Merck's Oral PCSK9 Cholesterol Pill, Lilly's $2.8B Psychedelics Buy, and Makary's Regulatory Ghost – This Week in Biotech #109
Lipfendra becomes the first oral drug to match injectable cholesterol lowering, Lilly enters psychedelics with an $2.8B AtaiBeckley acquisition, and the FDA dismantles Makary's methods (7/10-16, 2026)
Welcome back to This Week in Biotech by Biotech Blueprint, edition 109, covering biotech and pharma news from July 10 to July 16, 2026.
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VIDEO SUMMARY
THIS WEEK’S KEY TAKEAWAYS 🔑
The most important approval of the week is a pill developed by Merck. The company won US FDA clearance for Lipfendra (enlicitide), the first once daily oral drug that blocks PCSK9, the protein that clears the liver’s LDL receptors. For a decade, potent PCSK9 blockade meant an injection every two to four weeks, either Amgen’s Repatha or Novartis’s twice yearly Leqvio. Merck’s version matches injectable-grade LDL cholesterol reduction in a swallowable tablet at $315 a month. This is the same mechanism delivered through a format patients actually take. The pattern repeats down the page this week. Another company reported that an oral pill grew hair in women where the standard is a topical foam, and the obesity field has spent a year migrating from injections to oral GLP1s. Convenience, not novelty, is what companies are competing on right now.
There’s an irony inside the Merck approval. It cleared in one to two months because of the priority voucher program built by former FDA Commissioner Marty Makary, whose voucher Merck collected in December. Yet in the same week, the FDA’s acting leadership publicly walked back this practice, declaring that two of his medical journal articles never constituted actual agency policy. So the agency is dismantling his methods while cashing his vouchers. Makary the person is gone, but Makary’s machinery is still approving blockbusters.
The other big theme this week is capital, and how much of it is moving. Eli Lilly bought its way into psychedelics with a $2.8 billion upfront deal for AtaiBeckley, its eleventh acquisition of 2026. AI drug discovery startup Chai Discovery raised $400 million at a $3.8 billion valuation, and radiopharma maker AdvanCell pulled in $315 million, while at least four biotechs filed to go public in two weeks. The obesity cash machine is funding an acquisition spree, the IPO window is wide open, and China-sourced assets keep flowing to Western buyers. The bear case on biotech financing that dominated 2024 and 2025 seems to have disappeared.
There's one story from this week that cuts against the optimism, though. Celcuity won FDA approval for a genuinely differentiated breast cancer drug and the stock fell almost 20%. This is a reminder that FDA approval doesn’t automatically translate to a stock move up. If the label is narrower than expected, the launch is delayed, or the prescribing information shows worse safety than the trial data suggested, the stock can still fall. Small biotechs have to clear two bars and those are the FDA and whatever expectations investors had already priced in.
BIOTECH/PHARMA NEWS 🧬
🔹 Merck’s Lipfendra (enlicitide) became the first once-daily pill to inhibit PCSK9, approved to lower LDL cholesterol in adults with high cholesterol, including inherited heterozygous familial hypercholesterolemia. It’s a macrocyclic peptide, an unusually large molecule for an oral drug, engineered to survive the gut and block a target that injectable antibodies and RNA therapies had monopolized. The efficacy is the point. In the Phase 3 CORALreef Lipids trial, enlicitide cut LDL cholesterol by a placebo-adjusted 55.8% at 24 weeks and 61.5% at one year, with a 59% reduction in the familial hypercholesterolemia study and that’s injectable-class potency. At $315 for a 30 day supply, it undercuts branded injectables and prices near generic injectable PCSK9s ($500 to $600 a month), while offering the format advantage no injectable can match. RBC Capital Markets projects more than $5B in peak annual sales. Merck earned the fast review through the priority voucher it received in December, cutting the timeline to one to two months, and beat AstraZeneca’s competing oral candidate to market. Repatha ($3B in 2025) and Leqvio now face an oral competitor with equivalent LDL lowering, and the cardiovascular outcomes data Merck is still generating will decide whether pill convenience translates into franchise displacement.
🔹 Lilly agreed to buy AtaiBeckley for $6.75 per share, about $2.8B upfront, with a contingent value right of up to $2.50 per share pushing the total toward $3.8B. The lead asset is BPL-003, a mebufotenin analog (a molecular cousin of psilocybin) in late stage testing for treatment-resistant depression, where a single dose has produced rapid symptom reduction. This is the strongest signal yet that large pharma is done watching psychedelics from the sidelines. The commercial proof point is Johnson & Johnson’s ketamine-derived Spravato, which generated almost $1.1B in the first half of 2026, up 43% year over year, showing that a scheduled, clinic-administered psychiatric drug can scale commercially. For Lilly, this is deal number eleven of 2026, more than any peer, and it continues the pattern of using obesity cash flow to buy modality and indication breadth rather than adjacent metabolic assets. Compass Pathways, the longtime psychedelics company, now has a very well-funded competitor. The open question is regulatory and logistical. These therapies require monitored dosing sessions, and reimbursement plus clinic infrastructure, not efficacy, is the gating constraint.
🔹 The FDA approved Celcuity’s Revtorpyk (gedatolisib), a pan-PI3K/AKT/mTOR inhibitor, for second-line ER-positive, HER2-negative advanced breast cancer, in combination with fulvestrant and Ibrance (palbociclib) or with Ibrance alone. The differentiated angle is that the label covers patients without PIK3CA mutations, a segment competitors from Novartis and Roche have largely left alone while focusing on the mutant population. In VIKTORIA-1, the three drug regimen delivered median tumor control of 9.3 months versus 2 months for fulvestrant alone. The two drug regimen reached 7.3 months. Yet shares fell almost 20% on two disappointments buried in the fine print. The company signaled a later launch than its prior commentary implied (now late in Q3), and the prescribing information carried higher treatment discontinuation rates than the conference data had shown. This is the recurring lesson of 2026 small cap approvals. A genuinely useful drug in an underserved niche is not automatically a good stock day when the label and the launch timeline undershoot what investors had already paid for.
🔹 Two more Western-Chinese deals landed this week. AstraZeneca agreed to pay Shanghai-based Dizal $600M upfront, up to $1.5B total, for global rights to Zegfrovy, an already marketed lung cancer drug for EGFR exon 20 insertion mutations that did about $85M in 2025 sales. Buying a derisked, approved asset rather than a preclinical one is a notable escalation of the China sourcing model. Separately, Spero Therapeutics licensed most rights to Innovent’s anti-CD40L antibody IBI355 for immune diseases, with Innovent eligible for up to $1.1B. Meanwhile, the Biotech Investment National Security Act, the House bill that would subject US biotech deals with Chinese companies to national security review, is now stalled after unsettling the industry last month.
🔹There’s a lot of biotech financing happening right now. At least four biotechs filed to go public in two weeks, including Braveheart Bio, which is funding Phase 3 testing of a Hengrui-licensed cardiac myosin inhibitor aimed at Cytokinetics and BMS, and immunology and inflammation player Attovia. On the private side, AI structure prediction startup Chai Discovery raised $400M at a $3.8B valuation, the second-largest venture round tracked this year. Radiopharma maker AdvanCell closed a $315M Series D for a lead-based Pluvicto challenger, with Lilly and Sanofi both participating. Lipid nanoparticle startup Nava emerged with $89M. Investors are cutting big checks for early- tage companies in AI, radiopharma, cardiac disease, and gene delivery, and the IPO market is opening back up at the same time. Biotech financing hasn't looked this healthy since 2021.
🔹 The FDA’s acting chief formally walked back former Commissioner Marty Makary’s practice of setting policy through medical journal articles, stating that two such articles published over the past year did not represent agency policy. It’s the latest in a steady reversal of Makary-era actions since his departure in May, and it sharpens the strategic uncertainty for sponsors who had read those articles as signals of the review bar. The timing is worth pointing out. In the same week the agency said Makary’s journal articles were never actual policy, Merck’s oral PCSK9 approval came through on the fast track that Makary himself set up. So companies planning regulatory strategy have to figure out which parts of the Makary era still count. The voucher program and formal guidance clearly do. Informal signals from journal articles clearly don't. And the FDA still doesn't have a permanent commissioner three months in.
🔹 Kelun-Biotech’s TROP2 antibody-drug conjugate sac-TMT, partnered with Merck, hit its primary endpoint in Phase 3 OptiTROP-Lung06, a China trial testing sac-TMT plus Keytruda as first-line treatment for locally advanced or metastatic non-squamous non-small cell lung cancer with PD-L1-negative tumors. The combination showed a statistically significant, clinically meaningful improvement in progression-free survival versus standard chemotherapy, with an early positive trend in overall survival. Specific hazard ratios weren’t disclosed at the interim. This matters because PD-L1-negative patients respond poorly to immunotherapy alone, and this trial shows for the first time that an antibody-drug conjugate could anchor a first-line lung cancer regimen without chemotherapy in that group. It’s also the second Chinese trial to work for Merck’s sac-TMT program this year, after OptiTROP-Lung05 in May. Merck now has 17 Phase 3 studies running across breast, lung, gastrointestinal, genitourinary, and gynecological cancers. The open question is whether Western regulators will accept the survival curves from a China-only trial without a global confirmatory study.
🔹 Veradermics reported that its extended-release oral formulation of minoxidil, the active ingredient in Rogaine, worked in women with mild-to-moderate pattern hair loss. Across 28 women dosed once or twice daily for six months, the drug produced a mean increase of about 23 hairs per square centimeter, beating the 15 to 20 analysts had projected, with most patients reporting visible improvement by two months. Shares jumped toward $130 before settling near $116. The extended-release design is meant to sustain drug exposure and avoid the concentration spikes that drive side effects. If this holds up, it could become the first pill specifically approved for female pattern hair loss, a condition affecting roughly 30M American women by some estimates, replacing daily topical foam with a tablet. That said, this is a small single arm signal in only 28 patients with no head-to-head comparison, so the data is encouraging but far from definitive. Phase 3 data in men is expected in the second half of 2026 and the women’s Phase 2/3 in the first half of 2027. Absci’s AI-designed hair loss antibody, backed by Lilly, is the longer-dosing-interval competitor to watch alongside this.
Have a great rest of your week and thanks for reading Biotech Blueprint!
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Your weekly summaries / analysis are terrific. Thanks.