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LPCN Awaits FDA Panel Vote Today, APHB Slumps, BGNE Crosses $100 Again

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Today's Daily Dose brings you news about the release of FDA's briefing document related to Aradigm's investigational drug Linhaliq; AmpliPhi's stock offering; Halozyme's rosy outlook on royalty revenue growth and Tandem Diabetes' preliminary Q4 results.

Read on...

Shares of Aradigm Corp. (ARDM) slumped over 38% on Tuesday, following the release of FDA's briefing document for the Company's investigational drug Linhaliq, proposed for the treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa.

A panel of outside experts convened by the FDA will meet on January 11, 2018, to vote on the Linhaliq NDA.

The FDA panel will discuss whether or not the Company has provided substantial evidence of safety and effectiveness of the 28-day Linhaliq regimen in delaying the time to first exacerbation after starting treatment.

The FDA's final decision on Linhaliq is expected on January 26, 2018. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.

You can find more about the clinical development of Linhaliq in our Company Spotlight column.

ARDM closed Tuesday's trading at $3.70, down 38.23%. In after-hours, the stock was up 1.35% to $3.70.

Shares of AmpliPhi Biosciences Corp. (APHB) were down more than 20% in extended trading on Tuesday, after the Company announced that it intends to offer shares of its common stock in a public offering.

On January 3, 2018, the Company reported positive interim results from its single-patient expanded access program of its lead product candidates, AB-SA01, for Staphylococcus aureus infections, and AB-PA01, for Pseudomonas aeruginosa infections. The news sent the stock soaring more than 20% that day.

APHB closed Tuesday's trading at $1.50, down 19.79%. In after-hours, the stock fell another 22.67% to $1.16.

BeiGene Ltd. (BGNE) and Boehringer Ingelheim Biopharmaceuticals (China) Ltd. have entered into a commercial supply agreement for Tislelizumab.

Tislelizumab, also known as BGB-A317 is BeiGene's investigational anti-PD-1 antibody.

Under the agreement terms, Tislelizumab will be manufactured in Boehringer Ingelheim's world-class biopharmaceutical manufacturing facility in Shanghai as part of a Marketing Authorization Holder (MAH) trial project pioneered by BeiGene and Boehringer Ingelheim.

Tislelizumab is under a phase II trial in China in relapsed/refractory classical Hodgkin's lymphoma; a global phase 1a/1b trial in advanced tumors; phase III trial in China as a second- or third-line treatment for patients with advanced lung cancer; pivotal phase II trial in China in previously treated, PD-L1-positive, locally advanced or metastatic urothelial cancer; phase II trial in China in combination with chemotherapy as a first-line treatment for patients with advanced lung cancer; and a phase II trial in China in combination with chemotherapy as a first-line treatment for patients with locally advanced or metastatic esophageal, gastric, or gastroesophageal junction carcinoma.

BGNE closed Tuesday's trading at $100.33, up 3.00%.

Halozyme Therapeutics Inc. (HALO) expects 25 to 30 percent royalty revenue growth in 2018 and potential for royalty revenue to reach nearly $1 billion in 2027 based on the current and expected momentum of partners coformulating products with its ENHANZE technology.

The Company has partnerships with pharmaceutical companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb and Alexion for its ENHANZE drug delivery technology.

Halozyme expects to report fourth quarter and 2017 financial results in February.

HALO closed Tuesday's trading at $18.66, down 0.32%.

A panel of outside experts convened by the FDA is scheduled to review Lipocine Inc.'s (LPCN) New Drug Application for TLANDO today (January 10, 2018).

TLANDO, formerly known as LPCN 1021, is a twice-a-day oral testosterone product candidate that is designed to help restore normal testosterone levels in hypogonadal men.

This is TLANDO's second go-around with the FDA. The regulatory agency had turned down the oral testosterone product candidate in June 2016, citing deficiencies related to the dosing algorithm for the proposed label.

Addressing the concerns raised by the FDA, the Company resubmitted the NDA for TLANDO last August, which was deemed a complete response.

The final decision on TLANDO is expected on May 8, 2018. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.

If approved, TLANDO will be the first oral TRT option to patients in the U.S. Oral TRT product is available in Canada, Mexico and Europe but it has many drawbacks like short half-life, requiring very frequent (impractical) dosing, and liver safety issues. TLANDO is believed to overcome all these issues associated with oral TRT.

LPCN closed Tuesday's trading at $3.46, up 1.17%.

Tandem Diabetes Care Inc. (TNDM) has forecast preliminary results for the year and quarter ended December 31, 2017, well above analysts' expectations.

On a non-GAAP basis, the Company expects fourth quarter sales of about $39 million to $40 million, beating Thomson Reuters consensus estimate of $34.41 million. Non GAAP sales in the fourth quarter of 2016 were $24.8 million.

For full year 2017, non-GAAP sales are anticipated to be roughly $101 million to $102 million, while Wall Street analysts' consensus estimate is $98.32 million. The Company had reported non GAAP sales of $88.5 million in 2016.

The Company intends to report its fourth quarter and full year 2017 financial and operating results on Thursday, March 1, 2018 after the markets close.

TNDM closed Tuesday's trading at $2.86, down 8.04%.

by RTT Staff Writer

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