04.07.2016 05:00:01
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BIND Gallups On Stalking Horse Offer, KBIO Is Back, ALNY Abuzz
(RTTNews) - Aeterna Zentaris Inc. (AEZS) (AEZ.TO) has signed an exclusive license agreement with Cyntec Co., Ltd., an affiliate of Orient EuroPharma Co., Ltd, for its lead anti-cancer compound, Zoptrex for the initial indication of endometrial cancer, for Taiwan and nine countries in Southeast Asia.
Zoptrex is currently in a fully-enrolled Phase 3 clinical trial in endometrial cancer. Aeterna expects to complete the phase III clinical trial in the third quarter of 2016.
AEZS closed Friday's trading at $3.61, up 10.74%. In after -hours, the stock gained another 3.05% to $3.72.
Allergan plc (AGN) has received a Positive Opinion from the Swedish Medical Products Agency for BELKYRA, indicated for patients with submental fullness (or double chin).
BELKYRA is already approved in Canada, as well as in the U.S. as KYBELLA.
AGN closed Friday's trading at $234.02, up 1.27%.
Alnylam Pharmaceuticals Inc. (ALNY) has reported favorable results from its ongoing phase II open-label extension studies with investigational compounds Patisiran and Revusiran for the treatment of hereditary TTR-mediated amyloidosis.
According to the trial results, at 12 months, Revusiran achieved generally stable 6-minute walk distance results in majority of evaluable patients with hereditary TTR-mediated amyloidosis with cardiomyopathy.
At 24 months, Patisiran showed a mean 6.7 point decrease in modified neuropathy impairment score, demonstrating a potential to halt or improve neuropathy progression in patients with hereditary ATTR amyloidosis with polyneuropathy.
A phase III study of Revusiran in patients with hereditary TTR-mediated amyloidosis with cardiomyopathy, dubbed ENDEAVOUR, is underway - with enrollment expected to be completed by end of summer, ahead of schedule, and data now anticipated in early 2018.
A phase III trial of Patisiran in patients with hereditary ATTR amyloidosis with polyneuropathy, dubbed APOLLO is ongoing, and data is expected in mid-2017.
ALNY closed Friday's trading at $61.44, up 10.72%.
Shares of BIND Therapeutics Inc. (BIND) were up over 95% in extended trading on Friday on news of the company filing a motion for sale of its assets under stalking horse bid agreement with Pfizer Inc. (PFE).
Under terms of the agreement, Pfizer has agreed to acquire substantially all of BIND's assets for roughly $20 million in cash subject to certain price adjustments. Pfizer has also agreed to assume certain contractual liabilities of BIND. The transaction is expected to be completed in the third quarter of 2016.
BIND Therapeutics initiated voluntary Chapter 11 bankruptcy protection on May 1, 2016 and is conducting a sale of assets pursuant to Section 363 of the Bankruptcy Code.
*A stalking-horse bid is an initial bid on a bankrupt company's assets from an interested buyer chosen by the bankrupt company. From a pool of bidders, the bankrupt company chooses the stalking horse to make the first bid. (*Source: Investopedia).
BIND closed Friday's trading at $0.40, up 1.76%. In after hours, the stock was up 95.98% to $0.78.
KaloBios Pharmaceuticals Inc. (KBIOQ.OB) on Friday announced that it has emerged from Chapter 11 bankruptcy and received $14 million in equity financing to help recapitalize its business.
The company has also acquired the rights from Savant Neglected Diseases LLC to develop benznidazole for the treatment of Chagas disease.
Cameron Durrant, KaloBios chairman and CEO said, "The Company has risen from the ashes with a great deal of hard work and new thinking on how a biopharmaceutical company can operate and a clear vision to move forward as a successful, positive leader in our industry. As one of the few companies solely focused on neglected and rare diseases, KaloBios will continue to move swiftly and apply itself to the real task of bringing patients crucial treatments they need, but to which they may not have access. We also see a unique opportunity to bring new ideas to address concerns, such as drug pricing, for all stakeholders in healthcare - with our Responsible Pricing Model as just the beginning."
Pain Therapeutics Inc.'s (PTIE) New Drug Application for REMOXY will directly face the FDA's final decision scheduled for September 25, 2016.
The company has been informed that an Advisory Committee meeting for REMOXY, which had been tentatively scheduled for August 5th, is unnecessary and will not be held.
REMOXY is an investigational extended-release oral formulation of oxycodone for patients with moderate-to-severe chronic pain.
In December 2002, DURECT Corp. (DRRX) licensed to Pain Therapeutics the right to develop and commercialize on a worldwide basis REMOXY and other oral sustained release drug candidates using the ORADUR technology.
REMOXY had been at the FDA altar twice before, and it was issued a complete response letter on both the occasions - in December 2008 and in June 2011. Will the third time prove to be a charm?
PTIE closed Friday's trading at $2.17, down 0.68%.
XBiotech Inc.'s (XBIT) experimental drug Xilonix has demonstrated favorable results in a phase III trial in advanced colorectal cancer patients refractory to further treatment.
According to the trial results, improved clinical response was seen for multiple symptoms associated with disease progression and overall survival, with notable lack of toxicity.
Xilonix is under accelerated review by the European Medicines Agency, and an approval decision could come as early as fourth quarter 2016.
XBIT touched a new high of $25 on Friday, before closing the day's trading at $24.90, up 19.02%.
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Alnylam Pharmaceuticals Inc. | 234,00 | -0,21% | |
XBiotech Inc | 6,50 | 4,00% |