Biotechnology

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'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 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.

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.

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.

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.

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 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.

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.

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.

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.

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.

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.

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.

Puma Biotechnology, Inc. announced the initiation of its ALISCA-Lung2 Phase II trial of alisertib in combination with paclitaxel for the treatment of patients with advanced small cell lung cancer. The sequential dose escalation study, designated PUMA-ALI-4202 and registered as NCT07465757, will enroll approximately 50 patients with small cell lung cancer who have progressed on or after treatment with platinum-based chemotherapy and immunotherapy. The primary endpoint is the safety and tolerability of alisertib when administered with paclitaxel, while secondary endpoints include objective response rate, duration of response, disease control rate, progression-free survival and overall survival, and Puma will also evaluate clinical biomarkers to help identify which patients have the greatest benefit. Taofeek K. Owonikoko, Chair of the trial's Steering Committee, said treatment options for patients whose small cell lung cancer has progressed following platinum-based chemotherapy and immunotherapy remain limited and that prior trial results suggest alisertib may be a promising option, particularly for patient subsets whose tumors harbor potential molecular markers associated with the clinical activity of an aurora kinase A inhibitor. Puma CEO, President and Founder Alan H. Auerbach said the company views ALISCA-Lung2 as additive to the clinical development of alisertib in small cell lung cancer, where it is continuing to advance alisertib monotherapy in the ALISCA-Lung1 trial.

Ultragenyx Pharmaceutical Inc. announced that the U.S. Food and Drug Administration granted standard full approval of FAYUVI, also known as UX111, for pediatric patients with mucopolysaccharidosis type IIIA, or Sanfilippo syndrome Type A, making it the first-ever FDA-approved treatment for the progressive and fatal neurodegenerative disease. FAYUVI is a single-dose intravenous AAV9 gene therapy and marks the second gene therapy approval and sixth FDA approval overall for Ultragenyx, which also received a Priority Review Voucher upon the approval. The approval is supported by data from the pivotal Transpher A trial and long-term follow-up extending to nearly 8 years, in which FAYUVI-treated patients in the modified intention-to-treat population of 17 demonstrated a 23.5 point higher cognitive score over an external natural history cohort of 27 untreated patients, with a p-value of less than 0.0001. Ultragenyx expects commercial product to be available for shipment to Qualified Treatment Centers within 30-60 days, supported by its UltraCare program, and the therapy is manufactured entirely in the U.S. at the company's Gene Therapy Manufacturing Facility in Bedford, Massachusetts, and Andelyn Biosciences in Columbus, Ohio. Sanfilippo syndrome Type A is estimated to affect approximately 3,000 to 5,000 patients in commercially accessible geographies, with a median life expectancy of 15 years.

The US FDA has approved Ultragenyx Pharmaceutical's gene therapy Fayuvi, also known as rebisufligene etisparvovec, for pediatric treatment of Sanfilippo syndrome type A. Fayuvi is not only the first gene therapy approved for Sanfilippo in pediatric patients but also the first to treat underlying causes rather than just symptoms. The condition, formally known as mucopolysaccharidosis type IIIA, is a rare disease that progressively damages the brain and nervous system. Fayuvi is a one-time therapy that uses a non-infectious virus known as AAV9 to deliver a working copy of the SGSH gene into a patient's cells, allowing them to produce sulfamidase, an enzyme that is missing or lacking in Sanfilippo. Approval was based on the results of an open-label, single-arm study in which patients on Fayuvi maintained or improved cognitive function compared to a historical control cohort that received no treatment. Ultragenyx shares are up about 12% in late Thursday trading.

A European Medicines Agency panel has recommended approval of Frehemgo, Novo Nordisk's injectable treatment for hemophilia A, moving the Danish drugmaker closer to another commercial opportunity outside its diabetes and obesity franchise. The recommendation covers adults and children, including patients with or without inhibitors, and follows results from Novo's FRONTIER clinical program, in which Frehemgo reduced annualized bleeding rates compared with previous clotting-factor preventive treatments and therapies given when bleeding occurred. Novo plans to sell Frehemgo in a single-use, prefilled pen with dosing options ranging from once weekly to once monthly, offering patients more flexibility. The European Commission still needs to give final approval, but Novo is already preparing for commercialization and expects to introduce Frehemgo in a selected European market during the fourth quarter, followed by a broader European Union rollout early next year. The next catalyst is European Commission approval and whether Novo can begin that first launch before year-end.

BioCryst Pharmaceuticals is looking to acquire more rare disease treatments after reaching consistent profitability on the strength of its hereditary angioedema drug Orladeyo, CEO Charlie Gayer told CNBC on August 28, 2026. Gayer, who took the role in January, said the company expects profits to keep growing every year and does not want to depend on raising outside capital to fund operations. Orladeyo is projected to bring in up to $645 million in 2026 sales. BioCryst has already used its improved financial footing to acquire Astria Therapeutics in January, adding a late-stage hereditary angioedema candidate called navenibart to its pipeline. The company still carries negative shareholders' equity and roughly $822 million in combined term-loan and royalty obligations, and it recorded a $697.8 million non-cash charge tied to acquired in-process research and development from the Astria transaction.

Novo Nordisk is expanding its artificial intelligence capabilities through a new collaboration with Anthropic aimed at accelerating drug discovery and the development of new medicines. Under the agreement, Novo will use Anthropic's models and Claude Science across selected research and development workflows, while also applying Anthropic's frontier models to strengthen AI-driven software development. The collaboration will focus on drug discovery challenges identified by Novo's scientists and computational teams, with Claude Science initially tested in selected R&D applications involving biological reasoning. The deal adds to Novo's growing network of technology partnerships, following a strategic partnership with OpenAI in April 2026 and an August partnership with Amazon Web Services, which was named its preferred cloud provider and strategic AI partner and included a London co-innovation hub focused on drug discovery. Novo shares have lost 18% year to date against the industry's 10.9% growth, and the company currently carries a Zacks Rank #3 (Hold).

Novo Nordisk announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending marketing authorisation for FREHEMGO, also known as denecimig, for the treatment of haemophilia A with or without inhibitors in adults and children. FREHEMGO is the first factor VIIIa mimetic to offer once-monthly, once-every-two-weeks and once-weekly prophylaxis in a single-use pre-filled pen. The recommendation is based on the FRONTIER trial programme, in which denecimig significantly reduced annualised bleeding rate compared with prior clotting factor prophylaxis and on-demand treatment, with mean annualised bleeding rates generally below 1 in the reported phase 3 population and a substantial proportion of participants experiencing zero treated bleeds. Novo Nordisk expects to launch FREHEMGO in the first European countries in the fourth quarter of 2026 and broadly across the EU starting early 2027. In September 2025, Novo submitted denecimig for review to the US Food and Drug Administration through a Biologics License Application.

Moderna climbed 6% to $154 in morning trading, extending a 137% one-month rally driven by its Phase 2b adjuvant melanoma data showing intismeran autogene plus KEYTRUDA cut the risk of recurrence or death by 49% versus KEYTRUDA alone. No new Moderna announcement, filing, analyst action or trial result landed Thursday to explain the move, and the broader tape offered little help: the iShares Biotechnology ETF rose 1% to $204.5 and the SPDR S&P 500 ETF Trust rose 1% to $763.49. BioNTech, which runs a rival individualized messenger RNA cancer vaccine program with Genentech, edged up just 1% to $97.00, a muted response that suggests the market is paying for Moderna's specific asset rather than the messenger RNA cancer vaccine category as a whole; BioNTech chief medical officer Özlem Türeci has said the company sees no read-through between melanoma and colorectal cancer. Novavax, a vaccine-sector name but not a participant in the messenger RNA cancer vaccine program, rose 2% to $9.5 on what reads as group beta. Merck is Moderna's partner on the individualized neoantigen program, which now spans nine Phase 2/3 trials across melanoma, non-small cell lung cancer, bladder and renal cell carcinoma, and Moderna has guided to an interim analysis from its Phase 3 adjuvant melanoma trial in the second half of 2026, with management saying it is highly confident the interim will be conducted this year. For 2026, Moderna guided to up to 10% revenue growth and year-end cash of $4.7 billion to $5.2 billion, and chief executive Stéphane Bancel has described oncology as a key focus for the second half of 2026; the full dataset from the August readout has not yet been presented publicly, with the oncology congress in Madrid in late October the next scheduled opportunity.

Innate Pharma said its first-half 2026 developments included closing a strategic partnership with Sobi for lacutamab, completing dose-escalation enrollment for IPH4502, and completing enrollment in the PACIFIC-9 phase III study of monalizumab. Chief Executive Officer Jonathan Dickinson said the Sobi transaction became effective on closing and included a $75 million upfront payment, which combined with a €30 million equity financing is expected to extend the company's projected cash runway through the end of the first quarter of 2028. The Sobi agreement also carries up to $40 million in near-term Sézary syndrome milestones, up to an additional $465 million tied to development-rights options and future regulatory and commercial milestones, and tiered double-digit royalties on future net sales. Innate has initiated the TELLOMAK-3 confirmatory phase III trial of lacutamab in cutaneous T-cell lymphoma, with the first patient expected in the first quarter of 2027, and plans to seek accelerated approval in Sézary syndrome in the second half of 2027. The company expects key clinical updates in the second half of 2026, including a PACIFIC-9 phase III readout for monalizumab and initial phase I data for IPH4502, an antibody-drug conjugate that has shown preliminary responses in several heavily pretreated solid-tumor populations.

Corbus Pharmaceuticals announced positive results from its phase Ib CANYON-1 study of CRB-913, an oral cannabinoid-based small molecule for obesity, with once-daily treatment achieving statistically significant and clinically meaningful weight loss across all three dose levels at 12 weeks. The 20-mg and 40-mg doses delivered placebo-adjusted mean weight loss of 2.8% and 3.3%, respectively, while the 60-mg dose achieved 5%, with no evidence of a weight-loss plateau at any dose. Corbus said treatment discontinuations due to adverse events were lower than those reported for approved oral GLP-1 drugs such as Eli Lilly's Foundayo and Novo Nordisk's Wegovy pill, and that preclinical studies showed CRB-913 was 15 times more peripherally restricted than Novo Nordisk's monlunabant, which Novo discontinued in the second quarter of 2026. Detailed CANYON-1 results are expected at ObesityWeek 2026 in November, and Corbus intends to engage with the FDA on a clinical plan to advance CRB-913 to phase II development. Beyond the obesity candidate, Corbus has an oncology program in CRB-701, a Nectin-4-targeting antibody-drug conjugate that the FDA has cleared for the registrational phase III TEMPO-1 study in second-line oropharyngeal squamous cell carcinoma, with enrollment expected to start later this month. Corbus had about $118 million in cash, cash equivalents and investments as of June 30, 2026, which it expects to support operations into 2028.

FibroBiologics has closed a $0.5 million private placement with its Chief Scientific Officer, Hamid Khoja. The clinical-stage biotechnology company sold 298,508 shares of common stock and accompanying warrants to purchase up to 298,508 shares of common stock, priced at-the-market under Nasdaq rules. Each share and accompanying warrant was sold at a combined purchase price of $1.675, equal to the consolidated closing bid price of $1.55 per share on The Nasdaq Capital Market on September 14, 2026, plus $0.125 per warrant. The warrants have an exercise price of $1.55 per share, are immediately exercisable, and expire five years from issuance. FibroBiologics received gross proceeds of approximately $0.5 million before deducting offering expenses and intends to use the net proceeds for general corporate purposes and working capital. Chief Executive Officer Pete O'Heeron said Dr. Khoja is the scientific architect of the company's platform and that his decision to increase his investment as a shareholder speaks for itself, while Dr. Khoja said investing in FibroBiologics is his personal commitment to the science, the team, and the potential therapeutics being developed.

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

Orbis Medicines has entered a strategic collaboration and license agreement with Novo Nordisk to discover and develop next-generation oral macrocycle therapeutics for cardiometabolic diseases. Under the terms, Orbis Medicines is eligible to receive up to USD 1.4 billion in upfront and potential development and commercial milestone payments, plus tiered royalties on future product sales, and Novo will also make a strategic investment in Orbis Medicines. The collaboration will use Orbis Medicines' proprietary nGen platform, which integrates generative AI with high-throughput synthesis to design orally bioavailable macrocycles called nCycles. Morten Graugaard, chief executive officer of Orbis Medicines, said the partnership could unlock a new generation of oral medicines for cardiometabolic diseases, while Brian Vandahl, senior vice president of Therapeutics Discovery at Novo, said the collaboration could expand the possibilities of macrocycle therapeutics. Orbis Medicines, based in Copenhagen, Denmark and Lausanne, Switzerland, has raised EUR 116 million in venture funding to date, including a EUR 90 million Series A round led by NEA.

Twist Bioscience announced on 16 September 2026 an agreement with Lilly TuneLab under which Twist will provide antibody characterization data services using preferred Twist protocols to generate high-quality wet lab data that feed Lilly's AI/ML drug discovery models. The collaboration plugs Twist's DNA and antibody capabilities into Lilly's AI-driven discovery ecosystem, potentially deepening its role in data-rich, AI-enhanced antibody development workflows across the biopharma industry. The deal follows Twist's US$300,000,000 follow-on equity raise in August 2026, a pairing that highlights a company still funding growth externally while positioning itself as a preferred data and DNA supplier to big pharma and AI drug discovery partners. Twist's narrative projects $753.3 million in revenue and $127.9 million in earnings by 2029, yielding a $105.30 fair value, a 26% downside to its current price, while some of the most optimistic analysts already expected revenue of about US$715,300,000 and earnings of roughly US$128,500,000 by 2029. The agreement may reinforce that bullish view on AI-driven demand, though it does not by itself resolve the near-term issue of achieving a credible path toward breakeven or reduce dependence on a concentrated set of large NGS customers.

Asia Plus Securities said in an analysis that Novo Nordisk A/S is advancing its collaboration with Anthropic to apply artificial intelligence, or AI, in its research and development processes, including the discovery and development of new drugs. It plans to use Claude Science and Agentic AI technology to improve data analysis efficiency, shorten research timelines, and accelerate the process of bringing products to market. The collaboration reflects Novo Nordisk's strategy to elevate the organization into a more AI-driven healthcare company, alongside its emphasis on data governance and human oversight. The research team holds a positive view of this collaboration, assessing that it will help raise R&D efficiency and improve the quality of drug products in development, which is a key factor amid intensifying competition in the obesity and diabetes drug market, especially competition with Eli Lilly. However, the research team assesses that the positive effect on the share price in the short term remains limited, since the project is still in its early stages and the impact on revenue and profit cannot yet be clearly evaluated. As for Novo Nordisk shares, or NOVOB DC, they recently stood at 272.60 Danish kroner, while the Depositary Receipt, or NOVOB80, stood at 1.42 baht, using a reference exchange rate of 5.12 baht per Danish krone and a conversion ratio of 1 underlying share per 1,000 DR units. The research team gives a buy recommendation, with a one-year target price for NOVOB DC of 315.89 Danish kroner, equivalent to a target price for NOVOB80 of 1.62 baht. On the technical view for NOVOB80, the price is expected to move sideways, with support at 1.30-1.34 baht and resistance at 1.50-1.58 baht.

Spyre Therapeutics announced on September 8 that SPY003, its anti-IL-23 antibody, hit its primary endpoint in Part A of the Phase 2 SKYLINE trial, posting a 10.0-point reduction in Robart's Histopathology Index score at Week 12 with a p-value below 0.0001. The result completes proof-of-concept for all three molecules behind the company's inflammatory bowel disease combination strategy, following SPY001 and SPY002, which posted RHI reductions of 9.2 points and 10.7 points respectively in the same open-label monotherapy portion of the trial. SPY003 delivered a 20% clinical remission rate and 30% endoscopic improvement, while SPY001 and SPY002 posted remission rates of 40% and 33%, and all three monotherapies were described as well tolerated. Spyre held $1.1 billion in cash, cash equivalents, and marketable securities as of June 30, a position built in part on a $435.2 million stock offering in April, which management says funds operations into the second half of 2029. The combination thesis remains unproven: Part B, which tests the pairwise combinations SPY120, SPY130, and SPY230 against placebo, is still enrolling, with topline induction data not expected until 2027, while the company used $69.9 million in operating activities in the second quarter of 2026 and posted a net loss of $36.2 million.

Akeso, Inc. announced that AK158D1, its investigational next-generation bispecific antibody-drug conjugate targeting EGFR and TROP2, has secured Phase I clinical trial clearance from the Center for Drug Evaluation under China's National Medical Products Administration. The trial will assess the candidate in patients with advanced malignant solid tumors. AK158D1 is Akeso's fourth ADC to enter clinical development, joining a clinical-stage ADC portfolio that also includes AK146D1, AK138D1 and AK157D1, and it is the company's second bispecific ADC to reach the clinic. Preclinical data for AK158D1 have demonstrated potent anti-tumor activity with a favorable safety profile, supporting its potential for patients who are refractory to, intolerant of, or ineligible for existing standard of care regimens. Akeso said the candidate is designed to address the narrow tumor coverage, off-target toxicity and multidrug resistance that have constrained single-target ADCs directed against either EGFR or TROP2.