Heart and vascular disease is humanity's number-one killer — nearly 18 million lives a year. Yet in business terms it was long the "most boring field" there is, because its workhorse drugs, the statins, have all turned into cheap generics. So the exciting story isn't the overall market — it's the "new mechanisms": a cholesterol shot you take just twice a year, a diabetes drug that became a heart drug, and a weight-loss drug proven to actually cut heart attacks.
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.
Edwards Lifesciences Targets $2 Billion TMTT Business by 2030 as CMS Expands TAVR Access
Edwards Lifesciences outlined a structural heart growth plan that targets more than US$2 billion in transcatheter mitral and tricuspid revenue by 2030, anchored by its PASCAL, EVOQUE, and Sapien M3 technologies. The plan sits alongside updated Medicare coverage that could enable 100 to 200 additional U.S. centers to perform TAVR procedures, reinforcing the company's transcatheter ecosystem. Edwards' broader narrative projects $8.5 billion in revenue and $2.2 billion in earnings by 2029, requiring 9.3% yearly revenue growth and an earnings increase of about $1.2 billion from $979.9 million today. Three fair value estimates from the Simply Wall St Community cluster between US$91.47 and US$100.96 per share, against a $100.96 fair value that implies 14% upside to the current price. The company still faces risks around margins, tariffs, and competitive pressure in international markets.
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.
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.
Medtronic Raises Fiscal 2027 Outlook on Strong Heart Device Demand
Medtronic raised the lower end of its fiscal 2027 profit forecast and lifted its revenue growth outlook, citing strong demand for heart devices used in complex cardiovascular procedures. The Ireland-based company raised the lower end of its adjusted per-share profit forecast to $5.94 from $5.90 while keeping the upper end at $6.00, against an analyst average of $5.95, and now expects annual organic revenue growth of 7.25% to 7.75%, up from 6.75% to 7.25% previously. First-quarter fiscal 2027 revenue reached $9.756 billion, up 13.7% both reported and organically, beating the $9.55 billion analyst consensus, with adjusted earnings per share of $1.45 topping the $1.39 estimate. Growth was broad-based across segments, with Cardiovascular revenue up 19.5%, Diabetes up 16.9%, Neuroscience up 10.3%, and Medical Surgical up 10.0%, though Medtronic said about $570 million of the quarter's growth came from an extra week in the reporting period. The guidance still includes the diabetes business, which Medtronic has said it may fully separate before fiscal year-end, though CFO Thierry Pieton said the company is not under pressure to rush that timeline.
FDA Expands Kerendia Label to Type 1 Diabetes Chronic Kidney Disease
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.
AstraZeneca Rises as J.P. Morgan Reiterates Overweight on 2027 Phase III Readouts
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.
Eli Lilly Q2 Revenue Jumps 48% to $23 Billion as Merck Grows 5%
Eli Lilly reported second quarter revenue of $22.97 billion, up 47.7% year over year, while Merck posted $16.6 billion, up 5%, according to results from both drugmakers. Lilly's growth was driven by Mounjaro at $9.94 billion, up 91%, and Zepbound at $4.93 billion, up 46%, and the company raised its full-year guidance to $85 to $87 billion with an 85.8% gross margin. Merck's KEYTRUDA family brought in $8.4 billion, growing just 4%, and management said U.S. KEYTRUDA growth will moderate as the drug reaches peak penetration, while a $5.7 billion Terns acquisition charge pushed the company to a reported loss. Lilly's pipeline advanced with retatrutide showing weight loss approaching bariatric surgery levels in Phase 3, orforglipron, branded Foundeo, becoming the first once-daily oral GLP-1 with prescriber counts jumping from roughly 8,000 to 36,000 in one quarter, and FDA clearance of Mounjaro for cardiovascular risk reduction in type 2 diabetes on August 28. Merck is leaning on new launches including Lipvendra, the first oral PCSK9 inhibitor, and WINREVAIR, which grew 75% to $588 million, though GARDASIL China stayed weak and three Phase 3 oncology trials missed. Lilly trades at a forward P/E of 24 versus Merck at 15 with a 2.29% yield.
Abbott's Volt Pulsed Field Ablation System Used for First Time in Canada at McGill University Health Centre
Abbott announced that its Volt Pulsed Field Ablation System was used for the first time in Canada at the McGill University Health Centre in Montreal to treat patients with atrial fibrillation. The system, which received Health Canada authorization in April 2026, is designed to deliver more precise, targeted energy with fewer catheter exchanges and reduced radiation exposure than earlier-generation systems, and is also approved and available in the United States, Europe and Australia. Health Canada authorization was based on results from Abbott's VOLT-AF IDE study, a clinical trial of 392 patients conducted at 40 centres in the United States, Europe, Canada and Australia, which demonstrated clinically meaningful performance in both safety and effectiveness in treating paroxysmal AFib and persistent AFib. Dr. Atul Verma, director of cardiology at the McGill University Health Centre, said innovations like Volt are notable for combining real-time feedback with a distinctive catheter design that may help optimize contact and energy delivery during procedures. Christopher Piorkowski, chief medical officer of Abbott's electrophysiology business, said the system's introduction in Canada enables an approach that can support conscious sedation and may help make procedures more efficient while supporting quicker recovery. AFib affects between 500,000 to nearly one million Canadians, and people with the condition have 3 to 5 times greater risk for ischemic stroke.
Hengrui Medicine's Recaticimab Injection Receives Approval for Phase III Clinical Trial
Hengrui Medicine announced that its subsidiary Guangdong Hengrui has received the Drug Clinical Trial Approval Notice for Recaticimab Injection issued by the National Medical Products Administration, approving the product to proceed with a Phase III clinical trial. The indication sought is for adult patients with intracranial atherosclerotic stenosis, to reduce the risk of stroke recurrence. Recaticimab Injection is a self-developed anti-PCSK9 monoclonal antibody that inhibits the binding of PCSK9 to LDL receptors, increasing the number of LDL receptors available to clear low-density lipoprotein from the blood, thereby lowering LDL cholesterol levels. The announcement shows that the product was approved for marketing in China in 2025 for adult patients with hypercholesterolemia and mixed dyslipidemia. Cumulative R&D investment in this project is approximately 422 million yuan.
Ascendis Regains TransCon Rights in Metabolic and Cardiovascular Diseases After Novo Nordisk Termination
Ascendis Pharma A/S will regain the exclusive rights to develop, manufacture, and commercialize TransCon technology-based products in metabolic and cardiovascular diseases, including obesity, following the termination of its collaboration agreement with Novo Nordisk A/S announced in November 2024. Under the terms of the agreement, all licenses granted to Novo Nordisk in metabolic and cardiovascular diseases, including for once-monthly TransCon Semaglutide, will revert to Ascendis, and neither party has any continuing financial obligations to the other. Upon effective termination and reversion of rights, Ascendis plans to initiate multiple programs in both rare and large metabolic and cardiovascular indications, including advancing once-monthly TransCon Semaglutide, an investigational long-acting prodrug of the GLP-1 receptor agonist semaglutide, as a potential treatment for obesity and type 2 diabetes. Chief Executive Officer Jan Mikkelsen said the company's algorithm for product innovation has delivered three consecutive approved products and that it will apply its versatile TransCon platform with the same disciplined approach across these therapeutic areas, consistent with Vision 2030. Ascendis Pharma is headquartered in Copenhagen, Denmark, with additional facilities in Europe and the United States.
Boston Scientific to Buy Penumbra for $14.5 Billion in Thrombectomy Push
Boston Scientific has agreed to acquire Penumbra for $14.5 billion, a deal that would expand the company's presence in thrombectomy, the market for removing blood clots and blockages from blood vessels. The transaction is expected to close in the second half of 2026, subject to customary closing conditions including regulatory clearances, and will be integrated into Boston Scientific's Cardiovascular division. The company said the deal is expected to weigh on adjusted earnings per share by 6-8 cents in the first full year after closing, with the earnings impact improving thereafter. Earlier this year Boston Scientific acquired Valencia Technologies, adding the eCoin system to its Urology portfolio and expanding into implantable tibial nerve stimulation, a deal expected to have an immaterial impact on adjusted earnings per share in 2026 though more dilutive to GAAP earnings. The company also acquired full ownership of Nalu Medical, paying approximately $523 million upfront for the remaining stake, net of cash acquired, after holding an equity stake of approximately 9% since 2017, with the business integrated into the Neuromodulation division. In 2025, closed acquisitions added 340 basis points to sales, contributing to 15.8% organic revenue growth, while the additions of Bolt Medical and SoniVie advanced its coronary and peripheral disease and interventional cardiology strategies.
Pfizer Guides 2026 Revenue of $60.5B-$62.5B as Patent Cliff Looms
Pfizer is guiding 2026 total revenues to between $60.5 billion and $62.5 billion, a slight decline from 2025 revenues of $62.6 billion, as it absorbs the loss of exclusivity on key products and lower COVID-19 sales. The company expects the patent cliff to hurt sales by approximately $1.1 billion in 2026, with Eliquis, Ibrance, Xeljanz and Xtandi facing expirations during the 2026-2030 period. Adjusted earnings per share for 2026 are guided to $2.80-$3.00, down from 2025 EPS of $3.22, reflecting the dilutive impact of the 3SBio and Metsera deals, lower COVID revenues and higher taxes. Pfizer is leaning on recently launched and acquired products, which posted double-digit growth in both the first and second quarters of 2026, plus a high single-digit revenue CAGR target over five years starting from year-end 2028, to return to growth from 2029 onward. The Zacks Consensus Estimate for 2026 earnings per share has risen from $2.96 to $2.98 and for 2027 from $2.86 to $2.94 over the past 60 days, while Pfizer shares trade at 9.40 forward earnings versus 17.86 for the industry.
Novo Nordisk Rebrands as Novo to Close Obesity Market Gap With Eli Lilly
Novo Nordisk announced Monday that it is rebranding under the single name Novo and introducing a new corporate culture framework as it works to close a widening gap with Eli Lilly in the obesity drug market. The rebrand centers on the slogan "Lasting Health Starts Now," while Novo Nordisk A/S will remain the legal name of the company and the updated visual identity retains the Apis bull logo. Alongside the rebrand, the company introduced "The Novo Way," four cultural principles covering customer obsession, competitiveness, clarity, and care and integrity. The announcements come as Novo faces mounting pressure from rival Eli Lilly: in the second quarter, Novo accounted for 38.8% of the obesity drug market while Lilly commanded 60.9%, figures drawn from IQVIA data that appeared in a Lilly earnings presentation, according to CNBC. Novo shares have shed about 15% in 2026 and are off close to 20% measured over the trailing twelve months, according to STAT News, while the company's experimental cardiovascular drug ziltivekimab failed to reduce major adverse cardiac events in a late-stage clinical trial with a hazard ratio of 0.99, prompting a non-cash impairment charge in the third quarter even as Novo said the result would not affect its adjusted operating profit outlook for 2026. The oral formulation of Wegovy has offered some relief, crossing 3 million prescriptions through June, according to CNBC, and Novo plans to provide a detailed overview of its updated corporate strategy at a Capital Markets Day event on September 21 in London.
China Resources Double-Crane Subsidiary Receives Drug Registration Certificate for Ezetimibe and Atorvastatin Calcium Tablets
China Resources Double-Crane announced that its wholly owned subsidiary China Resources Saike has received the Drug Registration Certificate for Ezetimibe and Atorvastatin Calcium Tablets (I) and (II) issued by the National Medical Products Administration. The two specifications contain 10 mg of ezetimibe with 10 mg and 20 mg of atorvastatin calcium per tablet respectively, are registered as Category 4 chemical drugs, and are deemed to have passed the consistency evaluation. The drug is indicated for the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia. The announcement shows that China Resources Saike submitted the marketing application in May 2025, with cumulative research and development investment of approximately 20.36 million yuan.
UnitedHealth sells Optum Florida stake to TPG as CooperCompanies cuts guidance and Amgen slides
UnitedHealth has sold an interest in some of its Optum Health operations in Florida to private equity firm TPG, part of the health conglomerate's effort to recover from a collapse in profits last year. CFO Wayne DeVeydt told Bloomberg News that Optum Health margins will be around 2% this year, above prior expectations, and should rise to around 4% in 2027 and 6% the following year. Amgen fell more than 8%, its worst single-day decline since 2016, after Novartis announced a Phase 3 trial failure for the heart disease therapy pelacarsen, which it is developing with Ionis Pharmaceuticals; BMO Capital Markets downgraded Amgen to Market Perform from Market Outperform with a $450 price target. CooperCompanies dropped 13% after issuing fiscal 2026 guidance below consensus, with revenue of $4.229B-$4.252B versus the prior $4.285B-$4.321B and non-GAAP diluted EPS of $4.51-$4.55 versus $4.58-$4.66 previously, and said its board decided to keep CooperSurgical rather than sell it while raising its share buyback authorization to $3B from $2B. Novo Nordisk fell more than 1% premarket after Morgan Stanley downgraded the stock to Underweight from Equal-weight, citing the semaglutide patent cliff, and the S&P 500 Health Care Sector Index slipped more than 3.5% for the week.
Roivant Sciences shares surged 18% on September 8 after the biotech reported positive topline Phase 2 results for mosliciguat, an experimental treatment for pulmonary hypertension. In the PHocus trial, the drug produced a 56.3% placebo-adjusted reduction in pulmonary vascular resistance in patients with pulmonary hypertension associated with interstitial lung disease, well above the 20% threshold Leerink Partners analyst David Risinger had flagged as an important benchmark, along with a 35.2-meter placebo-adjusted improvement in six-minute walk distance at Week 16. Risinger said mosliciguat could potentially generate more than $10 billion in annual sales across multiple indications, a distinction that matters for Roivant's long-term growth strategy as it seeks to reduce reliance on a small number of products; Roivant has already secured U.S. approval for Lisraya. The company still must complete its Phase 3 PHrontier trial and show the benefits can be reproduced, and a disappointing late-stage result could trigger a significant valuation reset after the sharp post-results rally. Hedge fund holdings in Roivant rose to 64 in the second quarter from 60 in the first, though positioning was mixed, with QVT Financial cutting its exposure by 6% to approximately $839.6 million and Farallon Capital raising its stake by 48% to approximately $506.4 million.
Merck's Keytruda Franchise Drives $8.4 Billion as Cramer Calls It a Fantasy Defense Pick
Merck & Co. reported second-quarter worldwide sales of $16.6 billion, with its oncology franchise led by intravenous Keytruda and the subcutaneous formulation Keytruda QLEX generating $8.4 billion in quarterly revenue. The pulmonary arterial hypertension treatment Winrevair surged 75% to reach $588 million, and management raised its full-year 2026 sales guidance to a range between $66.3 billion and $67.3 billion. The company faces the loss of exclusivity for Keytruda toward the end of 2028, pushing it to fund and acquire new pipeline assets, including a personalized mRNA cancer vaccine collaboration with Moderna. According to Insider Monkey's database, 101 hedge funds held a stake in the company during the second quarter, up from 98 in the prior quarter, while short interest sits at just 0.99% of the float. Fisher Asset Management maintained the top position with 38.5 million shares, increasing its holdings by 46%.
Novartis' del-desiran and pelacarsen trial failures hit pipeline
Novartis AG suffered a major setback after its experimental drug del-desiran failed a late-stage trial for myotonic dystrophy type 1, a rare muscle-wasting disease with no approved treatments, missing statistical significance over placebo on the primary endpoint of video hand opening time. The failure came just days after Novartis' cholesterol drug pelacarsen also failed a major late-stage study, and del-desiran was one of the key assets acquired through Novartis' $12 billion acquisition of Avidity Biosciences, where Barclays analysts had estimated peak annual sales of about $3.1 billion and assigned it a 60% probability of success. The two failures increase pressure on CEO Vas Narasimhan as Novartis seeks to replace revenue from established medicines such as Entresto ahead of future patent expirations, though the company reaffirmed its target of 5%-6% annual sales growth through 2030. Attention now falls on remibrutinib, which recently succeeded in a late-stage multiple-sclerosis study, with additional data in another indication expected later this year and analysts seeing it as potentially capable of generating billions of dollars in peak annual sales. Novartis is evaluating the full del-desiran dataset and plans to engage with regulators, leaving some possibility the program could have a future depending on the underlying data and trial interpretation.
Novartis' experimental medicine pelacarsen failed the Phase 3 Lp(a)HORIZON study, lowering lipoprotein(a) but not producing a statistically significant reduction in cardiovascular events. Bank of America estimates the miss creates only low-single-digit percentage downside to its net-present-value calculation for Novartis and maintained its Buy rating and $185 price target, with attention shifting to four other Phase 3 readouts expected in the second half of 2026. Novartis reported 39 Phase 3 projects and three programs in registration in its second-quarter presentation, and second-quarter 2026 sales reached $14.41 billion, up 3% on a reported basis and 1% in constant currencies, with management reaffirming low-single-digit constant-currency sales growth for the year. Citi analyst Eric Joseph expects less than 5% immediate downside for Ionis Pharmaceuticals, which discovered pelacarsen and licensed it to Novartis in 2019, saying the result should not affect Ionis' fiscal 2026 guidance and maintaining a Buy rating and $100 price target. Novartis' first-half net income declined 16% on a reported basis while core operating income fell 6%.
United Therapeutics Commits $477.6 Million to Accelerated Share Repurchase
United Therapeutics Corporation committed the remaining $477.6 million under its $2 billion authorization to an accelerated share repurchase with Citibank, N.A. on September 8, following earlier transactions that included $1.5 billion of accelerated repurchases and $22.4 million of open-market purchases. The upfront payment was scheduled for around September 10, with initial delivery representing approximately 75% of anticipated shares based on the September 8 closing price, and settlement is expected in the fourth quarter of 2026. Upon completion, the company expects cumulative capital returned to reach approximately $4 billion over roughly two and a half years. The company reported $3.803 billion of cash, cash equivalents, and marketable investments as of June 30, before the latest repurchase and July acquisition payment, while second-quarter revenue declined 2% to $783.3 million and total Tyvaso revenue fell 4% to $452.6 million. United Therapeutics has FDA reviews pending for ralinepag in pulmonary arterial hypertension, with a June 24, 2027 target action date, and Nebulized Tyvaso in idiopathic pulmonary fibrosis, expected to finish in late April 2027.
Royalty Pharma plc disclosed that pelacarsen failed the Phase 3 Lp(a)HORIZON cardiovascular-outcomes trial run by Novartis AG, which enrolled 8,323 patients with elevated lipoprotein(a) and established cardiovascular disease. The drug lowered Lp(a) but did not meet the primary endpoint of reducing cardiovascular events versus placebo in the overall population, and complete results have not yet been presented. Royalty Pharma had provided Ionis Pharmaceuticals $500 million in January 2023, allocating $150 million to pelacarsen royalties and $350 million to Spinraza royalties, and it now expects to pay no pelacarsen milestone payments out of up to $625 million in potential regulatory and commercial milestones. The company holds 25% of Ionis's Spinraza royalties through 2027, rising to 45% in 2028 on Spinraza annual sales of up to $1.5 billion, with that interest reverting after aggregate payments reach $550 million, or 1.1 times the original funding. Management expects the structure to recover the entire investment and generate a modest positive return, and it maintained its 2030 target of at least $4.7 billion in company-defined Portfolio Receipts.
FDA Grants Fast Track to Liquidia's Yutrepia for Scleroderma-Linked Raynaud's
Liquidia Corporation announced that the FDA has granted Fast Track designation to Yutrepia (treprostinil) inhalation powder for the treatment of Raynaud's phenomenon associated with systemic sclerosis, or SSc-RP. Yutrepia, an inhaled dry-powder formulation of treprostinil developed with Liquidia's proprietary PRINT technology, was approved by the FDA in May 2025 for PAH and pulmonary hypertension associated with interstitial lung disease. Liquidia plans to initiate RE-WARM, a phase IIa, randomized, open-label, dose-finding study of Yutrepia in approximately 75 adults with SSc experiencing symptomatic Raynaud's phenomenon attacks, at up to 30 U.S. sites, with the study expected to begin in October 2026 and primary completion targeted for February 2027. Since its commercial launch in June 2025, Yutrepia has generated approximately $300.3 million in sales in the first half of 2026, with about 5,900 unique prescriptions and more than 5,000 patients initiated. The company also plans to evaluate the therapy in pulmonary hypertension associated with chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis and progressive pulmonary fibrosis, while competing in the PAH market against United Therapeutics' Tyvaso and Tyvaso DPI and Insmed's clinical-stage TPIP and INS1148 programs.
Medtronic plc reported fiscal first-quarter 2027 revenue of nearly $9.8 billion, up 13.7% organically, while non-GAAP diluted EPS rose 15.1% to $1.45. The company raised its full-year organic revenue-growth forecast to 7.25%-7.75% from 6.75%-7.25% and lifted the lower end of its non-GAAP diluted EPS guidance to $5.94 from $5.90. Cardiovascular revenue increased 18.9% organically to $3.927 billion, with Cardiac Ablation Solutions up 88%, while Neuroscience grew 9.3% and Medical Surgical increased 10.2%. The quarter included an extra fiscal week that Medtronic estimates benefited organic growth by approximately $570 million, and non-GAAP operating margin rose only 10 basis points to 23.7%. Medtronic also committed $700 million to Cornerstone Robotics for distribution rights to its Sentire surgical system in select markets outside the United States and agreed to invest up to $80 million in Pi-Cardia, with an option to acquire the company for up to $210 million, as it proceeds with the separation of its diabetes division by the end of the year.
Deutsche Bank Rates AstraZeneca 'Sell' Despite $5bn Tozorakimab Promise
Deutsche Bank kept a 'sell' rating and 11,500 pence target price on AstraZeneca even as it praised detailed OBERON and TITANIA results for tozorakimab in chronic obstructive pulmonary disease presented at the ERS conference. The shares traded at 11,634p, broadly flat. Analyst Emmanuel Papadakis said the data impressed despite minor caveats and supported the drug's commercial prospects, following headline results in March and AstraZeneca's decision to raise peak sales guidance above $5 billion alongside second-quarter results. Consensus sales forecasts stand around $4 billion for 2030 and beyond, leaving room for modest upward revisions, the note said. Papadakis also highlighted positive headline findings from a niche Imfinzi study in small cell lung cancer maintenance treatment, and the broker judged the developments a minor positive for AstraZeneca. The next financial catalyst is whether consensus sales estimates move higher as analysts absorb the detailed COPD findings and reassess tozorakimab's peak revenue potential.
Artisan Partners Urges Novartis Board Shake-Up After Trial Setbacks
A major Novartis shareholder is calling for a shake-up of the Swiss drugmaker's board, saying successive chairmen have failed the company on acquisitions. David Samra, managing director at Artisan Partners and founding partner of International Value Group, told Reuters that Artisan, among Novartis' 20 largest shareholders, is the first investor to publicly demand board changes after the company's shares suffered a record fall this week. On Tuesday, a muscle-wasting disorder drug acquired through Novartis' $12 billion takeover of U.S. firm Avidity failed a late-stage study, sending shares tumbling more than 10% and wiping nearly $30 billion off its market value, after the stock had already fallen 3% a day earlier when heart drug pelacarsen disappointed investors. Samra urged Chairman Giovanni Caforio to improve the team handling deals and to overhaul compensation that he said relies too heavily on adjusted measures excluding writedowns, though he did not blame CEO Vas Narasimhan, saying he had done a very good job running the business. Novartis said its financial guidance was unchanged by the recent setbacks and that it had a broad pipeline of medicines, adding that it continues a disciplined and shareholder friendly approach to capital allocation through organic investment, value-creating bolt-ons, a growing annual dividend and share buybacks.
Tectonic Therapeutic Hits Two Trial Milestones With Cash Through 2029
Tectonic Therapeutic reported second quarter results on August 6 built around two clinical wins rather than sales, since the clinical-stage biotech has no products on the market. The company completed enrollment for its APEX Phase 2 trial of TX45 in patients with pulmonary hypertension tied to heart failure with preserved ejection fraction in June, bringing in 191 patients across 14 countries, with 137 of them, about 70%, in the sicker CpcPH subgroup with pulmonary vascular resistance above 3 Wood Units. In July an independent data monitoring committee reviewed unblinded safety and efficacy data covering roughly 80% of expected patient exposure and recommended the trial continue without changes, with topline results expected in early Q1 2027. Tectonic also finished dosing all six single-dose cohorts of TX2100 in healthy volunteers in July as part of a Phase 1a trial in hereditary hemorrhagic telangiectasia, with topline results due by the end of Q3 2026 and plans to start a Phase 1b trial in transfusion- or iron-dependent HHT patients and a Phase 2 trial in moderate to severe patients in early 2027, both conditional on favorable data. The company posted a net loss of $22.3 million for the quarter ended June 30, 2026, up from $20 million a year earlier, as R&D spending rose to $18 million from $17.2 million and G&A climbed to $6.2 million from $5.2 million, while cash and cash equivalents fell to $227.1 million from $236.9 million even after raising roughly $11.7 million through an at-the-market stock offering; that runway is projected to last into Q1 2029. Hedge fund ownership rose to 23 funds from 19, while short interest sits at 17.86% of the float.
The domestic production drug registration marketing application for ticagrelor tablets, 60 mg and 90 mg, from Duoduo Pharmaceutical, a subsidiary of Zhongguancun, has been accepted by the National Medical Products Administration. Beijing Zhongguancun Science-Technology Development Holding Company announced on September 10, 2026, that Duoduo Pharmaceutical had received the acceptance notice issued by the National Medical Products Administration, with the registration classified as chemical drug category 4. Ticagrelor tablets are indicated for use with aspirin to reduce the incidence of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or those with a history of myocardial infarction and at least one high-risk factor for atherothrombotic events. The original drug was developed by AstraZeneca AB, approved for marketing in the European Union in December 2010, approved by the U.S. FDA in July 2011, and the original product was approved in China in 2012 and 2017 respectively. As of August 31, 2026, cumulative research and development investment in this project was 4.9738 million yuan. The company stated that acceptance of the marketing application marks the entry of this product into the review stage, and if approved smoothly it will enhance market competitiveness and have a positive impact on operating performance.
Bayer Initiates Phase II Trial of GIRK4 Inhibitor for Atrial Fibrillation
Bayer has announced the initiation of a global Phase II clinical trial evaluating BAY 3670549, an investigational highly selective GIRK4 inhibitor, as a potential new treatment for atrial fibrillation, the most common sustained cardiac arrhythmia affecting over 60 million people worldwide. The randomized, double-blind, placebo-controlled study will assess the drug's efficacy, safety, and pharmacokinetics in adult patients with AFib who require electrical cardioversion. Positive data from the Phase I first-in-human study supported advancing the compound, which emerged from Bayer's strategic research alliance with the Broad Institute of MIT and Harvard. If successful, BAY 3670549 could offer an alternative to electrical cardioversion, the current gold standard for restoring normal heart rhythm.
Diabetic Nephropathy Market to Reach $8.8B by 2025, Grow 5% CAGR to 2036
The diabetic nephropathy and diabetes kidney disease market across the seven major markets is valued at approximately USD 8.80 billion in 2025 and is projected to grow at a compound annual growth rate of about 5% from 2026 to 2036, according to a new report from ResearchAndMarkets.com. The total prevalent DKD population in the 7MM is estimated at nearly 34 million cases in 2025, with the United States accounting for nearly 15 million cases and representing the largest regional market. Approximately 70% of US DKD cases occur among individuals aged 60 years and older. Antidiabetic therapies generate the highest DKD-related revenue across the 7MM. Key marketed therapies include JARDIANCE from Boehringer Ingelheim and Eli Lilly, KERENDIA from Bayer, and FARXIGA/FORXIGA from AstraZeneca. In March 2026, a Phase III study of KERENDIA met its primary endpoint in chronic kidney disease patients, showing a statistically significant improvement in estimated glomerular filtration rate slope versus placebo. Emerging pipeline candidates include esaxerenone from Daiichi Sankyo, SER150 from Serodus, bremelanotide from Palatin Technologies, and INV-202 from Novo Nordisk and Inversago Pharma. The report highlights persistent unmet needs such as limited disease-modifying therapies, cardiovascular risk, and delayed diagnosis, creating opportunities for differentiated treatments.
Novartis Loses Potential $6 Billion Drug Opportunity After Trial Failure
Novartis AG has lost a potential $6 billion drug opportunity after its experimental cholesterol treatment pelacarsen failed in a late-stage study, failing to reduce major cardiovascular events as hoped. Analysts had projected annual sales of $3 billion to $6 billion if the drug proved effective, but that prospect now appears unlikely. The setback underscores the inherent risks in drug development, where a single trial can erase years of research and hundreds of millions of dollars in investment. While Novartis is large enough to absorb the clinical failure, the loss of a potential blockbuster shifts focus to the rest of its pipeline to deliver future growth. Investors will now look to other late-stage medications to fulfill the company's growth expectations.
BridgeBio Reports Signs of Cardiac Reversal With Acoramidis
BridgeBio Pharma reported new cardiac magnetic resonance imaging data from the Phase 3 ATTRibute-CM study and its open-label extension, suggesting that some acoramidis-treated patients experienced improvements in cardiac structure and function. In a completer analysis, 54% of acoramidis-treated patients achieved a clinically meaningful improvement in left ventricular systolic function at Month 30, compared with 20% of placebo-treated patients, while a more conservative analysis showed improvement in 34% of acoramidis-treated patients versus 9% of placebo-treated patients. Acoramidis also reduced the estimated mean percentage of days lost to death or cardiovascular hospitalization to 7.5% from 11.7% with placebo through Month 30, translating to 38 additional days alive outside the hospital, with the difference reaching 65 days by Month 36. However, these exploratory analyses are not randomized and cannot establish disease reversal, and no head-to-head comparison with competing therapies was provided. BridgeBio has initiated ASCEND-ATTR, a Phase 3b/4 study to prospectively evaluate sustained improvement in cardiac structure, function, and amyloid burden.
Cytokinetics Presents New Aficamten Data, Plans sNDA for nHCM
Cytokinetics announced additional results from its ACACIA-HCM and MAPLE-HCM studies at the European Society of Cardiology Congress 2026, showing that aficamten improves cardiac structure and diastolic function in non-obstructive HCM and outperforms metoprolol across pre-trial treatment groups in obstructive HCM. The company plans to submit a supplemental new drug application for aficamten in nHCM in the fourth quarter of 2026, potentially expanding its market beyond the approved oHCM indication under the brand name Myqorzo. The FDA has already accepted Cytokinetics' sNDA for MAPLE-HCM, with a target action date of November 14, 2026. Myqorzo faces competition from Bristol Myers Squibb's Camzyos and Edgewise Therapeutics' EDG-7500, which is entering phase III in late 2026. Cytokinetics shares have gained 12.4% year to date, and the Zacks Consensus Estimate for 2026 loss per share has narrowed to $6 from $6.26 over the past 60 days.
Trump Adds 9 Mid-Sized Drugmakers to MFN Pricing Deals
President Trump announced on Monday that his administration has signed separate drug-pricing agreements with nine mid-sized pharmaceutical companies, expanding his Most-Favored-Nation (MFN) pricing push beyond Big Pharma. The companies include Alcon, Astellas Pharma, BeOne Medicines, BridgeBio Pharma, CSL, Kyowa Kirin, Sun Pharma, Teva Pharmaceuticals, and UCB, which have agreed to reduce prescription drug prices to match those in comparable developed countries. In return, they receive a reprieve from import tariffs on pharmaceutical ingredients, contingent on expanding domestic manufacturing, with a collective commitment of at least $19.6 billion in U.S. manufacturing. Some companies also agreed to contribute active pharmaceutical ingredients to a government stockpile reserve, such as Teva supplying 45 metric tons of metronidazole and UCB providing 163 tons of levetiracetam. With these additions, the total number of drugmakers with MFN agreements has risen to 26, covering 89% of the branded drug market, and the administration has called on Congress to codify the policy through the Great Healthcare Plan.
Trump unveils drug-pricing deals with CSL, Astellas, and other biotechs
President Donald Trump introduced a new set of drug-pricing deals with global pharmaceutical companies and smaller biotechs on Monday, advancing efforts to cut healthcare costs for American consumers. Deals were signed with Astellas, BeOne Medicines, CSL, BridgeBio, Sun Pharmaceutical, and UCB SA, Trump said in an Oval Office event with executives, according to Reuters. These companies have offered drugs to state Medicaid programs at most-favored-nation prices, which Trump described as a tremendous discount that should bring down medical costs. Israel's Teva, which also attended, said it is still in discussions with the administration on a potential agreement. The number of drugs covered and the discounts remain unclear, as the White House did not release details and some companies described terms as private. The deals follow earlier agreements with 17 of the world's largest drugmakers, including Pfizer, Eli Lilly, and Novo Nordisk, which agreed to cut prices for federal health programs and sell some medicines directly to patients through a Trump-branded website in return for tariff relief.
ST Bailing Subsidiary's Inhaled BD77 Receives Clinical Trial Approval
ST Bailing's wholly-owned subsidiary, Bailing Yuxiu Zhuhai Pharmaceutical Co., Ltd., has received a Drug Clinical Trial Approval Notice issued by the National Medical Products Administration. The clinical trial application for the innovative drug inhaled BD77 has been approved, allowing clinical trials for chronic obstructive pulmonary disease. Inhaled BD77 is a small-molecule chemical drug derived from a single statutory Chinese herbal medicine through separation and purification, with purity exceeding 98 percent. The Institute of Chinese Materia Medica at the China Academy of Chinese Medical Sciences completed its druggability research over 25 years. Pharmacological studies suggest it may act by activating endogenous inflammatory inhibitory factors and maintaining lung protease-antiprotease homeostasis, while pharmacodynamic studies show treatment-related effects in multiple pneumonia models. The total number of COPD patients in China is nearly 100 million, with about 1 million deaths each year. The company stated that this approval is an important staged research achievement, but the drug still needs to complete clinical trials and pass review and approval before it can be marketed. There is a risk that preclinical results may not translate into clinical benefit in humans, and recent performance will not be affected.
United Therapeutics presents new data supporting two FDA filings
United Therapeutics is presenting new analyses of ralinepag and inhaled treprostinil at two European medical conferences as it seeks U.S. approval to expand its pulmonary disease treatments. The presentations draw on the Phase 3 ADVANCE OUTCOMES study of ralinepag in pulmonary arterial hypertension and the Phase 3 TETON program for inhaled treprostinil in idiopathic pulmonary fibrosis, and they could support two applications submitted to the FDA in June. An analysis from ADVANCE OUTCOMES found that ralinepag produced clinical improvement in a lower-risk population and reduced clinical worsening in patients with connective tissue disorders, though numerical results were not disclosed. From the TETON program, nebulized treprostinil improved lung function and reduced serious clinical worsening events, with a larger benefit at higher doses. The company will also present interim findings from the ARTISAN study on parenteral treprostinil dosing and preliminary results from the PHINDER screening study, at the European Society of Cardiology Congress in Munich and the European Respiratory Society Congress in Barcelona.
Tenax finds benefit in sicker patient subgroup after Phase 3 trial miss
Tenax Therapeutics reported that additional analyses from its Phase 3 LEVEL trial suggest its oral levosimendan treatment, TNX-103, may benefit pulmonary hypertension patients with more limited exercise capacity, even though the trial failed its primary endpoint in the overall population. The company presented the findings at the European Society of Cardiology Congress in Munich, where it also revealed that the trial missed a key secondary endpoint measuring heart failure symptoms. In the full population of 241 patients with PH-HFpEF, TNX-103 did not significantly improve six-minute walking distance or Kansas City Cardiomyopathy Questionnaire scores. However, a prespecified analysis of 119 patients who could walk less than the trial median of 333 meters at baseline showed a statistically significant 26.3-meter improvement in walking distance and a 5.7-point improvement in symptom scores, exceeding the clinically meaningful threshold. Tenax plans to target this higher-risk subgroup in a follow-up trial called LEVEL-2, but the strategy carries substantial clinical and regulatory risk because the encouraging results came from a subset of the original study population.
Bristol Myers Squibb Presents Five-Year Camzyos Data at ESC Congress
Bristol Myers Squibb presented results from the EXPLORER-LTE cohort of the MAVA-LTE study at the European Society of Cardiology Congress 2026, showing that Camzyos (mavacamten) provides sustained efficacy and safety for up to five years in patients with symptomatic obstructive hypertrophic cardiomyopathy. The single-arm, open-label extension of the Phase 3 EXPLORER-HCM study included 231 patients, with 97.4% achieving a Valsalva left ventricular outflow tract gradient of 30 mm Hg or less, 69.6% improving by at least one New York Heart Association class, and 59.2% becoming asymptomatic at 252 weeks. Mean resting and Valsalva LVOT gradients decreased by 38.7 mm Hg and 55.6 mm Hg, respectively, while left ventricular ejection fraction decreased by 10.2% but remained within normal range. Additional real-world data from the COLLIGO-HCM study and a German registry reinforced the drug's effectiveness across diverse populations, and a Swedish healthcare resource utilization study highlighted the disease burden of HCM. No new safety signals emerged, and the findings support Camzyos as the most-studied cardiac myosin inhibitor, with over 25,000 patients treated in the U.S. alone.