24.04.2018 04:58:37
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EVFM On Track, CMTA Turning Heads, INSM Gets A Boost On Upgrade, Check Out CHEK
(RTTNews) - The following are some of today's top gainers in the pharma/biotech sector.
1. Check-Cap Ltd. (CHEK)
Gained 78.82% to close Monday's (Apr.23) trading at $7.26.
News: No news
Check-Cap is a clinical stage medical diagnostics company developing a capsule-based system for preparation-free, colorectal cancer screening.
Recent events:
-- On January 10, 2018, the Company received CE Mark approval for the C-Scan system.
The C-Scan system, an ingestible capsule, offers an alternative to current colon cancer screening methods that require laxative preparation and invasive endoscopic procedures.
-- On March 12, 2018, the Company initiated an EU post approval study using its Advanced C-Scan system. -- On April 4, 2018, the Company implemented a 1-for-12 reverse stock split of its outstanding ordinary shares. -- On April 19, 2018, the Company regained compliance with Nasdaq Listing Rule 5550(a)(2), which concerns minimum bid price listing requirements.
Near-term Catalyst:
-- The Company is expected to initiate the US pilot trial for advanced C-Scan Version in the second half of 2018.
2. Evofem Biosciences Inc. (EVFM)
Gained 16.64% to close Monday's trading at $7.29.
News: No news
Clinical Trials & Near-term Catalysts:
The Company's lead product candidate is Amphora, a non-hormonal, surfactant-free bioadhesive vaginal gel.
-- A phase III clinical trial of Amphora for the prevention of pregnancy and a phase IIb/III clinical trial of Amphora for the prevention of urogenital chlamydia and gonorrhea in women are underway.
Data from the phase III clinical trial of Amphora for the prevention of pregnancy are expected in Q1, 2019.
-- A phase I trial of multipurpose prevention technology (MPT) vaginal gel for prevention of Bacterial Vaginosis was recently completed. The Company is currently designing a phase 2b/3 trial for this indication.
The first patient in the phase 2b/3 trial of MPT for Bacterial Vaginosis is expected to be enrolled in Q4, 2018.
-- Resubmit Amphora NDA for contraception in Q2, 2019.
3. CohBar Inc. (CWBR)
Gained 12.39% to close Monday's trading at $4.99.
News: No news
CohBar is an innovative biotechnology company focused on the research and development of mitochondria based therapeutics (MBTs), an emerging class of drugs for the treatment of age-related diseases.
Pipeline:
The Company's lead drug candidate is MOTS-c Analog CB4211, under preclinical testing, for NASH and obesity.
4. Insmed Inc.(INSM)
Gained 10.76% to close Monday's trading at $26.05.
News: Credit Suisse analyst Martin Auster has upgraded Insmed stock to Outperform from Neutral, and has raised the price target to $33 from $27.
Recent event:
-- On March 29, 2018, the Company submitted its New Drug Application for ALIS to the FDA for adult patients with Nontuberculous Mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC).
The FDA has 60 days to review the submission of the NDA to determine if it is complete and acceptable for filing.
5. Clementia Pharmaceuticals Inc. (CMTA)
Gained 10.44% to close Monday's trading at $19.47.
News: No news
Clinical Trials & Near-term Catalysts:
The lead product candidate is Palovarotene for the treatment of fibrodysplasia ossificans progressiva (FOP), a rare genetic condition, multiple osteochondromas (MO), and dry eye disease.
-- A phase III trial of Palovarotene for the treatment of fibrodysplasia ossificans progressiva, dubbed MOVE, is enrolling patients. -- Palovarotene is also being studied in a phase II extension study in patients with fibrodysplasia ossificans progressive. Preliminary results of the phase II Part A Open Label Extension (OLE) Palovarotene trial in the treatment of fibrodysplasia ossificans progressiva were announced last March. -- Preliminary results from the Part B open-label extension portion of its ongoing Phase 2 study of Palovarotene in FOP are expected in the second quarter of 2018. -- A phase II study of Palovarotene for the treatment of pediatric patients with multiple osteochondromas, dubbed MO-Ped Trial, was initiated as recently as last week.
The Company expects the 12-month interim data readout from the MO-Ped trial to be in the first half of 2020, with 24-month top-line results from the study to be released in the first half of 2021.
Recent event:
-- The Company went public on the NASDAQ Global Select Market on August 2, 2017, offering its shares at a price of $15.00 each.
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