Citing an increase in the number of outstanding shares due to option exercises and vesting of restricted share units, BeiGene (NASDAQ:BGNE) and cancer collaboration partner Amgen (NASDAQ:AMGN) have agreed to increase the number of shares allowable to the latter in order for it to maintain its 20.5% stake.
In a statement, Alexion Pharmaceuticals (NASDAQ:ALXN) says it has established a “strong foundation” to drive growth and boost shareholder value and does not plan to pursue an outright sale as proposed by shareholder Elliott Advisors.
Management cites it new leadership team, a refined strategy to convert the market to Ultomiris (ravulizumab-cwvz) from Soliris (eculizumab), the expansion of current assets into new diseases and a revamped pipeline.
Shares up 6% premarket on modest volume.
Gemphire Therapeutics’ (NASDAQ:GEMP) stockholders have approved all of the NeuroBo merger-related proposals, including: (i) the issuance of Gemphire common stock pursuant to the Agreement dated July 24, (ii) a reverse stock split of Gemphire common stock, at a ratio of one new share for every 15 to 25 shares outstanding and (iii) changing the name from “Gemphire Therapeutics” to “NeuroBo Pharmaceuticals, Inc.”
Upon closing of the transaction, the Company’s shares are expected to commence trading on Nasdaq under the symbol “NRBO”.
The FDA designates Johnson & Johnson (NYSE:JNJ) unit Janssen Pharmaceuticals’ CAR T candidate JNJ-682284528 (JNJ-4528) a Breakthrough Therapy for the treatment of relapsed/refractory multiple myeloma.
Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.
Bluebird bio (NASDAQ:BLUE) and licensee Bristol-Myers Squibb (NYSE:BMY) announce positive topline results from a Phase 2 clinical trial, KarMMa, evaluating CAR T therapy idecabtagene vicleucel (ide-cel) (bb2121) in treatment-resistant multiple myeloma (MM) patients.
The study met the primary and key secondary endpoints. Specifically, the overall response rate (ORR) was 73.4% (n=94/128) across three doses (primary endpoint). The response rate was dose-dependent, 50.0% (n=2/4) in the lowest, 68.6% (n=48/70) in the middle and 81.5% (n=44/54) in the highest. The complete response rates were 25%, 28.6% and 35.2%, respectively.
Median duration of response was 10.6 months and median progression-free survival was 8.6 months.
The safety profile was consistent with the Phase 1 CRB-401 trial. The rate of serious/life-threatening/fatal cytokine release syndrome (CRS) was 5.5% (n=7/128) including one death. CRS of any grade occurred in 83.6% of subjects (n=107/128). The rate of serious neurotoxicity events was 3.1% (n=4/128).
More detailed data will be submitted for presentation at a future medical conference.
BMY and BLUE are both up 1% after hours.