Recro Pharma gains on planned resubmission of IV meloxicam NDA

Thinly traded micro cap Recro Pharma (NASDAQ:REPH) is up 14% premarket on average volume in response to its announcement that, based on its meeting with the FDA, it will refile its marketing application for IV meloxicam by the end of the month. The revised NDA will incorporate revised language related to labeling and additional information on extractable and leachable items.

The company received a CRL in May citing data from ad hoc analyses and selected secondary endpoints that undermined its claimed efficacy.

Previously: FDA rejects Recro Pharma’s marketing application for IV meloxicam (May 24)

https://seekingalpha.com/news/3387421-recro-pharma-14-percent-premarket-planned-resubmission-iv-meloxicam-nda

Boston Scientific upgraded to Buy from Hold at Jefferies

Jefferies analyst Raj Denhoy upgraded Boston Scientific to Buy and raised his price target for the shares to $42 from $34.

https://thefly.com/landingPageNews.php?id=2784871

Weight Watchers initiated at Goldman Sachs

Weight Watchers initiated with a Neutral at Goldman Sachs. Goldman Sachs analyst Jason English started Weight Watchers International with a Neutral rating and $73 price target. The analyst expects strong subscriber growth from the company but views the valuation as full at current share levels.

https://thefly.com/landingPageNews.php?id=2784879

Piper remains buyer of Deciphera ahead of update on DCC2618

Piper Jaffray analyst Christopher Raymond remains a buyer of Deciphera Pharmaceuticals ahead of a “key” update for lead compound DCC2618 at this year’s European Society for Medical Oncology meeting. The analyst likes the near-term setup for the shares and keeps an Overweight rating on the name with a $50 price target. He thinks DCC2618’s “strong and competitive safety/efficacy profile” will “continue to hold up” at ESMO. Further, Raymond sees additional catalysts for Deciphera shares in 2019.

https://thefly.com/landingPageNews.php?id=2784881

United Therapeutics and MannKind enter into exclusive licensing agreement

United Therapeutics (UTHR) and MannKind (MNKD) announced that they have entered into a worldwide exclusive licensing and collaboration agreement for the development and commercialization of a dry powder formulation of treprostinil, an investigational product currently being evaluated in clinical trials for the treatment of pulmonary arterial hypertension. Under the agreement, United Therapeutics will be responsible for global development, regulatory and commercial activities. MannKind will manufacture clinical supplies and initial commercial supplies of the product at its manufacturing facility in Danbury, Connecticut. Long-term commercial supplies will be manufactured by United Therapeutics. Under the terms of the agreement, MannKind will receive an upfront payment of $45M and potential milestone payments of up to $50M, dependent upon the achievement of specific development targets. MannKind will also be entitled to receive low double-digit royalties on net sales of the product. In addition, MannKind granted United Therapeutics an option to expand the license to include other active ingredients for the treatment of pulmonary hypertension. Each optioned product would be subject to the payment to MannKind of up to $40M in additional option exercise and development milestone payments as well as a low double-digit royalty on net sales of any such product. The parties also entered into a research agreement for the conduct of research by MannKind on behalf of United Therapeutics for products outside the scope of the licensing and collaboration agreement. MannKind will receive an immediate payment of $10M in consideration for its performance under the research agreement.

https://thefly.com/landingPageNews.php?id=2784905

WellCare sees Meridian acquisition accretive to FY19 EPS by 40c-50c

WellCare Health Plans announced that, effective September 1, it completed its acquisition of Meridian Health Plan of Michigan, Meridian Health Plan of Illinois, and MeridianRx, a pharmacy benefit manager following the receipt of all required regulatory approvals. With the closing of the acquisition, Meridian is now a wholly-owned subsidiary of WellCare. The transaction is expected to produce 40c-50c of accretion to WellCare’s adjusted EPS in 2019, 70c-80c of accretion in 2020, and $1.00+ of accretion in 2021, inclusive of $30M-$40M in synergies that will ramp up over the next few years and exclusive of one-time transaction-related expenses of $75M-$85M and cumulative integration-related expenses of $50M-$60M.

https://thefly.com/landingPageNews.php?id=2784911

Can-Fite BioPharma expects results from cancer med trial by end of year

 Can-Fite BioPharma provided an update on its Phase II clinical trial of drug candidate Namodenoson, or CF102, for the treatment of advanced hepatocellular carcinoma, or HCC, in patients whose disease has progressed on sorafenib therapy. Top line efficacy results are expected by end of year. The global Phase II study is being conducted in the U.S., Europe and Israel.


https://thefly.com/landingPageNews.php?id=2785007