Last Week Tonight in BioPharma: March 28th - April 3rd
FOUNDAYO, oral PCSK9, big deals from LIlly and Biogen, plus Trump is at it again with tariffs
We’re back for the second edition of Last Week Tonight in BioPharma (LWTB)!
ICYMI, here is what I am trying to do with this series:
A short recap of the most interesting stories from the past week with strategic insights to get you ready for your Monday meetings.
Up to 3 key events per category:
Press Release Decoder: going beyond the company speak, reading between the lines, thinking about what isn’t being said, to illustrate the strategic implications of a company’s moves that don’t make it into the press release
Connecting the Dots: looking at stories that are either about the macro or from the mainstream news and how they may impact BioPharma
Follow the Money: quick takes on some key deals that were struck and what they mean for those companies, their competitors, or the sector at-large
Free to all subscriber levels! Although if you like my free content and have $8/month to spare (or expense to your company), I think you’ll love the deeper analyses my paid subscribers get. You can upgrade at any time by clicking the button below.
And with that, let’s get into what happened this past week.
📡 PRESS RELEASE DECODER
What the press releases actually mean
Eli Lilly’s Foundayo (Orforglipron) Becomes First Oral Small-Molecule GLP-1 Agonist Approved for Obesity
Source: STAT News | Date: April 1, 2026
The FDA approved Foundayo (orforglipron) on April 1, 2026, making it the first oral small-molecule GLP-1 receptor agonist cleared for obesity and overweight in adults — a milestone that reshapes the multi-billion dollar weight-loss drug market. Phase 3 trials demonstrated 11.2–15% body weight reduction over 36–72 weeks; the drug carries a boxed warning for thyroid C-cell tumor risk but requires no food or water restrictions unlike Novo Nordisk’s oral semaglutide. Lilly priced the lowest dose at $149/month through LillyDirect with launch availability beginning April 6, positioning it as a direct cash-market competitor to Novo’s oral Wegovy subscription at $249/month, which launched the day prior.
BPS’ Take: My guy Ashwin, who runs GLP-1 Digest, sent out a sharp note about FOUNDAYO vs. Oral WEGOVY, breaking down the channel-specific price difference, and why Lilly comes out ahead, even though their efficacy numbers are nominally lower (which I agree with).
Strategically, this approval might trigger an oral GLP-1 price war with massive downstream implications for pharmacy channel economics, telehealth platforms, and Novo Nordisk’s market share. The big thing Lilly has working in its favor over Novo is the small molecule chemistry that goes into FOUNDAYO. It can be made far more inexpensively than oral WEGOVY, giving Lilly far greater gross margins to play with in a price war. If it becomes a game of limbo and we are asking “how low can you go?”, Lilly has far more proverbial lower back flexibility than Novo or any other oral peptide that looks to enter the market. Over the long-term, I think GLP-1s moving into their small-molecule oral era will bring down costs for patients, improve access, and overall make a lot of people a lot healthier.
Merck’s Enlicitide Decanoate Hits Phase 3 with 64.6% LDL Reduction — NDA Filing Set for April 2026
Source: Merck Investor Relations | Date: March 31, 2026
Merck’s enlicitide decanoate, the first oral PCSK9 inhibitor designed to deliver antibody-class LDL-lowering efficacy, met its Phase 3 primary endpoint at ACC.26 (March 28–29), demonstrating a 64.6% reduction in LDL-C from baseline versus guideline-recommended non-statin oral comparators — a magnitude of effect previously achievable only with injectable monoclonal antibodies like evolocumab or alirocumab. Merck plans to submit its NDA in April 2026, with the FDA having already awarded the drug a Commissioner’s National Priority Voucher in December 2025 to accelerate the review timeline. The oral formulation targets the enormous unmet need in cardiovascular patients who remain poorly adherent to injectable PCSK9 inhibitors despite proven mortality benefit.
BPS’ Take: An oral drug achieving 60%+ LDL reduction would fundamentally change the PCSK9 inhibitor market by solving the adherence problem that has suppressed penetration of REPATHA and PRALUENT, potentially unlocking a patient population orders of magnitude larger than what injectables have captured. It’s easy to forget that PCSK9 antibodies have been on market since 2015 and garnered peak sales of (only) ~$2B for what is a MASSIVE market. A lot of people have high cholesterol and with the updated ACC/AHA guidelines now including more aggressive targets for higher-risk groups, we could see an influx of patients on oral PCSK9 inhibitor therapy in short order.
🌐 CONNECTING THE DOTS
When the outside world meets biopharma
🚨 FRIDAY DUMP — Major regulatory/trade risk event: 100% import tariffs imposed on non-exempt branded pharmaceuticals, creating bifurcated competitive landscape
Trump Signs 100% Pharma Tariff Executive Order — 16 Large Pharma Companies Exempt After MFN Deals
Source: BioPharma Dive / STAT News / CNBC | Date: April 2, 2026
President Trump signed an executive order on April 2, 2026 under Section 232 authority imposing 100% tariffs on imported patented pharmaceuticals; generics and biosimilars are fully exempt, and EU, Japan, Korea, Switzerland, and Liechtenstein face a reduced 15% rate, while 16 large drugmakers — including Pfizer, J&J, AstraZeneca, Novo Nordisk, Eli Lilly, AbbVie, BMS, Gilead, Merck, Roche, Novartis, Amgen, Sanofi, GSK, Boehringer Ingelheim, and EMD Serono — are fully exempt having already signed most-favored-nation pricing agreements and committed to $400 billion in U.S. manufacturing investments. Companies that have not signed MFN deals can reduce their tariff burden to 20% by pledging domestic onshoring; tariffs take effect in 120 days for large companies and 180 days for smaller ones. PhRMA president Stephen Ubl stated the order “undermines U.S. biopharmaceutical leadership.”
BPS’ Take: This executive order creates an unprecedented two-tier competitive dynamic in U.S. pharma, with exempt incumbents able to operate without import cost penalties, and mid-sized plus smaller biotechs without the resources to sign MFN deals or onshore manufacturing facing margin compression. Trump has potentially created a caustic environment for smaller innovative players that may accelerate the timetable under which these players look to exit and suppress innovation. For what I call the “BioPharma Middle Class” (thinking of folks like Alnylam and Biomarin), they are all probably too big to get acquired and will now need to play ball with one hand tied behind their back. With Trump, the rules are clear: pay a dowry or I’ll make your life miserable.
FDA Clarifies GLP-1 Compounding Rules: Shortage-List Removal Means Enforcement — Hims & Hers in the Crosshairs
Source: Reuters / FDA.gov | Date: April 1, 2026
On April 1, 2026 — the same day the FDA approved Lilly’s FOUNDAYO — the agency issued a policy clarification stating that compounding pharmacies and outsourcing facilities may only produce copies of GLP-1 drugs while those drugs remain on the FDA drug shortage database; once removed from the shortage list, “essentially a copy” formulations face enforcement action. The clarification directly targets the multi-billion dollar compounded semaglutide and tirzepatide market that exploded during the shortage period, with platforms like Hims & Hers having built significant revenue on compounded GLP-1 access. The one-two punch of FOUNDAYO’s approval and this FDA clarification on the same day represents a coordinated signal that the era of compounded GLP-1 tolerance is ending.
BPS’ Take: This ruling might be the final warning for the compounded GLP-1 business model and will force telehealth platforms that built direct-to-consumer GLP-1 revenue streams off of them to rapidly pivot to authorized generics, branded partnerships, or entirely new product strategies (unfortunately that probably means a whole host of RFK-approved but untested peptides). This is a positive move for the drug industry and our IP protection. Hopefully, this additional scrutiny also forces more telehealth players to play within the rule of law on other issues, but after seeing how some of the new companies operate, I am less optimistic.
💰 FOLLOW THE MONEY
Deals, dollars, and what they signal
Biogen Acquires Apellis Pharmaceuticals for $5.6B — Rebuilding Its Complement and Immunology Franchise
Source: STAT News / BioPharma Dive / Biogen IR | Date: March 31, 2026
Biogen announced on March 31, 2026 the acquisition of Apellis Pharmaceuticals for $41.00 per share in cash (approximately $5.6 billion total), plus a contingent value right of up to $4.00 per share tied to SYFOVRE global net sales milestones of $1.5 billion and $2.0 billion between 2027 and 2031, for a total potential deal value of approximately $5.9 billion — sending Apellis shares up 136%. The deal adds SYFOVRE (pegcetacoplan, geographic atrophy, $587 million in 2025 sales) and EMPAVELI (PNH/C3G/IC-MPGN, $689 million in combined 2025 sales), bringing Biogen approximately $1.28 billion in combined acquired product revenue and rebuilding its complement/rare disease immunology franchise as its MS drug portfolio faces ongoing generic pressure. Biogen CEO Chris Viehbacher explicitly cited Apellis’s nephrology commercial infrastructure as a strategic accelerator for Biogen’s own felzartamab late-stage asset, with the first Phase 3 readout expected H1 2027; the deal is expected to close Q2 2026 and was one of two major acquisitions announced simultaneously on “Takeover Tuesday,” which drove the XBI index up 7% in a single day.
BPS’ Take: You can catch my full thoughts on this deal in my latest paid post (here). But in short, I think this is quite a savvy deal for Biogen. They’re paying roughly 2-3x peak sales for two strong commercial products. More importantly, they gain a commercial footprint in Nephrology, where Biogen has high hopes for felzartamab (acquired via Hi-Bio). Overall, this deal accelerates the future Biogen’s CEO Chris Viehbacher set out for it when he took over the company in 2022. Become less dependent on a dying multiple sclerosis business, and diversify beyond CNS diseases into Rare Disease and Immunology.
Eli Lilly Acquires Centessa Pharmaceuticals for Up to $7.8B — A Bold Bet on Sleep-Wake Neuroscience
Source: STAT News / Reuters / CNBC / NYT | Date: March 31, 2026
Eli Lilly announced the acquisition of Centessa Pharmaceuticals for $38.00 per share in cash (~$6.3B upfront), with an additional $9.00 per share CVR tied to FDA approval milestones for narcolepsy or idiopathic hypersomnia within five years. The deal’s total potential value of $7.8B represents a 38% premium and underscores Lilly’s aggressive expansion into the neuropsychiatry and sleep-wake neuroscience sectors.
The centerpiece of the deal is cleminorexton (ORX750), a potent, orally bioavailable orexin-2 receptor (OX2R) agonist currently in Phase 2 development, chasing Takeda’s oveporexton and Alkermes’ alixorexton to unseat existing standards of care like Pitolisant (Wakix), Solriamfetol (Sunosi), or stimulants like modafinil across narcolepsy and Idiopathic Hypersomnia.
BPS’ Take: The conversation around Lilly always centers around GLP-1s, but it is easy to forget that one of Lilly’s longtime core areas has been neuroscience. They have an approved Alzheimer’s drug after all, and a long history in Psychiatry among other areas. Lilly is showing that they are not afraid to open up the bag to bring in potentially best-in-class novel assets. This has been a company, who as of late has been in the rhythm of doing $1B - $3B deals. The up to ~$8B price tag signifies both Lilly’s patience in waiting for the right asset to send in a big offer on and the might of the forward looking GLP-1 revenues they expect. Lilly can basically buy pretty much anything under the sun given the run they are on. A lot of leadership teams would find it tempting to just go on a deal spree, but it is refreshing to see this company’s discipline even with their immense war chest.
Otsuka Acquires Transcend Therapeutics for $1.225B — Largest Psychedelic/Neuroplastogen Deal in Pharma History
Source: BioPharma Dive / Fierce Biotech | Date: March 30, 2026
Otsuka Pharmaceutical announced on March 30, 2026 the acquisition of Transcend Therapeutics for $700 million upfront plus up to $525 million in sales-based milestones, totaling a potential $1.225 billion — the largest acquisition in the psychedelic/neuroplastogen sector to date. The lead asset, TSND-201 (methylone-based neuroplastogen), holds FDA Breakthrough Therapy Designation, published Phase 2 data in JAMA Psychiatry, and has Phase 3 trials currently enrolling in PTSD. Otsuka, facing headwinds from generics competition to Abilify (aripiprazole), is doubling down on CNS/psychiatry with a differentiated mechanism targeting PTSD — a high-unmet-need indication where the FDA has been willing to grant Breakthrough Therapy Designation to novel neuroplasticity-based approaches; deal close is expected Q2 2026.
BPS’ Take: Otsuka’s $1.225B bet on TSND-201 legitimizes neuroplastogens as a serious pharmaceutical drug class and sets a new valuation benchmark for other potential players interested in entering the novel psychedelics space. This is also another data point that both large companies like AbbVie and smaller CNS specific players like Otsuka (or even Lundbeck) believe in the therapeutic potential of next-gen psychedelics, which look to improve upon their recreational predecessors. By acquiring a non-hallucinogenic neuroplastogen, Otsuka is also signaling an interest in potentially removing the "service-layer" bottleneck. They are betting that the FDA will grant a label that does not require intensive, supervised psychotherapy, which could be seen as a commercial advantage.
Back next week with another edition of LWTB! Stay tuned and hope you have a strong start to your week!