30.10.2018 02:20:01
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CASI Turning Heads, GEN On Watch, MRKR For The Long Haul
(RTTNews) - The following are some of today's top gainers in the pharma/biotech sector.
1. LogicBio Therapeutics Inc. (LOGC)
LogicBio is a genome editing company focused on developing medicines for rare diseases.
Gained 25.06% to close Monday's (Oct.29) trading at $10.73.
News: No news
Recent events:
-- The Company went public on the Nasdaq Global Market on October 19, 2018, offering its shares at a price of $10 each. -- On October 23, the Company closed its IPO.
2. OncoMed Pharmaceuticals Inc. (OMED)
Gained 14.88% to close Monday's trading at $1.93.
News: No news
Recent event:
On Oct.20, the Company announced promising interim results from its ongoing Phase 1b trial investigating Navicixizumab in combination with paclitaxel in patients with platinum-resistant ovarian cancer.
Near-term Catalysts:
-- Data from a phase Ia dose-escalation portion of the trial, designed to assess safety and tolerability of escalating doses of Etigilimab monotherapy, in patients with advanced or metastatic solid tumors is expected in the fourth quarter of 2018. -- Data from a phase Ia trial of GITRL-Fc in patients with advanced or metastatic solid tumors are expected in 2019.
3. CASI Pharmaceuticals Inc. (CASI)
Gained 14.80% to close Monday's trading at $3.19.
News: No news
Recent event:
On October 23, the Company acquired a U.S. FDA-approved abbreviated new drug application (ANDA) for Tenofovir disoproxil fumarate, or TDF, from Laurus Labs Limited. The drug, (TDF), is indicated for the treatment of hepatitis B virus.
Near-term Catalysts:
-- The Company's Evomela (melphalan) application is under final stage of assessment by the China Food and Drug Administration (CFDA). The approval will mark a significant milestone toward addressing an unmet medical need for patients with multiple myeloma in China, as there are no versions of melphalan commercially available, according to the Company. -- CASI continues to work with the CFDA on advancing Marqibo's import drug clinical trial application, and the regulatory agency is expected to complete its review within the next two to four months. -- The import drug clinical trial application for ZEVALIN is also in process with the CFDA.
4. Genesis Healthcare Inc. (GEN)
Gained 14.58% to close Monday's trading at $1.65.
News: No news
Near-term Catalyst:
The Company is expected to release its third quarter 2018 results after the market closes on Wednesday, November 7, 2018.
5. Marker Therapeutics Inc. (MRKR)
Gained 12.27% to close Monday's trading at $7.96.
News: No news
Recent event:
-- On October 18, 2018, the combined company of TapImmune Inc. (TPIV) and privately-held Marker Therapeutics Inc, took on the name Marker Therapeutics Inc., and began trading on the Nasdaq Capital Market under the new ticker symbol "MRKR".
Pipeline:
-- A phase II clinical trial of novel therapeutic vaccine candidate TPIV200 in the prevention of cancer recurrence in women with triple-negative breast cancer (TNBC) who have completed first-line surgery and radiotherapy/chemotherapy is underway. *The study is expected to be completed in May 2019. (Source: ClinicalTrials.gov) -- A phase II clinical study of TPIV110 that will enroll women diagnosed with ductal carcinoma in situ, an early form of breast cancer is being planned by Mayo Clinic. -- A phase II study of TPIV110, in combination with Herceptin for treating women with HER2/neu-positive breast cancer is also being planned by Mayo Clinic.
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