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Protagonist Therapeutics develops peptide-based therapeutics using a proprietary discovery platform, with programs spanning inflammation and immunology, hematology and metabolic disease. Company news centers on ICOTYDE™ (icotrokinra), an oral IL-23 receptor-targeted peptide approved for moderate-to-severe plaque psoriasis, and rusfertide, a hepcidin mimetic peptide for polycythemia vera developed with Takeda.
Recurring updates also cover collaboration economics with Johnson & Johnson's Janssen Biotech and Takeda, clinical and regulatory milestones, R&D spending on wholly owned discovery programs, financial results, investor conference participation and equity-based inducement awards under Nasdaq rules.
Protagonist Therapeutics (Nasdaq: PTGX) has initiated a Phase 1 study for PN-235, an oral IL-23 receptor antagonist. This study, involving about 100 healthy volunteers, aims to assess the drug's safety and pharmacokinetics. PN-235 is the first oral candidate from a collaboration with Janssen Biotech. The study includes ascending doses and a solid dose comparison, focusing primarily on safety. Protagonist anticipates Phase 1 results in 2021, with potential applications in various diseases. The collaboration allows Protagonist to earn milestone payments as Janssen handles later development phases.
Protagonist Therapeutics (Nasdaq: PTGX) completed an underwritten public offering of 5,476,189 shares of common stock at a public price of $21.00 per share, raising approximately $115.0 million in gross proceeds. This includes 714,285 shares sold due to the underwriters' full exercise of their 'green shoe' option. The shelf registration statement was filed with the SEC on December 10, 2020. J.P. Morgan, SVB Leerink, Piper Sandler, and BMO Capital Markets managed the offering.
Protagonist Therapeutics, Inc. (Nasdaq: PTGX) has priced an underwritten public offering of 4,761,904 shares of common stock at $21.00 each, targeting $100 million in gross proceeds before expenses. The offering will close around December 15, 2020, subject to customary conditions. The underwriters have a 30-day option to buy an additional 714,285 shares. Joint book-running managers include J.P. Morgan, SVB Leerink, Piper Sandler, and BMO Capital Markets. A registration statement was filed with the SEC on the same day as the announcement.
Protagonist Therapeutics, Inc. (Nasdaq: PTGX) announced a public offering of $100 million of its common stock, with the possibility of granting underwriters a 30-day option to purchase an additional 15%. The offering is subject to market conditions, and there is no guarantee on its completion or the size of the offering. J.P. Morgan, SVB Leerink, Piper Sandler, and BMO Capital Markets are the joint book-running managers. A shelf registration statement was filed with the SEC on December 10, 2020. Investors are advised to consult the SEC filings for detailed information.
Protagonist Therapeutics (Nasdaq:PTGX) released findings from a significant analysis on treatment patterns for polycythemia vera, indicating that existing therapies fail to adequately control hematocrit levels in most patients. Specifically, only 22% maintained levels below the recommended 45%, with nearly 49% experiencing levels exceeding 50% during the observation. The results highlight an unmet need for effective treatment options in this patient population, with a Phase 2 study of PTG-300 currently enrolling participants. These findings will be discussed at the ASH 2020 meeting.
Protagonist Therapeutics (Nasdaq: PTGX) announced promising Phase 2 study results for PTG-300, aimed at treating polycythemia vera (PV). The study showed that most of the 18 patients treated could eliminate therapeutic phlebotomies while maintaining hematocrit levels below 45%. Additionally, PTG-300 demonstrated the ability to reverse iron deficiency and reduce symptom burden over time. The treatment was well tolerated with minimal adverse effects. Protagonist plans to share these findings with regulatory authorities and expects to complete patient enrollment by mid-2021.
Protagonist Therapeutics announced that its candidate PTG-300 received FDA Fast Track designation for treating polycythemia vera, a rare blood disorder. This designation could expedite the development process, including more frequent FDA interactions. PTG-300 is a synthetic hepcidin mimetic shown to significantly reduce phlebotomy needs in ongoing Phase 2 trials, which are expected to complete enrollment by mid-2021. The FDA's Fast Track program aims to accelerate therapies addressing serious conditions and unmet medical needs.
Protagonist Therapeutics, Inc. (Nasdaq: PTGX) announced on December 1, 2020, the issuance of an inducement award to Michelle Landolfi, Ph.D., its new Vice President of Regulatory Affairs. The award includes an option to purchase 50,000 shares at an exercise price of $24.16, with a four-year vesting schedule. This grant follows Nasdaq Marketplace Rule 5635(c)(4) and was approved by the company's compensation committee. Protagonist specializes in developing peptide-based therapeutics for unmet medical needs, with ongoing projects for polycythemia vera and inflammatory bowel disease.
Protagonist Therapeutics (Nasdaq:PTGX) announced a conference call on December 9, 2020, at 8:30 a.m. EST to provide an R&D and corporate update. The management team will be joined by Dr. Andrew Kuykendall from Moffitt Cancer Center, who is involved in the PTG-300 Phase 2 study. Interested parties can join the call by dialing 1-844-515-9178 (U.S./Canada) or 1-614-999-9313 (international) and referencing conference ID 8794865. The call will also be available via webcast on the company's website.
Protagonist Therapeutics, Inc. (NASDAQ: PTGX) announced that its CEO, Dinesh V. Patel, Ph.D., will participate in a fireside chat at the virtual Piper Sandler 32nd Annual Healthcare Conference from November 30 to December 3, 2020. Registered attendees can view the presentation on the conference site until December 3, and it will also be accessible via the company's Investors section starting November 30. Protagonist focuses on developing peptide-based therapeutics for unmet medical needs, with three clinical-stage assets targeting blood disorders and inflammatory bowel disease.