21.04.2017 02:28:16
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Gainers & Losers Of Apr.20: IMNP, AKTX, IMGN, ALDX, KMPH...
(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of April 20, 2017.
GAINERS
1. Immune Pharmaceuticals Inc. (IMNP)
Gained 49.59% to close Thursday's trading at $3.65.
News: The Company signed a Letter of Intent with Austria's Pint Pharma GesmbH regarding license and commercialization of Ceplene in Latin America.
Ceplene, the core asset of Immune Pharma's subsidiary Cytovia Oncology, is approved for use in Europe as a combination therapy with interleukin-2 (IL2) as maintenance treatment in adults with acute myeloid leukemia. The drug is not approved in the U.S. yet.
Under the licensing agreement, Pint has been granted exclusive rights to commercialize Ceplene throughout Latin America. The agreement is expected to be finalized within 30 days.
As part of the anticipated final agreement, Pint has agreed to invest $4 million into Cytovia, which will be used exclusively for oncology related activities, the Company noted.
2. Akari Therapeutics Plc (AKTX)
Gained 18.71% to close Thursday's trading at $16.37.
News: No news
Near-term catalyst:
-- Interim results from phase II trial evaluating Coversin in patients with Paroxysmal nocturnal haemoglobinuria (PNH) who have never received a complement blocking therapy will be released on April 24, 2017.
Read more at
Company Spotlight: Akari Therapeutics
3. ImmunoGen (IMGN)
Gained 17.04% to close Thursday's trading at $4.19.
News: No news
Recent event: On April 18th, analysts at Leerink Partners upgraded their rating on the Company's stock to Outperform from Market Perform.
Near-term catalysts:
-- Initial data from phase 1b/2 trial of Mirvetuximab soravtansine in combination with Avastin, carboplatin, Doxil or Keytruda in ovarian cancer, dubbed FORWARD II, are expected in Q2, 2017. -- Pooled data from over 100 ovarian cancer patients treated in multiple Mirvetuximab soravtansine phase 1 cohorts and data from phase I steroid eye drop expansion cohort are anticipated in Q2, 2017. -- Initial phase I data for IMGN779 for the treatment of acute myeloid leukemia are expected in mid-2017.
LOSERS
1. Aldeyra Therapeutics Inc. (ALDX)
Lost 16.35% to close Thursday's trading at $4.35.
News: No negative news
The Company announced that its experimental drug ADX-102 for the treatment of congenital ichthyosis, a severe skin disease characteristic of Sjögren-Larsson Syndrome (SLS), has been granted orphan drug status by the FDA.
A phase III study of ADX-102 in Sjögren-Larsson Syndrome is expected to begin later this year.
2. Cleveland BioLabs Inc. (CBLI)
Lost 16.27% to close Thursday's trading at $4.27. May be a pullback after yesterday's gain of over 46%.
News: No news
Recent event: On April 17th, the Company announced that it received consent from the FDA for initiation of an in vivo biocomparability study of two formulations of Entolimod - namely the one that is proposed for use under the pre-Emergency Use Authorization and the other drug formulation that was used in previously conducted preclinical and clinical studies.
Entolimod is a novel, broad-spectrum investigational drug being developed to mitigate the life-threatening consequences of a radiological or nuclear attack.
3. Apricus Biosciences Inc. (APRI)
Lost 11.04% to close Thursday's trading at $1.37.
News: No news
Near-term catalysts:
-- The Company expects to resubmit the NDA for Vitaros, a topical vasodilator cream in development for the treatment of erectile dysfunction, in the third quarter of 2017.
Vitaros was turned down by the FDA in July 2008, with the regulatory agency questioning the results of a transgenic mouse carcinogenicity study, which were completed in 2002.
-- Apricus is also working towards regaining compliance with the minimum $2.5 million shareholder equity requirement as required for continued listing on The NASDAQ Capital Market under NASDAQ Listing Rule 5550(b)(2) on or before May 30, 2017.
4. KemPharm Inc. (KMPH)
Lost 10.87% to close Thursday's trading at $4.10.
News: No news
Near-term catalysts:
-- Initiate additional pharmacokinetic studies with KP415 for the treatment of ADHD in the first half of this year. -- Report additional pharmacokinetic study data of KP415 in the second half of this year. -- Human clinical trials of KP201/IR for the short-term treatment of acute pain are anticipated to commence in 1H 2017 - with final intranasal human abuse liability (HAL) study data expected in the second half of this year. -- NDA submission for KP415 for the treatment of ADHD is planned for 2018.
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