Last Week Tonight in BioPharma, Week of June 15, 2026
Abbvie + Apogee, Neumora strikes out, Jazz bets on Abcellera, and the FDA starts to turn the page from the Prasad-Makary era.
Welcome back to Last Week Tonight in BioPharma (LWTB). What a week!
Abbvie looks to buy Apogee. Neumora watched navacaprant flame out in both KOASTAL-2 and KOASTAL-3, sending the stock to 98 cents after a 45% drop and a 35% workforce reduction, a rough end for a program that carried real expectations. We also cover Jazz’s $56M upfront deal with AbCellera in a T-cell engager collaboration worth up to $4.1B. Plus, major reversals of the Prasad-Makary era FDA rulings, with new green lights coming for UniQure’s Huntington’s Disease gene therapy and Moderna’s flu vaccines.
All that and more below. Let’s get into it!
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I recently discussed three interesting cell therapy readouts from ASCO 2026 that demonstrate notable progress and the field, but also how these treatments can succeed commercially with the right strategy.
You can check that out by following the link below:
Cell Therapy is Making Progress Against Solid Tumors — But is Anyone Noticing?
Traditional autologous ex vivo cell therapy has largely fallen out of favor. Attention (and dollars) are far more focused on in vivo approaches that massively condense the cost, speed, and complexity associated with the cell therapy supply chain.
⏪ Prior-Week Update(s)
Kardigan completed its upsized $400M IPO (25M shares at $16, top of range) with shares closing day-one at $22.00 (+37.5%), confirming the cardio-IPO premium thesis published in last week’s IPO Bundle. You can check out the full write-up on Kardigan in last week’s edition of LWTB.
📡 PRESS RELEASE DECODER
What the press releases actually mean.
Navacaprant fails primary endpoint in both KOASTAL-2 and KOASTAL-3 Phase 3 MDD trials. Neumora discontinues program, lays off 35%, pivots to Alzheimer’s and obesity
📅 June 15 | 🏢 Neumora Therapeutics ( NMRA 0.00%↑ ) | 💊 navacaprant (NMRA-335140), KOR antagonist for MDD | 🏷 Phase 3 Failure + 35% Layoffs
Neumora Therapeutics announced on June 15 that navacaprant, its kappa-opioid receptor antagonist for major depressive disorder, failed to meet the primary endpoint in both KOASTAL-2 and KOASTAL-3, the company’s two confirmatory Phase 3 trials. Key secondary endpoints also missed in both studies, leaving the program with no positive signal across either trial.
The failures complete a 0-for-3 record in Phase 3 for navacaprant, following the earlier miss in KOASTAL-1. Shares fell approximately 45% to 98 cents in pre-market trading on the news, putting the stock below one dollar.
Neumora is discontinuing the navacaprant program entirely and announced a 35% reduction in workforce. The company stated it will redirect resources toward Alzheimer’s disease and obesity.
🧠 BPS Take: Three Phase 3 swings and three misses in Major Depressive Disorder (MDD). That right there is psychiatry drug development in a nutshell. The KOR-antagonist mechanism in MDD appears to be finished as a clinical thesis. Neumora ran a clean, adequately powered program, which makes the 0-for-3 outcome pretty definitive. It means the biology probably doesn’t work the way the field hoped, not that the placebo effect or trial design muddled the results. Any other players pursing the same mechanism of action in MDD are on notice.
The psychiatry novel-mechanism graveyard keeps collecting names: SAGE 0.00%↑ burned years and capital on zuranolone in MDD before finding a narrower regulatory path, and BMY 0.00%↑ absorbed a Phase 3 failure on its adjunctive schizophrenia program for COBENFY (xanomeline/trospium). It feels like psychiatry drug development is harder than ever, but that is how it has always been.
Psychedelics and their variants continue to be the most attractive opportunity to me in this space, and with increased deal flow into that area over the last several months from the likes of Lundbeck, Otsuka, and AbbVie, among others, I think its clear larger players are getting smart to that too.
UniQure stock surges 80% after FDA reverses position on Huntington’s gene therapy filing; AMT-130 BLA submission planned for Q3 2026
📅 June 17 | 🏢 uniQure ( QURE 0.00%↑ ) | 💊 AMT-130 (AAV5-miHTT gene therapy for Huntington’s disease) | 🏷 Regulatory U-Turn / BLA Path Cleared
UniQure announced on June 17 that the FDA has reversed its prior position on the regulatory path for AMT-130, the company’s AAV-delivered gene therapy for Huntington’s disease, and will now accept the three-year analysis from the ongoing Phase 1/2 study as the primary basis for an accelerated approval filing. The company plans to submit its BLA in Q3 2026. Shares surged approximately 80% to $48.51 in premarket trading on the news.
The reversal is a sharp departure from the FDA’s position in March 2026, when the agency told UniQure the three-year dataset would not be sufficient and that additional trial data would be required. That March decision sent the stock down roughly 40% at the time and forced UniQure back to the negotiating table.
The shift in agency posture occurred after the departures of former FDA leadership Marty Makary and Vinay Prasad, both of whom held top positions when the original guidance was issued. UniQure and the FDA are now working toward alignment on the confirmatory study design, with the company proposing concurrent standard-of-care control rather than the sham procedure originally requested by the agency.
🧠 BPS Take: Well, well, well. How the turntables turn. It seems like this new interim FDA regime is keen to undo many of the unpopular decisions made in the Prasad-Makary era. Both this UniQure news and the later Moderna news (below) we cover are signals of that.
If you’re a melanoma patient or a Replimune REPL 0.00%↑ shareholder, that has to feel like great news for you too, because it aligns well with the UniQure story. Huntington’s is a brutal disease with limited options and patients with incredibly high unmet need. The same can be said for melanoma patients who fail PD-1s, but I am sure Replimune will be holding its breath until their final decision comes down.
The new leadership at the FDA has a new evidence vs. unmet need calculus, that feels a bit more traditional and grounded in reality. What’s hard to tell at this juncture is if this is indeed a reversion back to normal with how the FDA views single-arm study data in high unmet need indications, or simply the FDA trying to undo specific wrongs that got them a lot of bad press, with more unpredictability ahead for the industry.
🌐 CONNECTING THE DOTS
When the outside world meets biopharma.
Moderna’s mRNA flu vaccine clears VRBPAC 9-0 in twin votes; February refusal-to-file gets fully reversed and Prasad-era FDA gets a quiet rebuke
📅 June 18 | 🏢 Moderna ($MRNA) / FDA / HHS / ACIP | 💊 mFLUSIVA (mRNA-1010), seasonal influenza vaccine | 🏷 FDA AdComm + Vaccine Policy
The FDA’s Vaccines and Related Biological Products Advisory Committee voted 9-0 on June 18 in two back-to-back votes: full approval recommendation for mFLUSIVA in adults 50 through 64, and accelerated approval recommendation for adults 65 and older. This was VRBPAC’s first new vaccine review in over three years and the first vaccine to clear an FDA advisory committee under the second Trump administration. The PDUFA date is August 5, 2026. The FDA has historically followed AdComm recommendations 84% of the time from 2020 through 2025 per a Jefferies analysis.
In February 2026, the FDA’s Center for Biologics Evaluation and Research under then-director Dr. Vinay Prasad issued a refusal-to-file letter, declining to even review Moderna’s application on the grounds that the control group did not reflect best-available standard of care. Days later, under public criticism, the agency reversed itself and accepted the filing. Prasad left the FDA at the end of April amid reports of interference with drug reviews and a workplace conduct investigation. Former Commissioner Marty Makary, who had defended Prasad through multiple controversies, departed shortly after.
The Phase 3 trial in approximately 40,000 adults showed a roughly 27% relative reduction in confirmed influenza cases versus a standard-dose comparator. FDA reviewers in the briefing documents noted limited data in immunocompromised and frail adults but concluded the package “met all prespecified sequential success criteria.” Moderna shares were up 28% since briefing documents released earlier this week. mFLUSIVA carries an estimated $1 billion revenue opportunity for $MRNA, which lost $2.8 billion in 2025 and has a 2028 breakeven goal that the February RTF had materially threatened.
🧠 BPS Take: Both Prasad and Makary are gone, and the same agency that refused to file in February held a 9-0 twin vote in June on essentially the same dataset. That tells you the February RTF was a unilateral one and the broader CBER staff was always in a different place than its leadership. More “normal” less personal FDA rulings seem like they are ahead, especially given the VRBPAC was unanimous. That should be a welcome sign for vaccine developers more broadly.
The ACIP side remains the problem. Secretary Kennedy gutted the CDC’s vaccine recommendation committee earlier this year, the replacement has no published cadence, and without an ACIP recommendation before fall 2026, Moderna’s commercial launch slips into 2027 regardless of whether the August 5 PDUFA lands on time. mFLUSIVA’s $1 billion opportunity is a much needed boon to Moderna, which has seen downward stock pressure post-COVID. An ACIP recommendation would go a long way towards reinvigorating Moderna’s topline and place less pressure on its cancer vaccines to drive an era of future growth.
FDA’s Commissioner’s National Priority Voucher (CNPV) pilot program draws industry concern over criteria opacity and potential to be used for broader policy agenda
📅 June 19 | 🏢 POLICY | 💊, | 🏷 Policy/FDA
The FDA’s Commissioner’s National Priority Voucher (CNPV) pilot program is drawing industry scrutiny over how recipients are selected and whether the program serves purposes beyond pure review efficiency. The CNPV compresses standard 10-to-12-month review periods by roughly four months, placing it in the same general territory as the existing Priority Review Voucher (PRV) system while running entirely on Commissioner discretion rather than statutory criteria.
Achieve Life Sciences ($ACHV) received a CNPV for cytisinicline, a smoking cessation candidate with a PDUFA date of June 20. The ACHV grant is among the clearest public examples of how the program operates in practice, though FDA has not published formal selection criteria that would allow sponsors to assess eligibility in advance.
Industry trade groups have flagged the criteria opacity as a structural problem nine months into the pilot. Without codified standards, sponsors cannot predict CNPV access, which complicates development timelines, partnership valuations, and out-licensing deal terms that depend on regulatory timing assumptions.
🧠 BPS Take: I think pretty much every biotech company is in favor of a faster review process. But having some codified guidelines on what is and isn’t eligible is important. Right now, the CNPV feels more like a political tool for playing favorites. For sponsors in therapeutically and politically aligned areas, rare pediatric disease, antimicrobials, US-manufactured products, a CNPV is a major accelerator to market. Sponsors in less-aligned areas cannot model it at all because selection criteria remain unpublished a full year into the pilot.
I also somewhat question whether we need a CNPV at all, or if there are other mechanisms the FDA already has within its disposal to accelerate drug approvals. Perhaps wider use of emergency use authorization (EUA) could function similarly. Many were calling for EUA for daraxonrasib after seeing the ASCO 2026 data. Perhaps a combo of rolling submission plus EUA can work a bit more elegantly than the more opaque CNPV system as it currently stands. For the CNPV to work there should be clear rules so that it can’t be perceived as arbitrary, or the Commissioner picking their favorites, or worse, influenced by politicians and their special interests.
💰 FOLLOW THE MONEY
Deals, dollars, and what they signal.
🚨WEEKEND RUMOR🚨
AbbVie nears $10.9B all-cash acquisition of Apogee Therapeutics at 60% premium for next-gen IL-13 atopic dermatitis franchise
📅 June 19 (rumored) | 🏢 AbbVie ABBV 0.00%↑ Apogee Therapeutics (APGE 0.00%↑ ) | 💊 zumilokibart (APG777) IL-13 mAb + APG808 IL-4Rα mAb + APG279 IL-13/OX40L bispecific | 🏷 M&A Acquisition (Rumored, FT/Reuters)
Note: I am guessing this deal will be official by Monday/Tuesday, so I will update this section accordingly. Check back on the website for the latest and greatest if you are an email-only reader.
According to a June 19 Financial Times report citing people familiar with the matter, AbbVie is closing in on an all-cash deal to acquire Apogee Therapeutics for approximately $10.9 billion. The reported price represents a roughly 60% premium to Apogee’s June 18 closing price of $90.38 and values the company at roughly 60% above its market cap of $6.81 billion at the time of reporting. An announcement could come as early as Monday, June 22, contingent on negotiations closing without last-minute friction. Both AbbVie and Apogee declined comment when reached by Reuters.
Apogee’s lead asset is zumilokibart (APG777), an IL-13 monoclonal antibody being developed in atopic dermatitis as a Dupixent (dupilumab) and Ebglyss (lebrikizumab) competitor with a differentiated half-life engineered for quarterly or biannual subcutaneous dosing. Positive Phase 2 Part B 16-week data have been reported, with Phase 3 enrollment underway. The pipeline also includes APG808, an IL-4Rα antibody in Phase 1b for asthma with a 50% FeNO reduction signal at 12 weeks, and APG279, an IL-13/OX40L bispecific in earlier development. Apogee secured a $1.3B financing package from Blackstone Life Sciences in May 2026 to support APG777 late-stage development and potential commercialization.
🧠 BPS Take: There’s no need to really sell anyone on the strategic fit of this deal. AbbVie is the premier autoimmune disease company, even after HUMIRA has gone generic. SKYRIZI and RINVOQ have turned into cash cows. SKYRIZI dominates in psoriasis and IBD, and RINVOQ covers a broad footprint, but AbbVie lacks a premier, ultra-long-acting biologic specifically tailored to corner the atopic dermatitis and asthma markets, where Regeneron’s DUPIXENT has been the market leader.
AbbVie has been running head-to-head RINVOQ trials against DUPIXENT for a while trying to dislodge it in atopic dermatitis, with mixed commercial traction despite winning data. RINVOQ is limited by a black box warning, relegating it to a second-line setting. APG777’s quarterly-to-biannual dosing is the differentiation that could finally crack the dosing-burden argument that has kept Dupixent’s bi-weekly injection competitive.
Apogee took a $1.3B Blackstone royalty financing in May to fund Phase 3 commercialization on its own. Six weeks later they’re selling to AbbVie at a 60% premium. That sequencing tells me Apogee management was ready to go it alone until AbbVie came knocking. It will be interesting to see what AbbVie does about the Blackstone deal. Blackstone was set to give Apogee $800 million of synthetic royalty and up to $500 million of debt. The $800M is in exchange for low-to-mid single digit tiered royalties for a term of 15 years on worldwide annual sales of zumilokibart. The royalties do decrease based on sales with no royalties on global annual sales in excess of $8B, but I can’t imagine AbbVie wants to kick points on this product to Blackstone, so I would guess they will look to subsequently buy themselves out of this deal whenever the acquisition closes.
Jazz pays AbCellera $56M upfront in up-to-$4.1B T-cell engager partnership for GI cancers. Up to $792M milestones per program plus tiered royalties
📅 June 17 | 🏢 Jazz Pharmaceuticals ( JAZZ 0.00%↑ ) / AbCellera ( ABCL 0.00%↑ ) | 💊 Next-gen T-cell engaging multispecific antibodies (GI cancers/solid tumors) | 🏷 Licensing / Collaboration Deal
Jazz Pharmaceuticals and AbCellera announced a collaboration on June 17 to discover next-generation T-cell engaging multispecific antibodies targeting GI cancers and solid tumors. Jazz is paying $56 million upfront for rights to two discovery programs, with an option to add a third program within 12 months for up to $28 million more.
Each program carries up to $792 million in option fees and development, regulatory, and commercial milestones, with tiered royalties on net sales also included. The total potential deal value across all programs reaches $4.1 billion, though that figure assumes full option exercise, program advancement, and milestone achievement across multiple indications.
AbCellera will apply its antibody discovery platform to generate multispecific candidates. Jazz retains commercial rights and will lead development. The collaboration covers solid tumor indications with an emphasis on gastrointestinal cancers, a space where T-cell engaging formats have seen intensifying industry investment through 2025 and into 2026. No specific molecular targets for the programs were disclosed at announcement.
🧠 BPS Take: This feels like a well-balanced deal for Jazz. $56M is not much to pay upfront, and the backloaded economics are on a per program basis, given Jazz a lot of optionality. You would think for a partnership with an AI for drug development player like AbCellera, the upfront would be pricier, but these are still very early (discovery) stage programs that carry a lot of uncertainty. Perhaps this sort of deal can serve as a template for how mid-cap pharma builds pipeline in 2026 without committing acquisition-scale capital. Rather than paying premiums in the billions, Jazz is renting shots on goal. There are a plethora of AI platform discovery plays out there and it may be wise for the mid-caps to poke and around and see if they can find some low-risk high-reward type opportunities like this if they are eager to get into the AI space.
Denali sells priority review voucher for $195M, signaling rebound in PRV market after Congressional reauthorization
📅 June 18 | 🏢 Denali Therapeutics ( DNLI 0.00%↑ ) | 💊 PRV from Avlayah approval (Hunter syndrome) | 🏷 PRV Sale / Non-Dilutive Financing
Denali Therapeutics announced on June 18 that it has sold the priority review voucher earned from the March 2026 FDA approval of AVLAYAH for Hunter syndrome for $195 million. The buyer was not disclosed. Denali stated proceeds will support its TransportVehicle blood-brain barrier delivery platform and downstream pipeline including DNL126 (Sanfilippo syndrome type A), DNL593 (GRN-related FTD), DNL952 (Pompe disease), and DNL628 (Alzheimer’s disease).
The $195 million sale represents a meaningful price rebound for PRVs after a period of compression. Recent comparable transactions include Zevra Therapeutics selling a PRV for $150 million in 2024 following the Miplyffa approval, and Jazz Pharmaceuticals selling one for $200 million in January 2026 while the rare pediatric disease PRV program was awaiting Congressional reauthorization. The program lapsed in December 2024 and was reauthorized in February 2026 as part of a spending bill that also included PBM reform provisions.
PRVs are granted upon approval of drugs designated as rare pediatric disease therapies and can be redeemed by the holder for a four-month accelerated review on a different drug or sold to a third party for non-dilutive capital. Historical PRV pricing peaked at $350 million in the early years of the program and has fluctuated since.
🧠 BPS Take: This transaction lands inside the same week that the FDA’s Commissioner’s National Priority Voucher (CNPV) pilot is drawing industry criticism for opacity and discretionary selection. The two voucher programs are not substitutes for one another. The PRV market has an easy to determine fair market value. At one point PRVs were worth as much as $300M and then settled in at $100M, only to climb up to roughly $200M in recent years. For companies, this is predictable enough to underwrite in development planning, and produces non-dilutive capital that companies like Denali can deploy against pipeline expansion. T
For Denali specifically, the timing is sharp capital management. AVLAYAH is in its launch year, the TransportVehicle platform has a deep pipeline that needs funding, and pulling $195 million in non-dilutive capital to fund other high risk neurology programs can be a major stabilizing force.
I’m curious to see who the buyer of this PRV turns out to be. We typically won’t be able to figure that out until a filing or approval comes through where that voucher was redeemed, but there aren’t that many companies that have $200M lying around to spend on PRVs.
Back next week with more BioPharma strategy takes! Share this with a friend or colleague if you found it helpful.