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CLVS Gets FDA Nod, PBYI Leaves Big Board, LOXO Hits All-time High, CNAT On Watch


AmpliPhi Biosciences Corp.'s (APHB) phase I trial of AB-SA01 in patients with chronic rhinosinusitis has met the primary endpoints of safety and tolerability.

According to the trial results, all nine patients enrolled in the study experienced a reduction in the quantity of Staphylococcus aureus infecting their sinuses, with some patients showing complete eradication of the bacterial infection.

The company plans to advance AB-SA01 into a phase 2 trial in 2017.

APHB closed Monday's trading at $0.51, up 1.39%.

Conatus Pharmaceuticals Inc. (CNAT) has inked an exclusive option, collaboration and license agreement with Novartis (NVS) for the global development and commercialization of its investigational drug Emricasan.

A phase 2b study of Emricasan in reducing hepatic venous pressure gradient (HVPG) in patients with compensated or early decompensated liver cirrhosis caused by nonalcoholic steatohepatitis (NASH), dubbed ENCORE-PH; a phase 2b study of Emricasan in patients with NASH fibrosis, known as ENCORE-NF and a phase 2b study of Emricasan in Ishak Fibrosis Score in post-orthotopic liver transplant (POLT) recipients with liver fibrosis or cirrhosis post-transplant as a result of recurrent hepatitis C virus, named POLT-HCV-SVR, are ongoing. A phase 2b study of Emricasan on liver function and to collect chronic administration safety information in NASH cirrhosis patients, dubbed ENCORE-LF, is expected to begin in the first half of 2017.

As per the agreement terms, Conatus will receive $50 million upfront, and $7 million following the exercise of the license option. Conatus can borrow up to $15 million in the form of convertible promissory notes under an investment agreement with Novartis.

CNAT closed Monday's trading at $1.96, up 2.62%.

Shares of Clovis Oncology Inc. (CLVS) rose as much as 27% on Monday, following FDA's accelerated approval of the company's ovarian cancer drug Rubraca.

Rubraca, known generically as rucaparib, has been approved for women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation (deleterious BRCA) as identified by an FDA-approved companion diagnostic test.

Clovis partnered with Foundation Medicine Inc. (FMI) to co-develop FoundationFocus CDxBRCA, a companion diagnostic test for Rubraca, which also received the regulatory agency's "thumbs up" on Monday.

FoundationFocus CDxBRCA is the first and only companion diagnostic to detect tumor BRCA1/2 alterations, potentially increasing the number of women who are eligible for Rubraca therapy, according to Foundation Medicine.

CLVS closed Monday's trading at $40.48, up 8.82%. FMI closed the day's trading at $20.35, down 1.45%.

Shares of Loxo Oncology Inc. (LOXO) touched an all-time high on Monday, thanks to investors' excitement about the pipeline update.

The company's phase II study of Larotrectinib, dubbed NAVIGATE, in patients with solid tumors that harbor TRK gene fusions is currently approximately 85% enrolled to goal. The enrollment is scheduled for completion in early 2017. The top line data from the trial is expected in the second half of 2017 - with the New Drug Application planned for late 2017 or early 2018 and a European Marketing Authorisation Application in 2018.

A phase I study of LOXO-292 for treating patients with RET-dependent cancers is expected to be initiated in early 2017 - with data to be released potentially by next year-end.

Also in the company's pipeline is LOXO-195, a next-generation, selective TRK inhibitor capable of addressing potential mechanisms of acquired resistance that may emerge in patients receiving Larotrectinib or multikinase inhibitors with anti-TRK activity. The company plans to initiate a phase I study of LOXO-195 in mid-2017.

LOXO touched a new high of $36.71 on Monday, before closing the day's trading at $33.86, up 25.83%.

Seeking to enhance its public visibility, Puma Biotechnology Inc. (PBYI) has decided to voluntarily move its stock exchange listing from the New York Stock Exchange to the Nasdaq Stock Market effective on or about January 3, 2017.

The company believes that the move will also aid in cost savings in 2017 and beyond.

PBYI closed Monday's trading at $35.05, down 3.31%.

Portola Pharmaceuticals Inc. (PTLA) has signed a $50 million loan agreement with Bristol-Myers Squibb Co. (BMY) and Pfizer Inc. (PFE) for continued development of investigational compound AndexXa, a potential antidote for Factor Xa inhibitors.

AndexXa was turned down by the FDA on August 17, 2016, with the regulatory agency seeking additional information primarily related to manufacturing. Portola expects to resubmit the Biologics License Application for AndexXa in 2017.

PTLA closed Monday's trading at $20.24, up 7.55%.

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