Rigel Pharma not quite there with European application for fostamatinib

Despite announcing a lineup of positive opinions today, the European Medicines Agency’s advisory group CHMP could only muster a “positive trend vote” for Rigel Pharmaceuticals’ (NASDAQ:RIGL) fostamatinib disodium hexahydrate for the treatment of chronic immune thrombocytopenia (low blood platelets) in adults who have not responded to other treatments.

Rigal chief Raul Rodriguez says, “During the EMA review process for fostamatinib in adult chronic ITP, we have had very constructive interactions with the committee. We are pleased with this positive trend vote from the CHMP this week, which brings us one step closer to potentially providing a new therapeutic option for a patient population that has a clear unmet clinical need.”

CHMP should issue a final opinion at next month’s meeting.

https://seekingalpha.com/news/3506848-rigel-pharma-quite-european-application-fostamatinib

European advisory group backs biosimilar to Amgen’s Neulasta

The European Medicines Agency’s advisory group CHMP has adopted a positive opinion recommending approval of Spanish biotech Mundipharma Biologics S.L.’s biosimilar to Amgen’s (NASDAQ:AMGN) Neulasta (pegfilgrastim).

A final decision from the European Commission usually takes ~60 days

https://seekingalpha.com/news/3506860-european-advisory-group-backs-biosimilar-amgens-neulasta

Verrica Pharma reports positive data from VP-102 trial

Verrica Pharmaceuticals (NASDAQ:VRCA) announces positive data from three abstracts evaluating the efficacy and safety of VP-102 (cantharidin 0.7% Topical Solution) for the treatment of molluscum contagiosum and common warts.

Pooled analyses of the Phase 3 CAMP studies in molluscum contagiosum showed VP-102 achieved statistically significantly higher rate of complete lesion clearance and percentage of subjects with > 75% and > 90% lesion clearance rates over the course of therapy compared to vehicle.

VP-102 achieved positive results in the COVE-1 study on the endpoint of complete clearance of all common warts at Day 84 (primary endpoint) as well as Day 147 (exploratory endpoint).

https://seekingalpha.com/news/3506864-verrica-pharma-reports-positive-data-vpminus-102-trial

European advisory group thumbs down on Daiichi’s quizartinib

The European Medicines Agency’s advisory group CHMP has issued a negative opinion against approval of Daiichi Sankyo’s (OTCPK:DSKYF) Vanflyta (quizartinib) for the treatment of adults with acute myeloid leukemia (AML) citing the lack of evidence of enough of a survival benefit.

The company may request a re-examination of its application within 15 days of receiving the opinion.

https://seekingalpha.com/news/3506867-european-advisory-group-thumbs-daiichis-quizartinib

European advisory group backs expanded use of Sanofi’s insulin glargine

The European Medicines Agency’s advisory group CHMP has adopted a positive opinion recommending updated labeling for Sanofi’s (NASDAQ:SNY) Toujeo (insulin glargine) to include children and adolescents at least six years old.

A final decision from the European Commission usually takes ~60 days.

https://seekingalpha.com/news/3506873-european-advisory-group-backs-expanded-use-sanofis-insulin-glargine

European advisory group backs expanded label for Vertex’s Kalydeco

The European Medicines Agency’s advisory group CHMP has adopted a positive opinion recommending revised labeling for Vertex Pharmaceuticals’ (NASDAQ:VRTX) cystic fibrosis (CF) med Kalydeco (ivacaftor).

The new labeling, if approved by the European Commission (EC), includes the approval a new 25 mg strength and an extension to the existing indication to include infants at least six months old and weighing from 5 kg to less than 25 kg.

A final decision from the EC usually takes ~60 days.

https://seekingalpha.com/news/3506870-european-advisory-group-backs-expanded-label-vertexs-kalydeco

SoftBank Vision Fund’s climbing, sliding valuations

The $100 billion Vision Fund of Japan’s SoftBank Group Corp has in just over two years burned through much of its capital investing in money-losing, late-stage tech startups in areas as varied as autonomous driving, healthcare and finance.

The IPO flop of office-sharing firm WeWork, one of its biggest bets, and plunging valuations of other major investments such as ride-hailing pioneer Uber have cast a cloud over the efforts of SoftBank founder and Chief Executive Masayoshi Son to raise a second giant fund.
With WeWork trying to raise new capital, SoftBank has proposed a further $5 billion investment in the money-losing startup, sources told Reuters this week.
Following are highlights of the investments and performance of SoftBank Vision Fund, whose first major close was in 2017.
MAJOR INVESTMENTS
* $11.8 billion in Chinese ride-hailing firm Didi Chuxing
* $10.7 billion in U.S.-based office sharing startup WeWork parent The We Company (total includes SoftBank Group investment)
* $7.7 billion in U.S. ride-hailing firm Uber Technologies Inc
* $3 billion in Southeast Asian ride-hailing firm Grab
* $3 billion in South Korean e-commerce firm Coupang
Note: investment figures from company filings, Reuters reports
SIZE OF VISION FUND
* The fund has invested $71.4 billion in 83 firms, recording $20.2 billion in investment gains and distributing $6.4 billion to its investors as at the end of June.
* SoftBank contributed $20.5 billion to the fund. The firm has $25.3 billion in unrealized investment gains, $3.2 billion in undistributed manager performance fees and $1.6 billion in realized proceeds.
PAPER MONEY, BIG BLACK BOX
* The Vision Fund’s $20.2 billion of investment gains are mostly on paper and its valuations are under growing downward pressure as shares in four of the fund’s five listed portfolio firms have fallen sharply in the three months through September.
Those newly listed firms are Uber, Slack Technologies Inc, Guardant Health Inc, ZhongAn Online P&C Insurance Co Ltd and Ping An Healthcare and Technology Co Ltd (Ping An Good Doctor).
* The two major realized gains are from sales of its investments in Indian e-commerce firm Flipkart and U.S. chipmaker Nvidia Corp.
Shares in SoftBank Group fell over the same period.
INVESTMENT BY SECTOR
* Transportation & logistics:
Notable investments: Uber, Didi, Grab, General Motors Co’s self-driving unit Cruise, food delivery firm Doordash and German used-car dealing platform Auto1.
Total investments: $28.3 billion. SoftBank reported their worth at $33 billion at June-end.
* Frontier tech:
Notable investments: Chip designer Arm, autonomous robotics firm Brain, self-driving car camera firm Light and virtual simulation firm Improbable.
Total investments: $10.5 billion. Now worth $11.2 billion.
* Consumer tech:
Notable investments: Coupang, Indonesian e-commerce firm Tokopedia, Indian hotel chain Oyo and online grocer Grofers, U.S. indoor farming firm Plenty and dog walking app Wag.
Total investments: $10.1 billion. Now worth $14.8 billion.
* Real estate:
Notable investments: WeWork, online real estate marketplaces Compass and Opendoor and construction firm Katerra.
Total investments: $8 billion. Now worth $9.9 billion.
* Fintech:
Notable investments: Indian QR code payment app Paytm, online lenders Kabbage and Oaknorth and online insurance firms ZhongAn in China and PolicyBazaar in India.
Total investments: $3.7 billion. Now worth $4.2 billion.
* Health tech:
Notable investments: China’s Ping An Good Doctor, U.S. cancer testing firm Guardant and Swiss drugmaker Roivant Sciences.
Total investments: $2.8 billion. Now worth $4.7 billion.
* Enterprise:
Notable investments: Workplace messaging app Slack, data storage firm Cohesity and mapping company Mapbox.
Total investments: $2.7 billion. Now worth $4.1 billion.
Sources: SoftBank and portfolio company documents and filings.
https://www.marketscreener.com/PING-AN-HEALTHCARE-AND-TE-44548681/news/Snakes-and-ladders-SoftBank-Vision-Fund-s-climbing-sliding-valuations-29359093/