Biotech & Health Weekly: The Week a New Drug Class Got Approved

Thirteen years of research. One FDA approval. Arvinas crossed the finish line on May 1 with the first PROTAC therapy ever cleared by a regulator. The same day, Eli Lilly reported the most dominant quarter in GLP-1 history. A week later, Novo Nordisk answered with its own numbers. The biotech M&A machine kept running in the background. Four major stories, one unusually dense week.

The XBI is up 64% over the past year. Q1 biopharma M&A hit $15.6 billion across 19 deals, already outrunning full-year 2025 on IPO proceeds. The regulatory climate under new FDA leadership is producing faster timelines. Veppanu came in a month early. Jakafi XR cleared in the same week. The agency is moving. So is the capital.

1. The FDA Just Approved an Entirely New Kind of Drug

On May 1, the FDA approved Veppanu (vepdegestrant) for adults with ER-positive, HER2-negative, ESR1-mutated advanced breast cancer whose disease has progressed after at least one prior endocrine therapy. Veppanu is the first FDA-approved PROTAC — a protein degrader that does not just block a target protein but flags it for destruction by the cell’s own disposal system. Arvinas (Nasdaq: ARVN) has been developing the technology since 2013. Its partner on the drug is Pfizer (NYSE: PFE).

The VERITAC-2 Phase 3 data drove the approval. Among patients with an ESR1 mutation, Veppanu cut the risk of disease progression or death by 43% versus fulvestrant. Median progression-free survival was 5 months compared to 2.1 months on fulvestrant. The FDA also approved Guardant360 CDx as the companion diagnostic to identify eligible patients via liquid biopsy. The approval landed a month ahead of the June 5 PDUFA date.

Arvinas and Pfizer will not commercialize the drug themselves. The companies announced in September they would out-license commercialization rights to a third party. That partner has not been named. What does not change is what the approval means for the broader pipeline. Every major pharma company has PROTAC programs in development. Regulators just validated the entire modality. That is the real story here.

2. Eli Lilly Just Had Its Most Dominant GLP-1 Quarter Yet

Lilly reported Q1 2026 results on April 29. Mounjaro and Zepbound generated $8.7 billion in combined revenue, with more than half now coming from outside the US. Zepbound added $4.2 billion on its own. Adjusted EPS came in at $8.55 against a Wall Street consensus of $6.66 to $6.97. Shares jumped more than 6%.

The market share picture is stark. Lilly now holds 60.6% of the US GLP-1 market. Novo sits at 39.4%. The international numbers flipped too — Lilly at 53.2%, Novo at 46.8%. That is a complete reversal from where things stood 18 months ago. Full-year revenue guidance moved to $82 billion to $85 billion from $80 billion to $83 billion. EPS guidance lifted to $35.50 to $37.00.

Foundayo, the oral GLP-1 pill FDA-approved on April 1, is not yet in the numbers in any meaningful way. Its mainstream ad campaign does not launch until Q3. Barclays analysts noted that investors will need visibility on Foundayo’s trajectory to sustain current valuations. The GLP-1 pill war is just starting and Lilly has not yet fired its biggest commercial shot.

3. Novo Nordisk: Wegovy Pill Is Flying, but the Business Is Shrinking

Novo Nordisk reported Q1 on May 6. Headline sales jumped 32% at constant exchange rates to 96.8 billion Danish kroner ($15.2 billion), inflated by a one-time reversal from the 340B Drug Pricing Program. Strip that out and adjusted sales fell 4%. US operations were down 11% on lower realized prices. Ozempic fell 8% but beat expectations. Shares rose around 3% anyway.

The Wegovy pill is the bright spot. $355 million in Q1, its first full quarter on shelves. Over 1 million patients in 16 weeks. CEO Mike Doustdar called it “off to a record-breaking start.” Wegovy holds 65% of all new US obesity prescriptions. The pill is doing exactly what Novo needed it to do. The problem is everything else. Full-year guidance tightened to a 4% to 12% adjusted sales decline from a prior 5% to 13% range. That is still a decline.

The gap between the two companies is about more than market share. Lilly’s tirzepatide shows roughly 20% body weight reduction in trials versus approximately 14% for semaglutide. That clinical delta is showing up in prescriber preference. Novo moved first on the oral front. Lilly has the better drug. The next six months of prescription data will determine whether the pill launch can arrest Novo’s slide before Foundayo’s marketing machine gets running.

4. Incyte’s Jakafi XR Clears. The FDA Is Running Hot.

Incyte received FDA approval on May 4 for Jakafi XR, a once-daily extended-release formulation of ruxolitinib, for myelofibrosis, polycythemia vera, and graft-versus-host disease. A single 55mg XR tablet delivers bioequivalent day-long exposure to a twice-daily 25mg immediate-release dose. Same drug, better compliance profile. Incyte CEO Bill Meury described it as “expanded treatment options without changing the well-established role of Jakafi in clinical practice.”

The Jakafi XR approval is a smaller story on its own. In context it is part of a pattern. Veppanu came in a month early. Jakafi XR cleared in the same week. Earlier this year the FDA approved a gene therapy for genetic hearing loss, the first once-weekly basal insulin, and an oral GLP-1 pill across successive months. The agency under its new leadership structure has been moving faster on applications where the data is clean. For drug developers with strong trial packages, the regulatory runway is clearer than it has been in three years.

5. Biotech M&A Is Running at Its Fastest Pace Since 2018

Q1 2026 closed with $15.6 billion in biopharma M&A across 19 deals and six IPOs raising $1.8 billion, already topping full-year 2025 IPO proceeds. March alone produced seven deals over $1 billion totaling $29 billion. Jefferies called it a “breadth of appetite” story, noting four deals above $5 billion alongside smaller tuck-ins. Merck paid $6.7 billion for Terns Pharmaceuticals and its oral leukemia candidate. Eli Lilly put $6.3 billion upfront for Centessa Pharmaceuticals plus $1.5 billion in contingent payments.

Gilead has done three separate deals in 2026 totaling $14.77 billion. JP Morgan’s Q1 biopharma report flagged China-to-West licensing as a growing core vector, with Chinese biotechs running faster through trials than Western counterparts and Big Pharma buying structured access to that pipeline. The XBI is up 64% over the past year. The capital is there. The appetite is there. Oncology, obesity, and neurology are the primary battlegrounds.

The companies most likely to move next, according to Jefferies: mid-cap oncology developers with Phase 3 readouts due in the second half of 2026 and single-asset biotechs whose drugs address mechanisms where Big Pharma has active gaps. Loss-of-exclusivity pressure is mounting for Merck on Keytruda and for Novo on several international assets. Both need pipeline. Both have cash. That math does not change.

What to Watch: Week of May 7-14, 2026

May 10: FDA decision on VYVGART for seronegative generalized myasthenia gravis. argenx already has VYVGART approved for the antibody-positive form. This expansion would cover the harder-to-treat seronegative population, a segment with no approved options.

May 18: FDA decision on ENHERTU for neoadjuvant HER2-positive breast cancer. AstraZeneca and Daiichi Sankyo are seeking approval ahead of surgery for newly diagnosed patients. A positive decision would significantly expand ENHERTU’s addressable market.

May 24: The Leqembi Iqlik decisions. The FDA is expected to rule on a subcutaneous autoinjector formulation of Biogen and Eisai’s Alzheimer’s drug, along with a new weekly dosing formulation. If approved, subcutaneous delivery removes the need for IV infusions and opens Leqembi to a much broader patient population.

Arvinas commercialization partner announcement: the company said it is on track to name the third party taking over Veppanu commercialization. That name will tell you a great deal about how Big Pharma values the PROTAC modality right now.

Week 4 oral GLP-1 prescription data from IQVIA: Foundayo vs Wegovy pill. The early numbers favor Novo. Watch whether that gap holds once Lilly’s distribution network catches up in the month’s second half.

Sources

Editorial Disclosure

This roundup is based on a combination of press releases, regulatory filings, earnings disclosures, and independent market research sourced from publicly available information. It covers developments during the week of April 28 to May 7, 2026, in the biotechnology, pharmaceutical, and health sectors. Securities discussed in this article include Arvinas, Inc. (Nasdaq: ARVN), Pfizer Inc. (NYSE: PFE), Eli Lilly and Company (NYSE: LLY), Novo Nordisk A/S (NYSE: NVO), Incyte Corporation (Nasdaq: INCY), and Gilead Sciences (Nasdaq: GILD). None of these companies compensated aktiego.com for coverage. Drug approval status for all products referenced is current as of the date of publication. Clinical trial data and efficacy figures are sourced from FDA approval releases and company press releases and reflect results from specific study populations; real-world outcomes may vary. Pipeline developments and forward-looking statements attributed to named companies or analysts represent opinions at the time of publication and are not guarantees of regulatory approval, commercial success, or future performance. Market share and pricing data are sourced from company earnings presentations and named analyst reports. The information provided on this website is for informational and educational purposes only. Our content is derived strictly from verified online sources to ensure accuracy and objectivity. This analysis does not constitute financial, investment, or professional advice. Readers are encouraged to consult with qualified professionals before making decisions based on this information. For more information, please see our full DISCLAIMER.

Biotech & Health Weekly: The Week a New Drug Class Got Approved

Join our Mailing List