Repros Holds Constructive Meeting With FDA Regarding Androxal(R) NDA Filing

  • No New Clinical Studies Requested
  • Environmental Impact Assessment Plan Will be Discussed With FDA Prior to NDA Submission
  • Company to Host Conference Call on Friday, November 7, 2014, at 9 AM Eastern

THE WOODLANDS, Texas, Nov. 6, 2014  -- Repros Therapeutics Inc.(R) (RPRX) today reported the outcome from its meeting with the FDA to discuss the Company's expected NDA submission.

Read more: Repros Therapeutics Inc ( RPRX )

ANI Pharmaceuticals Reports Record Third Quarter 2014 Financial Results and Year-To-Date Highlights

- Record net revenues of $17.4 million, an increase of 122% over third quarter 2013
- Record adjusted non-GAAP EBITDA of $10.1 million
- Record adjusted non-GAAP diluted earnings per share of $0.66

BAUDETTE, Minn., Nov. 3, 2014 ANI Pharmaceuticals, Inc. ("ANI") (ANIP) today reported financial results for the three and nine months ended September 30, 2014 and increased its revenue and non-GAAP EBITDA guidance for the fourth quarter of 2014.

Third quarter net revenues were $17.4 million, an increase of 122% as compared to $7.8 million for the same period in 2013. Third quarter adjusted non-GAAP EBITDA was $10.1 million, an increase of 494% as compared to $1.7 million in the same period in 2013.

Read more: ANI Pharmaceuticals Inc ( ANIP )

Geron Announces Removal of Full Clinical Hold on Imetelstat IND

2014 Third Quarter and Year-to-Date Financial Results Also Reported

Menlo Park, Calif., November 3, 2014 - Geron Corporation (Nasdaq: GERN) announced today that the U.S. Food and Drug Administration (FDA) has removed the full clinical hold on Geron's investigational new drug (IND) application for imetelstat. In addition, the FDA stated that Geron's proposed clinical development plan for imetelstat that is focused on high-risk myeloid malignancies, such as myelofibrosis (MF), is acceptable. The FDA acknowledged that the company does not intend to conduct further studies in, or develop imetelstat for, the treatment of essential thrombocythemia (ET) or polycythemia vera, which is consistent with the company's plans as originally disclosed in April 2013.

Read more: Geron Corporation ( GERN )

Receptos Reports Positive Phase 2 Results for TOUCHSTONE Trial of RPC1063 in Ulcerative Colitis

-- Study met primary efficacy and all secondary endpoints with statistical significance for patients on 1 mg dose after 8 weeks of treatment --
-- Safety data are consistent with the favorable profile observed in Phase 2 trial in relapsing multiple sclerosis --
-- Receptos plans to initiate Phase 3 program in ulcerative colitis and Phase 2 program in Crohn's disease --
-- Investor conference call and webcast today at 5:00 p.m. ET (2:00 p.m. PT) --

SAN DIEGO, Oct. 27, 2014  -- Receptos, Inc. (RCPT) today announced that TOUCHSTONE, the Phase 2 trial of RPC1063 in ulcerative colitis (UC), met its primary endpoint and all secondary endpoints with statistical significance in patients on the 1 mg dose of RPC1063 in the 8-week induction period.

Read more: Receptos Inc ( RCPT )

CorMedix Receives Approval From FDA to Initiate a Clinical Trial for Neutrolin in the US

BRIDGEWATER, NJ--(Oct 27, 2014) - CorMedix Inc. (NYSE MKT: CRMD) is pleased to announce today that the United States Food and Drug Administration (FDA) has reviewed its Investigational New Drug application (IND) for Neutrolin® which was submitted September 24, 2014, and determined that the IND is not subject to a clinical hold, and that a pivotal clinical study can be initiated in the United States. CorMedix is a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases.

Read more: CorMedix Inc ( CRMD )