Leerink cut Bristol Myers and raised Zentalis. Barclays lowered uniQure. Cantor upgraded Rezolute. New Buy calls on Ovid, Maravai, and Regenxbio.
Option Care Health is in advanced talks on a joint bid from McKesson and CD&R valuing it at more than $5 billion, including debt.
Genmab and AbbVie say epcoritamab plus R-CHOP cut the risk of progression or death by 51% in newly diagnosed DLBCL in a Phase 3 trial.
Sofie joins GE HealthCare's diagnostics unit in a $945 million cash deal that adds U.S. PET manufacturing and FAPI-74 rights.
FDA granted HeartBeam Breakthrough status for its 3D ECG heart-attack tool. Priority review follows; clearance is still required.
New Capricor extension data support slower DMD arm decline, but H.C. Wainwright and Roth still see a complete response letter as more likely.
Alector grants Genentech exclusive rights to AL050, a brain-penetrant GCase enzyme therapy for Parkinson’s, for $100 million upfront and up to $1.17 billion more.
Vaxcyte shares surged after VAX-31 met adult Phase 3 goals versus Prevnar 20 and Capvaxive. A BLA filing is targeted for the first half of 2028.
FDA cleared a second Reykjavik suite for SIMLANDI, doubling U.S. drug-substance capacity and confirming earlier inspection issues are resolved.
The FDA says an Evolus Instagram post overstated Jeuveau benefits and downplayed risks. The firm has 15 working days to respond.
Novartis will pay $575 million upfront for worldwide rights to Abogen's mRNA T-cell engager, plus up to $7.2 billion in milestones.
Integra cut its 2026 revenue and earnings outlook after flood damage at its Cincinnati plant pushed results below Wall Street forecasts.
Analysts see GeneTAC protein gains translating into functional benefit in Friedreich ataxia. Cash of $207.4 million is guided to fund plans into 2029.
Biomarkers improved, but Phase 1 data, rivals, and the ZEUS miss kept buyers on the sidelines.
Off-treatment hair regrowth held in a small group, yet analysts said the Nektar selloff does not change the rezpeg thesis.
Wave plans a single two-year trial for WVE-006 in AATD after FDA feedback, with a one-year review for possible accelerated approval.
BofA kept Buy ratings, calling the news a clearing event.
Foghorn and Lilly will not advance FHD-909 or their SMARCA2 degrader. Foghorn is cutting about 40% of staff to fund its pipeline into late 2029.
Wainwright cites a $565M enterprise value, cash into 2029, and multiple trials.
Three ADC trials and cash into 2028 are the setup.
Merck’s tulisokibart met its Phase 2b HS goal and will move to Phase 3. H.C. Wainwright sees first anti-TL1A skin data as a class plus for Shattuck.
A Delaware judge found Liquidia’s Yutrepia infringes United Therapeutics’ PH-ILD patent. Final judgment is next.
If approved, it would be the first FDA-approved medicine for the circadian disorder.
Stifel initiates Achieve Life Sciences at Buy with an $18 target, citing a manufacturing, leadership, and capital reset ahead of a 2026 NDA resubmission.
Citi says Moderna’s rally after the INTerpath-001 melanoma win pushed its market value near Regeneron’s despite weaker near-term earnings.
FDA warned Neogen after HYCOAT, sold as sterile, was tied to fungal infections and horse deaths. Nearly 100 cases; at least 20 euthanized.
VYD2311 looked better tolerated than Comirnaty, but combo stats were mixed. Shorts, profit-taking, and a crowded COVID market weighed on IVVD.
The deal adds HRS-1596 to Novo’s pipeline as Lilly, daily pills and other oral GLP-1s intensify competition in obesity and diabetes.
Iovance lifts 2026 revenue guidance to $410–$420 million on strong Amtagvi demand, beating most Street estimates.
AMT-130 slowed Huntington’s 44% at four years, but the result lost statistical significance after stronger three-year data. Stock falls as FDA review begins.
Summit and AstraZeneca will co-develop ivonescimab combinations, starting with GI cancers. Each company keeps rights to its own medicines.
Eli Lilly CEO Dave Ricks says obesity-drug cash will fund slightly larger buys in sleep, cancer, brain disease, and other underserved science.
Cantor initiates LXRX Overweight with an $8 target on sotagliflozin’s fully enrolled Phase 3 SONATA-HCM trial and a Q1 2027 readout.
The firm points to bempikibart in severe alopecia, a 1H 2027 Phase 3 start, and a stronger cash runway.
4D-150 is now in Phase 3 for DME after two-year SPECTRA data showed durable vision gains and fewer injections, expanding the race with implants like AXPAXLI.
Total value can reach about $664 million if 2028–2030 targets are met.
MediciNova fell after mixed Phase 2 data for MN-001. HDL rose, but week-24 liver fat and triglycerides missed significance in 40 patients.
Zenkuda was non-inferior to Eylea in vision, dried fluid quickly, and put 54% of wet AMD patients on 24-week dosing under strict treat-to-dryness rules.
California jury found Lilly breached good faith in the 2017 rezpeg deal and awarded Nektar $90 million plus interest. Lilly plans to appeal.
Guggenheim named Damora a Best Idea, citing the potential for earlier, longer mCALR treatment to expand the myelofibrosis and essential thrombocythemia markets.
B. Riley rates Precigen Buy on Papzimeos, the first FDA-approved adult RRP therapy, plus Q2 profit and management’s year-end cash break-even goal.
The Glyph pipeline, 2027 catalyst, and cash runway into 2029 drive the case.
First human data are due in 2027. This is not an approval; Beam remains ahead in patients.
A missed Q3 RA readout, sector pressure, and high short interest hit CGEM. Cash still funds operations into 2029. Next data: November and December.
The bank says AURORA endpoints and teen compliance may not match China’s Phase 3 results.
FDA clears Lilly’s Onswik, a once-weekly basal insulin for adults with type 2 diabetes. It may cut 300+ shots a year and now competes with Novo’s Awiqli.
Acadia’s remlifanserin narrowly missed its Phase 2 primary endpoint in Alzheimer’s psychosis. Safety remained favorable, Phase 3 is continuing, and the stock sold off first.
Mesoblast received FDA approval for a new TIBA assay to check strength and stability of every commercial Ryoncil batch as manufacturing scales.
After EFZO-FIT missed, aTyr has FDA alignment on a narrower Phase 3 using FVC. Cash funds operations into 2028, but not the new trial.
FDA panel endorsed GRAIL’s Galleri as an add-on cancer blood test. Approval is not final. Coverage, labeling, and whether it saves lives remain open.
Arcturus shares positive OTC deficiency Phase 2 findings, plans to add ARCT-2601 by year-end 2026, and acquires AI firm myNEO.
Shares of Rapport Therapeutics dropped after conference remarks on RAP-219’s bipolar mania study, weeks before the planned October readout.
Early lab results show Claude found a CRISPR-like repeat array tied to a reverse transcriptase. No proven editing tool yet.
Analysts called the readout in line with base case. Next tests: 52-week EVERLAST-A in December and EVERLAST-B data in Q4.
Investors are watching liability and damages in Nektar’s breach case against Lilly, a key swing factor for the Rezpeg program. Analysts still see damages as the hard issue.
Immunovant ends IMVT-1402 in cutaneous lupus after a 57-patient study missed its CLASI-A primary endpoint. Other programs remain on track.
Guggenheim raised Editas Medicine to Buy with a $5 target, citing EDIT-401’s potential in high-LDL ASCVD patients as its first human trial nears.
Roche-Ionis sefaxersen beat placebo on proteinuria at week 37 in IgAN Phase 3. Monthly shot enters crowded market vs Novartis Fabhalta.
Doctors see 35%–40% U.S. share; peak sales estimate raised to about $400 million.
FDA clears TriSalus’ TriNav Advance, designed to push more treatment into liver tumors and less into healthy tissue via a SmartValve.
Chinese biotech BoomRay licenses a preclinical radioligand therapy to Novartis in a deal worth up to $900 million plus royalties.
Amgen’s dazodalibep met its Phase 3 goal in moderate-to-severe Sjögren’s disease, showing lasting improvement in systemic activity. A second trial is due later in 2026.
Truist calls Vertex’s Phase 2b inaxaplin data a validation of APOL1 inhibition in AMKD and sees a 100,000+ extra patient opportunity, plus positive readthrough for Maze.
Deal adds oral and brain-targeted FA treatments to Lexeo’s pipeline. LX2006 gene therapy stays top priority, with pivotal data due in late 2027.
FDA lifted the clinical hold on Filana’s simufilam, clearing a Phase 2a study in TSC-related epilepsy. Lucid Capital keeps a Buy rating and $8 target.
Compass disagrees with the FDA, but markets sold off after the agency said existing ORR and PFS data are not enough for a tovecimig filing.
Barzolvolimab met every Phase 3 CSU goal, with 42–54% complete responses. Shares still fell on high expectations, thin safety detail, and oral/injectable rivals.
Viking reported 16–19% weight loss at week 21 and strong maintenance on monthly dosing. GI side effects in the later phase looked like placebo.
CMS says Medicare pays 16% more than private insurers for lab tests. Preliminary 2027 rates could save $1B a year, with cuts capped at 15%. Craig-Hallum flags code confusion at GeneDx, Adaptive and Myriad, but says the WGS drop looks overdone.
AnaptysBio climbed in premarket after a $27.5M collaboration-revenue beat. Jemperli sales grew 26–34%; ignore the $5.11 EPS tax gain.
FDA posted Galleri briefing papers with no leftover lab-test questions. Panel meets Sept. 23; approval odds remain in focus.
Alkermes said ALKS 7290 improved adult ADHD scores in 14 days and was generally well tolerated. Phase 2 data are expected in 2027.
Prostate data look filing-ready, cash is $201.6M, and analysts see ~66% upside.
Helus Pharma sold off Friday after Barclays’ $35 initiation. The bank says APPROACH data are not the sole basis for its rating.
Phase 2 CSU data favored CUE-221 over placebo and Xolair. Missing IgE/PK results and a late fade drove a 24% drop. B. Riley: Buy, $83 PT.
Distant 2030 goals failed to ease concerns over patents and Lilly.
Xenon paused new MDD and BPD enrollment after a psychiatry safety review; X-NOVA2 data expected Q1 2027.
The FDA approved Ultragenyx’s Fayuvi for Sanfilippo syndrome type A following a manufacturing-related delay in 2025. Children ages 2–5 who received the treatment maintained or improved their cognitive scores.
CHMP recommends FREHEMGO (denecimig) for haemophilia A, with or without inhibitors. Novo and Orbis will develop oral cardiometabolic drugs.
FDA approved an IBTROZI label update showing 49.7 months median response in TKI-naïve ROS1+ lung cancer. Safety language was unchanged.
Qiagen reviews options with Goldman and Moelis.
Phase 2b/3 ALS data due Q4 2026; cash runway into late 2027.
ELPIS II missed its primary endpoint in HLHS. Longeveron plans an FDA talk, cost cuts, and a strategic review as cash runs into Q4 2026.
Twist Bioscience and Ginkgo Datapoints join Eli Lilly’s TuneLab to pair lab testing with AI for faster antibody drug discovery.
Barclays now sees two-times upside vs. downside for ALVO into December FDA reviews of Simponi, Eylea and Prolia biosimilars.
NucleoCapture and DNase will target NETs in sepsis, lupus, transplant and lymphoma.
FDA let Rocket keep its 12-patient Danon study and count the first 3 patients. Needham upgraded RCKT and removed a key regulatory overhang.
Tempest gets an exclusive option to license Senlang’s CD7-targeted lentiviral in-vivo CAR-T, now in Phase 1 for relapsed multiple myeloma.
Ascendis will develop TransCon obesity and cardiometabolic programs itself after ending its Novo collaboration and starting a $400M buyback.
FDA cleared a grant-dependent myeloma IND for GTB-5550. Cheap preferred, 100% warrants, and a tiny float explain the selloff.
Management cited Star-rating limits, HEI frustration, and a small cost rise.
GSK will buy a Chimagen trispecific T-cell engager for multiple myeloma. Phase I trials start in 2027. The deal is worth up to $750 million.
Phase 2 ADDRESS-LC missed statistical significance overall. 21 of 22 measures favored bezisterim; benefits were strongest in severe-symptom subgroups.
The catalyst: an out-of-court deal that keeps exclusive rights to onvansertib. Cash remains tight.
Berenberg upgraded Eli Lilly from Hold to Buy and lifted its target to $1,400, citing obesity-drug leadership and a likely 2026 guidance beat.
Vera’s Trutakna kept kidney function nearly stable over two years in IgAN, cut serious progression risk, and will support a full FDA filing.
Veracyte acquired Convergent Genomics for $150M cash plus up to $30M in milestones, adding UroAmp, a urine tumor DNA test for bladder cancer.
Sionna will start a Q1 2027 Phase 2a trial of SION-451 plus SION-2222 after a missed Trikafta add-on study. A 46% staff cut extends cash into 2H 2029.
Citizens cut Cellectis to Market Perform after it scrapped allogeneic CAR-T programs and pivoted to in-vivo gene editing for high triglycerides and cholesterol. Catalysts now 2027–28.
Contineum said its J&J-partnered drug PIPE-307 missed the Phase 2 primary goal of improving MADRS scores at Day 5 versus placebo.
