Corbus Pharmaceuticals (NASDAQ: CRBP) enters the weekend before Monday September 14, 2026 at 8:00 a.m. EDT conference call disclosing Phase 1b CANYON-1 topline data for CRB-913 (once-daily oral peripherally-restricted CB1 inverse agonist for obesity). The 16-week double-blind placebo-controlled dose-ranging study enrolled 240 obese non-diabetic U.S. adults across once-daily doses of 20 mg, 40 mg, and 60 mg (titrated from 20 mg) with a 4-week safety follow-up (NCT07310901). Harold Bays MD (investigator) will join Corbus management on the call. Investor focus is on the CB1 inverse agonist class safety-versus-efficacy trade-off — the peripheral restriction (approximately 15-fold lower brain penetration than monlunabant in preclinical models) is designed to preserve dose-responsive weight loss while limiting the psychiatric side effects that led to the 2008 withdrawal of Sanofi's Acomplia (rimonabant). Clean tolerability plus dose-responsive weight loss would enable Phase 2 initiation and position CRB-913 as a differentiated non-incretin add-on or alternative to the GLP-1 class. Monday's readout is one of the most-watched non-GLP-1 obesity data points on the September calendar.
Telix Pharmaceuticals Limited (NASDAQ: TLX) reached its FDA Prescription Drug User Fee Act (PDUFA) action date of Friday September 11, 2026 for TLX101-Px (Pixclara, floretyrosine F 18, also called 18F-FET), an investigational positron emission tomography (PET) imaging agent designed to help distinguish recurrent or progressive glioma from treatment-related changes in adult and pediatric patients with previously treated glioma. The FDA had accepted the resubmitted NDA in April 2026 following an earlier complete response letter. Pixclara carries FDA Fast Track and Orphan Drug designations. Standard MRI post-treatment surveillance struggles to differentiate true tumor progression from pseudoprogression or radiation necrosis; a PET imaging agent that binds selectively to actively metabolizing tumor cells addresses a substantial diagnostic gap. If approved, Pixclara would be one of the first tumor-specific glioma PET agents to enter the U.S. market. The company had not confirmed the FDA action outcome as of end of Friday U.S. business hours; investors were watching for a Monday morning announcement.
Corbus Pharmaceuticals (NASDAQ: CRBP) announced Friday September 11, 2026 that the company will host a conference call and webcast Monday September 14 at 8:00 a.m. EDT to discuss topline data from the Phase 1b CANYON-1 trial of CRB-913 (a once-daily orally-administered peripherally-restricted CB1 inverse agonist for obesity). The 16-week double-blind placebo-controlled dose-ranging study enrolled 240 obese non-diabetic U.S. adults at once-daily doses of 20 mg, 40 mg, and 60 mg with 4-week safety follow-up (NCT07310901). Last patient last visit was reported August 4, 2026. Harold Bays MD (investigator) will join the call as a guest speaker. CRB-913 is designed to remain peripheral (approximately 15-fold lower brain penetration than monlunabant in preclinical models) to preserve weight-loss efficacy while limiting the psychiatric side effects that led to the 2008 withdrawal of Sanofi's Acomplia (rimonabant). The Monday readout is one of the most-watched non-incretin obesity data points on the September calendar. Clean tolerability plus dose-responsive weight loss would enable Phase 2 initiation and position CRB-913 as a differentiated add-on or alternative to the GLP-1 class.
Sell-side analyst upgrades on Roivant Sciences (NASDAQ: ROIV) continued through Wednesday-Thursday September 9-10, 2026 following the Tuesday September 8 Pulmovant Phase 2 PHocus win in pulmonary hypertension associated with interstitial lung disease. TD Cowen raised its ROIV price target to $55 from $50 with a Buy rating; Jefferies raised to $52 from $42 with a Buy rating. These upgrades follow the Guggenheim ($46 from $42) and Piper Sandler ($55 from $40) targets published Wednesday September 9. Guggenheim estimated peak sales of approximately $3 billion in PH-ILD. Consensus analyst estimates now cluster around a $50-55 target range. The PHocus study achieved a 56.3% placebo-adjusted reduction in pulmonary vascular resistance at Week 16 (p<0.0001) with placebo-adjusted improvements of +35.2 meters six-minute walk distance and −53.2% NT-proBNP from baseline. The Phase 3 PHrontier study is enrolling approximately 375 patients globally in a 1:1 randomized double-blind placebo-controlled design.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced Thursday September 10, 2026 that the FDA granted Priority Review to a supplemental Biologics License Application (sBLA) for Enspryng (satralizumab, a humanized anti-interleukin-6 receptor monoclonal antibody using recycling-antibody technology for extended IL-6 receptor blockade) for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). MOGAD is a rare inflammatory central nervous system disorder attacking optic nerves, brain, and spinal cord with estimated prevalence of 0.51 to 3.42 per 100,000 people. It has no FDA-approved disease-modifying treatments. The Phase 3 METEOROID trial met its primary endpoint of time to first relapse during double-blind treatment with a 68% reduction in relapse risk versus placebo (p=0.0025) and secondary endpoints including 87% of Enspryng-treated patients relapse-free at 48 weeks (versus 67% on placebo), 66% lower annualized relapse rate, 79% fewer active MRI lesions, and 73% reduced rescue-therapy use. The FDA action date is January 10, 2027. Enspryng is currently approved in approximately 90 countries for neuromyelitis optica spectrum disorder (NMOSD).
Solstice Oncology, a Boston-based clinical-stage immuno-oncology company founded February 2026, announced Wednesday September 9, 2026 its formal launch and closing of an oversubscribed $225 million Series A financing to advance porustobart, a second-generation Fc-enhanced CTLA-4 monoclonal antibody licensed from Harbour BioMed. The Series A was led by RA Capital Management with participation from Canaan Partners, Forbion, and other investors. Porustobart is heading into a Phase 2 neoadjuvant trial combining with pembrolizumab (Merck's Keytruda) for microsatellite-stable clinical stage II-III colon cancer, targeting enrollment opening Q4 2026, plus a second undisclosed indication. Fc-enhancement is designed to improve the antibody's ability to deplete regulatory T-cells and enhance immunogenicity relative to first-generation CTLA-4 inhibitors like ipilimumab (Bristol Myers Squibb's Yervoy). The financing continues a Q3 2026 immuno-oncology financing wave and demonstrates continued investor appetite for differentiated checkpoint programs despite the maturity of the anti-PD-(L)1 class.
Sell-side analysts moved fast Wednesday September 9, 2026 following Tuesday's positive Phase 2 PHocus readout from Roivant Sciences (NASDAQ: ROIV) subsidiary Pulmovant. Guggenheim raised its ROIV price target to $46 from $42 while maintaining a Buy rating, and Guggenheim estimated peak sales of approximately $3 billion in pulmonary hypertension associated with interstitial lung disease. Piper Sandler analyst Yasmeen Rahimi raised her price target to $55 from $40 with an Overweight rating. Roivant shares closed up approximately 17% Tuesday on the ERS Congress presentation of a 56.3% placebo-adjusted reduction in pulmonary vascular resistance at Week 16 (p<0.0001), plus placebo-adjusted improvements of +35.2 meters six-minute walk distance and −357.7 pg/mL NT-proBNP (−53.2% from baseline). The Phase 3 PHrontier study in approximately 375 patients is enrolling. If PHrontier confirms the Phase 2 signal, mosliciguat would land in a PH-ILD market currently anchored by United Therapeutics' Tyvaso (treprostinil) — the only FDA-approved therapy specifically for PH-ILD — with orally-administered Merck Winrevair (sotatercept) as a pulmonary arterial hypertension option positioned differently.
Moonwalk Biosciences announced Tuesday September 8, 2026 an oversubscribed $70 million Series B financing to advance first-in-class adipose tissue-targeted RNA interference (RNAi) medicines for obesity and cardiometabolic diseases. The round was co-led by Alpha Wave and YK Bioventures with participation from Eli Lilly and Company, Gaorong Ventures, and existing investors ARCH Venture Partners, Khosla Ventures, and Future Ventures. Proceeds will move lead candidate MW101 toward first-in-human clinical studies in late 2027 and support the broader adipose-targeted siRNA pipeline. Moonwalk's approach uses siRNA delivery specifically to adipose tissue to modulate non-incretin pathways governing energy homeostasis, adipogenesis, lipolysis, and thermogenesis while minimizing systemic effects. The company claims preclinical models show reductions in body weight and fat mass with lean-muscle preservation — the same value proposition Enveda's ENV-308 and Amgen's MariTide are pitching from different mechanisms. Lilly's investor participation extends the Lilly obesity-adjacent equity portfolio that already includes stakes in Superluminal Medicines (MC4R agonist, $60M Series B September 3), Verve Therapeutics (base editing, acquired 2025), and others.
Amgen (NASDAQ: AMGN) shares fell approximately 10% to $394.38 by midday Tuesday September 8, 2026 as investors continued to reprice the entire Lp(a)-lowering cardiovascular hypothesis following Novartis' Friday September 4 announcement that pelacarsen missed the primary MACE endpoint in the Phase 3 Lp(a)HORIZON trial. Amgen's olpasiran (RNAi Lp(a) suppressor) is the most direct readthrough: the Phase 3 OCEAN(a) trial is enrolling patients with elevated Lp(a) and established cardiovascular disease with a similar Lp(a)-lowering-plus-cardiovascular-outcome design and is estimated to read out 2027-2028. Lilly's lepodisiran (RNAi) is running in a broader group including primary-prevention patients, which analyst commentary suggests partly insulates it from the Novartis-specific readthrough. Silence Therapeutics' zerlasiran (RNAi) lowered Lp(a) by up to 85% at 36 weeks in ALPACAR-360; Silence has FDA feedback on a proposed Phase 3 design but is dependent on securing a development partner. The Lp(a) hypothesis question is now whether the drug class lowers hard cardiovascular outcomes, not whether the class lowers Lp(a) levels — that latter question was already answered in the affirmative.
Insmed Incorporated (NASDAQ: INSM) presented Wednesday September 9, 2026 at the ERS Congress in Barcelona a post-hoc analysis of the Phase 3 ASPEN trial evaluating BRINSUPRI (brensocatib, a first-in-class oral dipeptidyl peptidase 1 (DPP1) inhibitor approved in August 2025 for non-cystic fibrosis bronchiectasis (NCFB) in ages 12+) in the subgroup of ASPEN patients with prior nontuberculous mycobacterial (NTM) infection. The analysis is one of five Insmed abstracts at the meeting, alongside a COMPERA 2.0 risk-assessment post-hoc analysis of treprostinil palmitil inhalation powder (TPIP) in pulmonary arterial hypertension, additional ARIKAYCE (amikacin liposome inhalation) data on the psychosocial burden and healthcare resource use of MAC lung disease, and treatment-pattern analyses. Brinsupri launched August 2025 via specialty pharmacy in the U.S. and is under EMA and MHRA review with Japanese filing in H2 2026. TPIP is Insmed's mid-stage prostacyclin analog delivered via dry powder inhaler, targeting PAH as a differentiated option relative to United Therapeutics' Tyvaso (nebulized treprostinil).
Pulmovant, a Roivant Sciences (NASDAQ: ROIV) company, announced Tuesday September 8, 2026 that the Phase 2 PHocus study of inhaled mosliciguat (a once-daily first-in-class inhaled soluble guanylate cyclase activator) met its primary endpoint in patients with pulmonary hypertension associated with interstitial lung disease. Placebo-adjusted pulmonary vascular resistance reduction was 56.3% at Week 16 (-51.3% mosliciguat vs +6.6% placebo, p<0.0001) — the largest PVR reduction reported in any randomized controlled pulmonary hypertension trial per Pulmovant. Secondary endpoints: placebo-adjusted six-minute walk distance +35.2 meters (p=0.0027) and NT-proBNP -357.7 pg/mL, a 53.2% reduction from baseline (p=0.0002). At Week 24 (exploratory), 6MWD was +52.7 meters placebo-adjusted and NT-proBNP was -487.1 pg/mL (-75.9%). Mosliciguat was well-tolerated with lower cough incidence (12.1%) than placebo (18.2%). The trial enrolled 135 patients across 87 sites in 20 countries. The Phase 3 PHrontier study is enrolling approximately 375 patients globally in a 1:1 randomized double-blind placebo-controlled design. Marc Humbert (Université Paris-Saclay) presented the data at the ERS Congress in Barcelona; Roivant shares closed up approximately 17% on the day. Mosliciguat activates sGC independently of heme and nitric oxide, differentiating it from sGC stimulators like riociguat.
Novo Nordisk (NYSE: NVO) confirmed Monday September 7, 2026 that it had informed investigators on Friday September 4 that the HERMES and ATHENA Phase 3 trials of ziltivekimab (an anti-IL-6 monoclonal antibody) would end early on the recommendation of an independent data monitoring committee that judged the studies unlikely to succeed. HERMES evaluated ziltivekimab against time to first occurrence of heart failure endpoints including cardiovascular death and heart-failure-linked hospitalisation or urgent visits; ATHENA evaluated the drug's effect on quality of life and other heart-failure-specific measures. The terminations follow the June 2026 ZEUS trial miss (chronic kidney disease plus cardiovascular disease) reported at the ESC Congress August 30, where ziltivekimab lowered inflammation markers but did not reduce major adverse cardiovascular events. A separate post-acute heart failure study of ziltivekimab remains ongoing. Novo shares finished down about 2% on the announcement day (Copenhagen trading open; NYSE closed for Labor Day), with the pediatric semaglutide win offset by the further narrowing of the company's non-GLP-1 growth options.
Roivant Sciences (NASDAQ: ROIV) and its Pulmovant subsidiary announced Sunday September 6, 2026 that Phase 2 PHocus topline results for mosliciguat (a once-daily inhaled soluble guanylate cyclase activator) in pulmonary hypertension associated with interstitial lung disease (PH-ILD) will be presented Tuesday September 8, 2026 at 12:15 CEST (6:15 a.m. ET) at the European Respiratory Society Congress 2026 in Barcelona by Marc Humbert MD PhD (Université Paris-Saclay; French National Reference Center for Pulmonary Hypertension). The randomized double-blind placebo-controlled global trial enrolled 135 adults with PH-ILD; the primary endpoint is change from baseline in pulmonary vascular resistance at week 16, with the controlled period running through week 24. Roivant will host an investor call at 8:00 a.m. ET the same day. Mosliciguat is an sGC activator that works independently of heme and nitric oxide, differentiating it from sGC stimulators like riociguat. In the earlier Phase 1b ATMOS study a single inhaled dose produced a mean peak reduction in pulmonary vascular resistance of up to 38%. The PVR change versus placebo is the metric investors are watching; the same endpoint anchored the Phase 3 program for United Therapeutics' Tyvaso (treprostinil) in PH-ILD.
Vicore Pharma Holding AB (STO: VICO) presented the trial-design abstract for its global 52-week Phase 2b ASPIRE trial of buloxibutid (a first-in-class oral angiotensin II type 2 receptor agonist small molecule) in idiopathic pulmonary fibrosis at the European Respiratory Society Congress 2026 on Monday September 7, 2026 in Barcelona. The randomized double-blind placebo-controlled parallel-group trial enrolled more than 360 IPF patients across 14 countries and 100 sites (29 in the United States), stratified between patients on background nintedanib standard of care and those without antifibrotic therapy. The primary endpoint is change in forced vital capacity (FVC) over 52 weeks, the regulatory endpoint for IPF. Buloxibutid activates AT2R to promote alveolar-epithelial-cell repair and downregulate aberrant fibrotic signalling. Enrollment completed in April 2026; topline results are guided for mid-2027 with cash runway into H2 2028. The ASPIRE readout will land in a crowded IPF competitive landscape following the March 2026 FDA approval of Boehringer's nerandomilast (BI 1015550) as the first non-antifibrotic mechanism approved for IPF in over a decade.
Insmed Incorporated (NASDAQ: INSM) presented late-breaking Phase 3b ENCORE results for ARIKAYCE (amikacin liposome inhalation suspension) in an oral session Sunday September 6, 2026 at the European Respiratory Society Congress in Barcelona. The 12-month study evaluated ARIKAYCE plus multidrug therapy (azithromycin 250 mg plus ethambutol 15 mg/kg) versus multidrug therapy alone in patients with a new occurrence of Mycobacterium avium complex (MAC) lung infection who had not received antibiotics — a substantially different population from ARIKAYCE's current U.S. label limited to refractory MAC. ENCORE met its primary endpoint of improvement in respiratory symptom score at month 13 and all multiplicity-controlled secondary endpoints; culture conversion at month 6 was 87.8% with ARIKAYCE plus multidrug versus 57.0% with multidrug alone. Insmed plans to file a supplemental new drug application in the second half of 2026 to expand the U.S. label to newly diagnosed MAC lung disease and convert the current accelerated approval in refractory MAC to traditional approval. Five Insmed abstracts total were accepted at the meeting including brensocatib (Brinsupri, DPP1 inhibitor) bronchiectasis analyses.
Trevi Therapeutics (NASDAQ: TRVI) confirmed via its September 3, 2026 conference-participation announcement that Marlies Wijsenbeek MD PhD (Erasmus MC) will deliver an oral presentation on quality-of-life outcomes measured by the Leicester Cough Questionnaire (LCQ) from the Phase 2b CORAL trial of nalbuphine extended-release (Haduvio, an oral kappa-opioid agonist / mu-opioid antagonist) in idiopathic pulmonary fibrosis patients with chronic cough at the European Respiratory Society Congress in Barcelona. The 165-patient Phase 2b CORAL topline (reported June 2025) documented statistically significant reductions in 24-hour objective cough frequency across all Haduvio dose groups at week 6, with reductions seen at week 2 (the first time point measured). Trevi has completed the End-of-Phase 2 FDA meeting and continued Phase 3 initiation preparation through 2026. Chronic cough affects approximately 85% of IPF patients and has no FDA-approved treatment; the Merck-Bellus P2X3 antagonist gefapixant (Lyfnua) was approved for refractory chronic cough in adults in 2024 but was not developed for IPF-specific cough.
Novartis (NYSE: NVS) initiated clinical holds on all rap-cel (YTB323, an autologous CD19-directed CAR-T cell therapy) autoimmune trials on August 24, 2026 following three fatal cases of immune effector cell-associated hemophagocytic syndrome, a rare life-threatening inflammatory reaction. Affected trials cover lupus (systemic lupus erythematosus), myasthenia gravis, multiple sclerosis, systemic sclerosis, idiopathic inflammatory myopathies, and additional autoimmune indications. Bristol Myers Squibb (NYSE: BMY) voluntarily paused enrollment in its own zola-cel (zolacabtagene autoleucel, another autologous CD19 CAR-T) autoimmune trials after detecting transient and reversible inflammatory events during routine safety surveillance; BMS had halted the enrollment in June 2026 after cases of brain inflammation but did not publicly disclose the pause until three months later. Novartis and BMS were the leading commercial-scale CAR-T-in-autoimmune-disease players; the paired pauses are a substantial setback for the category, which had been the hottest cell-therapy expansion area of 2026 after Kyverna, Cabaletta Bio, and multiple academic centers reported dramatic clinical responses in refractory lupus and neurological autoimmune disease.
Corbus Pharmaceuticals (NASDAQ: CRBP) continued through Sunday September 6, 2026 the countdown to CANYON-1 Phase 1b topline data for CRB-913 (a once-daily orally-administered peripherally-restricted CB1 inverse agonist for obesity). Last patient last visit was announced August 4, 2026, and topline is expected in September 2026 per company Q2 2026 corporate update — the specific readout date has not been disclosed but the September window narrows with each passing day. The 16-week double-blind placebo-controlled dose-ranging study enrolled 240 obese non-diabetic U.S. adults at once-daily doses of 20 mg, 40 mg, and 60 mg with 4-week safety follow-up. CRB-913 is engineered to remain peripheral (approximately 15-fold lower brain penetration than monlunabant in preclinical models) to preserve efficacy while limiting the psychiatric side effects that led to withdrawal of Sanofi's Acomplia (rimonabant) in 2008. Investor focus is on the CB1 inverse agonist class safety-versus-efficacy trade-off plus dose-responsive weight loss. Clean data enables Phase 2 initiation and would position CRB-913 as a non-incretin add-on or alternative to the GLP-1 class.