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The Pharma Closeout | Daily Pharmaceutical and Biotech News in 15 Minutes

Your daily pharmaceutical news briefing — FDA decisions, clinical trial results, biotech M&A, and drug pipeline updates in under 15 minutes, every weekday. Hosted by Alex Mercer and Maya Patel. Plus a Week in Review every Sunday synthesizing the week"s biggest moves in pharma and biotech. Covering drug approvals, licensing and M&A deals, biopharma investing, and healthcare market intelligence. Smart, fast, and built for pharma and biotech professionals who need to stay ahead. Transcripts,

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00:12:19

Daily Roundup | Amylyx Avexitide Wins Phase 3: 55%...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/08/19

Amylyx's avexitide cut serious hypoglycemic events 55% in Phase 3, sending shares up 54% to a three-year high - on a drug bought for $35 million out of bankruptcy. We break down BioMarin's $275 million Alesta acquisition and oral hypophosphatasia candidate ALE1, Leo Pharma's $435 million dersimelagon license from Tanabe in erythropoietic protoporphyria, EyePoint's 67% Duravyu crash in wet AMD against Eylea, and Moderna's mFlusiva mRNA flu vaccine approval. Visit us at

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00:11:38

Daily Roundup | EyePoint Crashes 67% After Duravyu...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/08/18

EyePoint stock crashed 67% after Duravyu missed its primary endpoint against aflibercept in the LUGANO Phase 3 for wet AMD - with nine vision-loss cases in the treatment arm versus zero. Also: argenx's Vyvgart Hytrulo hits in autoimmune myositis, AstraZeneca scraps its volrustomig bispecific in lung cancer while Enhertu and Tagrisso win, Sandoz signs a $322M biosimilar deal with Shanghai Henlius, Cytokinetics sues Bristol Myers Squibb over aficamten and Camzyos, and Slate Medicines merges with

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00:14:13

Week in Review | Lilly's Retatrutide Lawsuits:...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/08/17

Eli Lilly filed six lawsuits over black-market retatrutide and has referred more than 200 sellers to regulators — before it has even filed for approval. Plus Bristol Myers Squibb's accelerated approval of Zenbexus (iberdomide) with Darzalex in multiple myeloma on a 41% versus 21% MRD-negative complete response, Taiho and Cullinan's early Phase 3 unblinding for zipalertinib in EGFR exon 20 lung cancer, Silence Therapeutics' 88% versus 19% divesiran result in polycythemia vera, and

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00:10:39

Daily Roundup | Zenbexus Approval Tests a New...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/08/14

BMS won FDA accelerated approval for Zenbexus on a 41% versus 21% MRD-negative complete response — with no survival data required. We break down what the first CELMoD approval means for Bristol Myers' Revlimid replacement strategy, why the CD38-pretreated label limit caps the launch, and the confirmatory readout still owed. Plus Capricor's 71% surge on a refined deramiocel filing in Duchenne muscular dystrophy, Taiho and Cullinan's early-stopped Phase 3 for zipalertinib in EGFR exon 20

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00:09:53

Daily Roundup | Definium LSD Pill Beats Placebo in...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/08/13

Definium's DT120 separated from placebo by 5.4 points in Phase 3 generalized anxiety — from a single dose of pharmaceutical-grade LSD. Also: Taiho and Cullinan halt a first-line EGFR exon 20 lung cancer trial early with zipalertinib, raising the bar for J&J's Rybrevant, AstraZeneca and Dizal's Zegfrovy, and ArriVent's firmonertinib. Plus Karyopharm faces default on a September loan payment as it files Xpovio in myelofibrosis, and Eli Lilly escalates its fight against the

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00:10:37

Daily Roundup | Definium's LSD Pill Wins Phase 3 in...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/08/13

DT120 beat placebo by 5.4 points on the Hamilton Anxiety scale twelve weeks after a single dose — the first new mechanism in generalized anxiety disorder since 2007, and the real constraint isn't efficacy, it's who pays for the eight-hour monitored session. We break down Definium Therapeutics' Voyage results and the September Panorama readout that decides the functional-unblinding question. Plus: Eli Lilly files six lawsuits over a retatrutide black market before the obesity drug is even

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00:12:06

Daily Roundup | WuXi AppTec Wins Injunction:...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/08/12

A federal judge blocked the Pentagon's Chinese military designation of WuXi AppTec, finding the DoD's case rested on a misreading. Plus: Sionna Therapeutics' cystic fibrosis failure sends shares down ninety-two percent and leaves Vertex Pharmaceuticals' Trikafta franchise uncontested; BridgeBio's Attruby beats consensus at $222 million as the ATTR-cardiomyopathy market tilts stabilizer-first against Alnylam's Amvuttra; Tenax Therapeutics' oral levosimendan misses in

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00:11:46

Daily Roundup | Jazz Buys Actio Biosciences in $1.3B...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/08/10

Jazz Pharmaceuticals is paying $820 million upfront — up to $1.3 billion total — for Actio Biosciences and its first-in-class KCNT1 epilepsy drug ABS-1230. Plus: Sionna Therapeutics' SION-719 fails alongside Vertex's Trikafta in cystic fibrosis and shares fall nearly 92%, ITM receives a complete response letter for 177Lu-edotreotide in neuroendocrine tumors, Scholar Rock pulls a Novo Nordisk-owned Catalent site from the apitegromab SMA filing, Bristol Myers Squibb commits $2.3 billion to a

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00:12:14

Week in Review | Takeda's Orzeyful Approval Opens the...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/08/09

FDA approved Takeda's Orzeyful, a first-in-class orexin-2 agonist for narcolepsy type 1, with peak sales seen near $2B. Also: Replimune's Tudriqev wins accelerated approval with Opdivo in advanced melanoma after two rejections, Lantheus agrees to an up to $8.0 billion merger with Curium in radiopharmaceuticals, Tarsus buys Alkeus and its Stargardt disease candidate gildeuretinol for up to $800 million, reported AstraZeneca-Bristol Myers Squibb merger talks are denied, and LifeMine raises

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00:09:45

Daily Roundup | Vedanta's $60M Lifeline: What VE303...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/08/08

Vedanta Biosciences raised $60M, including $20M from BARDA, to finish the Phase 3 that decides its microbiome bet on VE303 in recurrent C. difficile infection. Plus Replimune's Tudriqev wins accelerated FDA approval in advanced melanoma after two rejections, LifeMine Therapeutics raises $263M for a fungal-derived calcineurin inhibitor in organ transplant, Revolution Medicines reports more than 2,000 compassionate use prescriptions for pancreatic cancer drug daraxonrasib, and Insmed lifts

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00:11:07

Daily Roundup | Replimune Wins FDA Approval for...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/08/07

FDA approved Replimune's Tudriqev for advanced melanoma after two rejections - and over its own reviewers' written objections. Plus Moderna's mRNA flu vaccine mFlusiva clears for adults 50 and older with a split label, Iovance jumps 34% on record Amtagvi revenue and a 56% gross margin, and Tarsus buys Alkeus for up to $800 million for gildeuretinol in Stargardt disease. Melanoma, influenza, cell therapy and inherited retinal disease in a single Thursday. Visit us at

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00:09:36

Daily Roundup | Merck's 2028 Keytruda Cliff: The Oral...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/08/05

Merck posted $16.61B in Q2 revenue and $8.37B in Keytruda sales — then cut profit guidance on acquisition charges. Alex and Maya break down the oral PCSK9 approval, the planned sacituzumab tirumotecan and Keytruda combination trial, and what the 2028 loss of exclusivity forces next. Plus Pfizer's additional $2.5 billion in cost savings and Eliquis strength, the sigvotatug vedotin miss in non-small cell lung cancer, the Oxbryta write-down in sickle cell disease, and BioNTech naming Sobi's Guido

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00:12:12

Daily Roundup | Curium Buys Lantheus for Up to $8B in...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/08/03

Curium will pay up to $8.0 billion for Lantheus — Asubstantial cash payment per share plus additional contingent value rights tied to milestones stretching out several years. We break down theradiopharmaceutical consolidation across PYLARIFY, DEFINITY and Neuraceq, the Supernus–Indivior all-stock merger creating a $2.2 billion CNS company spanningADHD, epilepsy, Parkinson's and opioid use disorder, and Amgen's cloud breachthat stole patient data and intellectual property. Plus the open

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00:11:11

Week in Review | AstraZeneca, Bristol Myers Squibb...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/08/03

AstraZeneca and Bristol Myers Squibb held months of merger talks valuing the combined company near $400 billion, per the Financial Times — a deal that would make AstraZeneca the world's fourth-largest drugmaker and draw antitrust scrutiny over two overlapping oncology portfolios. Plus: MapLight's ML-007C-MA hit its Phase 2 schizophrenia endpoint and still lost two-thirds of its market value against Bristol Myers' Cobenfy, an FDA advisory committee voted down Capricor's deramiocel in Duchenne-related

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00:09:25

Daily Roundup | Novo Nordisk's ZEUS Failure: The...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/08/01

Ziltivekimab missed its primary endpoint in the 6,300-patient Phase 3 ZEUS trial, sending Novo Nordisk down 10% and dragging BioAge Labs down 60% and Monte Rosa Therapeutics down 30%. Also: AbbVie's Skyrizi posts $5.5 billion in quarterly sales matching Humira's best quarter as J&J's Icotyde looms, Regeneron beats on Dupixent strength with Sanofi pledging to rebuild trust, Bristol Myers Squibb beats into its Revlimid and Eliquis patent cliff, Madrigal's Rezdiffra grows 71% in MASH, and IMPACT

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00:10:56

Daily Roundup | Replimune Wins 10-3 FDA Panel Vote...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/07/31

An FDA advisory panel backed Replimune's RP1 by 10 to 3, overriding agency reviewers, with an approval decision due August 2nd. Also: the same-day panel voted Capricor's Duchenne cell therapy deramiocel down 9 to 3, Johnson & Johnson took a $2.58 billion option on Flagship's in vivo CAR-T biotech Sail Biomedicines, Pfizer's Litfulo hit both Phase 3 endpoints in vitiligo, Eli Lilly's $2.8 billion AtaiBeckley deal drew competing bidders in treatment-resistant depression,

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00:11:12

Daily Roundup | Capricor's Duchenne Cell Therapy...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/07/30

FDA advisers recommended against Capricor's deramiocel — and the stock had already lost up to 60% before the vote. Also: Replimune falls nearly 40% as FDA reviewers call RP1's melanoma survival data uninterpretable ahead of Thursday's panel; Biogen posts $2.7 billion and cuts EPS guidance on Apellis dilution as Leqembi, Spinraza and Skyclarys beat; AstraZeneca defends its $80 billion 2030 target and GSK bets its growth plan on oncology expansion; Vertex pays AbCellera $28 million upfront for

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00:10:30

Daily Roundup | Replimune RP1 on the Brink: FDA Calls...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/07/29

FDA reviewers say Replimune's IGNYTE overall survival analysis is "not interpretable" days before Thursday's advisory committee — shares fell more than 32% to $5.78. We break down what it means for RP1, Opdivo combination therapy, and accelerated approval in advanced melanoma, plus Gossamer Bio reacquiring worldwide seralutinib rights from Chiesi ahead of a September NDA filing in pulmonary arterial hypertension, the FDA's parallel challenge to Capricor's Duchenne data, and

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00:09:20

Daily Roundup | Capricor Craters 67% as FDA Questions...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/07/28

Capricor fell roughly 67% after FDA briefing documentsquestioned deramiocel's efficacy days before its advisory committee — and the company's rebuttal is a fight over which statistical analysis plan governs. Webreak down what that means for cell therapy in Duchenne muscular dystrophy, argenx's $2.2 billion all-cash acquisition of Forte Biosciences for the anti-CD122 antibody FB102 in vitiligo and celiac disease, and the abrupt CEO exit at Legend Biotech as competitive pressure builds

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00:13:24

Week in Review | Amgen Refuses to Pull Tavneos: FDA...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/07/26

Amgen told the FDA no — a blinded Duke re-analysis of ADVOCATE met noninferiority at 68.1% versus 67.1% but lost superiority, and the deadline is July 29. We unpack the avacopan withdrawal fight, the ChemoCentryx acquisition that bought it, and the EMA committee already moving against it. Plus Elevar's complete response letter for rivoceranib and camrelizumab in first-line liver cancer over a manufacturing inspection, Summit's ivonescimab survival update ahead of its November decision, Sun Pharma's

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