- Tarsus Pharmaceuticals (NASDAQ:TARS) announces that it has received the written minutes of the (Type C) meeting held on December 8 with the FDA on specific NDA submission requirements for TP-03.
- NDA relates to TP-03 as a treatment for Demodex blepharitis, a common ocular condition with 45% or 9M cases in the US caused by Demodex mites. Currently, it has no FDA-approved treatments.
- TP-03, an ophthalmic solution, has completed four Phase 2 clinical trials in Demodex blepharitis, with all meeting their respective endpoints. The company has started enrolling patients in Saturn-1, a Phase 2b/3 pivotal trial, with plans to initiate the second pivotal registration trial, Saturn-2, in 2021.
- Confirming that the feedback received on the data requirements for an NDA filing was consistent with its existing plans for clinical development for TP-03, Sesha Neervannan, COO of Tarsus, said: “We are pleased to continue advancing TP-03 through its pivotal trials and towards a potential NDA filing.”
- Tarsus Pharma made its market debut in October, raising $91.7M as net proceeds.
- https://seekingalpha.com/news/3646932-tarsus-pharma-is-on-track-for-nda-filing-for-eye-treatment
- Cogent Biosciences (NASDAQ:COGT) is up +3.8% after Piper Sandler initiated the coverage with an overweight rating on the stock. The price target at $22 per share is +80.3% to yesterday’s close.
- Noting that the ‘risk/reward now meaningfully skews to the upside after the company’s acquisition of Kiq LLC and the divestment of its cell therapy assets’, the analyst Christopher Raymond terms the newly-added clinical-stage compound PLX9486 as 'a potent and selective KIT inhibitor’ that could become the standard of care for indolent systemic mastocytosis.'
- In August, Cogent, previously-known as Unum Therapeutics, announced the acquisition of the privately-held Kiq, in an all-stock deal.
- Raymond thinks PLX9486 could also become a treatment option in the advanced gastrointestinal stromal tumor, for which Blueprint Medicines (NASDAQ:BPMC) received conditional marketing authorization in Europe for its kinase inhibitor, AYVAKYT® (avapritinib) in September.
- Observing a more favorable safety profile of PLX9486 compared to avapritinib, the analyst highlights a ‘sizeable valuation gap’ between Cogent and the market opportunity for Blueprint in systemic mastocytosis.
- As the graph shows, Cogent has climbed +323.5% in the year so far, prompting Seeking Alpha contributor, Busted IPO Forum, to write a neutral thesis on the stock arguing ‘once its convertible preferred is factored into the algebra, it only has ~$0.62 a share in cash.’
- https://seekingalpha.com/news/3647018-cogent-biosciences-gets-piper-sandler-nod-on-kiq-acquisition
- Allogene Therapeutics (ALLO +0.0%) announced that the U.S. FDA has cleared an Investigational New Drug application to study ALLO-715 in combination with nirogacestat, SpringWorks Therapeutics’ investigational gamma secretase inhibitor, in patients with relapsed or refractory multiple myeloma.
- This combination represents one of Allogene’s three strategies to target BCMA for multiple myeloma and will be deployed in the ongoing UNIVERSAL trial.
- Enrollment in this cohort is expected to begin in Q1 2021.
- Multiple myeloma is the 2nd most common hematological malignancy in the U.S, with 32,270 new cases and 12,830 deaths estimated in 2020.
- “We look forward to investigating this combination as part of our comprehensive anti-BCMA strategy aimed at optimizing cell therapy for patients with relapsed/refractory multiple myeloma.” said Rafael Amado, M.D., Executive VP of R&D and Chief Medical Officer.
- https://seekingalpha.com/news/3647067-allogene-receives-ind-clearance-from-fda-for-allominus-715-nirogacestat-combination
- Arcturus Therapeutics (ARCT -10.3%) price affected after double downgraded after Roth Capital analyst Elemer Piros to Sell from Buy.
- While there could be a number of advantages to Arcturus' Covid vaccine, including a lower dose, potential single dose and storage advantage, the efficacy bar is 'significant' at over 90%, Piros tells investors in a research note.
- Price target unchanged $77.
- With the stock now significantly above the price target, the analyst downgrades Arcturus to Sell pending further information on the vaccine program.
- https://seekingalpha.com/news/3647070-arcturus-therapeutics-double-downgraded-to-sell-roth-capital-stock-slumps-11
- The clinical-stage micro-cap, Genprex (NASDAQ:GNPX), is up +13.6% after the company announced the completion of manufacturing scale-up for its lead product candidate, REQORSA™ immunogene therapy targeting non-small cell lung cancer.
- Subject to passing final testing currently underway, the scaled-up clinical production will fulfill the supply for the upcoming Phase 1/2 clinical trials combining REQORSA with Tagrisso® of AstraZeneca (Acclaim-1) and Keytruda® of Merck (Acclaim-2).
- Describing the scaled-up production of clinical-grade REQORSA as a ‘significant manufacturing milestone’, Genprex CEO said the achievement has positioned the company ‘with the manufacturing capability for potential future commercialization in the rapidly growing lung cancer therapeutics market, which is projected to grow to $26.3 billion by 2023.’
- In January, the company announced that the FDA granted Fast Track Designation for REQORSA for NSCLC in combination therapy with Tagrisso®.
- https://seekingalpha.com/news/3646755-genprex-completes-manufacturing-scale-up-of-lung-cancer-therapy
