth FDA approval overall. The decision was supported by nearly eight years of clinical data, including a 23.5-point higher mean change in Bayley-III Cognitive raw score versus an untreated natural-history cohort. Ultragenyx shares ended the last trading session 12.6% higher at $14.5 on above-average volume, though the stock has lost 50.9% over the past four weeks. The company is expected to post a quarterly loss of $0.65 per share, a year-over-year change of +64.1%, on revenues of $185.2 million, up 15.8% from the year-ago quarter, with its consensus EPS estimate revised 6.4% higher over the last 30 days.
Merck Wins Positive EU CHMP Opinion for KEYTRUDA Plus Padcev in Resectable Muscle-Invasive Bladder Cancer
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.
CHMP Backs Roche's Ocrevus for Children and Teens With Relapsing MS
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.
Novo Nordisk's once-weekly Sogroya wins positive CHMP opinion for idiopathic short stature in children
Novo Nordisk has received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency recommending once-weekly Sogroya, or somapacitan, for children in Europe living with idiopathic short stature with persistent growth disturbance. If approved, Sogroya would be the first and only growth hormone treatment approved for idiopathic short stature in the EU, a condition that affects up to 3% of children worldwide. The opinion follows the CHMP's May 2026 recommendation of Sogroya for short stature in children born small for gestational age and with Noonan Syndrome, and the decision now passes to the European Commission, whose ruling on marketing authorisation covering all three indications is expected later this year. The recommendation was supported by data from the REAL8 phase 3 basket trial, in which once-weekly Sogroya was non-inferior to once-daily growth hormone treatment for mean annualised height velocity at Week 52 in children with idiopathic short stature, those born small for gestational age and those with Noonan Syndrome. Sogroya is already authorised in the EU for growth hormone deficiency in adults since 31 March 2021 and in children aged 3 years and older since 24 July 2023.
Eli Lilly Partners With QurCan Therapeutics on Genetic Medicines for Nervous System Diseases
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.
Johnson & Johnson Weighs Roughly US$20b DePuy Synthes Sale
Johnson & Johnson is weighing a potential sale of DePuy Synthes for about US$20b, a move that has put the company back in focus for investors watching how management reshapes its MedTech footprint and capital allocation priorities. The shares sit at US$270.22, with a 1-day share price return of 1.10%, a 90-day share price return of 18.32%, a year-to-date share price return of 30.32% and a 1-year total shareholder return of 58.65%. The most followed valuation narrative pegs fair value at $270.59, almost exactly in line with the latest close, while analysts carry a consensus price target of $270.59, with the most bullish at $305.0 and the most bearish at $190.0. The SWS DCF model points to a future cash flow value of $364.57, implying the stock trades at a sizeable discount. Johnson & Johnson still faces real pressure from STELARA's loss of exclusivity and ongoing talc litigation, either of which could undercut the current fair value story.
Xenon plunges 27% on enrollment pause; Nucor and Steel Dynamics guide below consensus
Xenon Pharmaceuticals shares plunged 27% after the company paused enrollment in azetukalner studies for major depressive disorder and bipolar depression following reports of neuropsychiatric adverse events. Xenon said the events are consistent with the drug's known safety and tolerability profile and mechanism but had not previously been observed in its Phase 2 X-NOVA study in MDD, and it expects the pause to be temporary while it evaluates dosing adjustments; currently enrolled patients and those in open-label extension studies will continue treatment. The pause does not affect azetukalner studies in focal seizures or primary generalized tonic-clonic seizures, and Xenon has submitted an NDA to the FDA for focal seizures. Nucor fell 2% and Steel Dynamics fell 2% after both steelmakers issued Q3 earnings guidance below Wall Street expectations, with Nucor expecting Q3 earnings of $5.55-$5.65 per share versus the $5.99 consensus and Steel Dynamics expecting $5.34-$5.38 per share versus the $5.60 consensus. Intapp rose 3% after announcing a partnership with OpenAI to make Celeste, its expert AI coworker, available as a plug-in for ChatGPT Enterprise, with the plug-in available to eligible Intapp Celeste clients starting Thursday.
Neurocrine Posts KINECT-PRO Data as Revenue Jumps 39%
Neurocrine Biosciences on August 12 published KINECT-PRO Phase 4 findings showing INGREZZA eased the daily burden of tardive dyskinesia beyond what clinician rating scales capture. The study followed 59 tardive dyskinesia patients on daily INGREZZA for 24 weeks, with 52 reaching the final visit; among the 45 patients in the efficacy analysis, about 58% hit the threshold for symptomatic remission on clinician-rated movement severity, with gains exceeding the clinically meaningful threshold by Week 4 on movement severity and by Week 8 on patient-reported impact. The data landed weeks after Neurocrine's July 30 second-quarter report, which showed total revenue up 39% year over year to $959 million and INGREZZA sales climbing 15% to $716 million on record new prescriptions, prompting management to raise full-year INGREZZA guidance to $2.825 billion to $2.875 billion. CRENESSITY and the newly acquired VYKAT XR added $184 million and $54 million respectively. The growth came at a cost: cash and marketable securities fell from roughly $2.5 billion at the end of 2025 to about $482 million by June 30, largely because Neurocrine paid $53.00 a share in cash to acquire Soleno Therapeutics in a $2.9 billion deal that closed in May, backstopped by a new $1.0 billion revolving credit facility. Second-quarter R&D rose to $327 million from $244 million a year earlier, SG&A jumped to $440 million from $286 million, and the Soleno deal added roughly $2.2 billion of intangible assets that will amortize over 16 years, while INGREZZA still supplied about three-quarters of quarterly revenue.
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.
Halozyme prices upsized $1.3B convertible senior notes due 2033
Halozyme Therapeutics announced on Thursday the pricing of $1.3B aggregate principal amount of 1.50% convertible senior notes due 2033, an increase from the previously announced offering size of $1.05B aggregate principal amount. The company also granted the initial purchasers a 13-day option to buy up to an additional $200M aggregate principal amount of the convertible notes. Shares of Halozyme rose 1.3% in post market trading.
Halozyme Therapeutics announced the pricing of $1.3 billion aggregate principal amount of 1.50% convertible senior notes due 2033, upsized from the previously announced $1.05 billion offering, with a 13-day option granted to initial purchasers for up to an additional $200 million. The notes carry an initial conversion rate of 7.1509 shares per $1,000 principal, equivalent to a conversion price of approximately $139.84 per share, a premium of about 27.5% over the $109.68 closing price on September 17, 2026, and mature on October 1, 2033. Halozyme expects net proceeds of approximately $1.275 billion, or about $1.471 billion if the purchasers' option is exercised in full, and will use roughly $162.5 million to fund capped call transactions with a cap price of approximately $208.39 per share, a 90.0% premium. The company also agreed to repurchase approximately $151.7 million principal of its 0.25% convertible notes due 2027 for about $217.0 million and $220.0 million principal of its 1.00% convertible notes due 2028 for about $435.5 million, including accrued interest. The offering is expected to close on September 22, 2026, with the remainder of proceeds earmarked for general corporate purposes, including working capital, capital expenditures, and potential acquisitions.
AstraZeneca and Daiichi Sankyo Report First Phase III Win for HER2-Directed Lung Cancer Drug
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.
AstraZeneca's Tozorakimab Cuts COPD Flare-Ups by 30% in Late-Stage Trials
AstraZeneca PLC released full results from two successful late-stage trials of tozorakimab, an experimental chronic obstructive pulmonary disease drug that reduced moderate and severe flare-ups by roughly 30% across a broad patient population. The two trials showed reductions in moderate-to-severe COPD exacerbations of 29% to 34%, with the highest-eosinophil subgroup seeing a 43% reduction, and benefits appearing regardless of eosinophil levels, smoking status, or disease severity. The biologic, which blocks the inflammatory protein IL-33, is under priority review at the FDA with a decision expected in the first quarter of 2027, and AstraZeneca forecasts more than $5 billion in peak annual sales, an estimate CEO Pascal Soriot said the drug's commercial potential could exceed. AstraZeneca believes tozorakimab could reach a broader group of COPD patients than existing biologics such as Regeneron and Sanofi's Dupixent and GSK's Nucala, which only target those with high eosinophil counts. The company's oncology and respiratory portfolio made $14.1 billion in first-half 2026 revenue, up 15% year over year, as AstraZeneca targets $80 billion in annual revenue by 2030, though the drug still needs FDA approval and faces patent-expiry pressure on established products including Farxiga and Brilinta.
Novartis Shares Plunge 10% as Del-desiran Fails Late-Stage Trial
Novartis shares fell about 10% after the company said its experimental drug del-desiran failed to meet its primary goal in a late-stage trial for myotonic dystrophy type 1, marking its third clinical setback in a week. The earlier failures involved the cardiovascular drug pelacarsen and a pause of eight trials of the cell therapy rap-cel following three patient deaths. The decline erased roughly 24 billion Swiss francs, or about $29.6 billion, in market value and put Novartis on pace for one of its worst trading days in company history. Barclays had estimated peak annual sales of about $3.1 billion for del-desiran and assigned the drug a 60% probability of success after positive mid-stage results, and the failure raises questions about the $12 billion Avidity acquisition that brought the drug into Novartis' pipeline. Management reaffirmed its full-year financial guidance and maintained its target for 5% to 6% compound annual sales growth from 2025 through 2030, while the company reported successful late-stage results for remibrutinib in multiple sclerosis and expects more data later this year.
Hengrui Medicine makes first buyback of 335,000 shares, cumulative repurchase amount exceeds 2.8 billion yuan
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.
Novartis pelacarsen failure raises stakes for Amgen and Eli Lilly Lp(a) drugs
Novartis' failed pelacarsen trial has raised the stakes for rival experimental cholesterol drugs from Amgen and Eli Lilly, both racing to prove that lowering lipoprotein(a), or Lp(a), can meaningfully reduce heart attacks and strokes. Analysts said Amgen's olpasiran faces the clearest negative read-through given its similar trial design, while Lilly's lepodisiran is being tested in a broader patient population that could limit how directly Novartis' failure applies and is described as less material to Lilly's overall valuation than pelacarsen was for Novartis. The failure raises the scientific and regulatory burden for the entire Lp(a) drug class, and both companies still face binary clinical risk before either olpasiran or lepodisiran delivers definitive late-stage cardiovascular-outcome evidence. On hedge fund positioning, Amgen's position value nearly doubled to $3.14 billion in the second quarter from $1.63 billion in the first, with holder count roughly steady at 66 versus 65, while Lilly's holders rose to 152 from 132 and position value jumped to $17.24 billion from $12.58 billion.
Novo Nordisk Halts Two More Ziltivekimab Heart Trials After July Failure
Novo Nordisk A/S halted two additional trials of its experimental cardiovascular drug ziltivekimab, further denting the Danish drugmaker's efforts to diversify beyond its blockbuster obesity and diabetes franchise. The move follows a July disclosure that ziltivekimab failed to reduce major adverse cardiovascular events in a late-stage trial. An independent data monitoring committee found a low likelihood that the two additional heart-failure studies would produce a different result from that earlier failure, prompting Novo to end them ahead of schedule. Novo will continue testing ziltivekimab in patients recovering from a heart attack, with results expected in the first half of 2027. The company's oral Wegovy pill has already generated more than 2 million prescriptions shortly after its January 2026 launch, as Novo competes with Eli Lilly in the oral GLP-1 market.
PAHO and Gilead Sign Lenacapavir Access Deal for 14 Latin American Countries
The Pan American Health Organization and Gilead Sciences have reached a new agreement that could expand access to lenacapavir for HIV prevention in 14 countries across Latin America, a deal the AIDS Healthcare Foundation is calling a victory for civil society. AHF, the world's largest HIV care provider, said it was among the first organizations to mobilize after the initial Gilead-WHO agreement excluded Latin American countries, and it joined other civil society groups in calling for that agreement to be expanded. The AHF Global Public Health Institute, in partnership with the National Institute of Public Health of Mexico, conducted a study on lenacapavir's potential impact in the region, finding that greater public health impact will depend on both a significantly reduced price and acceptability among potential users. Dr. Jorge Saavedra, Executive Director of the AHF Global Public Health Institute and former Director General of Mexico's National AIDS Program, said the separate arrangement must aim not simply for a fair price but for a genuinely affordable one, warning that prevention should be less expensive than treatment. Dr. Patricia Campos, AHF Bureau Chief for Latin America and the Caribbean, noted that Argentina, Brazil, Mexico, and Peru helped generate the clinical evidence for lenacapavir through Gilead's pivotal PURPOSE 2 trial yet were excluded from the company's original voluntary licensing arrangement. AHF urged Gilead and PAHO to make pricing, timelines, regulatory requirements, and other key terms transparent, saying access cannot exist only on paper.
Charles River Launches Rapid Cell Banking Platform Cutting Timelines 40%
Charles River Laboratories International has introduced rapid cell banking programs that shorten cell bank production timelines by about 40% versus the 20-week industry standard, integrating rapid microbiological methods and CGMP-compliant Next-Generation Sequencing to support faster, higher-quality biologic and advanced therapy development. The launch aligns with Charles River's Alternative Methods Advancement Project, which aims to cut reliance on animal testing while still meeting stringent FDA, EMA, and ICH quality and safety expectations. The company leans on its Pathoquest NGS acquisition for the platform, tightening its end-to-end biologics offering, though the move is unlikely to immediately rewrite near-term revenue or earnings trends given management's already reduced 2026 guidance and the company's loss-making position. Four Simply Wall St Community fair value estimates cluster between about US$282 and US$318, with shares potentially undervalued by 6%.
Charles River Laboratories Launches Rapid Cell Banking Programs, Shares Rise 3.6%
Charles River Laboratories announced the launch of rapid cell banking programs designed to accelerate release timelines, sending its shares up 3.6% in the afternoon session. According to a company press release, the newly launched programs offer a 40% reduction in cell bank production time compared to the 20-week industry standard. Under the comprehensive solution, rapid cell bank and release packages are paired with Next-Generation Sequencing characterization. Charles River Laboratories stated that this solution is designed to improve product quality, safety, and regulatory readiness while reducing overall development timelines. The shares closed the day at $281.70, up 3% from the previous close.