FDA clears expanded label for Crysvita

Ultragenyx Pharmaceutical (NASDAQ:RARE) and Kyowa Kirin Co., announces that the FDA has approved a label expansion for Crysvita (burosumab).

The label has been updated to include new clinical data demonstrating superiority of treatment with Crysvita versus oral phosphate and active vitamin D (conventional therapy) in pediatric patients with X-linked hypophosphatemia (XLH), improvement in stiffness, and maintenance of efficacy of Crysvita in adult patients with longer-term treatment. The indication has also been expanded to include infants as young as six months of age.

Crysvita (burosumab-twza) is a recombinant fully human monoclonal IgG1 antibody, discovered by Kyowa Kirin, against the phosphaturic hormone fibroblast growth factor 23 (FGF23), indicated for the treatment XLH in adult and pediatric patients 6 months of age and older.

https://seekingalpha.com/news/3502574-fda-clears-expanded-label-crysvita

Dova Pharma to be acquired by Sobi

Dova Pharmaceuticals (NASDAQ:DOVA) is up 38% premarket after entering into an agreement and plan of merger with Swedish Orphan Biovitrum AB (OTCPK:BIOVF) (Sobi).

Under the terms agreement, an indirect subsidiary of Sobi will commence a tender offer for all outstanding shares of Dova, whereby Dova stockholders will be offered an upfront payment for $27.50/share in cash, along with one non-tradeable Contingent Value Right (CVR) that entitles them to an additional $1.50/share in cash upon regulatory approval of DOPTELET for the treatment of chemotherapy-induced thrombocytopenia, representing a total potential consideration of $29.00/share, or up to $915M on a fully diluted basis.

The transaction is expected to close in Q4 2019.

https://seekingalpha.com/news/3502580-dova-pharma-acquired-sobi-shares-38-percent-premarket

Trovagene reports positive mid-stage data from Onvansertib study at ESMO

Trovagene (TROV +14.3%) announces that results from the Phase 1b/2 study of onvansertib in patients with relapsed/refractory acute myeloid leukemia (AML) were presented at the 2019 European Society for Medical Oncology Conference in Barcelona, Spain, on Saturday, September 28th.

The presentation highlighted the favorable safety profile and clinical efficacy of onvansertib, as well as correlative biomarker data from the recently completed Phase 1b trial.

The Phase 2 AML trial of onvansertib in combination with decitabine will enroll 32 patients.

The primary efficacy endpoint of objective response (CR + CRi) will be assessed in patients who complete at least 1 cycle of treatment.

Onvansertib is an oral, highly-selective Polo-like Kinase 1 (PLK1) inhibitor with a half-life of ~24 hours.

https://seekingalpha.com/news/3502598-trovagene-reports-positive-mid-stage-data-onvansertib-study-esmo

Atossa Genetics reports positive Endoxifen data

Atossa Genetics (NASDAQ:ATOS) is up 2% premarket on announcing preliminary results from its Phase 1 study of its modified-release tablet form of oral Endoxifen. All objectives were successfully met.

No unexpected and serious adverse events were observed and tablet form of oral Endoxifen was well tolerated.

The results support advancing Company’s modified-release tablet into a Phase 2 study which expected to begin in Q4.

ATOS also recently completed a successful Phase 2 study of topical form of Endoxifen in which a significant reduction of MBD was achieved among study participants who applied the stronger dose of topical Endoxifen.

https://seekingalpha.com/news/3502588-atossa-genetics-reports-positive-endoxifen-data

Johnson & Johnson discloses positive Invokana development

Johnson & Johnson (NYSE:JNJ) announces that the FDA approved a new indication for Invokana to reduce the risk of end-stage kidney disease and treat diabetic kidney disease.

The company says Invokana is now the only type 2 diabetes medicine indicated to both treat diabetic kidney disease and reduce the risk of hospitalization for heart failure in patients with T2D and DKD.

Source: Press Release

JNJ +0.26% premarket to $128.94.

https://seekingalpha.com/news/3502565-johnson-and-johnson-discloses-positive-invokana-development

Humana, UNH downgraded on Medicare Advantage risk

BMO downgrades Humana (NYSE:HUM) and UnitedHealth (NYSE:UNH) from Outperform to Market Perform.

Analyst Matt Borsch cites “uncertainty regarding November 2020 election outcomes.”

The analyst says HUM and UNH are “more heavily tied” to Medicare Advantage, which seems to have continued bipartisan support, but there could be a shift towards less favorable regulation if President Trump loses re-election.

BMO cuts its HUM target from $345 to $290.

Humana shares are down 0.4% pre-market to $256.50. The company has an Outperform average Sell Side rating.

UnitedHealth are down 0.7% pre-market to $213.70, and UNH also has a bullish average Sell Side rating.

https://seekingalpha.com/news/3502531-humana-unh-downgraded-medicare-advantage-risk

Trump to give health care speech in Florida this week

President Trump will travel to Florida on Thursday to discuss his health care agenda and sign an executive order on Medicare, the White House announced Friday.
Trump will give the speech at The Villages, a massive retirement community to appeal to older voters in the swing state in the 2020 election.
Democrats, even amid their newly-opened impeachment inquiry of Trump, are touting health care as a key election issue, which Trump has sought to counter by making announcements on the issue of his own.Trump will sign an “Executive Order in relation to protecting and improving the Medicare program in the United States,” while there, the White House said. The executive order is expected to make relatively minor changes to the program, but it also allows Trump to contrast his views with Democrats’ “Medicare for All” plans. Attacking Medicare for All is a key part of Trump’s campaign against Democrats.
Trump may also discuss his efforts to lower drug prices. Florida’s GOP Governor, Ron DeSantis, is pushing the Trump administration to be granted approval to allow imports of cheaper drugs from Canada, something Trump has spoken favorably of, a break from the traditional GOP line.
In July, the administration took a preliminary step towards allowing some drug imports, but several steps remain before any cheaper imported drugs actually start making their way to consumers.
The administration has been touting a range of health care actions, from drug prices, to price transparency, to fighting HIV. But Trump has also signaled his desire to return to the fight over ObamaCare.
Trump told ABC News in June that he would be releasing an ObamaCare replacement plan in about two months, but the administration has not released a plan yet.
Democrats point to the administration’s backing of a lawsuit making its way through the courts seeking to overturn all of ObamaCare, something some GOP lawmakers have distanced themselves from.
Trump’s health care speech at The Villages was originally scheduled for August, but was delayed after mass shootings.
https://thehill.com/policy/healthcare/463450-trump-to-give-health-care-speech-in-florida-next-week