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FDA Nod For ABMD, AERI Faces FDA Panel In Oct, IPCI Put On Notice, PFE Sues JNJ

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Today's Daily Dose brings you news about Acceleron Pharma's public offering; pre-market approval of Abiomed's Impella RP heart pump; FDA panel review of Aerie's Rhopressa; NASDAQ notification for Intellipharmaceutics; positive data from Karyopharm's phase II/III SEAL study and Pfizer's suit against Johnson & Johnson.

Read on...

Acceleron Pharma Inc. (XLRN) has priced an underwritten public offering of 5.40 million shares of common stock at a price of $37.00 each. The gross proceeds from the offering are estimated to be about $200 million.

In connection with this offering, Acceleron has granted the underwriters a 30-day option to purchase up to an additional 810,810 shares of common stock.

The Company's lead product candidate is Luspatercept, which is being developed for Myelodysplastic Syndromes (MDS) Beta-Thalassemia, and Myelofibrosis.

A phase III study of Luspatercept in patients with anemia due to lower-risk MDS with ring sideroblasts who require regular RBC transfusions, dubbed MEDALIST, and a phase III study of Luspatercept in patients with anemia due to beta-thalassemia who require regular RBC transfusions, dubbed BELIEVE, are underway.

The top-line results from the MEDALIST and BELIEVE phase III trials are expected in mid-2018.

XLRN closed Wednesday's trading at $37.73, down 3.18%.

Abiomed Inc. (ABMD) has received FDA's pre-market approval for Impella RP heart pump, which is indicated for providing temporary right ventricular support for up to 14 days in patients who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.

With this approval, the Impella RP heart pump is the only percutaneous temporary ventricular support device that is FDA-approved as safe and effective for right heart failure.

ABMD closed Wednesday's trading at $157.42, up 0.20%. In after-hours, the stock gained 2.91% to $162.

Aerie Pharmaceuticals Inc.'s (AERI) New Drug Application for Rhopressa 0.02% for the treatment of patients with open-angle glaucoma or ocular hypertension is scheduled to be reviewed by an FDA panel on October 13, 2017.

The FDA's final decision is expected around February 28, 2018.

AERI closed Wednesday's trading at $53.40, down 8.87%. In after-hours, the stock was up 2.62% to $54.80.

Intellipharmaceutics International Inc. (IPCI) (IPCI.TO) has been notified that it is not in compliance with the minimum market value of listed securities requirement set forth in Nasdaq Rules for continued listing on The Nasdaq Capital Market.

The Company has been provided 180 calendar days, or until March 19, 2018, to regain compliance. If in case, the Company does not regain compliance by then, additional time will be provided for it to regain compliance.

IPCI closed Wednesday's trading at $0.91, down 1.09%.

Karyopharm Therapeutics Inc. (KPTI) has announced successful outcome from the phase II portion of its phase II/III study, dubbed SEAL, evaluating Selinexor in patients with previously treated advanced dedifferentiated Liposarcoma.

For the SEAL study's primary endpoint of progression-free survival (PFS), oral Selinexor showed superiority over placebo. In the phase II portion of the study, oral Selinexor demonstrated an expected and manageable safety profile, primarily with nausea, anorexia and fatigue, low levels of Grade 3/4 cytopenias, and no new or unexpected safety signals identified.

The phase III portion of the study is ongoing, and top-line data from the study are expected by the end of 2019.

KPTI closed Wednesday's trading at $11.16, up 6.08%.

Lipocine Inc.'s (LPCN) New Drug Application for TLANDO, proposed as a testosterone replacement therapy in adult males for hypogonadism, will be reviewed by a panel of outside experts before the FDA makes its final decision on February 8, 2018.

The advisory committee meeting date has not been finalized.

LPCN closed Wednesday's trading at $4.00, up 1.78%.

Pfizer (PFE) has filed a suit against Johnson & Johnson (J&J), alleging that it engaged in unlawful conduct to stifle competition from Inflectra.

Inflectra, launched by Pfizer in the U.S. in late 2016 as the first biosimilar monoclonal antibody, is a biosimilar to Johnson & Johnson's Remicade.

The suit alleges that "J&J's exclusionary contracts and other anticompetitive practices have denied U.S. patients access to therapeutic options and undermined the benefits of robust price competition in the innovative and growing biologics marketplace for patients. It further claims that J&J's systematic efforts to maintain its monopoly in connection with Remicade by inappropriately excluding biosimilar competitors violates federal antitrust laws and undermines the principal goals of the federal Biologics Price Competition and Innovation Act (BPCIA)".

In the first half of 2017, Inflectra sales were $172 million and Remicade sales were $3.20 billion.

PFE touched a new 52-week high of $36.21 on Wednesday, before closing the day's trading at $35.99, up 1.52%.

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