Aleth LifeSci Brief: 6-10 Oct 2025
Pharma stocks add $440bn after pricing deal
ALETH / LIFESCI-BRIEF / 2025-10-10 / PHARMA STOCKS ADD $440BN AFTER PRICING DEALIn this edition
Monday 6 October
Colorado became the first US state to cap what health plans and patients pay for a prescription drug, setting an upper payment limit on Amgen’s arthritis biologic Enbrel.
The state’s Prescription Drug Affordability Review Board voted at its 3 October hearing to set the limit at $600 per 50mg unit, about $30,000 a year, against an average of roughly $53,000 that insurers paid per patient in 2023. The cap binds both public and private payers in Colorado and takes effect on 1 January 2027, leaving insurers, pharmacy benefit managers and pharmacies time to adjust. Several other states run affordability boards that could copy the mechanism.
Sources:
Prescription Drug Affordability Review Board - Colorado Division of Insurance
The FDA opened a pilot that fast-tracks generic drug applications from companies that make and test their products in the United States.
Under the ANDA Prioritization Pilot, announced on 3 October, a generic applicant can request a faster review if it manufactures the finished dose in the US, uses a domestically produced active ingredient, or tests bioequivalence domestically. The agency framed it as a way to pull investment into US production and cut reliance on foreign suppliers, noting that only about 9% of active-ingredient makers sit in the US, against 22% in China and 44% in India. It fits the administration’s wider onshoring push.
Sources:
FDA Announces New ANDA Prioritization Pilot to Support U.S. Generic Drug Manufacturing and Testing - FDA
Tuesday 7 October
AstraZeneca said baxdrostat met the primary endpoint in the Bax24 phase 3 trial in patients with treatment-resistant hypertension.
The aldosterone synthase inhibitor cut 24-hour ambulatory systolic blood pressure against placebo at 12 weeks by a margin the company called statistically significant and highly clinically meaningful, holding across the full day including the early-morning hours when cardiovascular risk peaks. AstraZeneca said the drug was well tolerated, with a safety profile in line with the earlier BaxHTN study and no cases of adrenal insufficiency. It held the size of the reduction for a late-breaking session at the American Heart Association meeting in November. Baxdrostat is one of the assets AstraZeneca has put at the centre of its cardiovascular pipeline.
Sources:
Baxdrostat met the primary endpoint in Bax24 Phase III trial in patients with resistant hypertension - AstraZeneca
AstraZeneca agreed to pay Algen Biotechnologies up to $555m to hunt for new immunology targets using AI and CRISPR screening.
Algen, a San Francisco company spun out of Jennifer Doudna’s Berkeley lab, will run its AlgenBrain platform, which pairs high-throughput gene modulation with AI-driven functional genomics, to find targets in chronic inflammatory disease. AstraZeneca takes exclusive rights to develop and sell drugs against a defined set of them, and Algen gets an undisclosed upfront and near-term payment plus milestones up to the $555m total. The deal is one of a run of moves by large drugmakers to wire AI into early discovery.
Sources:
Algen Biotechnologies Announces Multi-Target Partnership to Advance AI-Powered Drug Discovery in Immunology with AstraZeneca - Algen Biotechnologies
AstraZeneca and Daiichi Sankyo said Datroway met both of its primary endpoints in a phase 3 trial in first-line metastatic triple-negative breast cancer.
In TROPION-Breast02, the antibody-drug conjugate improved both overall survival and progression-free survival against chemotherapy in patients whose disease was not suitable for immunotherapy, a result the companies called statistically significant and clinically meaningful. They described it as the first therapy to beat chemotherapy on overall survival in that first-line setting, and held the numbers for an upcoming medical meeting. Datroway is the pair’s second major antibody-drug conjugate after Enhertu.
Sources:
Datroway improved overall survival and progression-free survival in TROPION-Breast02 - AstraZeneca / Daiichi Sankyo
Amgen will sell its cholesterol drug Repatha direct to US patients at nearly 60% below list price, through a new platform called AmgenNow.
The drug goes for $239 a month, about $2,868 a year, which Amgen said is the lowest price among the G7 and is open to anyone, including the uninsured and those on high-deductible plans, without step therapy or prior authorisation. The company said it would also make AmgenNow reachable through the government’s TrumpRx site. It is the latest drugmaker to launch a direct-to-consumer offer under Trump’s pricing pressure, after Pfizer, Bristol Myers Squibb and others.
Sources:
MapLight Therapeutics launched a US initial public offering, aiming to raise about $251m on Nasdaq.
The company, which develops treatments for central nervous system disorders, filed to sell 14.75m shares at $17 each under the ticker MPLT, with an over-allotment option on top. Reuters reported the offering sought a valuation of up to $704m and that MapLight is backed by Novo Holdings. It was among the first biotech listings to press ahead during the US government shutdown, a test of investor appetite after a long drought.
Sources:
MapLight Therapeutics Announces Commencement of Initial Public Offering - MapLight Therapeutics
Drug developer MapLight aims to raise $251 million in US IPO - Reuters
Wednesday 8 October
Costa Rica warned that Donald Trump’s proposed tariffs on medical devices would raise prices for US patients and disrupt supply chains.
The country ships more than $5bn of devices to the US each year and is one of the largest suppliers to the American market, so a levy would land on US hospitals as much as on the exporter. Costa Rican officials argued the move cut against Trump’s pledge to make America healthy again. The threat stems from a Section 232 national-security investigation into medical-device imports that the administration opened in September.
Sources:
Costa Rica warns Trump’s medical device tariffs would raise US prices - Financial Times
Eli Lilly hired former FDA official Peter Marks as senior vice-president of molecule discovery and head of infectious diseases.
Marks ran the FDA’s biologics centre, CBER, for nearly a decade and left in the spring after clashing with Health and Human Services Secretary Robert F. Kennedy Jr over vaccine policy. His move to industry adds to a run of senior departures from the agency this year. Lilly pointed to his regulatory experience and his oversight of the FDA’s vaccine work during the pandemic.
Sources:
Lilly hires ex-CBER chief Marks - Endpoints News
Thursday 9 October
The UK government is preparing to let the NHS pay up to 25% more for medicines, the first change to its drug-pricing rules in about a quarter of a century.
The Times reported the plan, which responds to US tariff threats and sustained pressure from the industry and is aimed at keeping global drugmakers investing in Britain. It comes after months of pricing talks between the government and manufacturers, against a backdrop of stalled or paused UK investment. As reported it was a plan in preparation rather than a concluded agreement.
Sources:
NHS to pay up to 25% more for medicines - The Times
Global pharmaceutical stocks added about $440bn in value over the week after Pfizer struck its pricing deal with President Trump.
Investors read the agreement, which gave Pfizer three years of relief from Section 232 tariffs in return for direct-to-consumer discounts and most-favored-nation Medicaid pricing, as a sign that US tariff and pricing policy would hit the sector more softly than feared. The rally ran across US and European names, with the market pricing in expectations that other manufacturers would strike similar terms.
Sources:
Global pharma stocks add $440bn after Pfizer’s pricing deal with Trump - Financial Times
Friday 10 October
Novo Nordisk agreed to buy Akero Therapeutics for $4.7bn, the first large acquisition under new chief executive Maziar Mike Doustdar.
Shareholders get $54 a share in cash at closing plus a contingent value right worth a further $6 a share, about $0.5bn, if Akero’s lead drug wins US approval in compensated cirrhosis. That drug, efruxifermin, is an FGF21 analogue in phase 3 for MASH, the liver disease that is one of the most common complications of obesity. Doustdar said it could become a cornerstone therapy, alone or alongside Wegovy. Akero, founded in 2017 and based in San Francisco, has about 75 employees.
Sources:
Novo Nordisk to acquire Akero Therapeutics and its promising phase 3 FGF21 analogue to expand MASH portfolio - Novo Nordisk
Ottobock raised about €808m in its Frankfurt listing, Germany’s biggest IPO in 18 months, valuing the prosthetics maker at €4.2bn.
Shares priced at €66, the top of the range, and opened at €72 on debut on 9 October before closing at €69.10, up 4.7% on the offer price. Ottobock itself took about €100m from a capital increase, with the rest going to the founding Naeder family, which keeps more than 80% of the shares. The company had shelved a planned listing in 2022.
Sources:
AstraZeneca raised the planned investment in its new Virginia manufacturing site to $4.5bn, an increase of $500m.
The plant, at Rivanna Futures in Albemarle County, will make drug substance for the company’s weight-management and metabolic medicines, including its oral GLP-1, baxdrostat and oral PCSK9 candidates, alongside a new antibody-drug conjugate facility for cancer. AstraZeneca put the job count at about 3,600 direct and indirect roles and said the site should be running within four to five years. It is the largest single manufacturing investment in the company’s history and part of the $50bn US commitment it announced in July.
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