03.04.2017 06:05:53
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Setback For ACOR In Ampyra Suit, EARS Put On Notice, STDY On Steady Rise
(RTTNews) - Shares of Acorda Therapeutics Inc. (ACOR) were down more than 20% on Friday after a U.S. District Court invalidated four patents covering Ampyra, the Company's drug indicated to help improve walking in adults with multiple sclerosis.
The invalidated patent Numbers pertaining to Ampyra are 8,663,685 (the '685 patent), 8,007,826 (the '826 patent), 8,440,703 (the '703 patent), and 8,354,437 (the '437 patent)
The Company said it will appeal the ruling on the 4 patents.
Read more:
Who Will Win Ampyra Patent Fight - Acorda Or Kyle Bass?
ACOR closed Friday's trading at $21.00, down 21.50%.
Ascendis Pharma A/S (ASND) will be hosting a conference call and webcast on Monday, April 3, 2017 to discuss new data regarding its three rare disease pipeline candidates - TransCon Growth Hormone, TransCon PTH and TransCon CNP.
ASND closed Friday's trading at $28.00, down 3.32%.
Auris Medical Holding AG (EARS), whose shares have been trading below $1.00 per share for more than 30 consecutive business days, has been notified of bid price deficiency by the Listings Qualifications Department of the Nasdaq.
The Company has a compliance period of 180 calendar days, or until September 26, 2017, to regain compliance with Nasdaq's minimum bid price requirement.
EARS closed Friday's trading at $0.92, down 0.55%.
Bristol-Myers Squibb Co. (BMY) and Incyte Corp. (INCY) have agreed to advance their clinical development program evaluating the combination of Incyte's investigational drug Epacadostat with Bristol-Myers' blockbuster drug Opdivo into phase III registrational studies in first-line non-small cell lung cancer across the spectrum of PD-L1 expression and first-line head and neck cancer.
Additionally, the companies are expanding the ECHO-204 Phase 1/2 study, established under a collaboration between the companies in 2014, to include anti-PD-1/PD-L1 relapsed/refractory melanoma cohorts.
The expanded clinical development program, including the phase III registrational studies, will be co-funded by the two companies.
INCY closed Friday's trading at $133.67, down 2.98%.
Loxo Oncology Inc. (LOXO) has announced proof of concept clinical data for its drug candidate Larotrectinib in TRK fusion glioblastoma.
The clinical data include three patients with glioblastoma - one patient treated under an expanded access protocol and two patients treated in the ongoing Phase 2 NAVIGATE trial.
According to the trial results, Larotrectinib showed preliminary evidence of anti-tumor activity.
Josh Bilenker, chief executive officer of Loxo Oncology, said, " Glioblastomas have historically defied rational targeted therapy approaches, so we are encouraged that Larotrectinib may have a role in treating TRK fusion presentations of this devastating disease. We hope these early data lead to increased molecular profiling and referrals to appropriate clinical trials."
LOXO closed Friday's trading at $42.08, up 0.60%.
Mylan N.V.'s (MYL) manufacturing partner for EpiPen Auto-Injector has expanded a voluntary recall of select lots of EpiPen and EpiPen Jr Auto-Injectors to now include additional lots distributed in the U.S. and additional markets in Europe, Asia, North and South America due to a potential defect.
The potential defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis), the Company noted.
There have been two such reports outside of the U.S. that have already been disclosed.
The recall impacts the 0.3 mg and 0.15 mg strengths of EpiPen Auto-Injector and will not affect the authorized generic for EpiPen Auto-Injector, which is also manufactured by Meridian Medical Technologies.
MYL closed Friday's trading at $38.99, down 1.52%.
Shares of SteadyMed Ltd. (STDY) rose more than 46% on Friday, following a favorable ruling in the Inter Partes Review (IPR) proceeding against United Therapeutics covering patent No. 8,497,393.
The patent in question, No. 8,497,393, is related to a process to further purify prostacyclin derivatives, such as Treprostinil. Treprostinil is the active pharmaceutical ingredient used in United Therapeutics' Remodulin and SteadyMed's lead drug candidate, Trevyent, for the treatment of Pulmonary Arterial Hypertension (PAH).
In its ruling, the PTAB found all 22 claims in the '393 patent unpatentable and cancelled them, rendering the patent invalid.
SteadyMed remains on-track to submit a NDA for Trevyent by the end of the second quarter of 2017.
STDY closed Friday's trading at $5.80, up 46.84%.
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Aktien in diesem Artikel
Ascendis Pharma (spons. ADRs) | 121,00 | -1,63% | |
Bristol-Myers Squibb Co. | 52,88 | -1,03% | |
Incyte Corp. | 65,28 | -3,75% |