MacroGenics down 3% on uncertainty of margetuximab survival benefit

MacroGenics (MGNX -2.9%) is down on double normal volume in response to results from a second interim survival analysis of Phase 3 clinical trial, SOPHIA, comparing lead drug margetuximab + chemo to Roche’s Herceptin (trastuzumab) + chemo in patients with HER2-positive metastatic breast cancer who have previously received anti-HER2-targeted therapies. The data were presented at the San Antonio Breast Cancer Symposium.

Overall survival (OS) favored margetuximab, but the separation was not statistically significant. Specifically, median OS was 21.6 months versus 19.8 months for trastuzumab (p=0.326) (first reported in October). The final OS analysis will be based on 385 events, expected to occur in H2 2020.

The company says that margetuximab showed a statistically valid improvement in progression-free survival, although the median value (5.8 months) was only a few weeks better than trastuzumab (4.9 months) (p=0.033).

https://seekingalpha.com/news/3525585-macrogenics-down-3-on-uncertainty-of-margetuximab-survival-benefit

FDA clears new bone conduction implant from Cochlear

The FDA grants 510(k) clearance to Cochlear Limited’s (OTCPK:CHEOF) Osia 2 System, an osseointegrated steady-state bone conduction implant that stimulates the inner ear to improve hearing in people at least 12 years old with conductive hearing loss, mixed hearing loss and single-sided sensorineural deafness.

The device will be initially available in select U.S. clinics under limited release. Full commercial availability will happen in next quarter.

https://seekingalpha.com/news/3525591-fda-clears-new-bone-conduction-implant-from-cochlear

FDA warns Alkermes over Vivitrol misbranding

Alkermes plc (ALKS -2.9%) has received a Warning Letter from the FDA regarding misbranding of alcohol and opioid abuse prevention med Vivitrol (naltrexone extended-release injectable suspension).

Specifically, the agency cited a print ad that failed to adequately communicate the most serious risks, including vulnerability to opioid overdose.

https://seekingalpha.com/news/3525594-fda-warns-alkermes-over-vivitrol-misbranding

Bellicum out-licenses safety switch technology to MD Anderson; shares up

Nano cap Bellicum Pharmaceuticals (BLCM +14.6%) is up on 60% higher volume on the heels of its out-licensing deal with MD Anderson Cancer Center for its CaspaCIDe safety switch technology.

Under the terms of the agreement, Bellicum will receive $5M upfront, undisclosed milestones and royalties on net sales.

CaspaCIDe is designed to protect patients receiving cell-based therapies from cytokine release syndrome or neurotoxicity.

https://seekingalpha.com/news/3525598-bellicum-out-licenses-safety-switch-technology-to-md-anderson-shares-up-15

Novartis teams up with Forendo Pharma in liver diseases

Novartis (NVS -0.1%) inks an agreement with Finnish biotech Forendo Pharma aimed at discovering new drugs for chronic liver diseases.

Under the terms of the deal, Forendo will receive an upfront payment, research funding, milestones and tiered royalties on net sales in addition to an equity stake from the Swiss drugmaker.

Novartis will take over all development, manufacturing and commercialization activities after the end of the research collaboration.

The Helsinki-based drug developer’s core expertise is in an enzyme family called HSD17B (17-beta-hydroxysteroid dehydrogenase) that plays a key role in regulating hormone action. Its lead program is FOR-6219, an HSD17B inhibitor, in Phase 1b for endometriosis

https://seekingalpha.com/news/3525601-novartis-teams-up-forendo-pharma-in-liver-diseases

Aurelius bearish on Neurocrine Biosciences

Investors appear relatively unmoved, at least so far, over a bearish report on Neurocrine Biosciences (NBIX -0.6%) from Marcus Aurelius Value, citing its alleged employment of a physician kickback scheme that sunk Otsuka Holdings’ (OTCPK:OTSKF) Avanir Pharmaceuticals which had to pay $108M to settle U.S. DOJ charges over its promotional activities for Nuedexta (dextromethorphan hydrobromide and quinidine sulfate).

The architect of Avanir’s misbehavior is now the chief commercial officer at Neurocrine and is, allegedly, using the same approach to market Ingrezza (valbenazine), approved in the U.S. in April 2017 for tardive dyskinesia. The company is supposedly paying exorbitant speaking fees to the same doctors that Avanir did.

https://seekingalpha.com/news/3525551-aurelius-bearish-on-neurocrine-biosciences

Roche’s Perjeta regimen shows long-term benefit in breast cancer study

Six-year follow-up data from a Phase 3 clinical trial, APHINITY, evaluating a regimen of Roche’s (OTCQX:RHHBY -0.2%) Perjeta (pertuzumab), Herceptin (trastuzumab) and chemo for the adjuvant treatment of patients with HER2-positive breast cancer showed a durable treatment benefit. The results are being presented today at the San Antonio Breast Cancer Symposium.

The Perjeta regimen reduced the risk of breast cancer recurrence or death by 24% compared to Herceptin + chemo + placebo (hazard ratio = 0.76). At year 6, 90.6% of patients in the Perjeta arm were progression-free versus 87.8% of those in the control arm, representing an absolute benefit of 2.8%.

The absolute treatment benefit was 4.5% in patients with lymph node-positive cancer.

The Perjeta regimen is approved for patients with HER2-positive early breast cancer at high risk of recurrence in more than 86 countries, including the U.S. and across the EU.

https://seekingalpha.com/news/3525525-roches-perjeta-regimen-shows-long-term-benefit-in-breast-cancer-study