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

Akeso cleared AK157D1, a B7-H3 antibody-drug conjugate, into Phase 1 in solid tumors — its third differentiated ADC, and a late entry into an already crowded target. Alex and Maya argue whether three assets from one engine is platform depth or correlated risk, and why the dose-escalation ceiling matters more than any early response rate. Also: Leads Biolabs' opamtistomig, a PD-L1/4-1BB bispecific, has an NDA accepted by China's NMPA and is positioned as the first approved 4-1BB-targeting therapy — with liver-monitoring label language as the real open question. Plus Werewolf Therapeutics' reverse merger with Ambros Therapeutics and a $1...

Intismeran autogene plus KEYTRUDA met its primary and key secondary endpoints in the 1,137-patient Phase 3 INTerpath-001 melanoma trial — the first Phase 3 win for a neoantigen mRNA cancer therapy — as Moderna added roughly $44 billion in market value in a single session. Also: FDA approves Regeneron's Pasatru for fibrodysplasia ossificans progressiva at about $1.4 million a year, setting up a fight with Ipsen's Sohonos; Ultragenyx wins its first gene therapy approval for glycogen storage disease type Ia; Xspray Pharma takes a third Complete Response Letter on Dasynoc over contract manufacturing; and Roche commits $750 million to its Genentech site in Hillsboro, Oregon. Visit us a...

Trump names Heidi Overton to lead the FDA — and a Republican senator calls part of her record almost disqualifying on day one. We break down the confirmation fight, the regulatory risk to mRNA programs in oncology and immunology, Regeneron's Pasatru (garetosmab) approval for the ultra-rare bone disease fibrodysplasia ossificans progressiva, SK Biopharmaceuticals' Xcopri (cenobamate) patent settlement with MSN Laboratories, and SK Pharmteco's new high-potency API and ADC payload plants in Swords, Ireland. Visit us at thepharmacloseout.com.

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 thepharmacloseout.com.

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 Fulcrum Therapeutics. Visit us at thepharmacloseout.com.

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 Rhythm's UK expansion for IMCIVREE in acquired hypothalamic obesity. Visit us at thepharmacloseout.com.

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 lung cancer, and the Skye–Redx reverse merger creating Fibrx Therapeutics with $125 million for fibrostenotic Crohn's. Visit us at thepharmacloseout.com.

Taiho and Cullinan halt their first-line EGFR exon 20 lung cancer trial early with zipalertinib — the data was too good to stay blinded — raising the bar for J&J's Rybrevant, AstraZeneca and Dizal's Zegfrovy, and ArriVent's firmonertinib. Also: Definium's DT120 separates from placebo by 5.4 points in Phase 3 generalized anxiety from a single dose of pharmaceutical-grade LSD — and the stock gives back a third of its pop. Plus Karyopharm faces default on a September loan payment as it files Xpovio in myelofibrosis, and Eli Lilly escalates its fight against the retatrutide black market. Visit us at thepharmacloseout.com.

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 submitted for approval, Alfasigma acquires Nordic Group to expand its rheumatology portfolio and reach into Japan and Canada, Freenome wins FDA Breakthrough Device Designation for a bl...

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 PH-HFpEF; Vaderis raises $152 million for engasertib in hereditary hemorrhagic telangiectasia; and AbbVie, Novartis and Bristol Myers Squibb sue Illinois over 340B. Visit us at thepharmacloseout.com.

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 Houston manufacturing campus, and a new executive order targets the MMR vaccine schedule amid rising measles cases. Visit us at thepharmacloseout.com.

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 $263 million for a next-generation transplant immunosuppressant. Visit us at thepharmacloseout.com.

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 Brinsupri guidance after a record quarter. Visit us at thepharmacloseout.com.

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 thepharmacloseout.com.

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 Oelkers chief executive as it pivots toward oncology.

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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 biotech IPO window and Moderna's seasonal flu vaccine decision Wednesday.

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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 cardiomyopathy ahead of an August 22 decision, and Karyopharm's Xpovio failed a second Phase 3 in endometrial cancer. Eli Lilly's Q2 report and Moderna's mRNA-1010 flu vaccine decision both land August 5.

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 Therapeutics licenses senaparib to Pharmanovia.

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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, Alnylam fell 29% on Amvuttra, and the FTC sued Hims & Hers.

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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 autoimmune T-cell engagers; plus ProMIS in Alzheimer's, Atea in hepatitis C, and Altimmune in alcohol use disorder.

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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 IQVIA's second quarter earnings.

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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 around Carvykti.

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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 $11.75 billion Organon approval, Scribe Therapeutics' gene editing IPO, Ipsen's Bylvay failure in biliary atresia, and the FDA peptide panel that voted yes on thin evidence.

Novo Nordisk is asking a court to shut down Eli Lilly'scomparative obesity ads — an injunction bid that could reset the rules for GLP-1 promotion industry-wide. Also: Sanofi ends amlitelimab development in atopic dermatitis, Ipsen's Bylvay fails the Phase 3 BOLD trial in biliary atresia, CHMP recommends NewAmsterdam Pharma and Menarini's obicetrapib and its ezetimibe combination in Europe, the FDA's peptide advisory panel splits itsvotes, Amgen fights to keep Tavneos on the market, Lilly moves to file retatrutide, and Arrowhead posts best-case triglyceride data.

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J&J's Tecvayli–Talvey combo cut the risk of myeloma progression or death by 89% in earlier-line disease. Plus an FDA panel endorses wellness peptides including BPC-157, AstraZeneca's camizestran clears Europe in breast cancer, Repligen buys BioLife for $1.5B, BeOne's $300M reshoring push amid Trump's 200% generic tariff threat, Scribe's $129M gene-editing IPO, and Ipsen's Bylvay biliary atresia readout ahead.

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GSK's Jideytro cleared the FDA two months early — a week after the $10.6B Nuvalent deal closed — for GSK's first lung cancer approval. Plus Arrowhead's plozasiran (Redemplo) posts best-case triglyceride and pancreatitis data against Ionis's Tryngolza, Summit's ivonescimab two-year NSCLC survival ahead of its November decision, Celldex's Phase 2 failure in prurigo nodularis, Sanofi's FDA untitled letter over Beyfortus and Pfizer's RSV vaccine, and Trump's 200% generic tariff countdown.

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Novo Nordisk sued Eli Lilly in federal court over "deceptive" ads comparing high-dose Zepbound and Mounjaro to lower-dose Wegovy and Ozempic. Also: Gilead and Merck back the first weekly oral HIV pill (islatravir/lenacapavir) with 48-week Phase 3 data, Novartis beats Q2 on Kisqali and Pluvicto as pelacarsen looms, Agios scraps sickle cell drug tebapivat, Dimension closes an $800M AI-biotech fund, Bristol Myers builds an NVIDIA AI supercomputer, and Amgen settles a $74M investor suit.

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Tempus AI is buying Personalis for $1.5 billion, betting on cancer monitoring before reimbursement catches up. Plus Samsung Biologics' $1.8B all-cash bid for Swiss peptide maker PolyPeptide and its GLP-1 push, Legend Biotech's record Carvykti sales against a falling stock, Jennifer Doudna's Scribe Therapeutics CRISPR IPO, GSK shelving a $2B cough drug, Bristol Myers Squibb's Nvidia AI supercomputer, Takeda's dengue vaccine nod in India, and Novartis Fabhalta in IgA nephropathy.

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GSK wrote off most of a $2 billion bet as camlipixantbecomes the third P2X3 antagonist to fail in chronic cough. Plus Lilly's $2.8B AtaiBeckley deal and July's IPO wave, Novartis Fabhalta's full approval in IgAN, Celcuity's Revtorpyk, Merck's oral PCSK9 pill and sac-TMT lung-cancerdata, the Jasper–Kira merger, and the Sanofi Sarclisa FDA decision ahead.

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GSK shelved camlipixant after mixed Phase 3 data — the third P2X3 chronic cough drug to fail and a blow to its ~$2B Bellus Health deal. Plus Jasper Therapeutics' lifeline merger with Kira and a $132M raise, Novartis Fabhalta's full FDA approval in IgA nephropathy, Lilly's $2.8B AtaiBeckley psychedelics buyout, a Merck ADC lung cancer readout, and a Pfizer downgrade.

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Merck's sac-TMT beat chemotherapy in first-line PD-L1-negative lung cancer — the emerging answer to Keytruda's patent cliff. Plus: Europe approves Novo Nordisk's oral Wegovy ahead of Eli Lilly, Sanofi sues Pfizer and Moderna over mRNA patents, Bora and Insilico Medicine ink a $2.5B AI alliance, the FDA resumes publishing complete response letters, Q32 Bio surges on alopecia areata data, and Veradermics posts a Phase 2 win in female pattern hair loss.

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Celcuity's Revtorpyk (gedatolisib) wins FDA approval in HR+/HER2- breast cancer on a 0.24 hazard ratio — and the stock jumped to $111. Plus AstraZeneca's up-to-$1.5B Zegfrovy license from spinoff Dizal, Biogen's diranersen tau data at AAIC, the NextCure–Avere oral IL-23 merger, and Roche scrapping two Ionis Huntington's programs.

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GSK will file Jemperli with the FDA for dMMR rectal cancer after a Phase 2 win, extending its PD-1 franchise into curative-intent oncology. Plus Q32 Bio's bempikibart hits its alopecia areata goal, the FDA finalizes psychedelics guidance ahead of a Compass Pathways COMP360 decision, LEQEMBI clears a subcutaneous at-home dose for Eisai and Biogen, Hengrui and Elevar's PD-1 liver cancer combo is rejected a third time, and Biogen's tau drug diranersen takes the spotlight at AAIC.

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AstraZeneca's Wainua missed in cardiomyopathy — one of three clinical setbacks in five days even as pharma dealmaking stayed red-hot with Vertex's ~$10B Crinetics buy and GSK's biggest oncology bet in a decade. We break down what the Wainua miss means for the ATTR cardiomyopathy race, Bausch + Lomb's BL1107 glaucoma flop, the third Hengrui/Elevar liver-cancer rejection, Corcept's misread insider sale and late-2026 Cushing's catalyst for relacorilant, plus the week ahead: Q32 Bio's bempikibart in alopecia areata, Celcuity's gedatolisib FDA decision in breast cancer, Novartis's pelacarsen, and Lilly's muted Foundayo launch.

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GSK walked away from its $2.2 billion Alector alliance, ending its neuroscience re-entry as clinical setbacks piled up. Plus: the FDA resumes releasing rejection letters with fourteen new CRLs, Hengrui and Elevar's PD-1 liver cancer combo is rejected a third time, Sanofi's subcutaneous Sarclisa wins approval, Pfizer/Astellas and Merck expand Padcev-Keytruda in muscle-invasive bladder cancer, Vera Therapeutics scores an IgA nephropathy nod against Otsuka, AstraZeneca and Ionis miss a Phase 3 heart trial, Apnimed files to IPO amid its sleep apnea review, and Moderna sinks in a broad biotech selloff.

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AstraZeneca and Ionis's Wainua missed its Phase 3 ATTR-CM endpoint — Ionis fell ~20% while BridgeBio surged ~17%. We break down the CARDIO-TTRansform failure and what it means for Alnylam's Amvuttra and BridgeBio's Attruby, plus Roche scrapping tominersen in Huntington's, GSK exiting its Alector pact, Ipsen's Dysport dual Phase 3 migraine wins, Vera Therapeutics' IgA nephropathy approval versus Otsuka, NICE rejecting Amgen's Lumakras, and Sino Biopharm's China deals with AstraZeneca and GSK.

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The FDA quietly paused publishing complete response letters after a citizen petition — reversing the Makary-era transparency push and closing a live window into rival drug failures. Plus: Sino Biopharmaceutical's dual respiratory deals with AstraZeneca ($200M upfront, TQC3721 in COPD) and GSK (Trelegy and Anoro Ellipta China rights), Vera Therapeutics' Trutakna approval in IgA nephropathy, Bristol Myers' Krazati confirmatory failure in colorectal cancer, Kailera's oral GLP-1 Phase 3 obesity data, Tampa General's 340B suit against Lilly over Mounjaro, and Biohaven's taldefgrobep push into muscle-sparing obesity.

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Vera Therapeutics wins FDA accelerated approval for TRUTAKNA (atacicept) in IgA nephropathy on a 42% placebo-adjusted proteinuria cut — setting up a head-to-head with Otsuka's VOYXACT. Plus Oberland Capital's up-to-$400M royalty deal for MeiraGTx eye gene therapies, Novartis cuts 322 New Jersey jobs, Bristol Myers' Krazati confirmatory failure in colorectal cancer, Roche's divarasib KRAS win, and Teva's early repigmentation data.

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Vertex pays $10B cash for Crinetics Pharmaceuticals — its largest deal ever — betting on acromegaly drug Palsonify and Phase 3 CAH candidate atumelnant. Also: Novartis acquires ADC platform Myricx Bio for up to $1.5B; HSBC downgrades Pfizer to Hold after sigvotatug vedotin Phase 3 miss; BMS Krazati confirmatory study fails in CRC as Roche divarasib wins KRAS Phase 3; FDA closes H1 2026 with 23 novel approvals; Casgevy label expands to ages 2+; Roche licenses breast cancer asset from Astex.

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Federal court blocks Colorado's 70% price cap on Enbrel — ruling could shut down state drug pricing laws nationwide. Plus: Casgevy label expansion to age 2 for SCD/TDT sends CRISPR Therapeutics surging 8%. Moderna mFLUSIVA rally hits 70% ahead of August 5 FDA decision. AstraZeneca-CSPC $1.7B kidney deal; Celea raises $180M for IPF; Orca Bio prices Tregzi at $428K.

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pharma, biotech, FDA, clinical trials, drug approvals, Enbrel, Amgen, drug pricing, Casgevy, CRISPR Therapeutics, Moderna, sickle cell disease