Today's Daily Dose brings you news about FDA approval of a seborrheic keratoses product; lifting of clinical hold on Fitusiran trials; disappointing trial results of a pet therapeutics company; an update on the patent infringement suit related to Oxford Immunotec's T-SPOT TB test, a method for diagnosing TB infection, and Verastem's stock offering.
Read on...
Aclaris Therapeutics Inc.'s (ACRS) ESKATA topical solution, 40% (w/w) has won FDA approval for the treatment of raised seborrheic keratoses.
Seborrheic keratoses are non-cancerous skin growths that affect more than 83 million American adults and can be an aesthetic skin concern. The condition is said to be more prevalent than acne, psoriasis and rosacea combined.
ESKATA becomes the first and only FDA-approved topical, non-invasive treatment for raised seborrheic keratoses.
ACRS closed Friday's trading at $24.23, down 1.98%.
Alnylam Pharmaceuticals Inc. (ALNY) and Sanofi Genzyme, the specialty care global business unit of Sanofi, are all set to resume dosing in clinical trials of Fitusiran, now that the FDA has lifted the clinical hold.
The Fitusiran clinical studies include the ongoing Phase 2 open-label extension (OLE) study in hemophilia A and B patients with and without inhibitors, and the ATLAS Phase 3 program, which was recently initiated but in which patient dosing is yet to begin.
The Company had suspended dosing in all ongoing Fitusiran studies in September of this year, following a fatal thrombotic event in a patient with hemophilia A without inhibitors in the Phase 2 open-label extension (OLE) study of Fitusiran.
ALNY closed Friday's trading at $125.59, up 1.56%.
Pet therapeutics company Aratana Therapeutics Inc. (PETX) on Friday announced that its pivotal field effectiveness study with AT-016, an investigational adipose-derived allogeneic stem cell therapeutic candidate for the control of clinical signs associated with osteoarthritis, did not achieve protocol-defined efficacy success criteria.
The study was conducted by Aratana's license partner while Aratana had funded the clinical study and other work.
PETX closed Friday's trading at $5.73, up 2.69%.
Egalet Corporation (EGLT) has been granted tentative approval by the FDA for an expanded label for ARYMO ER extended-release (ER) tablets C-II for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
The final approval is expected to be granted when the exclusivity period expires on October 2, 2018.
EGLT closed Friday's trading at $1.22, up 20.79%.
QIAGEN N.V. (QGEN) and Oxford Immunotec Ltd. (OXFD) have settled a patent infringement lawsuit that commenced in August 2015.
In 2015, Oxford Immunotec had sued Qiagen, Quest Diagnostics, and Laboratory Corp. of America Holdings for allegedly infringing 6 of its patents related to T-SPOT TB test, a method for diagnosing TB infection.
Oxford Immunotec's T-SPOT.TB test has been approved for sale in over 50 countries, including the United States, where it has received pre-market approval from the FDA and Europe, where it has obtained a CE mark, as well as Japan and China.
Oxford had alleged that Qiagen's QuantiFERON-TB Gold and QuantiFERON-TB Plus products infringe patents related to T-SPOT.TB test.
Now that a settlement has been reached, all pending claims between Oxford and QIAGEN and the co-defendants have been resolved. As part of the settlement, Oxford has granted QIAGEN a royalty-free, non-exclusive license that extends to all current and future customers of QuantiFERON-TB Gold and QuantiFERON-TB Gold Plus in exchange for a one-time, lump-sum payment of $27.5 million.
QGEN closed Friday's trading at $32.12, up 1.61%.
Repros Therapeutics Inc.'s (RPRX) centralized marketing authorization application for Enclomiphene for the treatment of secondary hypogonadism is likely to be turned down when the Committee for Medicinal Products for Human Use of the European Medicines Agency issues an opinion in January 2018.
In the U.S. too, the Company has not succeeded in getting Enclomiphene under the brand name Androxal approved yet. The FDA had issued a Complete Response Letter for Androxal in December 2015.
RPRX closed Friday's trading at $0.66, unchanged from the previous day's close.
Surgery Partners Inc's (SGRY) Board of Directors has authorized a share repurchase program under which the Company may repurchase up to $50.0 million of its common stock.
The authorization does not have a specified expiration date, and the share repurchase program may be suspended, recommenced or discontinued at any time or from time to time without prior notice, noted the Company.
Last month, Surgery Partners reported Q3, 2017 results, and presented an optimistic picture of its business for the next year.
For full-year 2017, the Company trimmed its revenue outlook to a range of $1.30 billion to $1.33 billion, from its prior outlook of $1.34 billion to $1.36 billion range. The continuation of broader industry softness related to residual effects of the hurricanes as well as the ongoing impact of slower volumes and a less favorable payor mix are the reasons for the tapered outlook.
However, given the integration with National Surgical Healthcare, or NSH, progressing as planned, the Company is confident of entering 2018 with a stronger business capable of delivering improved, sustainable long-term financial performance.
Surgery partners acquired NSH from Irving Place Capital for roughly $760 million in May of this year.
SGRY closed Friday's trading at $11.15, up 14.3%.
The European Medicines Agency's Committee for Medicinal Products for Human Use, in conjunction with the Committee for Advanced Therapies, has recommended approval of TiGenix NV's (TIG) Cx601 to treat complex perianal fistulas in Crohn's disease.
The European Commission's decision on Cx601 is expected in the coming months. If approved, Cx601 will be marketed in all 28 member states of the EU, plus Norway, Iceland and Lichtenstein.
Cx601 is a local administration of expanded adipose-derived stem cells (eASCs), and has been designated as an orphan drug by the FDA, EMA and SwissMedic.
This recommendation marks the first allogeneic stem cell therapy to receive a positive CHMP opinion in Europe for the treatment of patients with fistulizing Crohns disease, noted the Company.
TiGenix retains full rights to Cx601 in the US as well as to the development of the product in other indications. Takeda Pharmaceuticals has an exclusive right to develop and commercialize Cx601 for complex perianal fistulas in Crohn's disease patients outside of the U.S.
TIG closed Friday's trading at $24.92, up 14.99%.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a Positive Opinion recommending the conditional marketing authorisation of Burosumab for the treatment of X-Linked hypophosphatemia in children.
Burosumab is developed by Ultragenyx Pharmaceutical Inc. (RARE), Kyowa Hakko Kirin Co., Ltd. and Kyowa Kirin International PLC.
In the U.S., the Biologics License Application (BLA) for Burosumab to treat pediatric and adult patients with X-Linked Hypophosphatemia is under FDA review, with a decision date set for April 17, 2018.
RARE closed Friday's trading at $44.68, up 1.50%.
Shares of Verastem Inc. (VSTM) plunged nearly 14% on Friday, following the pricing of its $25 million public offering of common stock.
The offering is expected to close on or about December 19, 2017.
The Company's lead product candidate is Duvelisib. A phase II study of Duvelisib in patients with relapsed or refractory *PTCL is expected to be initiated by year end.
The NDA for Duvelisib requesting full approval for it for the treatment of patients with relapsed or refractory *CLL/SLL and accelerated approval for the treatment of patients with relapsed or refractory FL is expected to be submitted during the first quarter of 2018.
* Peripheral T-cell lymphoma (PTCL); Chronic lymphocytic leukemia (CLL); Small lymphocytic lymphoma (SLL); Follicular lymphoma (FL).
VSTM closed Friday's trading at $3.14, down 13.97%.
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