Novo Nordisk Buys Akero & Regeneron’s Libtayo Wins Adjuvant CSCC Nod — This Week in Biotech #73
Repatha $239 cash launch, Dyne’s DM1 gains, Skye’s CB1 combo signal, Novavax-Sanofi EU handoff, Humacyte data + financing, Rocket pulls FA gene therapy (Sept 29-Oct 9, 2025).
Hi and welcome to This Week in Biotech by Biotech Blueprint, edition 73, covering biotech & pharma news from October 3rd to 10th, 2025.
This week’s edition is without a video summary due to international travel, but I will resume next week.
🎙️ Biotech Blueprint brings you weekly video updates on the latest biotech and pharma news, plus in-depth podcast interviews with industry leaders. You can find us on YouTube, Spotify, and Apple Podcasts.
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THIS WEEK’S KEY TAKEAWAYS 🔑
Novo buys Akero for up to $5.2B. Novo Nordisk is adding an FGF21 (efruxifermin) onto its GLP-1 empire for $54/share cash now + a $6 CVR if the drug wins U.S. approval in compensated MASH cirrhosis by mid-2031.
Libtayo moves PD-1 into prevention mode for skin cancer. FDA cleared Regeneron’s Libtayo as the first adjuvant therapy for high risk cutaneous squamous cell carcinoma post-surgery/radiation.
Amgen cuts Repatha’s cash price 60% via AmgenNow. $239/month outside insurance price answers political heat and prior-auth friction, and lands days after VESALIUS-CV showed primary-prevention outcomes.
Dyne’s DM1 drug shows year-long functional gains. Z-basivarsen delivered sustained improvements across strength and dexterity measures with clean safety at the selected registrational dose. Small n, but consistency across endpoints upgrades this from interesting biomarker to credible disease-modifying signal.
Skye’s CB1 antibody whiffs solo, hints in combo. Nimacimab missed weight loss vs placebo as monotherapy but added 3 pts on top of semaglutide without extra GI or neuropsychiatric baggage. The monotherapy thesis is cracked; the combo path now has a pulse.
Ovid’s next-gen GABA-AT inhibitor hits target cleanly. OV329 boosted cortical inhibition on transcranial magnetic stimulation 53% over 7 days with mild AEs and no retinal signals. Phase 2a in drug-resistant focal seizures is the next gate.
Humacyte: real-world win, financing overhang. Ukraine trauma data for Symvess showed 87% patency, 100% limb salvage, zero conduit infections up to 18 months - excellent field validation. Shares then fell on a $60M registered direct with warrants: more runway, but near-term stock pressure.
Novavax hands EU reins to Sanofi. Transfer of Nuvaxovid authorization triggers $25M now, with more milestones/royalties tied to U.S. transfer, tech handoff, combos, and Matrix-M-powered vaccines, shifting COVID economics to a partner-led annuity.
Rocket trims sails. RP-L102 (Fanconi anemia) BLA withdrawn in the U.S. (and earlier in the EU), framed as strategy not safety, keeping optionality while capital concentrates on nearer-path programs after the Danon hold saga (now lifted). Execution on the refocus is the stock driver.
BIOTECH/PHARMA NEWS 🧬
🔹 Novo Nordisk is buying Akero Therapeutics in a deal worth up to $5.2B, paying $54/share in cash now for $4.7B upfront plus a $6/share CVR if efruxifermin wins full U.S. approval for compensated cirrhosis due to MASH by June 30, 2031. The bet gives Novo an FGF21 analogue in phase 3 (SYNCHRONY) to pair with its GLP-1 franchise, aiming at a large metabolic liver market where efruxifermin has already shown fibrosis reversal signals in cirrhosis. Board approved, expected to close around year-end.
🔹 Regeneron’s Libtayo won FDA approval as the first immunotherapy for adjuvant use in high risk cutaneous squamous cell carcinoma (CSCC) after surgery and radiation, backed by the phase 3 C-POST trial showing a 68% reduction in recurrence or death vs. placebo (HR 0.32; p<0.0001). Safety tracked the known PD-1 profile (rash/itching and hypothyroidism most common), but the strategic punch is earlier disease: moving checkpoint blockade from salvage to prevention territory in CSCC. Translation for models and margins alike: a new standard in a common skin cancer and incremental expansion of Libtayo’s total addressable market ahead of an EU decision expected by mid-2026.
🔹 Novavax transferred EU marketing authorization for its COVID-19 vaccine Nuvaxovid to Sanofi, handing over all commercial and regulatory duties and triggering a $25M milestone. The deal sets up ongoing royalties and additional milestones tied to combo products and Sanofi vaccines using Novavax’s Matrix-M adjuvant. Next up are a $25M U.S. authorization-transfer milestone and $75M on manufacturing tech transfer, turning Nuvaxovid into a partner-led cash stream while Novavax keeps upside via royalties and add on milestones.
🔹 Oragenics inked a strategic tie-up with Receptor.AI to use generative modeling to predict receptor-binding profiles for compounds acquired in 2023, aiming to prioritize lab validation and expand beyond its lead intranasal concussion drug, ONP-002 (Phase 2a start targeted for Q4 2025). Framed as a shift from single asset to platform, the pitch is capital efficiency: de-risk discovery, focus on programs with the cleanest signal, and seed a broader neuro/psych pipeline (Alzheimer’s, Parkinson’s, PTSD, addiction, anxiety).
🔹 Biomea Fusion jumped 24% after mid-stage data showed its covalent menin inhibitor, icovamenib, delivered durable glycemic control. At Week 52, nine months after dosing stopped, patients with severe insulin deficiency on background meds saw a 1.8% placebo-adjusted HbA1c drop, and GLP-1 users who hadn’t hit targets responded meaningfully after just 12 weeks. Safety looked clean across arms through 52 weeks. Next up is phase 2b in severe insulin-deficient patients and a GLP-1 combo trial starting Q4 2025.
🔹 Humacyte popped 18% after publishing real-world data from Ukraine showing its vascular graft Symvess kept vessels open in 87% of 17 wartime trauma patients, with 100% limb salvage and no conduit infections through 18 months. This is a strong field validation for an FDA-approved trauma use. Shares then reversed on a $60M registered direct: 28.4M shares plus equal warrants at $2.11/unit (exercisable in 180 days), i.e., immediate dilution and overhang. Clinically the story looks de-risked, financially the raise adds risk. It extends runway, but the heavy use of warrants creates near-term selling pressure.
🔹 Amgen launched U.S. sales of Repatha at $239/month, about 60% below list, via its AmgenNow portal, bypassing prior auth/step-therapy hurdles but limited to cash payers (not insurance). Framed as the industry’s response to intensifying price pressure (tariff threats, TrumpRx marketplace), Amgen says the cash price matches its lowest in any G-7 country. The timing follows last week’s VESALIUS-CV win showing outcomes benefit in primary prevention, potentially widening the eligible funnel.
🔹 Rocket Pharmaceuticals withdrew its U.S. approval application for RP-L102, a gene therapy for Fanconi anemia, citing strategy, not safety or efficacy. The company had already halted new internal spending and pulled the European filing in July while it searches for a partner. The move looks like resource triage toward programs with clearer regulatory and commercial paths, especially after the Danon disease study’s clinical hold (since lifted in August 2025) raised operational risk. Investor read-through: optionality preserved on RP-L102, but near-term sentiment depends on flawless execution as the Danon program restarts.
CLINICAL TRIAL UPDATES 📊
🔹 Dyne ticked up 9% after one year data from its phase 1/2 ACHIEVE trial in myotonic dystrophy type 1 showed its antisense candidate zeleciment basivarsen drove sustained gains in function and strength across multiple measures, including better performance on the 9 hole peg test, with no treatment-related serious adverse events. The consistency across upper and lower limb endpoints (and patient and clinician global impressions) pushes this beyond biomarker noise into real-world utility. Next question is scale: can these signals hold in the expansion cohort and translate into a clean path to approval?
🔹 AbbVie’s phase 2 ELATE study found Botox improved upper-limb essential tremor, meeting the primary goal on the tremor disability scale at 18 weeks and clearing all six secondary endpoints. Safety tracked the known profile (muscle weakness was the most common effect, typically mild and transient). Botox isn’t approved for essential tremor today, but these data set up a plausible path to later stage testing.
🔹 Skye cratered 60% after its antibody nimacimab flunked a phase 2a obesity trial as a stand-alone placebo-adjusted weight loss was only -1.26% at 26 weeks. The twist: pairing nimacimab with semaglutide (Wegovy) delivered -13.2% vs -10.25% for semaglutide alone (p=0.037), with better lean-to-fat ratios and no additive gastrointestinal or neuropsychiatric issues. Management is eyeing higher doses and a follow up study, but for now the equity signal is clear: monotherapy thesis broke, combo looks intriguing, and capital needs plus dose-finding risk move to the front of the deck.
🔹 Ovid Therapeutics reported positive phase 1 results for OV329, an oral next-generation GABA-aminotransferase inhibitor being developed for drug-resistant epilepsy (with a phase 2a planned in focal onset seizures). In healthy volunteers, 5 mg daily increased cortical inhibition by 53% over 7 days on transcranial magnetic stimulation, evidence of brain penetration and target engagement. Safety looked clean with only mild, transient events and no retinal changes, sidestepping the vision-loss liability seen with the older drug vigabatrin.
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Amgen's $239/month cash pricing for Repatha is a brilliant preemptive move against political pressure and the TrumpRx marketplace threat. By matching G-7 lows and bypassing prior auth barriers, they're essentialy removing the utilization friction that was killing uptake despite strong clinical data. The VESALIUS-CV primary prevention win expands the addressable population dramatically, so this pricing strategy could actually boost total revenue even at lower per-unit margins by converting more of the ~50M eligible statin-intolerant patients.