Protagonist Therapeutics Inc

Protagonist Therapeutics, Inc. (Nasdaq: PTGX) announced that its Board of Directors has authorized a share repurchase program of up to $300 million of its outstanding common stock. The company plans to fund the buybacks from its cash, cash equivalents, and marketable securities, as well as from royalties and payments from collaborations with Takeda and Johnson & Johnson. As of June 30, 2026, Protagonist held $849.5 million in cash and equivalents, excluding a $200 million opt-out payment and a $75 million milestone payment from Takeda expected in the fourth quarter of 2026. The repurchase program does not obligate the company to acquire a specific number of shares and may be modified or discontinued at any time.

DelveInsight projects the ulcerative colitis market across the seven major markets—the US, EU4, UK, and Japan—will grow from approximately USD 9.4 billion in 2025 at a CAGR of 7.6% through 2036, driven by novel targeted therapies and a robust pipeline of late-stage candidates. Among these, Abivax's obefazimod, a first-in-class oral miR-124 enhancer, met its primary endpoint in Phase III ABTECT induction studies, with a pooled placebo-adjusted clinical remission rate of 16.4% at Week 8. Merck's tulisokibart, acquired via Prometheus Biosciences, achieved clinical remission in the Phase 3 ATLAS-UC study, while Roche's afimkibart, from its $7.1 billion Telavant acquisition, showed a 35% remission rate in Phase IIb TUSCANY-2. Johnson & Johnson and Protagonist Therapeutics' icotrokinra, a first-in-class oral IL-23 receptor antagonist, met its primary endpoint in the Phase 2b ANTHEM-UC trial, and Teva and Sanofi's duvakitug, backed by a $400 million Blackstone funding deal, is in Phase III. These therapies target unmet needs in moderate-to-severe disease, with the market shifting toward IL-23 inhibitors and oral advanced therapies, though biosimilars and established anti-TNFs remain widely used.

Protagonist Therapeutics reported second-quarter 2026 results that flipped the company from a loss to a $162.8 million profit, or $2.29 per diluted share, compared with a $34.8 million loss a year earlier. The swing came as the company banked payments tied to two drugs: ICOTYDE, an oral psoriasis treatment, and rusfertide, an injectable awaiting an FDA decision. ICOTYDE, approved on March 18, triggered a $50 million milestone payment from partner Johnson & Johnson, with up to $580 million more in milestones and royalties averaging around 7.25 percent at $4 billion in annual sales. Rusfertide, under Priority Review with a PDUFA date in August, has already brought in $200 million from partner Takeda, with another $200 million and a $75 million approval milestone due, plus royalties up to 29 percent of sales above $1.5 billion. However, $192.4 million of the $213.5 million in license and collaboration revenue came from recognizing Takeda's opt-out payment, not repeatable product sales, and management expects R&D costs to rise significantly in the second half of 2026. Cash and marketable securities stood at $849.5 million, with short interest at 13.99 percent of float and a forward P/E of 36.90 as of September 4.

FDA approval of MIMRYLO for polycythemia vera triggered $275 million in payments to Protagonist Therapeutics, comprising a $200 million opt-out fee and a $75 million approval milestone. Protagonist chose royalties over the original 50:50 U.S. profit-sharing with Takeda, securing tiered royalties of 14% to 29% on worldwide net sales and eligibility for up to $875 million in additional milestones. The company reported $849.5 million in cash and equivalents as of June 30, which already included the initial $200 million opt-out payment. In the Phase 3 VERIFY trial, 76.9% of patients on MIMRYLO achieved the primary endpoint versus 32.9% on placebo. However, Protagonist no longer controls pricing or market access, and the $875 million in milestones is contingent on regulatory and commercial success.

Protagonist Therapeutics announced that the U.S. FDA approved MIMRYLO (rusfertide) as a first-in-class hepcidin mimetic peptide for adults with polycythemia vera, making it the only FDA-approved hepcidin mimetic therapy for this rare blood cancer. The approval triggers milestone payments from partner Takeda, including a $275 million payment, providing non-dilutive capital and validating Protagonist's peptide drug platform. With a market cap of about $9.3 billion, Protagonist now transitions from a development-stage company to one with a potential commercial revenue stream, though future success depends on real-world uptake and competition with existing treatments. The first commercial update, including patient starts and payer coverage, will be key to assessing the drug's market performance.

Takeda Pharmaceutical Co. Ltd. has secured U.S. FDA approval for MIMRYLO (rusfertide), a first-in-class treatment for polycythemia vera, a blood cancer that causes overproduction of red blood cells and increases the risk of life-threatening blood clots. The approval is based on the global Phase 3 VERIFY study, which included 293 patients and showed that MIMRYLO, when added to standard care, achieved superior hematocrit control, reduced the need for phlebotomy, and improved fatigue compared to placebo. Takeda will commercialize MIMRYLO under a 2024 worldwide license and collaboration agreement with Protagonist Therapeutics Inc., which discovered the drug and led development through Phase 3. The FDA approval triggers $275 million in payments to Protagonist, comprising a $200 million opt-out fee and a $75 million approval milestone, with potential for up to an additional $875 million in milestones and tiered royalties of 14% to 29% on worldwide net sales. Takeda shares were down 0.19% at $17.99 at the time of publication on Monday.

Johnson & Johnson's pipeline is becoming an increasingly important growth driver as the company looks to offset future pressure from mature products such as Stelara and eventually Darzalex. The company has a particularly strong set of catalysts in oncology, immunology and neuroscience, with several potential approvals, label expansions and important phase III readouts scheduled. In the past year, it has gained approval for new products like Inlexzo/TAR-200, a first-of-its-kind drug-releasing system, for treating high-risk non-muscle invasive bladder cancer, Imaavy (nipocalimab) for treating generalized myasthenia gravis and Icotyde (icotrokinra), an oral targeted peptide inhibitor of the IL-23 receptor, for treating moderate-to-severe plaque psoriasis. J&J markets Icotyde in partnership with Protagonist Therapeutics. On the second-quarter conference call, J&J said that it is seeing strong launches of Inlexzo, Icotyde, as well as Imaavy. Nipocalimab, an FcRn blocker, is also being evaluated for various immune-mediated conditions. It is under priority review in the United States for warm autoimmune hemolytic anemia, in late-stage studies for hemolytic disease of the fetus and newborn, systemic lupus erythematosus and Sjogren's disease, and in mid-stage studies for idiopathic inflammatory myopathy. J&J believes that nipocalimab has pipeline-in-a-product potential. J&J believes that Icotyde/icotrokinra has the potential to revolutionize the treatment of plaque psoriasis with a once-daily pill, whereas most currently available effective options for treating plaque psoriasis are injectables, such as AbbVie's popular injection, Skyrizi, and J&J's own injection, Tremfya. Icotyde offers a compelling advantage over existing plaque psoriasis treatments by combining biologic-level precision with the convenience of an oral pill. Unlike injectable IL-23 biologics, such as AbbVie's Skyrizi and Tremfya, it eliminates the need for injections, improving patient comfort and adherence. Icotrokinra is also being evaluated in phase III studies for ulcerative colitis and psoriatic arthritis and in phase II for Crohn's Disease. It has the potential to be J&J's largest product ever, with $10 billion in sales potential. J&J expects several meaningful pipeline catalysts in the second half of the year, including potential FDA regulatory approval for Imaavy for warm autoimmune hemolytic anemia. In July, J&J announced positive top-line data from the phase III MonumenTAL-6 study evaluating Tecvayli plus Talvey in patients with relapsed or refractory multiple myeloma who had received one to four prior lines of therapy. The combination regimen reduced the risk of disease progression or death by 89% versus investigator's choice of standard care while reducing the risk of death by 62%. Other important data readouts expected later this year include Inlexzo in high-risk bladder cancer, Icotyde in psoriatic arthritis and Caplyta in bipolar mania. A key pipeline candidate is JNJ-4804, a co-antibody therapeutic being developed in phase III studies for ulcerative colitis and Crohn's disease. The company is also working on expanding labels of currently marketed products like Darzalex, Tremfya, Carvykti, Erleada, Rybrevant/Lazcluze and others. As regards its MedTech segment, a key product approved recently in the United States was the OTTAVA robotic surgery system, J&J's next-generation soft-tissue surgical robot. It was approved in July. VARIPULSE Pro, an advanced Pulsed Field Ablation platform, is expected to be approved by the FDA later this year. VARIPULSE Pro was launched in the EU in April. Overall, J&J's robust pipeline and a steady stream of clinical and regulatory catalysts should support growth in the second half of 2026 and beyond. The potential expansion of newer drugs, strong late-stage candidates and continued MedTech innovation provide multiple avenues for J&J to offset patent pressures and sustain long-term growth. J&J's shares have outperformed the industry so far this year. The stock has risen 30.6% year to date compared with 18.2% appreciation of the industry. From a valuation standpoint, J&J is expensive. Going by the price/earnings ratio, the company's shares currently trade at 21.84 forward earnings, higher than 19.50 for the industry. The stock is also trading above its five-year mean of 15.65. The Zacks Consensus Estimate for 2026 earnings has risen from $11.58 per share to $11.59 per share over the past 60 days, while that for 2027 earnings has gone up from $12.65 per share to $12.80 over the same time frame. J&J has a Zacks Rank #3 (Hold) at present.

Protagonist Therapeutics shares have surged 64% over the past six months, far outpacing the industry's 4.5% gain, driven by advances in its rare hematology candidate rusfertide and the approval of partnered therapy Icotyde. The FDA accepted the rusfertide new drug application with priority review and set an August 2026 target action date, while Protagonist restructured its deal with Takeda to receive a $400 million upfront payment, a $75 million approval milestone, up to $775 million in sales milestones, and tiered royalties of 14% to 29% on global sales. Separately, the FDA approved Icotyde, an oral IL-23 receptor inhibitor co-developed with Johnson & Johnson, for moderate-to-severe plaque psoriasis, triggering a $50 million milestone payment and leaving Protagonist eligible for up to $580 million in additional milestones plus tiered royalties of 6% to 10% on net sales. The company is also advancing wholly owned pipeline assets, including an oral IL-17 antagonist expected to enter phase II in 2026.

Six biotech stocks profiled by RTTNews have delivered stunning gains for patient investors, with Inhibrx Biosciences surging as much as 746% since its profile was published on July 8, 2025. Palvella Therapeutics rose up to 505% from its March 10, 2025 profile, driven by positive trial results and an FDA rolling review for its rare-disease therapy. MBX Biosciences gained up to 363% since June 18, 2025, following encouraging data from multiple clinical programs. Protagonist Therapeutics advanced as much as 204% from its January 6, 2025 profile after FDA approval of its psoriasis drug. Absci Corp. climbed up to 290% since September 12, 2025, on positive interim data for its AI-designed hair-loss treatment. Belite Bio increased up to 187% from its September 15, 2025 profile, supported by a completed rolling NDA submission for its retinal-disease therapy.