CRY Has Reason To Smile, AKCA Braces For Busy Year, GEMP Down After-hours

pharma aug 7

Today's Daily Dose brings you news about ACADIA's North American License Agreement with Neuren Pharma; upcoming milestones of Akcea; product development agreement between Antares and Pfizer; CryoLife's Q2 results and upbeat outlook; partial clinical hold on Gemphire's Gemcabene, and InspireMD's and Vericel's Q2 financial results.

Read on...

ACADIA Pharmaceuticals Inc. (ACAD) and Neuren Pharmaceuticals Limited have entered into an exclusive North American License Agreement for the development and commercialization of Trofinetide for Rett syndrome and other indications. Neuren retains rights to develop and commercialize Trofinetide for all indications outside of North America.

Trofinetide, developed by Neuren Pharma, showed statistically significant and clinically meaningful improvement in girls aged 5 to 15 years with Rett syndrome in a phase II study.

ACADIA plans to initiate a phase III study evaluating Trofinetide in Rett syndrome in the second half of 2019.

ACAD closed Monday's trading at $13.91, down 8.61%.

Adamis Pharmaceuticals Corp. (ADMP) has closed its previously announced underwritten public offering of 11.6 million shares of its common stock at a public offering price of $3.00 each, as well as 1.75 million additional shares of its common stock pursuant to the full exercise of the over-allotment option granted to the underwriters.

The gross proceeds from the offering are expected to be approximately $40.25 million.

The Company's Symjepi (epinephrine) Injection 0.3mg was approved by the FDA last June for the emergency treatment of allergic reactions (Type I) including anaphylaxis.
Symjepi (epinephrine) Injection 0.15mg product is under FDA review, with a decision expected on September 3, 2018.

Also in the pipeline are APC-6000- Naloxone Injection for opioid overdose, APC-1000- HFA Inhaled Oral Steroid and APC-4000- Fluticasone DPI for asthma/COPD.

ADMP closed Monday's trading at $3.40, up 6.25%.

Akcea Therapeutics Inc. (AKCA) has a couple of catalysts to watch out for in the coming months.

The FDA is scheduled to announce its final decision on Akcea's WAYLIVRA (Volanesorsen), proposed for the treatment of a rare lipid disorder called familial chylomicronemia syndrome (FCS), on August 30, 2018.

The FDA decision on TEGSEDI for the treatment of hereditary transthyretin amyloidosis (hATTR) is expected on October 6, 2018. The drug was approved by the European Commission last month, and is expected to be launched this year.

The Company expects to report top-line results from a phase II trial of AKCEA-APO(a)-LRx in patients with cardiovascular disease caused by elevated lipoprotein(a) in the second half of 2018.

AKCA closed Monday's trading at $34.19, up 0.94%.

Antares Pharma Inc. (ATRS) has entered into an agreement with Pfizer Inc. (PFE) to develop a combination drug device rescue pen. This rescue pen will utilize the Antares QuickShot auto injector and an undisclosed Pfizer drug.

As part of the agreement, Pfizer will pay for the development of the product and will be responsible for obtaining FDA approval of the combination product. The parties intend to enter into a separate supply agreement pursuant to which Antares will provide fully packaged commercial ready finished product to Pfizer at cost plus margin and Pfizer will then be responsible for commercializing the product in the United States, pending FDA approval.

Antares is also eligible to receive royalties on net sales on the combination product.

ATRS closed Monday's trading at $2.89, up 11.15%.

CryoLife Inc. (CRY) has reported strong second quarter revenue results and an upbeat outlook for the full-year 2018.

Non-GAAP net income for the second quarter of 2018 declined to $3.9 million or $0.10 per share from $4.8 million or $0.14 per share for the second quarter of 2017. Revenues for the second quarter of 2018 increased 43% to $68.5 million, compared to $47.8 million for the second quarter of 2017.

For the third quarter of 2018, revenue is expected to be between $61.0 million and $63.0 million.

Looking ahead to full year 2018, the Company now expects revenue to range between $256.0 million and $260.0 million, up from its prior guidance range of $250.0 million to $256.0 million.

CRY closed Monday's trading at $29.60, down 0.84%.

Shares of Gemphire Therapeutics Inc. (GEMP) were down nearly 24% in after-hours trading on Monday, following FDA's request to produce data from a sub-chronic toxicology study in order to lift the partial clinical hold on Gemcabene.

There is a partial clinical hold on Gemcabene with respect to clinical trials of longer than six months in duration.

The Company's ongoing phase IIa proof-of-concept studies investigating Gemcabene as a treatment for familial partial lipodystrophy (FPL) and for pediatric NAFLD are not affected by the FDA's request for additional data. The top-line interim data from the two studies are expected in late 2018 and in the first half of 2019, respectively.

GEMP closed Monday's trading at $7.34, down 2.26%. In after-hours, the stock was down 23.71% to $5.60.

InspireMD Inc. (NSPR) has reported 57% revenue growth in the second quarter of 2018, thanks to an increase in sales of CGuard EPS helped by its continued focus on expanding existing markets such as Germany, Italy and Russia, transition from its prior exclusive distribution partner for most of Europe to local distributors and expanding into new geographies such as India.

Net loss for the recent second quarter narrowed to $627,000 or $0.15 per share from $2.29 million or $7.30 per share in the same period in 2017. Revenue for the second quarter ended June 30, 2018 was $1 million, up from $640,000 during the same period in 2017.

NSPR closed Monday's trading at $0.22, up 7.44%.

Reata Pharmaceuticals Inc. (RETA) is scheduled to host a conference call and live webcast on Wednesday, August 8, 2018, at 4:30 p.m. ET to report its second quarter 2018 financial results and give an update on recent progress on its development programs.

Last month, the Company announced results from two phase II studies of bardoxolone methyl (bardoxolone) in patients with chronic kidney disease - positive one-year results for the Phase 2 portion of CARDINAL, a study of bardoxolone in patients with CKD due to Alport syndrome, and positive final results for the phase II autosomal dominant polycystic kidney disease (ADPKD) cohort of PHOENIX.

RETA closed Monday's trading at $71.89, up 1.38%.

Vericel Corp. (VCEL) has reported solid revenue growth in the second quarter of 2018 and boosted its outlook for the full year.

Total net revenues for the quarter ended June 30, 2018 were $19.0 million compared to $16.95 million in the year-earlier quarter.

On a GAAP basis, the net loss for the recent quarter was $4.7 million or $0.12 per share compared to a net loss of $2.4 million or $0.07 per share in the year-ago quarter.

Looking ahead to full year 2018, the company now expects total net product revenues to be in the range of $80 million to $83 million, up from its previous guidance of $73 million to $78 million.

VCEL closed Monday's trading at $10.20, up 0.49%.

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