Last Week Tonight in BioPharma: Week of July 13th, 2026

Oral PCSK9 inhibitor approval, Kalshi wants to predict trial outcomes, Lilly acquires Atai Beckley, and more!

Welcome back to Last Week Tonight in BioPharma (LWTB)!

This week: Merck gets the first oral PCSK9 inhibitor approved, Kalshi opens prediction markets for clinical trial outcomes, and Eli Lilly enters the psychedelics space with its acquisition of Atai Beckley.

All that and more below!

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📡 PRESS RELEASE DECODER

What the press releases actually mean

Merck’s Enlicitide (LIPFENDRA) Wins FDA Approval as First Oral PCSK9

📅 July 15, 2026 🏢 Merck ( MRK 0.00%↑ ) 💊 LIPFENDRA (enlicitide) 20 mg once-daily oral macrocyclic peptide PCSK9 inhibitor 📊 56% placebo-adjusted LDL-C reduction (CORALreef Lipids); 59% (CORALreef HeFH) 🔗 Merck press release | FDA announcement

FDA approved LIPFENDRA as the first oral PCSK9 inhibitor for adults with hypercholesterolemia, including HeFH, as an adjunct to diet and exercise. Approval is based on CORALreef Lipids and CORALreef HeFH, which delivered placebo-adjusted LDL-C reductions of 56% and 59% respectively at week 24 (both p<0.001), with parallel drops in ApoB and non-HDL-C. Safety was similar to placebo in the broader hypercholesterolemia population; HeFH patients saw higher rates of diarrhea (7% vs 2%) and dizziness (9% vs 4%). The cardiovascular outcomes trial, CORALreef Outcomes, has completed enrollment and is ongoing. MACE data is not yet available.

🧠 BPS Take: Called this one back in March when the Phase 3 hit at ACC26. Now that the approval is out of the way, the commercial challenge begins. LIPFENDRA enters into a market with three other approved PCSK9 inhibitors, all of which have underperformed relative to previous expectations. With the entrant of the first oral offering, we are about to find out why. Was underutilization of PCSK9 mostly driven by the on-market offering being injectibles? Was it less aggressive guidelines, which recently changed to more aggressively treat LDLc to lower target ranges?

My bet is the convenience advantage of an oral once daily pill, paired with an eventual cost parity (and maybe cost advantage) to injectables will quickly drive LIPFENDRA past REPATHA, the current market leader, which has only recently cleared $3B globally.

I wouldn’t sleep on the guideline shift being a major unlock for the entire lipid lowering class. More aggressive LDL targets should increase utilization of both generics (statins, ezetimibe) as well as PCSK9s, increasing the overall drug-treatable patient pool considerably.

RBC’s Brian Abrahams and UBS both peg peak sales around $5B, while Scotiabank’s Louise Chen sees “tens of billions” and Guggenheim sees a path above the $2.8B consensus. The buy-side range is quite wide, but you see a lot of “Bs” in those numbers and projections at a minimum that are on par with REPATHA’s best year.

The overhang is CV outcomes data. Amgen and Regeneron/Sanofi both had to run FOURIER and ODYSSEY OUTCOMES before payers meaningfully opened access. Merck could face the same hurdles, however it will be interesting to see how their formulary conversations go. The link between LDLc lowering and CV outcomes (to me at least) is already well established. If payers agree and Merck can offer better pricing, maybe LIPFENDRA can secure a favorable formulary position without it.

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Biogen’s Diranersen Delivers Tau Signal in Alzheimer’s

📅 July 14, 2026 🏢 Biogen ( BIIB 0.00%↑ ), Ionis-partnered (IONS 0.00%↑) 🧬 Diranersen (BIIB080), tau MAPT mRNA antisense oligonucleotide (ASO), intrathecal 📊 CELIA Phase 2: 26% CDR-SB slowing at 60mg; 50–65% CSF total tau reduction; tau PET reductions across brain regions 🔗 Biogen press release | AP coverage

Biogen presented full CELIA Phase 2 data at AAIC 2026 for diranersen, an intrathecal ASO targeting MAPT mRNA to reduce all tau isoforms. At 18 months, the 60 mg every-six-months arm (n=60) delivered a 26% slowing on CDR-SB (0.54 points), 42% on ADAS-Cog13, and 50% on MMSE versus placebo (n=115). CSF total tau dropped 50–65% across doses, with tau PET reductions across evaluated brain regions. CELIA missed its primary endpoint of dose-response on CDR-SB, since higher doses did not deliver greater benefit. ARIA is not anticipated with a tau mechanism. Biogen plans to advance to confirmatory Phase 3.

🧠 BPS Take: Kudos to Biogen for continuing to invest in Alzheimer’s research, especially with non beta-amyloid MOAs. This data brings some possibility that tau can be a therapeutically relevant target, and may also validate the growing view that amyloid was never going to be enough on its own.

That said, let’s not get ahead of ourselves. This is a Phase 2 with 60 patients in the best-performing arm and the drug did not show dose-response. The 60 mg arm outperforming both higher doses is a strange inverted dose curve that leaves confidence headed into Phase 3 a little bit lacking. AD is the proverbial graveyard of Phase 2 signals that did not replicate, from semagacestat to gantenerumab to a long line of tau vaccines and antibodies. Lecanemab and donanemab both hit their Phase 3 endpoints and barely moved the needle clinically.

For diranersen to be transformative, Biogen needs a large, well-powered Phase 3 in prodromal-to-mild AD that shows a clear cognition improvement. Intrathecal q6-month dosing is workable in a specialty neuro setting but is a real commercial constraint versus oral or subcutaneous. This fits the Biogen post-molt thesis, another anchor asset in a diversified late-stage pipeline, but AD requires Phase 3 confirmation to really feel confidence.

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🌐 CONNECTING THE DOTS

When the outside world meets biopharma

Kalshi and AppliedXL Bring Prediction Markets to Clinical Trials

📅 July 17, 2026 🏢 Kalshi (regulated event exchange) partnering with AppliedXL (scientific intelligence platform) 📄 Pilot launches prediction market contracts on clinical trial outcomes and FDA approvals 🔗 AppliedXL partnership announcement | Kalshi biopharma markets

Kalshi is launching contracts on clinical trial outcomes and FDA drug approvals with AppliedXL as exclusive resolution partner. Each contract poses one binary question resolved against a pre-specified public document (ClinicalTrials.gov endpoint, FDA approval letter, AdCom vote record). AppliedXL detects the triggering event, extracts the outcome, has domain experts confirm it, and produces an audit trail. AppliedXL employees are prohibited from trading on prediction markets. AppliedXL is also launching Biopharma News, an AI-powered newsroom covering the same markets.

🧠 BPS Take: I wrote in April that prediction markets for clinical trials were prone to false precision, thin liquidity, MNPI abuse over long time horizons, and structural risks to trial enrollment and industry alignment. This sort of partnership and concerted effort to expand offerings in drug related markets is what I was worried about. Everything I said before still stands. What is worth acknowledging is that AppliedXL’s involvement does address one specific concern I raised, which is the accuracy and integrity of resolution. Pre-specifying the source document, using primary regulatory and clinical artifacts rather than press release spin, and building a defensible audit trail is a real improvement on the settlement side.

The problems I care about most, though, are upstream of resolution. Resolution integrity does not fix thin liquidity, and thin liquidity is what makes a $1,000 wager move the retatrutide market 40 percentage points. It does not solve MNPI, where 50 to 100 people at a sponsor, CRO, DSMB, or FDA touch directional signal for months before topline. It does not stop patients and referring physicians from anchoring on a “72% probability of success” as if it were an oracle. And it does not prevent the perverse-incentive scenario where insiders profit from failure. AppliedXL solving the “what happened” question does not solve the “who knew what when” question or the “does this warp enrollment” question.

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💰 FOLLOW THE MONEY

Deals, dollars, and what they signal

Lilly Acquires Atai Beckley for $2.8B, I Called It

📅 July 16, 2026 🏢 Eli Lilly ( LLY 0.00%↑ ) acquiring Atai Beckley ( ATAI 0.00%↑ ) 💰 $6.75/share cash upfront (~$2.8B equity) + up to $2.50/share CVR (~$1.0B) 💊 BPL-003 (5-MeO-DMT intranasal) in Phase 3 for TRD; VLS-01 (DMT buccal film) Phase 2b; EMP-01 (R-MDMA) Phase 2 🔗 Lilly press release

Lilly is acquiring atai Beckley for $6.75 per share cash plus a $2.50 per share CVR tied to BPL-003 and VLS-01 development and regulatory milestones. Upfront equity is ~$2.8B, with up to ~$1.0B additional through the CVR. Lead asset BPL-003 (mebufotenin benzoate), an intranasal 5-MeO-DMT for treatment-resistant depression, has FDA Breakthrough Therapy Designation and Phase 3 initiated. In-clinic dosing runs ~2 hours per Phase 2b. Deal expected to close Q3.

🧠 BPS Take: Called this one in my predictions post at the beginning of the year. I flagged that at least one of Definium (formerly Mindmed) , Cybin, Compass, Attai, or GH Research was going to get taken out in 2026, and specifically pointed to major psychiatry players and Big Pharma as the logical acquirers. Lilly buying Atai Beckley fits that mold perfectly.

The broader read is that acquirer interest in psychedelics is real and building. The critique I hear most is that the in-clinic dosing model, REMS requirements, and specialty psychiatry training make these drugs commercially unworkable at scale. Look no further than J&J’s Spravato as the counter argument. Intranasal esketamine did $1.08B in 2024 and is projected around $1.7B in 2025 with ~57% YoY growth (and just posted a $585M quarter in Q2’26), with a network of certified treatment centers, payer coverage, and referring psychiatrist adoption that all had to be built from scratch. The infrastructure argument was fair for a time, but the work JNJ has done to build the rails can now enable others to run on them.

BPL-003’s ~2-hour in-clinic session is materially shorter than psilocybin’s 6-to-8-hour window, which is the real commercial differentiator over Compass and Definium if it holds up in Phase 3. Lilly gets a Phase 3 lead asset plus VLS-01 optionality plus a next-generation 5-HT2A discovery engine at a price that looks reasonable relative to SPRAVATO’s trajectory. Watch the other psychedelics names carefully over the rest of th year. Psychedelics is not a fringe category anymore and we should not be surprised if specialty psychiatry players or psych-curious Big Pharmas look at these names ass their entry point.

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Alright, legal department says I gotta tell you. None of the above is financial advice. Please do your own due diligence. I am just a guy on the internet. Not a financial advisor.

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Braveheart Files for IPO, Ticker BRVE

📅 July 14, 2026 🏢 Braveheart Bio filing S-1 on Nasdaq, ticker $BRVE (pending) 💊 BHB-1893, oral cardiac myosin inhibitor for oHCM and nHCM, licensed from Hengrui 📊 Phase 2 oHCM (n=42) showed rapid LVOT-G reduction; Phase 2 nHCM (n=84) improved diastolic function and cardiac biomarkers 🔗 FierceBiotech coverage | S-1 filing

Braveheart, led by former Hi-Bio CEO Travis Murdoch (who sold Hi-Bio to Biogen $BIIB in 2024 for $1.15B), filed to list on Nasdaq under ticker BRVE. The company licensed BHB-1893 from Jiangsu Hengrui in 2025 in a ~$1B biobuck deal with $65M upfront, followed by a $185M Series A led by a16z, Forbion, OrbiMed, Enavate, and Frazier. Phase 3 in oHCM starts H2 2026, nHCM in H1 2027. BHB-1893 will compete with BMS’s Camzyos and Cytokinetics’s $CYTK Myqorzo, both approved in oHCM.

🧠 BPS Take: The IPO window in cardiovascular-metabolic disease is way open, and Braveheart is the latest read on how wide. Kailera raised $625M in its IPO earlier this year on a similar Hengrui-licensed thesis in obesity. Kardigan priced an upsized $400M IPO at $16 in early 2026, and Scribe, Apnimed, and Attovia have all filed in the last two weeks. Capital is coming back to cardio and metabolic disease specifically because the exit math works. Cytokinetics’s trajectory post-aficamten approval and BMS’s willingness to pay $13B for MyoKardia in 2020 gave every investor a comp, and the China-in-licensing template is producing near-commercial assets at a fraction of the R&D cost of building from scratch.

BHB-1893’s competitive position is where it gets interesting. Camzyos missed its nHCM Phase 3 earlier this year, and Myqorzo showed a positive Phase 3 in nHCM in May, opening a real second indication for the class. Braveheart is arguing BHB-1893 has a differentiated PK profile that could sidestep the echo-monitoring burden that has slowed Camzyos and Myqorzo uptake. That could be a real commercial edge if the Phase 3 deilvers.