Search This Blog

Thursday, October 17, 2019

Endo International’s big gain

Shares of Endo International (NASDAQ:ENDP) were 22.6% higher as of 11:38 a.m. EDT on Wednesday. The big gain came on speculation that a settlement could be at hand related to multiple opioid lawsuits involving Endo.
Drugmakers Johnson & Johnson and Teva Pharmaceutical are reportedly offering multibillion-dollar settlements in opioid cases. Drug wholesale distributors AmerisourceBergen, Cardinal Health, and McKesson are also negotiating potential settlements.
A reasonable settlement to end its opioid-related headaches would be fantastic news for Endo. The drugmaker has already announced settlements of opioid lawsuits with two Ohio counties.
Despite all of the buzz over other pharmaceutical companies and drug distributors proposing deals to settle opioid litigation, though, Endo hasn’t announced any new developments. And the company’s name hasn’t been mentioned as a party to any potential deals in recent reports.
As such, investors probably shouldn’t become too enthusiastic that a comprehensive settlement is near for Endo. It could happen, but at this point, all we have are rumors — and rumors that don’t yet involve Endo itself.
It’s now a waiting game to see what happens with all of the buzz about potential settlement deals. If J&J and Teva are successful in reaching agreements that aren’t too costly and put the opioid issues largely behind them, the odds that Endo will be able to follow in their footsteps will improve.
Until there’s something more concrete, however, investors are better off staying on the sidelines with Endo. Investing in pharmaceutical stocks involves enough risks without throwing in the possibility of a multibillion-dollar payout to settle litigation.
https://www.fool.com/investing/2019/10/16/why-endo-international-stock-is-skyrocketing-today.aspx

Baxter in talks with Sanofi for Seprafilm unit

Baxter International (NYSE:BAX) is reportedly negotiating with Sanofi (NASDAQ:SNY) to acquire its Seprafilm business for $300M – 400M.
Seprafilm makes an adhesion barrier used in abdominal or pelvic laparotomy (surgical incision into the abdominal or pelvic cavity) as an adjunct to reduce the risk and severity of postoperative adhesions between the abdominal wall and underlying viscera.
SNY is up 1% premarket on light volume.
https://seekingalpha.com/news/3506492-baxter-talks-sanofi-seprafilm-unit

Hepion Pharma up 80% on encouraging NASH data

Thinly traded nano cap Hepion Pharmaceuticals (NASDAQ:HEPA) is up 80% premarket on increased volume in reaction to preclinical data on NASH candidate CRV431. The data were just published in the Journal of Pharmacology and Experimental Therapeutics.
In an in vitro cyclophilin assay, CRV431 potentially inhibited all cyclophilin isoforms, implying multiple disease mechanisms in the liver could be targeted.
Daily oral dosing in mice and rats (range of dose levels) resulted in up to a 15x accumulation of CRV31 in the liver versus the blood, ideal for treating liver diseases.
In a six-week mouse model of fibrosis, CRV431 decreased liver fibrosis by 43% compared to control whereas comparator obeticholic acid [Intercept Pharmaceuticals’ (NASDAQ:ICPT) Ocaliva] showed no statistically significant direct effect on fibrosis.
Three studies in a high-fat diet mouse model of NASH, 50 mg/kg doses of CRV431 decreased fibrosis by ~50% compared to control.
In a late-stage NASH model in mice that developed liver tumors, 10 weeks’ treatment with CRV431 decreased tumor burden by about half.
The company says CRV431 inhibits a family of proteins called cyclophilins that play key roles in a range of cellular functions. It is also being investigated as a treatment for HBV infection.
https://seekingalpha.com/news/3506418-hepion-pharma-80-percent-encouraging-crv431-data

FDA accepts application for AstraZeneca/Daiichi breast cancer ADC

Daiichi Sankyo (OTCPK:DSNKY) and commercialization partner AstraZeneca (NYSE:AZNannounce that the FDA has accepted for review the marketing application for antibody-drug conjugate (ADC) [fam-] trastuzumab deruxtecan (DS-8201) for HER2-positive metastatic breast cancer. Under Priority Review status, the agency’s action date is in Q2 2020.
The companies are jointly developing and commercializing the product globally (expect Japan where Daiichi has exclusive rights) under a March 2019 agreement.
https://seekingalpha.com/news/3506446-fda-accepts-application-astrazeneca-daiichi-adc-breast-cancer

Innate Pharma prices $69M IPO

Innate Pharma (OTCPK:IPHYF) has priced its initial public offering by way of a capital increase of 12.5M new ordinary shares, consisting of 8,047,227 ordinary shares in the form of ADSs at $5.50/ADS, and a concurrent private placement of 4,452,773 ordinary shares in Europe at €4.97/ordinary share, for aggregate gross proceeds of ~$68.8M (~€62.1M).
Underwriters over-allotment is an additional 1,875,000 ADSs. The ADSs are expected to trade on Nasdaq today under the ticker symbol “IPHA”.
Net proceeds will be used for the development of monalizumab, IPH4102, IPH5401, to build commercial capabilities for Lumoxiti and to expand the preclinical pipeline, including transitioning IPH5301.
A portion of net proceeds might also be used to in-license, acquire or invest in complementary technologies, products, businesses or assets, and for general corporate purposes.
Closing date is October 21, 2019.
https://seekingalpha.com/news/3506449-innate-pharma-prices-69m-ipo

Verona Pharma completes enrollment in mid-stage COPD trial

Verona Pharma (NASDAQ:VRNA) has randomized the last patient in its Phase 2b dose-ranging study evaluating the effect of nebulized ensifentrine as an add-on to treatment with a long acting bronchodilator in patients with moderate-to-severe chronic obstructive pulmonary disease (“COPD”).
Top-line data are expected around year end.
Preparations are underway for End-of-Phase 2 meeting with the FDA expected in 1H 2020.
Commencement of Phase 3 trials are expected in 2020.
The trial enrolled a total of 416 patients. The primary endpoint is improvement in lung function with ensifentrine after four weeks of treatment.
https://seekingalpha.com/news/3506454-verona-pharma-completes-enrollment-mid-stage-nebulized-ensifentrine-trial

Centene and Walgreens team up with RxAdvance in pharmacy management

Centene (NYSE:CNC), Walgreens (NASDAQ:WBA) and RxAdvance have agreed to partner on introducing a new model for pharmacy management aimed at improved transparency, an enhanced customer experience and better health outcomes at lower costs.
The partnership will leverage RxAdance’s Collaborative PBM Cloud transactional platform and clinical intelligence with Walgreens’ retail pharmacy knowhow and Centene’s leadership in delivering comprehensive healthcare services to the underserved.
Centene has increased its ownership stake in RxAdance while Walgreens has made a “small” investment. Specific financial terms are not disclosed.
https://seekingalpha.com/news/3506466-centene-walgreens-team-rxadvance-pharmacy-management