Celgene will not exercise option to license OncoMed ovarian cancer candidate

OncoMed (OMED) announced that Celgene (CELG) has notified OncoMed that due to strategic product portfolio considerations Celgene has decided not to exercise its option to license OncoMed’s bispecific antibody navicixizumab. Celgene continues to retain its options to license OncoMed’s etigilimab and rosmantuzumab under the collaboration. OncoMed and Celgene are working to formalize the termination of the collaboration agreement with respect to navicixizumab, and OncoMed expects to retain worldwide rights to navicixizumab. OncoMed is currently conducting a Phase 1b clinical trial of navicixizumab in combination with paclitaxel in patients with platinum-resistant late-stage ovarian cancer.
https://thefly.com/landingPageNews.php?id=2793057

Pfizer granted FDA Breakthrough Therapy tag for pneumonia vax

Pfizer announced that its 20-Valent Pneumococcal Conjugate Vaccine candidate, PF-06482077, received Breakthrough Therapy designation from the US Food and Drug Administration for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults aged 18 years and older. Pfizer expects to start Phase 3 trials in a few months. The FDA decision is informed by the results of the 20vPnC Phase 2 randomized, double-blind trial to evaluate the safety and immunogenicity of a multivalent pneumococcal conjugate vaccine in adults 60 through 64 years of age. Pfizer will seek to present and publish outcomes from this clinical trial at a future date. Breakthrough Therapy Designation is designed to expedite the development and review of drugs and vaccines that are intended to treat or prevent serious conditions and preliminary clinical evidence indicates that the drug or vaccine may demonstrate substantial improvement over available therapy on a clinically significant endpoint. Drugs and vaccines that receive Breakthrough Therapy Designation are eligible for all features of the FDA’s Fast Track designation, which may include more frequent communication with the FDA about the drug’s development plan and eligibility for Accelerated Approval and Priority Review, if relevant criteria are met. The FDA previously granted Fast Track designation for 20vPnC in October 2017 for use in adults aged 18 years and older. The FDA’s Fast Track approach is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address an unmet medical need.
https://thefly.com/landingPageNews.php?id=2793059

Galectin has prelim data from Phase 1b trial of Keytruda combo

Galectin Therapeutics announced additional preliminary clinical data from cohort 3 of an investigator-initiated Phase 1b clinical trial of GR-MD-02 used in combination with Keytruda in patients with metastatic melanoma for which Keytruda is indicated or those patients whose melanoma progressed during or recently after Keytruda monotherapy. The Providence Cancer Institute translational medicine team is conducting this phase 1b clinical trial, initiated under direction of principal investigator Brendan D. Curti. The objectives of this study were to determine a safe dose of GR-MD-02 used in combination with Keytruda and to measure the response rate to combined therapy. When aggregated with the cohorts previously reported, the data shows a 50% objective response rate in advanced melanoma with GR-MD-02 in combination with Keytruda, and a significant decrease in the frequency of suppressive myeloid-derived suppressor cells, or MDSC, following treatment in the responding patients was observed. The published data on Keytruda alone have shown an objective response rate of 33% in this patient population. Fourteen advanced melanoma patients across three dose cohorts now have objective response rate, or ORR and disease control rate, or DCR, data. Six patients in cohort 3 have now been added to the three patients in cohort 2 and the five patients in cohort 1. Cohorts 1 and 3 each had two patients with an objective response. All three patients in cohort 2 had an objective response.
https://thefly.com/landingPageNews.php?id=2793063

Portola Pharmaceuticals names Scott Garland CEO

Portola Pharmaceuticals announced the appointment of Scott Garland as president and CEO effective October 8. Garland brings to his new role more than two decades of broad executive leadership experience, including a track record driving multiple billion dollar product launches. He will also serve on the company’s board. Garland joins Portola from Relypsa where he was president and previously CCO. During his tenure, Garland was responsible for the integration and growth of the U.S. operations after Relypsa was acquired.
https://thefly.com/landingPageNews.php?id=2793115

PDL BioPharma shareholder SevenSaoi issues letter to board

PDL BioPharma shareholder Capital, with 2,590,198 shares of common stock, has delivered a letter to the Board of Directors of PDL. The letter addresses SevenSaoi’s “serious concerns with the company’s failed acquisition strategy” and calls upon the Board to authorize a large share repurchase. The letter states, among other things: “PDL is grossly overcapitalized – the company currently has $375M in cash, an additional $400M+ in expected royalty cash flow through 2022, and low working capital requirements. As a percent of market capitalization, PDL’s cash balance is currently 7.6x that of its median peer and 2.2x that of the most overcapitalized peer (…) : PDL’s share price discount persists in large part due to investor concern that PDL’s massive cash balance will be deployed in expensive acquisitions that destroy shareholder value (…) management’s, and especially Mr. McLaughlin’s, poorly-devised compensation scheme includes massive incentives for them to make acquisitions, to the exclusion of other productive and value enhancing uses of capital, such as share repurchases.”
https://thefly.com/landingPageNews.php?id=2793119

Top 22 Canadian cannabis stocks up 127% since Constellation pact, says Stifel

Yesterday’s significant outperformance for Canadian cannabis stocks, led by Tilray (TLRY), at one point pushed the total market capitalization for Canadian Licensed Producers above $C80B, before they closed with a combined market cap of C$73B, calculates Stifel analyst Christopher Growe. Since August 15, when Constellation Brands (STZ) announced a pact to invest C$5B into Canopy Growth (CGC), the top 22 Canadian cannabis stocks are up 127% in stock price, noted Growe. A $C73B market cap in relation to what he estimates to be an addressable Canadian market of C$10B is “difficult to fathom,” so valuations require global opportunities to be realized, added Growe, who said he questions the pace of development and degree of advantage for these companies. Companies in the cannabis space that can be traded in the U.S. include Aurora Cannabis (ACBFF), CV Sciences (CVSI), Canopy Growth, Cronos Group (CRON) and Tilray.
https://thefly.com/landingPageNews.php?id=2793123

Cigna price target raised to $250 from $235 at Leerink

Leerink analyst Ana Gupte raised her price target on Outperform-rated Cigna (CI) to $250 from $235 following meetings with a panel of PBM and Specialty Rx specialists, which increased her bullishness on Cigna and Market Perform-rated Express Scripts (ESRX). In a research note to investors, Gupte says she also came away with raised confidence on the achiveability of the $4B annual drug cost savings from the Express Scripts switch by Anthem (ANTM) to IngenioRx in partnership with CVS (CVS). She adds that smaller independent PBMs still have niche opportunities with smaller regional third-party health plans, noting that Magellan Health (MGLN) is well positioned in this market, though loss of substantial business in Florida Seriously Mentally Ill is a headwind in Rx as well.
https://thefly.com/landingPageNews.php?id=2793131